Soliris


Generic Name: eculizumab (E kue LIZ oo mab)
Brand Names: Soliris

What is eculizumab?

Eculizumab is a monoclonal antibody that binds to proteins in the blood that can destroy red blood cells in people with a genetic condition that affects the natural defenses of red blood cells.

Eculizumab is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia (PNH).

Eculizumab is also used to treat a rare chronic blood disease called atypical hemolytic (HEEM-oh-LIT-ik yoo-REEM-ik) uremic syndrome.

Eculizumab may also be used for purposes not listed in this medication guide.

What is the most important information I should know about eculizumab? Do not shake the eculizumab vial (bottle) or you may ruin the medicine. Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis. You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. If you have been vaccinated in the past, you may need a booster dose. Call your doctor at once if you have a serious side effect such as severe headache, high fever, chills, stiffness in your neck or back, confusion, sensitivity to bright light, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions). With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times. Seek emergency medical attention or call your doctor right away if you notice any of these symptoms. You should not use this medication if you are allergic to eculizumab, if you have bacterial meningitis, or if you have not been vaccinated against meningitis.

Before using eculizumab, tell your doctor if you have a fever or any type of infection.

Do not stop using eculizumab without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells. This may result in symptoms such as pale skin, easy bruising, confusion, chest pain, blood clots, or kidney problems.

Eculizumab is available only under a special program called Soliris REMS. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

What should I discuss with my health care provider before taking eculizumab? Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis. Get emergency medical help if you have any signs of meningitis, such as severe headache with fever, confusion, purple spots on the skin, and nausea or vomiting, stiffness in your neck or back, sensitivity to bright light, or a high fever (103 degrees or higher), chills, body aches, and other flu-like symptoms. You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. If you have been vaccinated in the past, you may need a booster dose. It is best to stay current on all of your vaccinations while you are using eculizumab, and your doctor may recommend other vaccines before or during treatment. You should not use this medication if you are allergic to eculizumab, if you have bacterial meningitis, or if you have not been vaccinated against meningitis.

With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times. Seek emergency medical attention or call your doctor right away if you notice any of these symptoms.

Eculizumab is available only under a special program called Soliris REMS. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

To make sure you can safely use eculizumab, tell your doctor if you have a fever or any type of infection.

FDA pregnancy category C. It is not known whether eculizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether eculizumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How is eculizumab given?

Eculizumab is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Eculizumab is usually given every 7 days for 5 weeks, and then once every 2 weeks thereafter. Follow your doctor's instructions. The medicine must be given slowly through an IV infusion, and can take up to 2 hours to complete.

You may have a reaction to the infusion (when the medicine is injected into the vein). If this happens, you may need to slow down the speed of your IV infusion, and the infusion should not take more than 2 hours to complete. A caregiver or family member should then watch you for at least 1 hour after your injection to make sure you have no further side effects.

Eculizumab must be mixed in an IV bag with a liquid (diluent) before injecting it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Do not shake the medication vial (bottle) or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. To reduce discomfort from your injection, allow the mixed medicine to reach room temperature before using, but never warm the medicine in hot water or a microwave. You may store the mixture at room temperature but you must use it within 24 hours or throw the mixture away.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Do not stop using eculizumab without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells. This may result in symptoms such as pale skin, easy bruising, confusion, chest pain, blood clots, or kidney problems.

If you stop using eculizumab for any reason, your blood may need to be tested on a regular basis for 8 to 12 weeks. Do not miss any scheduled visits to your doctor during this follow-up period.

Store in the refrigerator. Protect from light and do not freeze. Keep unopened eculizumab vials in their original carton. Throw away any unused vials after the expiration date on the label has passed. What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking eculizumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Eculizumab side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

severe headache with fever, confusion, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions);

stiffness in your neck or back;

sensitivity to bright light;

high fever (103 degrees or higher), chills, body aches, flu symptoms;

pain or burning when you urinate;

any signs of a new illness or infection; or

signs that the medication is not working (pale skin, easy bruising, weakness, dark urine, feeling short of breath, or sudden numbness, severe headache, deep leg pain, or problems with vision, speech, or balance).

Less serious side effects may include:

nausea;

diarrhea;

mild headache;

runny nose, sore throat; or

back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect eculizumab?

There may be other drugs that can interact with eculizumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Soliris resources Soliris Side Effects (in more detail) Soliris Use in Pregnancy & Breastfeeding Soliris Drug Interactions Soliris Support Group 0 Reviews for Soliris - Add your own review/rating Soliris Prescribing Information (FDA) Soliris Monograph (AHFS DI) Soliris Advanced Consumer (Micromedex) - Includes Dosage Information Soliris Consumer Overview Soliris MedFacts Consumer Leaflet (Wolters Kluwer) Eculizumab Professional Patient Advice (Wolters Kluwer) Compare Soliris with other medications Hemolytic Uremic Syndrome Myasthenia Gravis Paroxysmal Nocturnal Hemoglobinuria Where can I get more information? Your pharmacist can provide more information about eculizumab.

See also: Soliris side effects (in more detail)


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abacavir and lamivudine


Generic Name: abacavir and lamivudine (a BAK a veer and la MIV yoo deen)
Brand Names: Epzicom

What is abacavir and lamivudine?

Abacavir and lamivudine is an antiviral medication. It is in a group of human immunodeficiency virus (HIV) medicines called reverse transcriptase inhibitors. Abacavir and lamivudine helps keep the HIV virus from reproducing in the body.

Abacavir and lamivudine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Abacavir and lamivudine is not a cure for HIV or AIDS.

Abacavir and lamivudine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about abacavir and lamivudine? Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general tiredness, body aches; shortness of breath, cough, sore throat. Once you have had an allergic reaction to abacavir and lamivudine, you must never use it again.

Before taking abacavir and lamivudine, tell your doctor if you have kidney disease, heart disease, high blood pressure, or a risk factor for heart disease such as smoking, diabetes, or high cholesterol.

You may need a blood test before you start taking abacavir and lamivudine for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.

Read the Warning Card that comes with this medication, and carry it with you at all times so you will know the symptoms of allergic reaction to watch for.

Some people develop lactic acidosis while taking abacavir and lamivudine. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired. Do not allow this medicine to run out completely before you get your prescription refilled. If you miss several doses, you could have a dangerous or even fatal allergic reaction when you start taking the medicine again. If you stop taking abacavir and lamivudine for any reason, talk to your doctor before you start taking the medication again. What should I discuss with my healthcare provider before taking abacavir and lamivudine? You should not take abacavir and lamivudine if you have liver disease. Do not take this medicine if you have ever had an allergic reaction to abacavir. Tell your doctor if you have had an allergic reaction to any medicine that contains abacavir, such as Trizivir or Ziagen. Once you have had an allergic reaction to abacavir and lamivudine, you must never use it again.

You may need a blood test before you start taking abacavir and lamivudine for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.

Some people develop a life-threatening condition called lactic acidosis while taking abacavir and lamivudine. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

To make sure you can safely take abacavir and lamivudine, tell your doctor if you have any of these other conditions:

kidney disease;

heart disease or high blood pressure; or

a risk factor for heart disease such as smoking, diabetes, or high cholesterol.

FDA pregnancy category C. It is not known whether abacavir and lamivudine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. This medication should not be given to children under 18 years old. How should I take abacavir and lamivudine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take abacavir and lamivudine with or without food.

This medicine comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Read this information carefully and carry the Warning Card with you at all times so you will know what symptoms to watch for.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using abacavir and lamivudine. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

See also: Abacavir and lamivudine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not allow this medicine to run out completely before you get your prescription refilled. It is important that you not stop taking the medicine once you have started. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking abacavir again. If you stop taking abacavir and lamivudine for any reason, talk to your doctor before you start taking the medication again. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking abacavir and lamivudine? Avoid taking other medications that contain abacavir or lamivudine, such as Combivir, Epivir, Trizivir, or Ziagen. Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person. Abacavir and lamivudine side effects Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction to abacavir:

Group 1 - fever;

Group 2 - rash;

Group 3 - nausea, vomiting, diarrhea, stomach pain;

Group 4 - general tiredness, body aches;

Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to abacavir, you must never use it again. If you stop taking abacavir and lamivudine for any reason, talk to your doctor before you start taking the medication again. Other serious side effects that may not be signs of an allergic reaction include:

stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired;

fever, chills, body aches, flu symptoms; or

white patches or sores inside your mouth or on your lips.

Less serious side effects include:

changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk);

sleep problems or strange dreams;

headache, depression, anxiety; or

mild diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Abacavir and lamivudine Dosing Information

Usual Adult Dose for HIV Infection:

1 tablet orally once every 24 hours

Usual Adult Dose for Nonoccupational Exposure:

1 tablet orally once every 24 hours
Duration: Prophylaxis should be initiated as soon as possible, within 72 hours of exposure, and continued for 28 days.
In general, the alternative regimens recommended for nonoccupational postexposure HIV prophylaxis include abacavir-lamivudine as part of nonnucleoside reverse transcriptase inhibitor (NNRTI)-based, protease inhibitor (PI)-based, or triple nucleoside reverse transcriptase inhibitor (NRTI) regimens.

What other drugs will affect abacavir and lamivudine?

Tell your doctor about all other medicines you use, especially:

methadone (Methadose, Dolophine);

ribavirin (Copegus, Rebetron, Virazole);

interferon (Rebetron, Roferon, Intron, Alferon, Infergen, Avonex, Rebif, Betaseron, Actimune); or

other medications that contain abacavir or lamivudine (Combivir, Epivir, Trizivir, Ziagen).

This list is not complete and other drugs may interact with abacavir and lamivudine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More abacavir and lamivudine resources Abacavir and lamivudine Side Effects (in more detail) Abacavir and lamivudine Dosage Abacavir and lamivudine Use in Pregnancy & Breastfeeding Abacavir and lamivudine Drug Interactions Abacavir and lamivudine Support Group 1 Review for Abacavir and lamivudine - Add your own review/rating Compare abacavir and lamivudine with other medications HIV Infection Nonoccupational Exposure Where can I get more information? Your pharmacist can provide more information about abacavir and lamivudine.

See also: abacavir and lamivudine side effects (in more detail)


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Proplex T


Generic Name: factor IX complex (FAK tor NINE KOM plex)
Brand Names: Bebulin VH, Konyne 80, Profilnine SD, Proplex T

What is Proplex T (factor IX complex)?

Factor IX (nine) is a naturally occurring protein in the blood that helps blood to clot. A lack of clotting factors can cause uncontrolled bleeding, as the blood is unable to clot properly.

Factor IX complex is a combination of four different clotting factors and other proteins. This medication works by temporarily raising levels of these clotting factors in the blood to aid in clotting.

Factor IX complex is used to treat or prevent bleeding episodes in people with hemophilia B. It is also used to control bleeding related to surgery or dentistry in people with hemophilia B.

Factor IX may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Proplex T (factor IX complex)?

Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX or factor VIII (eight) deficiency.

Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Factor IX complex is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my healthcare provider before using Proplex T (factor IX complex)?

Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX or factor VIII (eight) deficiency.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether factor IX complex passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Factor IX complex is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex. How should I use Proplex T (factor IX complex)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Factor IX complex is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Always wash your hands before preparing and giving your injection.

Factor IX complex must be mixed with a liquid (diluent) before injecting it. If you store your medicine in the refrigerator, take a medicine and diluent vial out of the refrigerator and allow each to warm to room temperature before mixing them. Do not heat the medicine or diluent.

After mixing, gently swirl the mixture and allow the medicine to completely dissolve.

After mixing the medicine and diluent, the mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.

Draw your dose into a syringe only when you are ready to give yourself an injection. Each vial is for one use only. After measuring your dose, throw the vial away, even if there is medicine left in it.

Do not use this medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Check your pulse before and during your injection. If your pulse rate changes, slow or stop the injection until your pulse rate returns to normal.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder. Store the medication and the diluent in the refrigerator and do not allow them to freeze.

Throw away any leftover medicine and diluent if the expiration date has passed.

What happens if I miss a dose?

Factor IX is sometimes used only as needed, so you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Call your doctor if you think you have used too much of this medicine. An overdose of factor IX complex is not expected to produce life-threatening symptoms.

What should I avoid while using Proplex T (factor IX complex)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using factor IX complex.

Proplex T (factor IX complex) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; nausea, vomiting; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

cough, chest pain;

weak or shallow breathing;

feeling short of breath;

headache, feeling like you might pass out;

fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later;

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

easy bruising, increased bleeding episodes; or

bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

mild nausea or stomach pain; or

mild tingly or jittery feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Proplex T (factor IX complex)?

