Travatan Drops


Pronunciation: TRAV-oh-prost
Generic Name: Travoprost
Brand Name: Travatan
Travatan Drops are used for:

Treating increased pressure in the eye (ocular hypertension) and open-angle glaucoma in patients who cannot use or do not respond to other medicines.

Travatan Drops are a prostaglandin analog. It works to lower pressure in the eye by increasing fluid drainage from the eye.

Do NOT use Travatan Drops if: you are allergic to any ingredient in Travatan Drops you have inflammation in the eye (eg, iritis, uveitis)

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

Before using Travatan Drops:

Some medical conditions may interact with Travatan Drops. 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 swelling, infection, or injury of the eye, or you have a history of inflammation in the eye (eg, iritis, uveitis) if you do not have a lens in your eye or have had the lens in your eye replaced if you have other types of glaucoma (eg, narrow-angle, neovascular) if you will be having eye surgery

Some MEDICINES MAY INTERACT with Travatan Drops. However, no specific interactions with Travatan Drops are known at this time.

Ask your health care provider if Travatan Drops 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 Travatan Drops:

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

Use Travatan Drops in the evening unless your doctor tells you otherwise. Soft contact lenses may absorb a chemical in Travatan Drops. Remove contact lenses before you use Travatan Drops; lenses may be placed back in the eyes 15 minutes after use of Travatan Drops. Wash your hands before and after using Travatan Drops. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed. Use Travatan Drops at least 5 minutes apart from any other medicine that you put in your eye. Continue to use Travatan Drops even if you feel well. Do not miss any doses. If you miss a dose of Travatan Drops, use 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 use 2 doses at once.

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

Important safety information: Travatan Drops are for use in the eye only. Do not get it in your nose or mouth. Travatan Drops may cause blurred vision or make your eyes more sensitive to light. Use Travatan Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. If your eyes become sensitive to light, wearing sunglasses may help. Travatan Drops may cause the colored part of your eye (iris) to turn brown. This change may be permanent. It may not be noticeable for several months to years. If it occurs, you will need to have regular eye examinations. Discuss any questions or concerns with your doctor. Travatan Drops may cause your eyelids to darken. It may also cause changes in the way that your eyelashes grow (eg, length, thickness, number of lashes). This change may be permanent. Discuss any questions or concerns with your doctor. Do NOT use more than the recommended dose without checking with your doctor. If you will be having eye surgery, tell your doctor that you use Travatan Drops. Lab tests, including eye pressure, may be performed while you use Travatan Drops. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Travatan Drops should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Travatan Drops while you are pregnant. It is not known if Travatan Drops are found in breast milk. If you are or will be breast-feeding while you use Travatan Drops, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Travatan Drops:

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:

Bloodshot eyes; blurred vision; changes in eyelash growth; eye dryness, itching, or discomfort; feeling of having something in your eye; headache; increased tear production.

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); chest pain; darkening of the eyelid or eye color; eye or eyelid crusting, discharge, inflammation, irritation, pain, or swelling; severe headache or dizziness; slow heartbeat; vision changes.

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: Travatan 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 Travatan Drops:

Store Travatan Drops between 36 and 77 degrees F (2 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Travatan Drops out of the reach of children and away from pets.

General information: If you have any questions about Travatan Drops, please talk with your doctor, pharmacist, or other health care provider. Travatan Drops are 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 Travatan Drops. 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 Travatan resources Travatan Side Effects (in more detail) Travatan Use in Pregnancy & Breastfeeding Travatan Drug Interactions Travatan Support Group 1 Review for Travatan - Add your own review/rating Compare Travatan with other medications Glaucoma, Open Angle Intraocular Hypertension


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Travatan Z Drops


Pronunciation: TRAV-oh-prost
Generic Name: Travoprost
Brand Name: Travatan Z
Travatan Z Drops are used for:

Treating increased pressure in the eye (ocular hypertension) and open-angle glaucoma in patients who cannot use or do not respond to other medicines.