There may be other drugs that can affect factor IX complex. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Proplex T resources Proplex T Side Effects (in more detail) Proplex T Use in Pregnancy & Breastfeeding Proplex T Drug Interactions Proplex T Support Group 0 Reviews for Proplex T - Add your own review/rating Proplex T MedFacts Consumer Leaflet (Wolters Kluwer) Proplex T Advanced Consumer (Micromedex) - Includes Dosage Information Bebulin VH Prescribing Information (FDA) Profilnine SD Prescribing Information (FDA) Compare Proplex T with other medications Factor IX Deficiency Factor VII Deficiency Hemophilia A with Inhibitors Hemophilia B Where can I get more information? Your doctor or pharmacist can provide more information about factor IX.

See also: Proplex T side effects (in more detail)


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Koate-DVI injection


Generic Name: antihemophilic factor (factor VIII) (injection) (an TEE hee moe FIH lick FAC tor)
Brand Names: Advate rAHF-PFM, Alphanate, Helixate, Helixate FS, Hemofil-M, Humate-P, Koate-DVI, Koate-HP, Kogenate, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, Refacto

What is antihemophilic factor (factor VIII)?

Antihemophilic factor (factor VIII) is a naturally occurring protein in the blood that helps blood to clot. A lack of factor VIII is the cause of hemophilia A.

Antihemophilic factor (factor VIII) is used to treat or prevent bleeding in people with hemophilia A.

Antihemophilic factor (factor VIII) may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about antihemophilic factor (factor VIII)?

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before using antihemophilic factor (factor VIII)?

This medication comes in many different strengths. Be sure the strength printed on the medicine bottle label is correct for the dose your doctor has prescribed for you.

Do not use this medication if you have:

a history of allergy to antihemophilic factor; or

a history of allergy to products made with human or animal proteins, especially mouse proteins.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

How should I use antihemophilic factor (factor VIII)?

This medication is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give your first injection. Then you will be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

Store the powder medicine in the refrigerator. Do not freeze. Do not mix this medicine with the liquid diluent until you are ready to give the injection. Once the medicine has been mixed, you must use it within 3 hours. Do not refrigerate the mixed medicine. Keep it at room temperature. You may also store the powder at room temperature for up to 6 months or until the expiration date printed on the label (whichever comes first). Do not put the medicine back into the refrigerator once you have kept it at room temperature. What happens if I miss a dose?

Contact your doctor for instructions if you miss a dose of this medication.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. What should I avoid while using antihemophilic factor (factor VIII)?

There are no restrictions on food, beverages, or activity while using this medication unless your doctor has told you otherwise.

Antihemophilic factor (factor VIII) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain;

fast heart rate, chest pain, trouble breathing;

feeling light-headed, fainting; or

pain, redness, swelling, or oozing where the medicine was injected.

Other, less serious side effects may be more likely to occur, such as:

unusual taste in your mouth;

cough, runny or stuffy nose;

mild itching;

swelling in your hands, ankles, or feet;

headache or dizziness;

mild nausea, diarrhea, stomach pain;

sweating;

joint pain; or

chills or flushing (warmth or tingly feeling).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect antihemophilic factor (factor VIII)?

Other drugs that affect bleeding or blood-clotting may interact with antihemophilic factor (factor VIII) and cause dangerous side effects or make the medicine less effective.

There may be other drugs that can affect antihemophilic factor (factor VIII). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information? Your pharmacist has additional information about antihemophilic factor (factor VIII) written for health professionals that you may read. What does my medication look like?

Antihemophilic factor (factor VIII) is available with a prescription under several brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.


read more


Helixate injection


Generic Name: antihemophilic factor (factor VIII) (injection) (an TEE hee moe FIH lick FAC tor)
Brand Names: Advate rAHF-PFM, Alphanate, Helixate, Helixate FS, Hemofil-M, Humate-P, Koate-DVI, Koate-HP, Kogenate, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, Refacto

What is antihemophilic factor (factor VIII)?

Antihemophilic factor (factor VIII) is a naturally occurring protein in the blood that helps blood to clot. A lack of factor VIII is the cause of hemophilia A.

Antihemophilic factor (factor VIII) is used to treat or prevent bleeding in people with hemophilia A.

Antihemophilic factor (factor VIII) may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about antihemophilic factor (factor VIII)?

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before using antihemophilic factor (factor VIII)?

This medication comes in many different strengths. Be sure the strength printed on the medicine bottle label is correct for the dose your doctor has prescribed for you.

Do not use this medication if you have:

a history of allergy to antihemophilic factor; or

a history of allergy to products made with human or animal proteins, especially mouse proteins.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

How should I use antihemophilic factor (factor VIII)?

This medication is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give your first injection. Then you will be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

Store the powder medicine in the refrigerator. Do not freeze. Do not mix this medicine with the liquid diluent until you are ready to give the injection. Once the medicine has been mixed, you must use it within 3 hours. Do not refrigerate the mixed medicine. Keep it at room temperature. You may also store the powder at room temperature for up to 6 months or until the expiration date printed on the label (whichever comes first). Do not put the medicine back into the refrigerator once you have kept it at room temperature. What happens if I miss a dose?

Contact your doctor for instructions if you miss a dose of this medication.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. What should I avoid while using antihemophilic factor (factor VIII)?

There are no restrictions on food, beverages, or activity while using this medication unless your doctor has told you otherwise.

Antihemophilic factor (factor VIII) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain;

fast heart rate, chest pain, trouble breathing;

feeling light-headed, fainting; or

pain, redness, swelling, or oozing where the medicine was injected.

Other, less serious side effects may be more likely to occur, such as:

unusual taste in your mouth;

cough, runny or stuffy nose;

mild itching;

swelling in your hands, ankles, or feet;

headache or dizziness;

mild nausea, diarrhea, stomach pain;

sweating;

joint pain; or

chills or flushing (warmth or tingly feeling).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect antihemophilic factor (factor VIII)?

Other drugs that affect bleeding or blood-clotting may interact with antihemophilic factor (factor VIII) and cause dangerous side effects or make the medicine less effective.

There may be other drugs that can affect antihemophilic factor (factor VIII). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information? Your pharmacist has additional information about antihemophilic factor (factor VIII) written for health professionals that you may read. What does my medication look like?

Antihemophilic factor (factor VIII) is available with a prescription under several brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.


read more


Helixate FS injection


Generic Name: antihemophilic factor (factor VIII) (injection) (an TEE hee moe FIH lick FAC tor)
Brand Names: Advate rAHF-PFM, Alphanate, Helixate, Helixate FS, Hemofil-M, Humate-P, Koate-DVI, Koate-HP, Kogenate, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, Refacto

What is antihemophilic factor (factor VIII)?

Antihemophilic factor (factor VIII) is a naturally occurring protein in the blood that helps blood to clot. A lack of factor VIII is the cause of hemophilia A.

Antihemophilic factor (factor VIII) is used to treat or prevent bleeding in people with hemophilia A.

Antihemophilic factor (factor VIII) may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about antihemophilic factor (factor VIII)?

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before using antihemophilic factor (factor VIII)?

This medication comes in many different strengths. Be sure the strength printed on the medicine bottle label is correct for the dose your doctor has prescribed for you.

Do not use this medication if you have:

a history of allergy to antihemophilic factor; or

a history of allergy to products made with human or animal proteins, especially mouse proteins.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

How should I use antihemophilic factor (factor VIII)?

This medication is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give your first injection. Then you will be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

Store the powder medicine in the refrigerator. Do not freeze. Do not mix this medicine with the liquid diluent until you are ready to give the injection. Once the medicine has been mixed, you must use it within 3 hours. Do not refrigerate the mixed medicine. Keep it at room temperature. You may also store the powder at room temperature for up to 6 months or until the expiration date printed on the label (whichever comes first). Do not put the medicine back into the refrigerator once you have kept it at room temperature. What happens if I miss a dose?

Contact your doctor for instructions if you miss a dose of this medication.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. What should I avoid while using antihemophilic factor (factor VIII)?

There are no restrictions on food, beverages, or activity while using this medication unless your doctor has told you otherwise.

Antihemophilic factor (factor VIII) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain;

fast heart rate, chest pain, trouble breathing;

feeling light-headed, fainting; or

pain, redness, swelling, or oozing where the medicine was injected.

Other, less serious side effects may be more likely to occur, such as:

unusual taste in your mouth;

cough, runny or stuffy nose;

mild itching;

swelling in your hands, ankles, or feet;

headache or dizziness;

mild nausea, diarrhea, stomach pain;

sweating;

joint pain; or

chills or flushing (warmth or tingly feeling).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect antihemophilic factor (factor VIII)?

Other drugs that affect bleeding or blood-clotting may interact with antihemophilic factor (factor VIII) and cause dangerous side effects or make the medicine less effective.

There may be other drugs that can affect antihemophilic factor (factor VIII). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information? Your pharmacist has additional information about antihemophilic factor (factor VIII) written for health professionals that you may read. What does my medication look like?

Antihemophilic factor (factor VIII) is available with a prescription under several brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.


read more


Kogenate FS injection


Generic Name: antihemophilic factor (factor VIII) (injection) (an TEE hee moe FIH lick FAC tor)
Brand Names: Advate rAHF-PFM, Alphanate, Helixate, Helixate FS, Hemofil-M, Humate-P, Koate-DVI, Koate-HP, Kogenate, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, Refacto

What is antihemophilic factor (factor VIII)?

Antihemophilic factor (factor VIII) is a naturally occurring protein in the blood that helps blood to clot. A lack of factor VIII is the cause of hemophilia A.

Antihemophilic factor (factor VIII) is used to treat or prevent bleeding in people with hemophilia A.

Antihemophilic factor (factor VIII) may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about antihemophilic factor (factor VIII)?

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before using antihemophilic factor (factor VIII)?

This medication comes in many different strengths. Be sure the strength printed on the medicine bottle label is correct for the dose your doctor has prescribed for you.

Do not use this medication if you have:

a history of allergy to antihemophilic factor; or

a history of allergy to products made with human or animal proteins, especially mouse proteins.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

How should I use antihemophilic factor (factor VIII)?

This medication is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give your first injection. Then you will be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

Store the powder medicine in the refrigerator. Do not freeze. Do not mix this medicine with the liquid diluent until you are ready to give the injection. Once the medicine has been mixed, you must use it within 3 hours. Do not refrigerate the mixed medicine. Keep it at room temperature. You may also store the powder at room temperature for up to 6 months or until the expiration date printed on the label (whichever comes first). Do not put the medicine back into the refrigerator once you have kept it at room temperature. What happens if I miss a dose?

Contact your doctor for instructions if you miss a dose of this medication.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. What should I avoid while using antihemophilic factor (factor VIII)?

There are no restrictions on food, beverages, or activity while using this medication unless your doctor has told you otherwise.

Antihemophilic factor (factor VIII) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain;

fast heart rate, chest pain, trouble breathing;

feeling light-headed, fainting; or

pain, redness, swelling, or oozing where the medicine was injected.

Other, less serious side effects may be more likely to occur, such as:

unusual taste in your mouth;

cough, runny or stuffy nose;

mild itching;

swelling in your hands, ankles, or feet;

headache or dizziness;

mild nausea, diarrhea, stomach pain;

sweating;

joint pain; or

chills or flushing (warmth or tingly feeling).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect antihemophilic factor (factor VIII)?

Other drugs that affect bleeding or blood-clotting may interact with antihemophilic factor (factor VIII) and cause dangerous side effects or make the medicine less effective.

There may be other drugs that can affect antihemophilic factor (factor VIII). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information? Your pharmacist has additional information about antihemophilic factor (factor VIII) written for health professionals that you may read. What does my medication look like?

Antihemophilic factor (factor VIII) is available with a prescription under several brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.


read more


Humate-P injection


Generic Name: antihemophilic factor (factor VIII) (injection) (an TEE hee moe FIH lick FAC tor)
Brand Names: Advate rAHF-PFM, Alphanate, Helixate, Helixate FS, Hemofil-M, Humate-P, Koate-DVI, Koate-HP, Kogenate, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, Refacto

What is antihemophilic factor (factor VIII)?

Antihemophilic factor (factor VIII) is a naturally occurring protein in the blood that helps blood to clot. A lack of factor VIII is the cause of hemophilia A.

Antihemophilic factor (factor VIII) is used to treat or prevent bleeding in people with hemophilia A.

Antihemophilic factor (factor VIII) may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about antihemophilic factor (factor VIII)?

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before using antihemophilic factor (factor VIII)?

This medication comes in many different strengths. Be sure the strength printed on the medicine bottle label is correct for the dose your doctor has prescribed for you.

Do not use this medication if you have:

a history of allergy to antihemophilic factor; or

a history of allergy to products made with human or animal proteins, especially mouse proteins.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

How should I use antihemophilic factor (factor VIII)?