Travatan Z Drops are a prostaglandin analog. It works to lower pressure in the eye by increasing fluid drainage from the eye.

Do NOT use Travatan Z Drops if: you are allergic to any ingredient in Travatan Z Drops you have inflammation in the eye (eg, iritis, uveitis)

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

Before using Travatan Z Drops:

Some medical conditions may interact with Travatan Z Drops. 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 swelling, infection, or injury of the eye, or you have a history of inflammation in the eye (eg, iritis, uveitis) if you do not have a lens in your eye or have had the lens in your eye replaced if you have other types of glaucoma (eg, narrow-angle, neovascular) if you will be having eye surgery

Some MEDICINES MAY INTERACT with Travatan Z Drops. However, no specific interactions with Travatan Z Drops are known at this time.

Ask your health care provider if Travatan Z Drops 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 Travatan Z Drops:

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

Use Travatan Z Drops in the evening unless your doctor tells you otherwise. Remove contact lenses before you use Travatan Z Drops; lenses may be placed back in the eyes 15 minutes after use of Travatan Z Drops. Wash your hands before and after using Travatan Z Drops. Some brands of Travatan Z Drops contain a chemical (benzalkonium chloride) that can be absorbed by contact lenses. Check with your pharmacist to see if your brand contains this chemical. If so, you will need to remove your contact lenses before you use Travatan Z Drops; lenses may be placed back in the eyes 15 minutes after use of Travatan Z Drops. Wash your hands before and after using Travatan Z Drops. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed. Use Travatan Z Drops at least 5 minutes apart from any other medicine that you put in your eye. Continue to use Travatan Z Drops even if you feel well. Do not miss any doses. If you miss a dose of Travatan Z Drops, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Travatan Z Drops.

Important safety information: Travatan Z Drops are for use in the eye only. Do not get it in your nose or mouth. Travatan Z Drops may cause blurred vision or make your eyes more sensitive to light. Use Travatan Z Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. If your eyes become sensitive to light, wearing sunglasses may help. Travatan Z Drops may cause the colored part of your eye (iris) to turn brown. This change may be permanent. It may not be noticeable for several months to years. If it occurs, you will need to have regular eye examinations. Discuss any questions or concerns with your doctor. Travatan Z Drops may cause your eyelids and eyelashes to darken. This change may be reversible in some patients. Discuss any questions or concerns with your doctor. Travatan Z Drops may cause changes in the way that your eyelashes grow (eg, length, thickness, number of lashes). These changes are usually reversible after the medicine is stopped. Discuss any questions or concerns with your doctor. Do NOT use more than the recommended dose without checking with your doctor. If you will be having eye surgery, tell your doctor that you use Travatan Z Drops. Contact your doctor if you develop an eye infection or if you injure your eye. Lab tests, including eye pressure, may be performed while you use Travatan Z Drops. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Travatan Z Drops should not be used in CHILDREN younger than 16 years 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 Travatan Z Drops while you are pregnant. It is not known if Travatan Z Drops are found in breast milk. If you are or will be breast-feeding while you use Travatan Z Drops, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Travatan Z Drops:

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:

Bloodshot eyes; blurred vision; changes in eyelash growth; eye dryness, itching, or discomfort; feeling of having something in your eye; headache; increased tear production.

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); chest pain; darkening of the eyelid or eye color; eye or eyelid crusting, discharge, inflammation, irritation, pain, or swelling; severe headache or dizziness; slow heartbeat; vision changes.

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: Travatan Z 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 Travatan Z Drops:

Store Travatan Z Drops between 36 and 77 degrees F (2 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Travatan Z Drops out of the reach of children and away from pets.

General information: If you have any questions about Travatan Z Drops, please talk with your doctor, pharmacist, or other health care provider. Travatan Z Drops are 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 a summary only. It does not contain all information about Travatan Z Drops. 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 Travatan Z resources Travatan Z Side Effects (in more detail) Travatan Z Use in Pregnancy & Breastfeeding Travatan Z Drug Interactions Travatan Z Support Group 1 Review for Travatan Z - Add your own review/rating Compare Travatan Z with other medications Glaucoma, Open Angle Intraocular Hypertension


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Travatan Z


Generic Name: travoprost ophthalmic (TRA voe prost off THAL mik)
Brand Names: Travatan, Travatan Z

What is travoprost ophthalmic?

Travoprost ophthalmic (for the eye) reduces pressure in the eye by increasing the amount of fluid that drains from the eye.

Travoprost ophthalmic is used to treat certain types of glaucoma and other causes of high pressure inside the eye.

Travoprost ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about travoprost ophthalmic?

Travoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

After using this medication, wait at least 5 minutes before using any other eye drops that your doctor has prescribed.

What should I discuss with my health care provider before using travoprost ophthalmic? Do not use this medication if you are allergic to travoprost.

Before using travoprost, tell your doctor if you are allergic to any drugs, or if you have swelling or infection of your eye.

Travoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

FDA pregnancy category C. It is not known whether travoprost is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether travoprost 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 travoprost ophthalmic?

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.

Wash your hands before using the eye drops.

To apply the eye drops:

Tilt your head back slightly and pull down on the lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper. Squeeze out a drop and close your eye. Gently press your finger to the inside corner of the eye (near the nose) for about 1 minute to keep the liquid from draining into your tear duct.

If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop. Also wait at least 5 minutes before using any other eye drops that your doctor has prescribed.

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye. At any time during your use of travoprost ophthalmic, tell your doctor at once if you have an eye injury, if you develop an eye infection, or if you plan to have eye surgery. Do not use the eye drops if the liquid changes colors or has particles in it. Store the drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use. 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 use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

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

An overdose of travoprost ophthalmic used in the eyes is not expected to produce life-threatening symptoms.

What should I avoid while using travoprost ophthalmic? Avoid using too much of this medication, which can actually make it less effective in lowering the pressure inside the eye.

Avoid using any eyedrop medicine that has not been prescribed by your doctor.

Travoprost ophthalmic 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. Stop using travoprost ophthalmic and call your doctor at once if you have any of these serious side effects:

redness, swelling, itching, or pain in or around your eye;

oozing or discharge from your eye;

increased sensitivity to light;

vision changes; or

chest pain.

Less serious side effects may include:

mild eye discomfort;

headache;

feeling like something is in your eye;

blurred vision;

dry or watery eyes; or

stinging or burning of the eyes after using the drops.

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 travoprost ophthalmic?

There may be other drugs that can affect travoprost ophthalmic. 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 Travatan Z resources Travatan Z Side Effects (in more detail) Travatan Z Use in Pregnancy & Breastfeeding Travatan Z Drug Interactions Travatan Z Support Group 1 Review for Travatan Z - Add your own review/rating Travatan Z Consumer Overview Travatan Z Drops MedFacts Consumer Leaflet (Wolters Kluwer) Travatan Prescribing Information (FDA) Travatan Monograph (AHFS DI) Travatan Advanced Consumer (Micromedex) - Includes Dosage Information Travatan Consumer Overview Travatan Drops MedFacts Consumer Leaflet (Wolters Kluwer) Compare Travatan Z with other medications Glaucoma, Open Angle Intraocular Hypertension Where can I get more information? Your pharmacist can provide more information about travoprost ophthalmic.

See also: Travatan Z side effects (in more detail)


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travoprost ophthalmic


Generic Name: travoprost ophthalmic (TRA voe prost off THAL mik)
Brand Names: Travatan, Travatan Z

What is travoprost ophthalmic?

Travoprost ophthalmic (for the eye) reduces pressure in the eye by increasing the amount of fluid that drains from the eye.