This medication is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give your first injection. Then you will be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

Store the powder medicine in the refrigerator. Do not freeze. Do not mix this medicine with the liquid diluent until you are ready to give the injection. Once the medicine has been mixed, you must use it within 3 hours. Do not refrigerate the mixed medicine. Keep it at room temperature. You may also store the powder at room temperature for up to 6 months or until the expiration date printed on the label (whichever comes first). Do not put the medicine back into the refrigerator once you have kept it at room temperature. What happens if I miss a dose?

Contact your doctor for instructions if you miss a dose of this medication.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. What should I avoid while using antihemophilic factor (factor VIII)?

There are no restrictions on food, beverages, or activity while using this medication unless your doctor has told you otherwise.

Antihemophilic factor (factor VIII) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain;

fast heart rate, chest pain, trouble breathing;

feeling light-headed, fainting; or

pain, redness, swelling, or oozing where the medicine was injected.

Other, less serious side effects may be more likely to occur, such as:

unusual taste in your mouth;

cough, runny or stuffy nose;

mild itching;

swelling in your hands, ankles, or feet;

headache or dizziness;

mild nausea, diarrhea, stomach pain;

sweating;

joint pain; or

chills or flushing (warmth or tingly feeling).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect antihemophilic factor (factor VIII)?

Other drugs that affect bleeding or blood-clotting may interact with antihemophilic factor (factor VIII) and cause dangerous side effects or make the medicine less effective.

There may be other drugs that can affect antihemophilic factor (factor VIII). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information? Your pharmacist has additional information about antihemophilic factor (factor VIII) written for health professionals that you may read. What does my medication look like?

Antihemophilic factor (factor VIII) is available with a prescription under several brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.


read more


Monoclate-P injection


Generic Name: antihemophilic factor (factor VIII) (injection) (an TEE hee moe FIH lick FAC tor)
Brand Names: Advate rAHF-PFM, Alphanate, Helixate, Helixate FS, Hemofil-M, Humate-P, Koate-DVI, Koate-HP, Kogenate, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, Refacto

What is antihemophilic factor (factor VIII)?

Antihemophilic factor (factor VIII) is a naturally occurring protein in the blood that helps blood to clot. A lack of factor VIII is the cause of hemophilia A.

Antihemophilic factor (factor VIII) is used to treat or prevent bleeding in people with hemophilia A.

Antihemophilic factor (factor VIII) may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about antihemophilic factor (factor VIII)?

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before using antihemophilic factor (factor VIII)?

This medication comes in many different strengths. Be sure the strength printed on the medicine bottle label is correct for the dose your doctor has prescribed for you.

Do not use this medication if you have:

a history of allergy to antihemophilic factor; or

a history of allergy to products made with human or animal proteins, especially mouse proteins.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

How should I use antihemophilic factor (factor VIII)?

This medication is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give your first injection. Then you will be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

Store the powder medicine in the refrigerator. Do not freeze. Do not mix this medicine with the liquid diluent until you are ready to give the injection. Once the medicine has been mixed, you must use it within 3 hours. Do not refrigerate the mixed medicine. Keep it at room temperature. You may also store the powder at room temperature for up to 6 months or until the expiration date printed on the label (whichever comes first). Do not put the medicine back into the refrigerator once you have kept it at room temperature. What happens if I miss a dose?

Contact your doctor for instructions if you miss a dose of this medication.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. What should I avoid while using antihemophilic factor (factor VIII)?

There are no restrictions on food, beverages, or activity while using this medication unless your doctor has told you otherwise.

Antihemophilic factor (factor VIII) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain;

fast heart rate, chest pain, trouble breathing;

feeling light-headed, fainting; or

pain, redness, swelling, or oozing where the medicine was injected.

Other, less serious side effects may be more likely to occur, such as:

unusual taste in your mouth;

cough, runny or stuffy nose;

mild itching;

swelling in your hands, ankles, or feet;

headache or dizziness;

mild nausea, diarrhea, stomach pain;

sweating;

joint pain; or

chills or flushing (warmth or tingly feeling).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect antihemophilic factor (factor VIII)?

Other drugs that affect bleeding or blood-clotting may interact with antihemophilic factor (factor VIII) and cause dangerous side effects or make the medicine less effective.

There may be other drugs that can affect antihemophilic factor (factor VIII). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information? Your pharmacist has additional information about antihemophilic factor (factor VIII) written for health professionals that you may read. What does my medication look like?

Antihemophilic factor (factor VIII) is available with a prescription under several brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.


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Adcortyl Intra-Articular / Intradermal Injection 10mg / ml


The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

ADCORTYL

INTRA-ARTICULAR/INTRADERMAL INJECTION 10 mg/ml

Triamcinolone acetonide

Adcortyl IA/ID Injection is a steroid medicine, prescribed for many different conditions, including serious illnesses. You need to take it regularly to get the maximum benefit. Don’t stop taking this medicine without talking to your doctor – you may need to reduce the dose gradually. Adcortyl IA/ID Injection can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away. Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information). If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you. Keep away from people who have chicken pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.

Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.

Your doctor has prescribed Adcortyl injection for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

Q. What Is In Adcortyl Intra-Articular / Intradermal (Ia/Id) Injection?

A. Adcortyl IA/ID Injection belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Adcortyl IA/ID Injection) is an effective way to treat various illnesses involving inflammation in the body. Adcortyl IA/ID Injection reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

The injection contains triamcinolone acetonide 10mg/ml and is supplied in packs of 5 x 1.0ml glass ampoules or a single 5ml glass vial. The other ingredients are benzyl alcohol, polysorbate 80, carmellose, sodium chloride and water for injection.

UK PRODUCT LICENCE

Held by:

E. R. Squibb & Sons Limited Uxbridge UB8 1DH England Tel.:0800 7311736

IRISH PRODUCT AUTHORISATION

Held by:

Bristol-Myers Squibb Pharmaceuticals Ltd. Swords County Dublin Tel.:1-800-749-749

MANUFACTURER

Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso 03012 Anagni (FR) Italy Q. What Is This Medicine For?

A. Adcortyl IA/ID Injection is for the treatment of joint pain, swelling and stiffness in inflammatory disorders such as rheumatoid arthritis. It is also used to treat various forms of allergic dermatitis, skin overgrowths such as thickened scar tissue, and patchy baldness, which is usually reversible.

Before Receiving Your Medicine Q. Should I be receiving Adcortyl IA/ID injection?

A. You should not receive this medicine if you have ever had an allergic reaction to similar medicines or to any of the ingredients in Adcortyl IA/ID injection. You should not receive this medicine if you are suffering from an infection unless your doctor has also prescribed a treatment for the infection.

Q. Is there anything else I should discuss with my doctor before receiving Adcortyl IA/ID injection?

A. Check with your doctor before receiving Adcortyl IA/ID injection if you have had any recent infection, tuberculosis (TB), bowel disorders, an ulcer, blood clots, cancer, thin (brittle) bones, high blood pressure or heart failure, mental disorders, epilepsy, myasthenia gravis or glaucoma (increased pressure in your eyes).

Check with your doctor first:

If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Adcortyl IA/ID Injection. If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before taking Adcortyl IA/ID Injection.

Q. What if I have been in contact with someone who has an infectious disease such as Chickenpox, Shingles or Measles?

A. Steroid medicines suppress your body's natural immune response. Therefore, if you come into contact with anyone who has an infectious disease such as chickenpox, shingles or measles, consult your doctor promptly, especially if you have not had the disease before. You should take particular care to avoid these diseases.

Q. Can I be immunised (vaccinated)?

A. While you are being treated with this medicine (or if you have recently stopped a course of treatment) do not have any immunisation without consulting your doctor.

Q. What if I am pregnant or think I may be pregnant? What if I am planning to become pregnant? What if I am breast-feeding?

A. You should make sure you discuss this with your doctor as soon as possible before receiving Adcortyl IA/ID injection.

Q. What if I have had problems with my kidneys, liver or thyroid?

A. Remind your doctor as the dose of Adcortyl may need to be adjusted.

Q. Can I take other medicines?

A. Corticosteroids can increase the chance of bleeding from the gut caused by aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs). If you have hypothrombinaemia (a tendency to bleed), your doctor will be more careful about giving you Adcortyl IA/ID injection if you are taking ibuprofen or another NSAID. Always tell your doctor about all other medicines you are taking, even those you have bought at a pharmacy or other places, e.g. supermarket. Some medicines used to treat epilepsy, tuberculosis or breast cancer can reduce the effectiveness of Adcortyl. On the other hand, Adcortyl can affect the action of some medicines used to treat diabetes, high blood pressure or to thin the blood.

Always tell your doctor if you are taking oral contraceptives, hormone replacement therapy (HRT), growth hormone, thyroid drugs, cyclosporin, or medicines for treating fungal infections, or if you are to be vaccinated or to be given an anaesthetic.

Q. Is it all right to take exercise?

A. You must take care not to over-use a joint which feels better after you receive Adcortyl IA/ID injection as the joint will still need to recover from the inflammation which caused your symptoms.

Q. Is it all right to drive?

A. This medicine does not usually affect your ability to drive but it can affect your eyesight. Tell your doctor immediately if you have any pain in the eyes or visual disturbances.

Q. Is it all right to drink alcohol?

A. There is no known interaction between Adcortyl and alcohol.

Q. What if I am diabetic?

A. Remind your doctor as your insulin dose may need to be changed.

Q. Who should I tell that I have received this injection?

A. Your doctor or pharmacist will have given you a Steroid Treatment Card with your prescription or medicine. YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must be shown to any of the following persons:

Doctor or Nurse - before having any surgery or emergency treatment or if any new treatment is prescribed. Dentist - before having any dental surgery Pharmacist - before buying any medicine Optician - it is advisable to have regular eye tests Q. Is there any important information about the ingredients of Adcortyl that I need to know?

A. Adcortyl IA/ID Injection contains 15mg/ml benzyl alcohol which may cause harmful or allergic reactions in infants and children. Adcortyl IA/ID injection must not be given to premature or newly born babies.

Administraton Of Your Medicine Q. How will Adcortyl IA/ID injection be given and how often?

A. The effect of the injection will vary from patient to patient and further injections may be given when symptoms return and not at regular intervals.

Use in inflammatory joint disorders:

The dose of injection to be given into a joint or into a tendon sheath depends upon the size of the joint to be treated and the severity of the condition. Doses of 2.5 - 5mg (0.25-0.5ml) for smaller joints and 5-15mg (0.5-1.5ml) for larger joints usually give relief of symptoms. This medicine should not be used for injection into the Achilles tendon.

Use in allergic dermatitis:

The dose is usually 2-3mg (0.2-0.3ml) depending on the size of the problem area of the skin but no more than 5mg (0.5ml) should be injected at any one site. If several sites are injected the total dose given should not exceed 30mg (3ml). Further doses may be given if necessary at one or two week intervals.

Children: Adcortyl IA/ID is not recommended for children under 6 years of age. It may be given to older children but the dose is adjusted according to their size and weight and is always kept as low as possible for the shortest possible time.

During times of illness or stress, patients on long-term treatment may require the addition of oral steroid tablets or, if they have recently finished a course of Adcortyl IA/ID injections, may need to start taking oral steroid tablets for a while.

Q. How long should I continue receiving Adcortyl IA/ID injection?

A. Your doctor will advise you whether it is wise for you to have further injections.

Treatment with steroids is usually kept as short as possible and must not be stopped abruptly. Joints may become permanently damaged by repeated injections over a long period of time.

When the treatment is stopped you may notice flu-like symptoms, runny nose or itchy eyes or skin.

Mental problems while taking Adcortyl IA/ID injection

Mental health problems can happen while taking steroids like Adcortyl IA/ID Injection (see also section 4 Possible Side Effects).

These illnesses can be serious. Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen they might need treatment.

Talk to a doctor if you (or someone taking this medicine), shows any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

Undesirable Effects Q. Are there any unwanted effects of Adcortyl IA/ID injection?

A. All medicines may cause some unwanted or “side” effects. Some which can occur with steroid treatment are as follows. Tell your doctor immediately if you get ulcer pains in your stomach or severe pain in your abdomen, facial swelling or an unexpected rash. Patients have reported increased appetite, weight gain, indigestion, sickness, feeling tired or weak. Steroid treatment may cause increased risk of infection, thinning of bones or tendons causing fractures or torn muscles, water retention, irregular heart beat, high blood pressure or blood clots. Skin disorders or eye problems, including glaucoma and cataracts, may occur and wounds or broken bones may be slow to heal. Treatment with steroids can stop the body from producing some hormones and may slow or stop children’s growth rate. If you are female, your periods may become irregular. Elevation or depression of mood, sleeplessness and severe headaches have been reported. Very rare instances of blindness have been reported following injection to the face.