Travoprost ophthalmic is used to treat certain types of glaucoma and other causes of high pressure inside the eye.

Travoprost ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about travoprost ophthalmic?

Travoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

After using this medication, wait at least 5 minutes before using any other eye drops that your doctor has prescribed.

What should I discuss with my health care provider before using travoprost ophthalmic? Do not use this medication if you are allergic to travoprost.

Before using travoprost, tell your doctor if you are allergic to any drugs, or if you have swelling or infection of your eye.

Travoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

FDA pregnancy category C. It is not known whether travoprost is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether travoprost 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 travoprost ophthalmic?

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.

Wash your hands before using the eye drops.

To apply the eye drops:

Tilt your head back slightly and pull down on the lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper. Squeeze out a drop and close your eye. Gently press your finger to the inside corner of the eye (near the nose) for about 1 minute to keep the liquid from draining into your tear duct.

If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop. Also wait at least 5 minutes before using any other eye drops that your doctor has prescribed.

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye. At any time during your use of travoprost ophthalmic, tell your doctor at once if you have an eye injury, if you develop an eye infection, or if you plan to have eye surgery. Do not use the eye drops if the liquid changes colors or has particles in it. Store the drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use. 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 use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

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

An overdose of travoprost ophthalmic used in the eyes is not expected to produce life-threatening symptoms.

What should I avoid while using travoprost ophthalmic? Avoid using too much of this medication, which can actually make it less effective in lowering the pressure inside the eye.

Avoid using any eyedrop medicine that has not been prescribed by your doctor.

Travoprost ophthalmic 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. Stop using travoprost ophthalmic and call your doctor at once if you have any of these serious side effects:

redness, swelling, itching, or pain in or around your eye;

oozing or discharge from your eye;

increased sensitivity to light;

vision changes; or

chest pain.

Less serious side effects may include:

mild eye discomfort;

headache;

feeling like something is in your eye;

blurred vision;

dry or watery eyes; or

stinging or burning of the eyes after using the drops.

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.

Travoprost ophthalmic Dosing Information

Usual Adult Dose for Intraocular Hypertension:

Instill 1 drop in the affected eye(s) once daily in the evening.

Usual Adult Dose for Glaucoma (Open Angle):

Instill 1 drop in the affected eye(s) once daily in the evening.

Usual Pediatric Dose for Intraocular Hypertension:

16 years and older:
Instill 1 drop in the affected eye(s) once daily in the evening.

Usual Pediatric Dose for Glaucoma (Open Angle):

16 years and older:
Instill 1 drop in the affected eye(s) once daily in the evening.

What other drugs will affect travoprost ophthalmic?

There may be other drugs that can affect travoprost ophthalmic. 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 travoprost ophthalmic resources Travoprost ophthalmic Side Effects (in more detail) Travoprost ophthalmic Dosage Travoprost ophthalmic Use in Pregnancy & Breastfeeding Travoprost ophthalmic Drug Interactions Travoprost ophthalmic Support Group 2 Reviews for Travoprost - Add your own review/rating Travatan Advanced Consumer (Micromedex) - Includes Dosage Information Travatan Consumer Overview Travatan Drops MedFacts Consumer Leaflet (Wolters Kluwer) Travatan Prescribing Information (FDA) Travatan Monograph (AHFS DI) Travatan Z Drops MedFacts Consumer Leaflet (Wolters Kluwer) Travatan Z Consumer Overview Compare travoprost ophthalmic with other medications Glaucoma, Open Angle Intraocular Hypertension Where can I get more information? Your pharmacist can provide more information about travoprost ophthalmic.