In particular, when Adcortyl IA/ID is injected into a joint you may notice some indentation appearing after a while in the surrounding area. There may also be some temporary worsening of the pain and discomfort after the injection. Similarly, injections given under the skin may cause slight changes in skin colour around the site of injection. These changes should disappear in time.

Serious effects: tell a doctor straight away

Steroids including Adcortyl IA/ID injection can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Adcortyl IA/ID injection.

Feeling depressed, including thinking about suicide. Feeling high (mania) or moods that go up and down. Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory. Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

Tell your doctor or pharmacist if you notice any other troublesome side effects.

Looking After Your Medicine

Adcortyl IA/ID injection will be kept in the pharmacy until it is given to you by your doctor or nurse. It should be stored upright, at a temperature not exceeding 25°C and should not be allowed to freeze. After first opening, the 5ml multidose vial may be stored for 28 days below 25°C. It should not be used after the expiry date shown on the outer packaging. Keep out of reach and sight of children.

DATE OF LAST REVISION April 2008

1041116A7


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coagulation factor IX


Generic Name: coagulation factor IX (koh AG yoo LAY shun FAK tor)
Brand names: AlphaNine SD, BeneFIX, Mononine, BeneFIX 250 Int'l Units

What is coagulation factor IX?

Coagulation factor IX is a man-made protein that is similar to a natural protein in the body that helps the blood to clot.

Coagulation factor IX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VII deficiency.

Coagulation factor IX may also be used for purposes other than those listed here.

What is the most important information I should know about coagulation factor IX? Do not use this medication if you have ever had an allergic reaction to a clotting factor medication, or if you are allergic to hamster proteins.

Before using this medication, tell your doctor if you are allergic to latex rubber, or if you have liver disease, coronary artery disease (hardening of the arteries), or a history of stroke or heart attack.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition. What should I discuss with my healthcare provider before using coagulation factor IX? Do not use this medication if you have ever had an allergic reaction to a clotting factor medication, or if you are allergic to hamster proteins.

Before using this medication, tell your doctor if you are allergic to latex rubber, or if you have:

liver disease;

coronary artery disease (hardening of the arteries); or

history of stroke or heart attack.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether coagulation factor IX passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use coagulation factor IX?

Coagulation factor IX is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your injections at home.

Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

Use each disposable needle only one time. Throw away used needles and syringes in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Coagulation factor IX is a powder medication that must be mixed with a liquid (diluent) before injecting it. Use the injection within 3 hours after mixing your dose.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition. If you store this medication at home, keep the powder medicine in the refrigerator. Do not freeze. Avoid exposing the medication to sunlight. The diluent can be stored at room temperature. You may also coagulation factor IX powder at cool room temperature for up to 6 months. What happens if I miss a dose?

Contact your doctor if you miss a dose of this medication.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of coagulation factor IX is not expected to produce life-threatening symptoms.

What should I avoid while using coagulation factor IX?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using coagulation factor IX.

Coagulation factor IX side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

fever or chills;

continued bleeding after treatment;

feeling like you might pass out;

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance; or

swelling in your feet or ankles, weight gain, loss of appetite.

Less serious side effects may be more likely to occur, such as:

headache;

warmth, redness, or tingly feeling under your skin;

nausea, vomiting;

dizziness; or

pain, redness, or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Coagulation factor IX Dosing Information

Usual Adult Dose for Factor IX Deficiency:

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.
In general, one IU of coagulation factor IX per kilogram of body weight increased the circulating activity of factor IX as follows: 0.8 + or - 0.2 IU/dL [range 0.4 to 1.2 IU/dL].
Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue:
Circulating Factor IX Activity Required: 20-30 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 1 to 2 days
Moderate
Intramuscular or soft tissue with dissection, mucous membranes, dental extractions, or hematuria:
Circulating Factor IX Activity Required: 25 to 50 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: Treat until bleeding stops and healing begins, about 2 to 7 days
Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery:
Circulating Factor IX Activity Required: 50 to 1000 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days

Usual Adult Dose for Hemophilia B:

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.
In general, one IU of coagulation factor IX per kilogram of body weight increased the circulating activity of factor IX as follows: 0.8 + or - 0.2 IU/dL [range 0.4 to 1.2 IU/dL].
Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue:
Circulating Factor IX Activity Required: 20-30 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 1 to 2 days
Moderate
Intramuscular or soft tissue with dissection, mucous membranes, dental extractions, or hematuria:
Circulating Factor IX Activity Required: 25 to 50 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: Treat until bleeding stops and healing begins, about 2 to 7 days
Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery:
Circulating Factor IX Activity Required: 50 to 1000 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days

Usual Pediatric Dose for Factor IX Deficiency:

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.
In general, one IU of coagulation factor IX per kilogram of body weight increased the circulating activity of factor IX as follows: 0.7 + or - 0.3 IU/dL [range 0.2 to 2.1 IU/dL].
Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue:
Circulating Factor IX Activity Required: 20-30 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 1 to 2 days
Moderate
Intramuscular or soft tissue with dissection, mucous membranes, dental extractions, or hematuria:
Circulating Factor IX Activity Required: 25 to 50 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: Treat until bleeding stops and healing begins, about 2 to 7 days
Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery:
Circulating Factor IX Activity Required: 50 to 1000 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days

Usual Pediatric Dose for Hemophilia B:

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.
In general, one IU of coagulation factor IX per kilogram of body weight increased the circulating activity of factor IX as follows: 0.7 + or - 0.3 IU/dL [range 0.2 to 2.1 IU/dL].
Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue:
Circulating Factor IX Activity Required: 20-30 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 1 to 2 days
Moderate
Intramuscular or soft tissue with dissection, mucous membranes, dental extractions, or hematuria:
Circulating Factor IX Activity Required: 25 to 50 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: Treat until bleeding stops and healing begins, about 2 to 7 days
Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery:
Circulating Factor IX Activity Required: 50 to 1000 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days

What other drugs will affect coagulation factor IX?

There may be other drugs that can interact with coagulation factor IX. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More coagulation factor IX resources Coagulation factor IX Side Effects (in more detail) Coagulation factor IX Use in Pregnancy & Breastfeeding Coagulation factor IX Support Group 1 Review for Coagulation factor IX - Add your own review/rating AlphaNine SD MedFacts Consumer Leaflet (Wolters Kluwer) Alphanine SD Prescribing Information (FDA) Alphanine SD Advanced Consumer (Micromedex) - Includes Dosage Information BeneFIX Monograph (AHFS DI) BeneFIX Prescribing Information (FDA) BeneFix MedFacts Consumer Leaflet (Wolters Kluwer) Mononine Prescribing Information (FDA) Mononine MedFacts Consumer Leaflet (Wolters Kluwer) Compare coagulation factor IX with other medications Factor IX Deficiency Hemophilia B Where can I get more information? Your pharmacist can provide more information about coagulation factor IX.

See also: coagulation factor IX side effects (in more detail)


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EXUBERA


Generic Name: insulin inhalation (IN soo lin in hel AY shun)
Brand Names: EXUBERA

What is insulin inhalation?

Insulin inhalation is a rapid-acting form of human insulin that is inhaled through the mouth. It works by lowering levels of glucose (sugar) in the blood.

Insulin inhalation is used to treat type 1 (insulin dependent) or type 2 (non-insulin dependent) diabetes in adults.

Insulin inhalation (Exubera) was withdrawn from the U.S. market in 2007 due to lack of consumer demand for the product. No drug safety concerns were cited in this withdrawal.

Insulin inhalation may also be used for purposes other than those listed here.

What is the most important information I should know about insulin inhalation?

Insulin inhalation (Exubera) was withdrawn from the U.S. market in 2007 due to lack of consumer demand for the product. No drug safety concerns were cited in this withdrawal.

Do not use insulin inhalation if you smoke, or if you have recently quit smoking (within the past 6 months). If you start smoking while using insulin inhalation, you will have to stop using this medication and switch to another form of insulin to control your blood sugar.

Before using this medicine, tell your doctor if you have kidney disease, liver disease, or lung disorders such as asthma or COPD (chronic obstructive pulmonary disease).

You should not insulin inhalation if you have a lung disease that is not well controlled with medication or other treatments.

There are many other drugs that can potentially interfere with the glucose-lowering effects of insulin inhalation. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

If you use insulin inhalation as a meal-time insulin, use it no more than 10 minutes before eating the meal.

This medication is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

What should I discuss with my health care provider before taking insulin inhalation?

Before using this medicine, tell your doctor if you have kidney disease, liver disease, or lung disorders such as asthma or COPD (chronic obstructive pulmonary disease).

You should not use insulin inhalation if you have a lung disease that is not well controlled with medication or other treatments.

If you have type 1 diabetes, you should use this medication in addition to another long-acting type of insulin.

If you have type 2 diabetes, this may be the only medication you use to control your blood sugar, or your doctor may prescribe another long-acting insulin or diabetes medicine you take by mouth.

This medication is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Insulin inhalation can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take insulin inhalation?

Use insulin inhalation exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

If you use insulin inhalation as a meal-time insulin, use it no more than 10 minutes before eating the meal.

To be sure this medication is not causing certain side effects, your lung function will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Continue using insulin inhalation if you have a cold or flu virus that causes upper respiratory symptoms (cough, sore throat, nasal congestion). Check your blood sugar carefully during a time of stress or illness, since this can also affect your glucose levels.

Insulin inhalation is a powder that is supplied in "dose blisters" on cards that are packaged in a clear plastic tray. This tray is sealed inside a foil pouch that also contains a moisture-absorbing preservative packet. The 1-milligram (mg) dose blisters are supplied on a card printed with green ink. The 3-mg dose blisters are supplied on a card printed with blue ink.

Each 1-milligram dose blister of insulin inhalation powder is equal to 3 units of injectable insulin and each 3-milligram dose blister is equal to 8 units of injectable insulin. Using three of the 1-mg dose blisters will not give you the same amount of medicine as one 3-mg dose blister. You may receive too much insulin when using three 1-mg dose blisters together, which could result in hypoglycemia.

If you are combining 1-mg and 3-mg dose blisters to get your correct dose of insulin, always use the least number of blisters possible. For example, if your dose is 4 mg, use a 1-mg blister and a 3-mg blister (a total of two blisters). Do not use four 1-mg blisters or you may receive too much of this medication

The inhaler unit supplied with this medication includes a base, a chamber, and a release unit. Each release unit may be used for up to 2 weeks before replacing. You may use the inhaler for up to 1 year before replacing it.

Store the medication at room temperature, away from moisture and heat. Do not refrigerate or freeze. Protect the medicine from moisture and humidity at all times. Do not store the medicine in a bathroom where you shower.

Once you have opened the foil pouch, keep the unused dose blisters in the pouch and use them within 3 months after opening the pouch. Keep the moisture-absorbing preservative packet contained in the foil pouch and do not open the packet or use its contents.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

If you use this medication as meal-time insulin and you forget to use your dose before a meal, use the insulin when you remember and wait 10 minutes before eating.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an insulin inhalation overdose may be the same as signs of low blood sugar: confusion, drowsiness, weakness, fast heartbeat, sweating, tremor, and nausea.

What should I avoid while taking insulin inhalation? Do not smoke while using insulin inhalation. You should not use this medication if you have smoked within the past 6 months. If you start smoking while using insulin inhalation, you will have to stop using the medication and switch to another form of insulin to control your blood sugar.

Avoid letting your blood sugar get too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Insulin inhalation side effects

Hypoglycemia (low blood sugar) is the most common side effect of insulin inhalation. Watch for signs of low blood sugar, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Get emergency medical help if you have any of these signs of an allergic reaction: rash, hives, or itching; wheezing, gasping for breath; fast heartbeat; sweating; feeling light-headed or fainting.

Other less serious side effects are more likely to occur, such as:

cough, sore throat;

runny or stuffy nose;

dry mouth; or

ear pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect insulin inhalation?

There are many other drugs that can potentially interfere with the glucose-lowering effects of insulin inhalation. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

If you use other inhaled medications, use them before using insulin inhalation.

More EXUBERA resources EXUBERA Side Effects (in more detail) EXUBERA Use in Pregnancy & Breastfeeding EXUBERA Drug Interactions EXUBERA Support Group 4 Reviews for EXUBERA - Add your own review/rating Exubera Prescribing Information (FDA) Exubera Powder MedFacts Consumer Leaflet (Wolters Kluwer) Exubera Consumer Overview Compare EXUBERA with other medications Diabetes, Type 1 Diabetes, Type 2 Where can I get more information? Your pharmacist can provide more information about insulin inhalation.

See also: EXUBERA side effects (in more detail)


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Abacavir Solution


Pronunciation: a-BAK-a-vir
Generic Name: Abacavir
Brand Name: Ziagen

Abacavir Solution has caused severe and sometimes fatal allergic reactions. Contact your doctor right away if you develop fever; rash; nausea, vomiting, diarrhea, or stomach pain; cough; sore throat, or trouble breathing; unusual tiredness or achiness; or general feeling of being unwell. Do NOT take Abacavir Solution again or take any other medicine that contains abacavir if you have had an allergic reaction to Abacavir Solution. You may be at risk for an even more severe allergic reaction.

Patients who have a certain gene type called HLA-B*5701 have an increased risk of allergic reaction. A lab test may be performed before you start Abacavir Solution to see if you have this gene type. Discuss any questions or concerns with your doctor.

Abacavir Solution may cause severe and sometimes fatal liver problems or high blood acid levels (lactic acidosis). Contact your doctor right away if you develop yellowing of the skin or eyes; dark urine; pale stools; stomach pain; nausea; vomiting; diarrhea; persistent loss of appetite; fast or difficult breathing; slow or irregular heartbeat; unusual weakness or tiredness; muscle pain or tenderness; unusual feeling of cold (eg, in arms or legs); or unusual drowsiness, dizziness, or lightheadedness.


Abacavir Solution is used for:

Treating HIV infection with other medications.

Abacavir is a nucleoside analog reverse transcriptase inhibitor (NRTI). It works by slowing down the growth of HIV, the virus that causes AIDS.

Do NOT use Abacavir Solution if: you are allergic to any ingredient in Abacavir Solution you have had a recent abnormal liver function test or have moderate to severe liver problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Abacavir Solution:

Some medical conditions may interact with Abacavir Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding or thinking about breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of heart problems (eg, heart attack), high blood pressure, high cholesterol, diabetes, or smoking if you have been tested and know whether or not you have a gene type called HLA-B*5701

Some MEDICINES MAY INTERACT with Abacavir Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Alcohol because it may increase the risk of Abacavir Solution's side effects and toxic effects Methadone because its effectiveness may be decreased by Abacavir Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Abacavir Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Abacavir Solution:

Use Abacavir Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Abacavir Solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Abacavir Solution refilled. Abacavir Solution comes with a warning card that provides information about recognition of allergic reactions. Carry the warning card of allergy symptoms with you. Tell your health care provider immediately about any side effects you experience while taking Abacavir Solution. Take Abacavir Solution by mouth with or without food. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. Taking Abacavir Solution at the same times each day will help you to remember to take it. Continue to take Abacavir Solution even if you feel well. Do not miss any doses. If you miss a dose of Abacavir Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Abacavir Solution.

Important safety information: Talk to your doctor before you take Abacavir Solution if you drink more than 3 drinks with alcohol per day. Tell your doctor or dentist that you take Abacavir Solution before you receive any medical or dental care, emergency care, or surgery. If you must stop taking Abacavir Solution for any reason other than a serious allergic reaction, do not start taking Abacavir Solution again without talking with your health care provider. If your health care provider decides that you may take Abacavir Solution again, you should do so only in a setting with other people in case you need immediate access to a doctor. When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Abacavir Solution, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat. Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Abacavir Solution. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. Abacavir Solution does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Abacavir Solution is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor. Lab tests, including liver function tests and monitoring for hypersensitivity reactions, may be performed while you use Abacavir Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Abacavir Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially liver, kidney, or heart problems. Caution is advised when using Abacavir Solution in CHILDREN; they may be more sensitive to its effects, especially fever; chills; rash; or ear, nose, or throat infection. Abacavir Solution should not be used in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Abacavir Solution while you are pregnant. It is not known if Abacavir Solution is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Abacavir Solution to the baby. Possible side effects of Abacavir Solution:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; lack of energy; mild nausea; tiredness; trouble sleeping; unusual dreams; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling of the skin; change in the amount of urine produced; chest pain or discomfort, numbness of an arm or leg, or sudden vision changes; ear pain; eye pain, redness, or swelling; fainting; fever or chills; general feeling of being unwell; mental or mood changes (eg, depression); mouth sores; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent nausea, vomiting, or diarrhea; shortness of breath, cough, or sore throat; stomach pain; swollen lymph nodes; symptoms of lactic acidosis (eg, fast breathing; muscle pain; unusual cold feeling in the arms or legs; sluggishness; unusual drowsiness, dizziness, or lightheadedness); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, severe or persistent tiredness); unusual achiness or swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Abacavir side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Abacavir Solution:

Store Abacavir Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Abacavir Solution out of the reach of children and away from pets.

General information: If you have any questions about Abacavir Solution, please talk with your doctor, pharmacist, or other health care provider. Abacavir Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is summary only. It does not contain all information about Abacavir Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Abacavir resources Abacavir Side Effects (in more detail) Abacavir Use in Pregnancy & Breastfeeding Abacavir Drug Interactions Abacavir Support Group 0 Reviews for Abacavir - Add your own review/rating Compare Abacavir with other medications HIV Infection Nonoccupational Exposure
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Abacavir


Pronunciation: a-BAK-a-vir
Generic Name: Abacavir
Brand Name: Ziagen

Abacavir has caused severe and sometimes fatal allergic reactions. Contact your doctor right away if you develop fever; rash; nausea, vomiting, diarrhea, or stomach pain; cough; sore throat, or trouble breathing; unusual tiredness or achiness; or general feeling of being unwell. Do NOT take Abacavir again or take any other medicine that contains abacavir if you have had an allergic reaction to Abacavir. You may be at risk for an even more severe allergic reaction.

Patients who have a certain gene type called HLA-B*5701 have an increased risk of allergic reaction. A lab test may be performed before you start Abacavir to see if you have this gene type. Discuss any questions or concerns with your doctor.

Abacavir may cause severe and sometimes fatal liver problems or high blood acid levels (lactic acidosis). Contact your doctor right away if you develop yellowing of the skin or eyes; dark urine; pale stools; stomach pain; nausea; vomiting; diarrhea; persistent loss of appetite; fast or difficult breathing; slow or irregular heartbeat; unusual weakness or tiredness; muscle pain or tenderness; unusual feeling of cold (eg, in arms or legs); or unusual drowsiness, dizziness, or lightheadedness.


Abacavir is used for:

Treating HIV infection with other medications.

Abacavir is a nucleoside analog reverse transcriptase inhibitor (NRTI). It works by slowing down the growth of HIV, the virus that causes AIDS.

Do NOT use Abacavir if: you are allergic to any ingredient in Abacavir you have had a recent abnormal liver function test or have moderate to severe liver problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Abacavir:

Some medical conditions may interact with Abacavir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding or thinking about breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of heart problems (eg, heart attack), high blood pressure, high cholesterol, diabetes, or smoking if you have been tested and know whether or not you have a gene type called HLA-B*5701

Some MEDICINES MAY INTERACT with Abacavir. Tell your health care provider if you are taking any other medicines, especially any of the following:

Alcohol because it may increase the risk of Abacavir's side effects and toxic effects Methadone because its effectiveness may be decreased by Abacavir

This may not be a complete list of all interactions that may occur. Ask your health care provider if Abacavir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Abacavir:

Use Abacavir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Abacavir comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Abacavir refilled. Abacavir comes with a warning card that provides information about recognition of allergic reactions. Carry the warning card of allergy symptoms with you. Tell your health care provider immediately about any side effects you experience while taking Abacavir. Take Abacavir by mouth with or without food. Using Abacavir at the same times each day will help you remember to take it. Continue to take Abacavir even if you feel well. Do not miss any doses. If you miss a dose of Abacavir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Abacavir.

Important safety information: Talk to your doctor before you take Abacavir if you drink more than 3 drinks with alcohol per day. Tell your doctor or dentist that you take Abacavir before you receive any medical or dental care, emergency care, or surgery. If you must stop taking Abacavir for any reason other than a serious allergic reaction, do not start taking Abacavir again without talking with your health care provider. If your health care provider decides that you may take Abacavir again, you should do so only in a setting with other people in case you need immediate access to a doctor. When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Abacavir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat. Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Abacavir. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. Abacavir does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Abacavir is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor. Lab tests, including liver function and monitoring for hypersensitivity reactions, may be performed while you use Abacavir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Abacavir with caution in the ELDERLY; they may be more sensitive to its effects, especially liver, kidney, or heart problems. Caution is advised when using Abacavir in CHILDREN; they may be more sensitive to its effects, especially fever; chills; rash; or ear, nose, or throat infection. Abacavir should not be used in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Abacavir while you are pregnant. It is not known if Abacavir is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Abacavir to the baby. Possible side effects of Abacavir:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; lack of energy; mild nausea; tiredness; trouble sleeping; unusual dreams; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling of the skin; change in the amount of urine produced; chest pain or discomfort, numbness of an arm or leg, or sudden vision changes; ear pain; eye pain, redness, or swelling; fainting; fever or chills; general feeling of being unwell; mental or mood changes (eg, depression); mouth sores; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent nausea, vomiting, or diarrhea; shortness of breath, cough, or sore throat; stomach pain; swollen lymph nodes; symptoms of lactic acidosis (eg, fast breathing; muscle pain; unusual cold feeling in the arms or legs; sluggishness; unusual drowsiness, dizziness, or lightheadedness); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, severe or persistent tiredness); unusual achiness or swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Abacavir side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Abacavir:

Store Abacavir at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Abacavir out of the reach of children and away from pets.

General information: If you have any questions about Abacavir, please talk with your doctor, pharmacist, or other health care provider. Abacavir is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is summary only. It does not contain all information about Abacavir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Abacavir resources Abacavir Side Effects (in more detail) Abacavir Dosage Abacavir Use in Pregnancy & Breastfeeding Abacavir Drug Interactions Abacavir Support Group 0 Reviews for Abacavir - Add your own review/rating abacavir Advanced Consumer (Micromedex) - Includes Dosage Information abacavir Concise Consumer Information (Cerner Multum) Abacavir Sulfate Monograph (AHFS DI) Ziagen Prescribing Information (FDA) Compare Abacavir with other medications HIV Infection Nonoccupational Exposure
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Ziagen Solution


Pronunciation: a-BAK-a-vir
Generic Name: Abacavir
Brand Name: Ziagen

Ziagen Solution has caused severe and sometimes fatal allergic reactions. Contact your doctor right away if you develop fever; rash; nausea, vomiting, diarrhea, or stomach pain; cough; sore throat, or trouble breathing; unusual tiredness or achiness; or general feeling of being unwell. Do NOT take Ziagen Solution again or take any other medicine that contains abacavir if you have had an allergic reaction to Ziagen Solution. You may be at risk for an even more severe allergic reaction.

Patients who have a certain gene type called HLA-B*5701 have an increased risk of allergic reaction. A lab test may be performed before you start Ziagen Solution to see if you have this gene type. Discuss any questions or concerns with your doctor.

Ziagen Solution may cause severe and sometimes fatal liver problems or high blood acid levels (lactic acidosis). Contact your doctor right away if you develop yellowing of the skin or eyes; dark urine; pale stools; stomach pain; nausea; vomiting; diarrhea; persistent loss of appetite; fast or difficult breathing; slow or irregular heartbeat; unusual weakness or tiredness; muscle pain or tenderness; unusual feeling of cold (eg, in arms or legs); or unusual drowsiness, dizziness, or lightheadedness.


Ziagen Solution is used for:

Treating HIV infection with other medications.

Abacavir is a nucleoside analog reverse transcriptase inhibitor (NRTI). It works by slowing down the growth of HIV, the virus that causes AIDS.

Do NOT use Ziagen Solution if: you are allergic to any ingredient in Ziagen Solution you have had a recent abnormal liver function test or have moderate to severe liver problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ziagen Solution:

Some medical conditions may interact with Ziagen Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding or thinking about breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of heart problems (eg, heart attack), high blood pressure, high cholesterol, diabetes, or smoking if you have been tested and know whether or not you have a gene type called HLA-B*5701

Some MEDICINES MAY INTERACT with Ziagen Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Alcohol because it may increase the risk of Ziagen Solution's side effects and toxic effects Methadone because its effectiveness may be decreased by Ziagen Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ziagen Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ziagen Solution:

Use Ziagen Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ziagen Solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ziagen Solution refilled. Ziagen Solution comes with a warning card that provides information about recognition of allergic reactions. Carry the warning card of allergy symptoms with you. Tell your health care provider immediately about any side effects you experience while taking Ziagen Solution. Take Ziagen Solution by mouth with or without food. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. Taking Ziagen Solution at the same times each day will help you to remember to take it. Continue to take Ziagen Solution even if you feel well. Do not miss any doses. If you miss a dose of Ziagen Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ziagen Solution.