See also: travoprost side effects (in more detail)


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Ophthalmic glaucoma agents


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

See also

Medical conditions associated with ophthalmic glaucoma agents:

Eye Conditions Glaucoma Glaucoma, Open Angle Glaucoma/Intraocular Hypertension Intraocular Hypertension Postoperative Increased Intraocular Pressure Production of Miosis Drug List: Travatan Travatan_Z Cosopt Lumigan Timoptic-Ocudose Xalatan Istalol Alphagan Combigan Timoptic-Drops Alphagan-P Ak-Beta Azopt-Drops Betagan-Drops Betaxon Betimol-Drops Betoptic Betoptic-S-Drops Carbastat-Ocular Carboptic-Drops E-Pilo-1 E-Pilo-2 E-Pilo-4 E-Pilo-6 Epifrin Eppy-N Eserine-Sulfate-Ophthalmic Glaucon Humorsol-Ocumeter Iopidine-Drops Isopto-Carbachol-Drops Isopto-Carpine-Drops Miochol-E Miostat-Ocular Ocu-Carpine Ocupress Optipranolol-Drops P1E1 P2E1 P3E1 P4E1 P6E1 Phospholine-Iodide-Eye-Drops Pilocar-Drops Pilopine-Hs-Gel Pilostat Propine Rescula Timoptic-Xe-Gel-Eye-Drops Trusopt-Drops


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Travatan



Dosage Form: ophthalmic solution
FULL PRESCRIBING INFORMATION Indications and Usage for Travatan

Travatan Z® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Travatan Dosage and Administration

The recommended dosage is one drop in the affected eye(s) once daily in the evening. Travatan Z® (travoprost ophthalmic solution) should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect.

Reduction of the intraocular pressure starts approximately 2 hours after the first administration with maximum effect reached after 12 hours.

Travatan Z® may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

Dosage Forms and Strengths

Ophthalmic solution containing travoprost 0.04 mg/mL.

Contraindications

None

Warnings and Precautions Pigmentation

Travoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known.

Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with Travatan Z® (travoprost ophthalmic solution) 0.004% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. (see PATIENT COUNSELING INFORMATION, 17.1).

Eyelash Changes

Travatan Z® may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.

Intraocular Inflammation

Travatan Z® should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

Macular Edema

Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. Travatan Z® should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Angle-closure, Inflammatory or Neovascular Glaucoma

Travatan Z® has not been evaluated for the treatment of angle-closure, inflammatory or neovascular glaucoma.

Bacterial Keratitis

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PATIENT COUNSELING INFORMATION, 17.3).

Use with Contact Lenses

Contact lenses should be removed prior to instillation of Travatan Z® and may be reinserted 15 minutes following its administration.

Adverse Reactions Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The most common adverse reaction observed in controlled clinical studies with Travatan® (travoprost ophthalmic solution) 0.004% and Travatan Z® (travoprost ophthalmic solution) 0.004% was ocular hyperemia which was reported in 30 to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5 to 10% in these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain and pruritus.

Ocular adverse reactions reported at an incidence of 1 to 4% in clinical studies with Travatan® or Travatan Z® included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage and tearing.

Nonocular adverse reactions reported at an incidence of 1 to 5% in these clinical studies were allergy, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence and urinary tract infections.

In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.

USE IN SPECIFIC POPULATIONS Pregnancy

Pregnancy Category C

Teratogenic effects: Travoprost was teratogenic in rats, at an intravenous (IV) dose up to 10 mcg/kg/day (250 times the maximal recommended human ocular dose (MRHOD), evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, such as fused sternebrae, domed head and hydrocephaly. Travoprost was not teratogenic in rats at IV doses up to 3 mcg/kg/day (75 times the MRHOD), or in mice at subcutaneous doses up to 1 mcg/kg/day (25 times the MRHOD). Travoprost produced an increase in post-implantation losses and a decrease in fetal viability in rats at IV doses > 3 mcg/kg/day (75 times the MRHOD) and in mice at subcutaneous doses > 0.3 mcg/kg/day (7.5 times the MRHOD).