Important safety information: Talk to your doctor before you take Ziagen Solution if you drink more than 3 drinks with alcohol per day. Tell your doctor or dentist that you take Ziagen Solution before you receive any medical or dental care, emergency care, or surgery. If you must stop taking Ziagen Solution for any reason other than a serious allergic reaction, do not start taking Ziagen Solution again without talking with your health care provider. If your health care provider decides that you may take Ziagen Solution again, you should do so only in a setting with other people in case you need immediate access to a doctor. When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Ziagen Solution, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat. Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Ziagen Solution. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. Ziagen Solution does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Ziagen Solution is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor. Lab tests, including liver function tests and monitoring for hypersensitivity reactions, may be performed while you use Ziagen Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Ziagen Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially liver, kidney, or heart problems. Caution is advised when using Ziagen Solution in CHILDREN; they may be more sensitive to its effects, especially fever; chills; rash; or ear, nose, or throat infection. Ziagen Solution should not be used in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ziagen Solution while you are pregnant. It is not known if Ziagen Solution is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Ziagen Solution to the baby. Possible side effects of Ziagen Solution:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; lack of energy; mild nausea; tiredness; trouble sleeping; unusual dreams; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling of the skin; change in the amount of urine produced; chest pain or discomfort, numbness of an arm or leg, or sudden vision changes; ear pain; eye pain, redness, or swelling; fainting; fever or chills; general feeling of being unwell; mental or mood changes (eg, depression); mouth sores; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent nausea, vomiting, or diarrhea; shortness of breath, cough, or sore throat; stomach pain; swollen lymph nodes; symptoms of lactic acidosis (eg, fast breathing; muscle pain; unusual cold feeling in the arms or legs; sluggishness; unusual drowsiness, dizziness, or lightheadedness); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, severe or persistent tiredness); unusual achiness or swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ziagen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Ziagen Solution:

Store Ziagen Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ziagen Solution out of the reach of children and away from pets.

General information: If you have any questions about Ziagen Solution, please talk with your doctor, pharmacist, or other health care provider. Ziagen Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is summary only. It does not contain all information about Ziagen Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Ziagen resources Ziagen Side Effects (in more detail) Ziagen Use in Pregnancy & Breastfeeding Drug Images Ziagen Drug Interactions Ziagen Support Group 0 Reviews for Ziagen - Add your own review/rating Compare Ziagen with other medications HIV Infection Nonoccupational Exposure
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Naprelan Dose Card


Generic Name: naproxen (Oral route)

na-PROX-en

Oral route(Tablet;Tablet, Enteric Coated;Suspension)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

Aflaxen Aleve Aleve Arthritis Anaprox Anaprox DS EC Naprosyn Naprelan Naprelan 500 Naprelan Dose Card Naprosyn

In Canada

Naxen

Available Dosage Forms:

Tablet Suspension Tablet, Enteric Coated Tablet, Extended Release

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Naprelan Dose Card

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis) such as inflammation, swelling, stiffness, and joint pain. Naproxen also helps relieve symptoms of ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.

This medicine may also be used to treat mild to moderate pain, including acute gout and other painful conditions such as bursitis, tendonitis, or menstrual cramps.

This medicine is available only with your doctor's prescription.

Before Using Naprelan Dose Card

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of naproxen controlled-release tablets in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of naproxen delayed release tablets, suspension, and tablets in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naproxen in the elderly. However, elderly patients may be more sensitive to the effects of naproxen than younger adults, and are more likely to have age-related kidney or stomach problems, which may require caution and an adjustment in the dose for patients receiving naproxen.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac Pentoxifylline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab Ardeparin Argatroban Aspirin Beclamide Beta Glucan Bivalirudin Caramiphen Carbamazepine Certoparin Chlormethiazole Cilostazol Citalopram Clopidogrel Clovoxamine Dabigatran Etexilate Dalteparin Danaparoid Desirudin Diazepam Dipyridamole Enoxaparin Escitalopram Ethotoin Felbamate Femoxetine Flesinoxan Fluoxetine Fluvoxamine Fondaparinux Fosphenytoin Gabapentin Ginkgo Heparin Lacosamide Lepirudin Mephenytoin Mephobarbital Methotrexate Nadroparin Nefazodone Oxcarbazepine Paraldehyde Paramethadione Parnaparin Paroxetine Pemetrexed Phenacemide Phenobarbital Phenytoin Piracetam Pregabalin Protein C Reviparin Rivaroxaban Rufinamide Sertraline Sibutramine Stiripentol Tacrolimus Tiagabine Ticlopidine Tinzaparin Tirofiban Topiramate Trimethadione Valproic Acid Vigabatrin Vilazodone Warfarin Zimeldine Zonisamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Acetohexamide Alacepril Alprenolol Amiloride Arotinolol Atenolol Azilsartan Medoxomil Azosemide Befunolol Bemetizide Benazepril Bendroflumethiazide Benzthiazide Betaxolol Bevantolol Bisoprolol Bopindolol Bucindolol Bumetanide Bupranolol Buthiazide Candesartan Cilexetil Canrenoate Captopril Carteolol Carvedilol Celiprolol Chlorothiazide Chlorpropamide Chlorthalidone Cilazapril Clopamide Cyclopenthiazide Cyclosporine Delapril Desvenlafaxine Dilevalol Duloxetine Enalaprilat Enalapril Maleate Eprosartan Esmolol Ethacrynic Acid Fosinopril Furosemide Gliclazide Glimepiride Glipizide Gliquidone Glyburide Hydrochlorothiazide Hydroflumethiazide Imidapril Indapamide Irbesartan Labetalol Landiolol Levobetaxolol Levobunolol Lisinopril Lithium Losartan Mepindolol Methyclothiazide Metipranolol Metolazone Metoprolol Milnacipran Moexipril Nadolol Nebivolol Nipradilol Olmesartan Medoxomil Oxprenolol Penbutolol Pentopril Perindopril Pindolol Piretanide Polythiazide Propranolol Quinapril Ramipril Sotalol Spirapril Spironolactone Talinolol Tasosartan Telmisartan Temocapril Tertatolol Timolol Tolazamide Tolbutamide Torsemide Trandolapril Triamterene Trichlormethiazide Valsartan Venlafaxine Xipamide Zofenopril Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Anemia or Bleeding problems or Blood clots or Edema (fluid retention or body swelling) or Heart attack, history of or Heart disease (e.g., congestive heart failure) or Hypertension (high blood pressure) or Kidney disease or Liver disease (e.g., hepatitis) or Stomach or intestinal ulcers or bleeding, history of or Stroke, history of—Use with caution. May make these conditions worse. Aspirin-sensitive asthma or Aspirin sensitivity, history of—Should not be used in patients with these conditions. Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery. Proper Use of naproxen

This section provides information on the proper use of a number of products that contain naproxen. It may not be specific to Naprelan Dose Card. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

Check with your doctor first before changing dosage forms (e.g., tablets, suspension). These forms are very different from each other.

Swallow the delayed-release tablet whole. Do not crush, break, or chew it.

If you are using the suspension, shake it gently before using it. Use the marked measuring cup included in the package to measure the dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For naproxen (e.g., Naprosyn®) tablet and oral suspension dosage forms: For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: Adults—At first, 250 milligrams (mg) (10 milliliters (mL)/2 teaspoonfuls), 375 mg (15 mL/3 teaspoonfuls), or 500 mg (20 mL/4 teaspoonfuls) two times a day, in the morning and evening. Your doctor may increase your dose, as needed, up to a total of 1500 mg per day. Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 milligrams (mg) per kilogram (kg) of body weight two times a day. Children younger than 2 years of age—Use and dose must be determined by your doctor. For bursitis, tendonitis, menstrual cramps, and other kinds of pain: Adults—500 milligrams (mg) for the first dose, then 250 mg every 6 to 8 hours as needed. Children—Use and dose must be determined by your doctor. For acute gout: Adults—750 milligrams (mg) for the first dose, then 250 mg every 8 hours until the attack is relieved. Children—Use and dose must be determined by your doctor. For naproxen controlled-release tablet (e.g., Naprelan®) dosage form: For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: Adults—At first, 750 milligrams (mg) (taken as one 750 mg or two 375 mg tablets) or 1000 mg (taken as two 500 mg tablets) once a day. Your doctor may adjust your dose as needed, up to a total of 1500 mg (taken as two 750 mg or three 500 mg tablets) per day. Children—Use and dose must be determined by your doctor. For bursitis, tendonitis, menstrual cramps, and other kinds of pain: Adults—At first, 1000 milligrams (mg) (taken as two 500 mg tablets) once a day. Some patients may need 1500 mg (taken as two 750 mg or three 500 mg tablets) per day, for a limited period. However, the dose is usually not more than 1000 mg per day. Children—Use and dose must be determined by your doctor. For acute gout: Adults—1000 to 1500 milligrams (mg) (taken as two to three 500 mg tablets) once a day for the first dose, then 1000 mg (taken as two 500 mg tablets) once a day until the attack is relieved. Children—Use and dose must be determined by your doctor. For naproxen delayed-release tablet (e.g., EC-Naprosyn®) dosage form: For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: Adults—At first, 375 or 500 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day. Children—Use and dose must be determined by your doctor. For naproxen sodium (e.g., Anaprox®, Anaprox® DS) tablet dosage form: For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: Adults—At first, 275 or 550 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day. Children—Use and dose must be determined by your doctor. For bursitis, tendonitis, menstrual cramps, and other kinds of pain: Adults—550 milligrams (mg) for the first dose, then 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed. Your doctor may increase the dose, if necessary, up to a total of 1375 mg per day. Children—Use and dose must be determined by your doctor. For acute gout: Adults—825 milligrams (mg) for the first dose, then 275 mg every 8 hours until the attack is relieved. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Naprelan Dose Card

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs; severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert. .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Naprelan Dose Card Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Belching bruising difficult or labored breathing feeling of indigestion headache itching skin large, flat, blue, or purplish patches in the skin pain in the chest below the breastbone shortness of breath skin eruptions stomach pain swelling tightness in the chest wheezing Less common Bloating bloody or black, tarry stools blurred or loss of vision burning upper abdominal or stomach pain cloudy urine constipation decrease in urine output or decrease in urine-concentrating ability disturbed color perception double vision fast, irregular, pounding, or racing heartbeat or pulse halos around lights indigestion loss of appetite nausea or vomiting night blindness overbright appearance of lights pale skin pinpoint red or purple spots on the skin severe and continuing nausea severe stomach burning, cramping, or pain skin rash swelling or inflammation of the mouth troubled breathing with exertion tunnel vision unusual bleeding or bruising unusual tiredness or weakness vomiting of material that looks like coffee grounds weight loss Rare Anxiety back or leg pains bleeding gums blindness blistering, peeling, or loosening of the skin blood in the urine or stools blue lips and fingernails canker sores change in the ability to see colors, especially blue or yellow chest pain or discomfort clay-colored stools cold sweats coma confusion cool, pale skin cough or hoarseness coughing that sometimes produces a pink frothy sputum cracks in the skin darkened urine decreased vision depression diarrhea difficult, burning, or painful urination difficult, fast, or noisy breathing difficulty with swallowing dilated neck veins dizziness dry cough dry mouth early appearance of redness, or swelling of the skin excess air or gas in the stomach extreme fatigue eye pain fainting fever with or without chills fluid-filled skin blisters flushed, dry skin frequent urination fruit-like breath odor greatly decreased frequency of urination or amount of urine hair loss high fever hives increased hunger increased sensitivity of the skin to sunlight increased sweating increased thirst increased urination increased volume of pale, dilute urine irregular breathing joint or muscle pain large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas of skin, may extend to unexposed areas light-colored stools lightheadedness loss of heat from the body lower back or side pain nervousness nightmares no blood pressure no breathing no pulse nosebleeds numbness or tingling in the hands, feet, or lips pain in the ankles or knees pain or burning in the throat pain or discomfort in the arms, jaw, back, or neck painful, red lumps under the skin, mostly on the legs pains in the stomach, side, or abdomen, possibly radiating to the back pale or blue lips, fingernails, or skin pounding in the ears puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue rapid, shallow breathing red, irritated eyes red skin lesions, often with a purple center red-green color blindness redness or other discoloration of the skin redness, swelling, or soreness of the tongue scaly skin seizures severe sunburn shakiness skin thinness slurred speech sneezing sore throat sores, ulcers, or white spots on the lips or tongue or inside the mouth sores, welting, or blisters spots on your skin resembling a blister or pimple stiff neck or back stomach cramps or tenderness stomach upset swelling in the legs and ankles swelling of the face, fingers, feet, or lower legs swollen, painful, or tender lymph glands in the neck, armpit, or groin tiny bumps on the inner lining of the eyelid unexplained weight loss unpleasant breath odor watery or bloody diarrhea weakness or heaviness of the legs weight gain yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose Bleeding under the skin confusion about identity, place, and time muscle tremors restlessness sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Continuing ringing or buzzing or other unexplained noise in the ears hearing loss Less common Acid or sour stomach change in hearing feeling of constant movement of self or surroundings passing gas sensation of spinning stomach soreness or discomfort Rare Appetite changes burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings burning, dry, or itching eyes difficulty with moving discharge, excessive tearing general feeling of discomfort or illness lack or loss of strength menstrual changes muscle aching, cramping, stiffness, or weakness not able to concentrate redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid seeing, hearing, or feeling things that are not there shakiness in the legs, arms, hands, or feet sleeplessness swollen joints trembling or shaking of the hands or feet trouble getting pregnant trouble performing routine tasks trouble sleeping unable to sleep unusual drowsiness, dullness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Naprelan Dose Card side effects (in more detail)