In the offspring of female rats that received travoprost subcutaneously from Day 7 of pregnancy to lactation Day 21 at doses of = 0.12 mcg/kg/day (3 times the MRHOD), the incidence of postnatal mortality was increased, and neonatal body weight gain was decreased. Neonatal development was also affected, evidenced by delayed eye opening, pinna detachment and preputial separation, and by decreased motor activity.

There are no adequate and well-controlled studies of Travatan Z® (travoprost ophthalmic solution) 0.004% administration in pregnant women. Because animal reproductive studies are not always predictive of human response, Travatan Z® should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

A study in lactating rats demonstrated that radiolabeled travoprost and/or its metabolites were excreted in milk. It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Travatan Z® is administered to a nursing woman.

Pediatric Use

Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

Hepatic and Renal Impairment

Travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in patients with renal impairment. No clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients.

Travatan Description

Travoprost is a synthetic prostaglandin F analogue. Its chemical name is [1R - [1?(Z),2?(1E,3R*),3?,5?]] - 7 - [3,5 - Dihydroxy - 2 - [3 - hydroxy - 4 - [3 - (trifluoromethyl) phenoxy]-1-butenyl]cyclopentyl]-5-heptenoic acid, 1-methylethylester. It has a molecular formula of C26H35F3O6 and a molecular weight of 500.55. The chemical structure of travoprost is:

Travoprost is a clear, colorless to slightly yellow oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is practically insoluble in water.

Travatan Z® (travoprost ophthalmic solution) 0.004% is supplied as sterile, buffered aqueous solution of travoprost with a pH of approximately 5.7 and an osmolality of approximately 290 mOsmol/kg.

Travatan Z® contains Active: travoprost 0.04 mg/mL; Inactives: polyoxyl 40 hydrogenated castor oil, sofZia® (boric acid, propylene glycol, sorbitol, zinc chloride), sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water, USP. Preserved in the bottle with an ionic buffered system, sofZia®.

Travatan - Clinical Pharmacology Mechanism of Action

Travoprost free acid, a prostaglandin analog is a selective FP prostanoid receptor agonist which is believed to reduce intraocular pressure by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time.

Pharmacokinetics

Travoprost is absorbed through the cornea and is hydrolyzed to the active free acid. Data from four multiple dose pharmacokinetic studies (totaling 107 subjects) have shown that plasma concentrations of the free acid are below 0.01 ng/ml (the quantitation limit of the assay) in two-thirds of the subjects. In those individuals with quantifiable plasma concentrations (N=38), the mean plasma Cmax was 0.018 ± 0.007 ng/ml (ranged 0.01 to 0.052 ng/mL) and was reached within 30 minutes. From these studies, travoprost is estimated to have a plasma half-life of 45 minutes. There was no difference in plasma concentrations between Days 1 and 7, indicating steady-state was reached early and that there was no significant accumulation.

Travoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea to its biologically active free acid. Systemically, travoprost free acid is metabolized to inactive metabolites via beta-oxidation of the ?(carboxylic acid) chain to give the 1,2-dinor and 1,2,3,4-tetranor analogs, via oxidation of the 15-hydroxyl moiety, as well as via reduction of the 13,14 double bond.

The elimination of travoprost free acid from plasma was rapid and levels were generally below the limit of quantification within one hour after dosing. The terminal elimination half-life of travoprost free acid was estimated from fourteen subjects and ranged from 17 minutes to 86 minutes with the mean half-life of 45 minutes. Less than 2% of the topical ocular dose of travoprost was excreted in the urine within 4 hours as the travoprost free acid.

Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year carcinogenicity studies in mice and rats at subcutaneous doses of 10, 30, or 100 mcg/kg/day did not show any evidence of carcinogenic potential. However, at 100 mcg/kg/day, male rats were only treated for 82 weeks, and the maximum tolerated dose (MTD) was not reached in the mouse study. The high dose (100 mcg/kg) corresponds to exposure levels over 400 times the human exposure at the maximum recommended human ocular dose (MRHOD) of 0.04 mcg/kg, based on plasma active drug levels.