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More Naprelan Dose Card resources Naprelan Dose Card Side Effects (in more detail) Naprelan Dose Card Use in Pregnancy & Breastfeeding Drug Images Naprelan Dose Card Drug Interactions Naprelan Dose Card Support Group 131 Reviews for Naprelan Dose Card - Add your own review/rating Naproxen Monograph (AHFS DI) Naproxen Professional Patient Advice (Wolters Kluwer) Naproxen Prescribing Information (FDA) Aleve Consumer Overview Aleve MedFacts Consumer Leaflet (Wolters Kluwer) Anaprox MedFacts Consumer Leaflet (Wolters Kluwer) EC-Naprosyn Enteric-Coated Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Naprosyn Consumer Overview Naprosyn Prescribing Information (FDA) Compare Naprelan Dose Card with other medications Ankylosing Spondylitis Aseptic Necrosis Back Pain Bursitis Costochondritis Diffuse Idiopathic Skeletal Hyperostosis Dysautonomia Fever Frozen Shoulder Gout, Acute Headache Juvenile Rheumatoid Arthritis Muscle Pain Osteoarthritis Pain Period Pain Rheumatoid Arthritis Sciatica Spondylolisthesis Tendonitis
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insulin inhalation


Generic Name: insulin inhalation (IN soo lin in hel AY shun)
Brand names: EXUBERA, EXUBERA Combination Pack 12, EXUBERA Combination Pack 15, EXUBERA Kit

What is insulin inhalation?

Insulin inhalation is a rapid-acting form of human insulin that is inhaled through the mouth. It works by lowering levels of glucose (sugar) in the blood.

Insulin inhalation is used to treat type 1 (insulin dependent) or type 2 (non-insulin dependent) diabetes in adults.

Insulin inhalation (Exubera) was withdrawn from the U.S. market in 2007 due to lack of consumer demand for the product. No drug safety concerns were cited in this withdrawal.

Insulin inhalation may also be used for purposes other than those listed here.

What is the most important information I should know about insulin inhalation?

Insulin inhalation (Exubera) was withdrawn from the U.S. market in 2007 due to lack of consumer demand for the product. No drug safety concerns were cited in this withdrawal.

Do not use insulin inhalation if you smoke, or if you have recently quit smoking (within the past 6 months). If you start smoking while using insulin inhalation, you will have to stop using this medication and switch to another form of insulin to control your blood sugar.

Before using this medicine, tell your doctor if you have kidney disease, liver disease, or lung disorders such as asthma or COPD (chronic obstructive pulmonary disease).

You should not insulin inhalation if you have a lung disease that is not well controlled with medication or other treatments.

There are many other drugs that can potentially interfere with the glucose-lowering effects of insulin inhalation. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

If you use insulin inhalation as a meal-time insulin, use it no more than 10 minutes before eating the meal.

This medication is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

What should I discuss with my health care provider before taking insulin inhalation?

Before using this medicine, tell your doctor if you have kidney disease, liver disease, or lung disorders such as asthma or COPD (chronic obstructive pulmonary disease).

You should not use insulin inhalation if you have a lung disease that is not well controlled with medication or other treatments.

If you have type 1 diabetes, you should use this medication in addition to another long-acting type of insulin.

If you have type 2 diabetes, this may be the only medication you use to control your blood sugar, or your doctor may prescribe another long-acting insulin or diabetes medicine you take by mouth.

This medication is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Insulin inhalation can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take insulin inhalation?

Use insulin inhalation exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

If you use insulin inhalation as a meal-time insulin, use it no more than 10 minutes before eating the meal.

To be sure this medication is not causing certain side effects, your lung function will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Continue using insulin inhalation if you have a cold or flu virus that causes upper respiratory symptoms (cough, sore throat, nasal congestion). Check your blood sugar carefully during a time of stress or illness, since this can also affect your glucose levels.

Insulin inhalation is a powder that is supplied in "dose blisters" on cards that are packaged in a clear plastic tray. This tray is sealed inside a foil pouch that also contains a moisture-absorbing preservative packet. The 1-milligram (mg) dose blisters are supplied on a card printed with green ink. The 3-mg dose blisters are supplied on a card printed with blue ink.

Each 1-milligram dose blister of insulin inhalation powder is equal to 3 units of injectable insulin and each 3-milligram dose blister is equal to 8 units of injectable insulin. Using three of the 1-mg dose blisters will not give you the same amount of medicine as one 3-mg dose blister. You may receive too much insulin when using three 1-mg dose blisters together, which could result in hypoglycemia.

If you are combining 1-mg and 3-mg dose blisters to get your correct dose of insulin, always use the least number of blisters possible. For example, if your dose is 4 mg, use a 1-mg blister and a 3-mg blister (a total of two blisters). Do not use four 1-mg blisters or you may receive too much of this medication

The inhaler unit supplied with this medication includes a base, a chamber, and a release unit. Each release unit may be used for up to 2 weeks before replacing. You may use the inhaler for up to 1 year before replacing it.

Store the medication at room temperature, away from moisture and heat. Do not refrigerate or freeze. Protect the medicine from moisture and humidity at all times. Do not store the medicine in a bathroom where you shower.

Once you have opened the foil pouch, keep the unused dose blisters in the pouch and use them within 3 months after opening the pouch. Keep the moisture-absorbing preservative packet contained in the foil pouch and do not open the packet or use its contents.

See also: Insulin inhalation dosage (in more detail)

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

If you use this medication as meal-time insulin and you forget to use your dose before a meal, use the insulin when you remember and wait 10 minutes before eating.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an insulin inhalation overdose may be the same as signs of low blood sugar: confusion, drowsiness, weakness, fast heartbeat, sweating, tremor, and nausea.

What should I avoid while taking insulin inhalation? Do not smoke while using insulin inhalation. You should not use this medication if you have smoked within the past 6 months. If you start smoking while using insulin inhalation, you will have to stop using the medication and switch to another form of insulin to control your blood sugar.

Avoid letting your blood sugar get too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Insulin inhalation side effects

Hypoglycemia (low blood sugar) is the most common side effect of insulin inhalation. Watch for signs of low blood sugar, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Get emergency medical help if you have any of these signs of an allergic reaction: rash, hives, or itching; wheezing, gasping for breath; fast heartbeat; sweating; feeling light-headed or fainting.

Other less serious side effects are more likely to occur, such as:

cough, sore throat;

runny or stuffy nose;

dry mouth; or

ear pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Insulin inhalation Dosing Information

Usual Adult Dose for Diabetes Mellitus Type II:

Initial pre-meal doses may be calculated using the following formula: [Body weight (kg) X 0.05 mg/kg = pre-meal dose (mg)] rounded down to the nearest whole milligram number (e.g., 3.7 mg rounded down to 3 mg).
A 1 mg blister of insulin inhalation is approximately equivalent to 3 units of subcutaneously injected regular human insulin. A 3 mg blister is approximately equivalent to 8 units of subcutaneously injected regular human insulin.
Patients should combine 1 mg and 3 mg blisters so that the least number of blisters per dose are taken (e.g., a 4 mg dose should be administered as one 1 mg blister and one 3 mg blister). Consecutive inhalation of three 1 mg unit dose blisters results in significantly greater insulin exposure than inhalation of one 3 mg unit dose blister. Therefore, three 1 mg doses should not be substituted for one 3 mg dose
Insulin inhalation doses should be administered immediately prior to meals (no more than 10 minutes prior to each meal).
In patients with type 1 diabetes, insulin inhalation should be used in regimens that include a longer acting insulin.
For patients with type 2 diabetes, insulin inhalation may be used as monotherapy or in combination with oral agents or longer-acting insulin.

Usual Adult Dose for Diabetes Mellitus Type I:

Initial pre-meal doses may be calculated using the following formula: [Body weight (kg) X 0.05 mg/kg = pre-meal dose (mg)] rounded down to the nearest whole milligram number (e.g., 3.7 mg rounded down to 3 mg).
A 1 mg blister of insulin inhalation is approximately equivalent to 3 units of subcutaneously injected regular human insulin. A 3 mg blister is approximately equivalent to 8 units of subcutaneously injected regular human insulin.
Patients should combine 1 mg and 3 mg blisters so that the least number of blisters per dose are taken (e.g., a 4 mg dose should be administered as one 1 mg blister and one 3 mg blister). Consecutive inhalation of three 1 mg unit dose blisters results in significantly greater insulin exposure than inhalation of one 3 mg unit dose blister. Therefore, three 1 mg doses should not be substituted for one 3 mg dose
Insulin inhalation doses should be administered immediately prior to meals (no more than 10 minutes prior to each meal).
In patients with type 1 diabetes, insulin inhalation should be used in regimens that include a longer acting insulin.
For patients with type 2 diabetes, insulin inhalation may be used as monotherapy or in combination with oral agents or longer-acting insulin.

What other drugs will affect insulin inhalation?

There are many other drugs that can potentially interfere with the glucose-lowering effects of insulin inhalation. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

If you use other inhaled medications, use them before using insulin inhalation.

More insulin inhalation resources Insulin inhalation Dosage Insulin inhalation Use in Pregnancy & Breastfeeding Insulin inhalation Drug Interactions Insulin inhalation Support Group 4 Reviews for Insulin - Add your own review/rating Compare insulin inhalation with other medications Diabetes, Type 1 Diabetes, Type 2 Where can I get more information? Your pharmacist can provide more information about insulin inhalation.
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antihemophilic factor human


Generic Name: antihemophilic factor (human) (an tee hee moe FIL ik FAK tor)
Brand Names: Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P

What is human antihemophilic factor?

Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is the cause of hemophilia A.

This medication works by temporarily raising levels of factor VIII in the blood to aid in clotting.

Human antihemophilic factor is used to treat or prevent bleeding episodes in adults and children with hemophilia A. It is also used to control bleeding related to surgery or dentistry in a person with hemophilia.

Human antihemophilic factor is not for use in people with von Willebrand disease.

Human antihemophilic factor may also be used for purposes not listed in this medication guide.

What is the most important information I should know about human antihemophilic factor? Do not use this medicine if you have ever had a severe allergic reaction to antihemophilic factor in the past, or if you are allergic to mouse proteins.

Before using human antihemophilic factor, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Human antihemophilic factor will not treat von Willebrand disease.

Your body may develop antibodies to this medication, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

To be sure this medication is helping your condition and is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder. This medicine is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication. What should I discuss with my health care provider before using human antihemophilic factor? Do not use this medicine if you have ever had a severe allergic reaction to antihemophilic factor in the past, or if you are allergic to mouse proteins.

Before using human antihemophilic factor, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Human antihemophilic factor will not treat von Willebrand disease.

FDA pregnancy category C. It is not known whether antihemophilic factor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether human antihemophilic factor passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. This medicine is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication. Your doctor may want you to receive a hepatitis vaccination before you start using human antihemophilic factor. How should I use human antihemophilic factor?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Human antihemophilic factor is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Always wash your hands before preparing and giving your injection.

Human antihemophilic factor must be mixed with a liquid (diluent) before injecting it. If you store your medicine in the refrigerator, take a medicine and diluent vial out of the refrigerator and allow each to reach room temperature before mixing them.

Gently swirl the medicine and diluent to mix them and allow the medicine to completely dissolve.

After mixing the medicine and diluent, the mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Each vial is for one use only. After measuring your dose, throw the vial away, even if there is medicine left in it.

Do not use this medicine if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Check your pulse before and during your injection. If your pulse becomes rapid, slow down or stop the injection until your pulse rate returns to normal.

Human antihemophilic factor is usually given every 8 to 24 hours for 1 to 4 days, depending on the reason you are using the medication. For surgery, you may need to use the medicine for 10 to 14 days.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.

Your body may develop antibodies to antihemophilic factor, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder. Store the medication and the diluent in the refrigerator and do not allow them to freeze. You may also store the medicine and diluent at room temperature until the expiration date on the label. Some brands of this medicine (such as Koate-DVI and Monoclate) may be stored at room temperature for up to 6 months. Follow the storage directions on the medicine label.

Do not store this medicine in bright light. Throw away any leftover medicine and diluent if the expiration date has passed.

What happens if I miss a dose?

Human antihemophilic factor is sometimes used only as needed, so you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using human antihemophilic factor?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Human antihemophilic factor side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat. Stop using this medicine and call your doctor at once if you have a serious side effect such as:

easy bruising, increased bleeding episodes;

bleeding from a wound or where the medicine was injected;

fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later; or

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

mild nausea or stomach pain;

tingly or jittery feeling;

blurred vision;

headache; or

swelling, stinging, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Antihemophilic factor Dosing Information

Usual Adult Dose for Hemophilia A:

Although dosage must be individualized according to the needs of the patient (weight, severity of hemorrhage, presence of inhibitors), the following general dosages are suggested:
Number of AHF I.U. required = (body weight (in kg) x desired Factor VIII increase (% normal)) x 0.5
Dosage necessary to maintain the therapeutic plasma level bases on bleeding episode:
Minor hemorrhage (superficial, early hemorrhages, hemorrhages into joints): Therapeutically necessary plasma level of FVIII activity is 20% to 40% of normal, repeated every 12 to 24 hours as necessary until resolved. (At least 1 day, depending upon the severity of the bleeding episode.)
Moderate (bleeding into muscles, mild head trauma, bleeding into the oral cavity): Therapeutically necessary plasma level of FVIII activity is 30% to 60% of normal, repeated every 12 to 24 hours for 3-4 days or until adequate local hemostasis is achieved.
Major (gastrointestinal bleeding, intracranial, intraabdominal or intrathoracic bleeding, fractures): Therapeutically necessary plasma level of FVIII activity is 60% to 100 % of normal, repeated every 8 to 24 hours until bleeding is resolved, resolved, or in the case of surgery, until adequate local hemostasis and wound healing are achieved.

Usual Pediatric Dose for Hemophilia A:

Routine prophylaxis to prevent or reduce the frequency of bleeding episodes:
Up to 16 years of age: 20 to 40 IU per kg every other day (3 to 4 times weekly). Alternatively, an every third day dosing regimen targeted to maintain Factor VIII trough levels greater than 1% may be employed.
Dosage necessary to maintain the therapeutic plasma level based on an active bleeding episode:
Although dosage must be individualized according to the needs of the patient (weight, severity of hemorrhage, presence of inhibitors), the following general dosages are suggested: Number of Antihemophilic Factor IU required = (body weight (in kg) x desired Factor VIII increase (% normal)) x 0.5
or
Minor hemorrhage (superficial, early hemorrhages, hemorrhages into joints): Therapeutically necessary plasma level of Factor VIII activity is 20% to 40% of normal, repeated every 12 to 24 hours as necessary until resolved. (At least 1 day, depending upon the severity of the bleeding episode.)
Moderate (bleeding into muscles, mild head trauma, bleeding into the oral cavity): Therapeutically necessary plasma level of Antihemophilic Factor VIII activity is 30% to 60% of normal, repeated every 12 to 24 hours for 3-4 days or until adequate local hemostasis is achieved.
Major (gastrointestinal bleeding, intracranial, intra abdominal or intrathoracic bleeding, fractures): Therapeutically necessary plasma level of Antihemophilic Factor VIII activity is 60% to 100 % of normal, repeated every 8 to 24 hours until bleeding is resolved, resolved, or in the case of surgery, until adequate local hemostasis and wound healing are achieved.

What other drugs will affect human antihemophilic factor?

There may be other drugs that can interact with human antihemophilic factor. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More antihemophilic factor resources Antihemophilic factor Side Effects (in more detail) Antihemophilic factor Dosage Antihemophilic factor Use in Pregnancy & Breastfeeding Antihemophilic factor Support Group 0 Reviews for Antihemophilic factor - Add your own review/rating Compare antihemophilic factor with other medications Hemophilia A Where can I get more information? Your pharmacist can provide more information about human antihemophilic factor.

See also: antihemophilic factor side effects (in more detail)


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Solaraze


Generic Name: diclofenac topical (dye KLOE fen ak TOP ik al)
Brand Names: Pennsaid, Solaraze, Voltaren Topical

What is Solaraze (diclofenac topical)?

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Diclofenac topical 1% gel (Voltaren Topical) is used to treat joint pain in the hands, wrists, elbows, knees, ankles, or feet caused by osteoarthritis. This medication may not be effective in treating arthritis pain elsewhere in the body.

Diclofenac topical 1.5% solution (Pennsaid) is used to treat pain in the knees caused by osteoarthritis. This medication may not be effective in treating arthritis pain elsewhere in the body.

Diclofenac topical 3% gel (Solaraze) is used to treat warty overgrowths of skin (actinic keratoses) on sun-exposed areas of the body.

Diclofenac topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Solaraze (diclofenac topical)? Do not use this medication if you have ever had asthma or a severe allergic reaction caused by aspirin, diclofenac (Cataflam, Voltaren), or another non-steroidal anti-inflammatory drug (NSAID). Do not use diclofenac just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Before using this medication, tell your doctor if you have heart disease, congestive heart failure, high blood pressure, a history of heart attack or stroke, a history of stomach ulcer or bleeding, liver or kidney disease, a blood clotting disorder, asthma, or nasal polyps.

While the risk of absorbing diclofenac topical into your bloodstream is low, an NSAID may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using diclofenac topical, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds. What should I discuss with my healthcare provider before using Solaraze (diclofenac topical)?

While the risk of absorbing diclofenac topical into your bloodstream is low, an NSAID can cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using diclofenac topical, especially in older adults.

Do not use this medication if you have ever had asthma or a severe allergic reaction caused by aspirin, diclofenac (Cataflam, Voltaren), or another NSAID. Do not use diclofenac just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

To make sure you can safely use diclofenac topical, tell your doctor if you have any of these other conditions:

a history of drug allergies;

a history of heart attack, stroke, or blood clot;

heart disease, congestive heart failure, high blood pressure;

a history of stomach ulcer or bleeding;

liver or kidney disease;

a bleeding or blood clotting disorder; or

asthma, or polyps in your nose.

This medication may be harmful to an unborn baby. If you are pregnant, ask your doctor if it is safe for you to use diclofenac topical. Tell your doctor if you become pregnant during treatment. Diclofenac topical can pass into breast milk and may harm a nursing baby. You should not breast-feed while using diclofenac topical. How should I use Solaraze (diclofenac topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. When treating osteoarthritis, keep using any oral medications your doctor has prescribed.

Do not use diclofenac topical on an open skin wound, or on areas of eczema, infection, skin rash, or burn injury. Do not cover the treated skin with a bandage or expose it to heat from a hot tub, heating pad, sauna, or heated water bed. Heat or bandaging can increase the amount of drug you absorb through your skin and may cause harmful effects. Wash your hands after applying this medication, unless you are treating the skin on your hands. Do not wear gloves for at least 10 minutes after applying diclofenac topical to the hands.

After you apply diclofenac topical gel, wait at least 10 minutes before dressing and at least 1 hour before you bathe or shower.

To treat actinic keratosis (with Solaraze): Apply enough gel to cover each lesion and rub in gently. Do not apply Solaraze gel more than 2 times daily and never use more than your prescribed dose.

To treat osteoarthritis knee pain (with Pennsaid): Apply the solution only to clean, dry skin. Place 10 drops at a time into your hand and spread the solution over the front, back, and sides of the knee. Apply a total of 40 drops to each affected knee, 4 times per day. You may also drop the medicine directly onto the knee, spreading after every 10 drops.

Wait until the solution is completely dry before covering treated skin with clothing or applying any other skin products, including sunscreen.

To treat osteoarthritis pain (with Voltaren Topical): This medicine is supplied with dosing cards that show you how much gel to use for a 2-gram dose or a 4-gram dose. Squeeze the gel onto this card along the line for your dose. Use no more gel than will fit on the length of your dosing line. Wipe the card directly onto the treatment area and rub gently into the skin.

To treat arthritis pain in the foot, spread the gel out onto all areas of the foot including the toes and soles. When treating the hand, spread the gel out onto all areas of the hand including the fingers and palms.

Store at room temperature away from moisture and heat. Do not freeze. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Solaraze (diclofenac topical)? Avoid drinking alcohol. It may increase your risk of stomach bleeding. Do not use cosmetics, sunscreen, lotions, insect repellant, or other medicated skin products on the same area you treat with diclofenac topical. Avoid getting this medication in your mouth, nose, or eyes. If this does happen, rinse with water. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds) while you are using diclofenac topical.

Avoid taking aspirin, oral (pill form) diclofenac (Cataflam, Voltaren), or other NSAIDs without your doctor's advice. This includes ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others.

Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Aspirin and other medicines similar to diclofenac are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen. Solaraze (diclofenac topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;

bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

pale or yellowed skin, dark colored urine, confusion;

swelling or rapid weight gain, urinating less than usual or not at all;

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

bruising, severe tingling, numbness, pain, muscle weakness;

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

mild nausea, stomach pain, upset stomach;

diarrhea, gas; or

mild itching, dryness, redness, scaling, or other skin irritation where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Solaraze (diclofenac topical)?

Tell your doctor about all other medicines you use, especially:

a blood thinner such as warfarin (Coumadin, Jantoven);

cyclosporine (Gengraf, Neoral, Sandimmune);

lithium (Eskalith, Lithobid);

methotrexate (Rheumatrex, Trexall);

a diuretic (water pill);

steroids (prednisone and others); or

heart or blood pressure medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

It is not likely that other drugs you take orally or inject will have an effect on topically applied diclofenac. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Solaraze resources Solaraze Side Effects (in more detail) Solaraze Use in Pregnancy & Breastfeeding Solaraze Drug Interactions Solaraze Support Group 0 Reviews for Solaraze - Add your own review/rating Solaraze Prescribing Information (FDA) Solaraze topical Monograph (AHFS DI) Solaraze Topical Advanced Consumer (Micromedex) - Includes Dosage Information Solaraze Gel MedFacts Consumer Leaflet (Wolters Kluwer) Pennsaid Solution MedFacts Consumer Leaflet (Wolters Kluwer) Pennsaid Prescribing Information (FDA) Pennsaid Consumer Overview Compare Solaraze with other medications Actinic Keratosis Where can I get more information? Your pharmacist can provide more information about diclofenac topical.

See also: Solaraze side effects (in more detail)


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Allegra Suspension


Pronunciation: FEX-oh-FEN-a-deen
Generic Name: Fexofenadine
Brand Name: Allegra
Allegra Suspension is used for:

Treating seasonal allergy symptoms such as sneezing, runny nose, itchy throat, or itchy, watery eyes. It is also used to treat hives and skin itching. It may also be used for other conditions as determined by your doctor.

Allegra Suspension is an antihistamine. It works by blocking a substance in the body called histamine. This helps to decrease allergy symptoms.

Do NOT use Allegra Suspension if: you are allergic to any ingredient in Allegra Suspension

Contact your doctor or health care provider right away if any of these apply to you.

Before using Allegra Suspension:

Some medical conditions may interact with Allegra Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have kidney problems or trouble urinating

Some MEDICINES MAY INTERACT with Allegra Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Erythromycin or ketoconazole because they may increase the risk of Allegra Suspension's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Allegra Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Allegra Suspension:

Use Allegra Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Allegra Suspension by mouth with or without food. Shake well before each use. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. Do not drink fruit juice at the same time that you take Allegra Suspension. Certain fruit juices (eg, grapefruit, apple, orange) may decrease Allegra Suspension's effectiveness. If you take antacids that contain aluminum or magnesium, do not take them at the same time as Allegra Suspension. Ask your doctor or pharmacist how to take them with Allegra Suspension. If you miss a dose of Allegra Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Allegra Suspension.

Important safety information: Allegra Suspension may cause dizziness. It does not usually cause drowsiness when used under normal circumstances at the recommended doses. However, these effects may be worse if you take Allegra Suspension with alcohol or certain medicines. Use Allegra Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Allegra Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Allegra Suspension for a few days before the tests. Use Allegra Suspension with caution in the ELDERLY; they may be more sensitive to its effects. Allegra Suspension should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Allegra Suspension while you are pregnant. It is not known if Allegra Suspension is found in breast milk. If you are or will be breast-feeding while you use Allegra Suspension, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Allegra Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); earache; fever; severe or persistent coughing or vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Allegra side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include unusual or severe dizziness, drowsiness, or dry mouth.

Proper storage of Allegra Suspension:

Store Allegra Suspension between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Allegra Suspension out of the reach of children and away from pets.

General information: If you have any questions about Allegra Suspension, please talk with your doctor, pharmacist, or other health care provider. Allegra Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people. Carry an identification card at all times that says you are taking Allegra Suspension. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Allegra Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Allegra resources Allegra Side Effects (in more detail) Allegra Use in Pregnancy & Breastfeeding Drug Images Allegra Drug Interactions Allegra Support Group 21 Reviews for Allegra - Add your own review/rating Compare Allegra with other medications Hay Fever Urticaria
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