Travoprost was not mutagenic in the Ames test, mouse micronucleus test or rat chromosome aberration assay. A slight increase in the mutant frequency was observed in one of two mouse lymphoma assays in the presence of rat S-9 activation enzymes.

Travoprost did not affect mating or fertility indices in male or female rats at subcutaneous doses up to 10 mcg/kg/day [250 times the maximum recommended human ocular dose of 0.04 mcg/kg/day on a mcg/kg basis (MRHOD)]. At 10 mcg/kg/day, the mean number of corpora lutea was reduced, and the post-implantation losses were increased. These effects were not observed at 3 mcg/kg/day (75 times the MRHOD).

Clinical Studies

In clinical studies, patients with open-angle glaucoma or ocular hypertension and baseline pressure of 25-27 mmHg who were treated with Travatan® (travoprost ophthalmic solution) 0.004% or Travatan Z® (travoprost ophthalmic solution) 0.004% dosed once-daily in the evening demonstrated 7-8 mmHg reductions in intraocular pressure. In subgroup analyses of these studies, mean IOP reduction in black patients was up to 1.8 mmHg greater than in non-black patients. It is not known at this time whether this difference is attributed to race or to heavily pigmented irides.

In a multi-center, randomized, controlled trial, patients with mean baseline intraocular pressure of 24-26 mmHg on TIMOPTIC* 0.5% BID who were treated with Travatan® (travoprost ophthalmic solution) 0.004% dosed QD adjunctively to TIMOPTIC* 0.5% BID demonstrated 6-7 mmHg reductions in intraocular pressure.

How Supplied/Storage and Handling

Travatan Z® (travoprost ophthalmic solution) 0.004% is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg/mL) supplied in Alcon's oval DROP-TAINER® package system.

Travatan Z® is supplied as a 2.5 mL solution in a 4 mL and a 5 mL solution in a 7.5 mL natural polypropylene dispenser bottle with a natural polypropylene dropper tip and a turquoise polypropylene or high density polyethylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

2.5 mL fill           NDC 0065-0260-25

5 mL fill              NDC 0065-0260-05

Storage: Store at 2° - 25°C (36° - 77°F).

Patient Counseling Information Potential for Pigmentation

Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of Travatan Z® (travoprost ophthalmic solution) 0.004%.

Potential for Eyelash Changes

Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye during treatment with Travatan Z®. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.

Handling the Container

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

When to Seek Physician Advice

Patients should also be advised that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of Travatan Z®.

Use with Contact Lenses

Contact lenses should be removed prior to instillation of Travatan Z® and may be reinserted 15 minutes following its administration.

Use with Other Ophthalmic Drugs

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications.

Rx Only

U.S. Patent Nos. 5,631,287; 5,889,052; 6,011,062; 6,235,781; 6,503,497 and 6,849,283

* TIMOPTIC is a registered trademark of Merck & Co., Inc.

ALCON®

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

© 2006, 2010, 2011 Novartis

9007509-1111

PRINCIPAL DISPLAY PANEL

NDC 0065 - 0260 - 25                   Rx Only

Travatan

(travoprost ophthalmic

solution) 0.004%

Alcon®                                      2.5 mL

                                                STERILE

      


Travatan
travoprost  solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0065-0260 Route of Administration OPHTHALMIC DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAVOPROST (TRAVOPROST) TRAVOPROST 0.04 mg  in 1 mL Inactive Ingredients Ingredient Name Strength POLYOXYL 40 CASTOR OIL   BORIC ACID   PROPYLENE GLYCOL   SORBITOL   ZINC CHLORIDE   SODIUM HYDROXIDE   HYDROCHLORIC ACID   WATER   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0065-0260-25 2.5 mL In 1 BOTTLE None 2 0065-0260-05 5 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021994 10/20/2006
Labeler - Alcon Laboratories, Inc (008018525) Registrant - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Operations Alcon Laboratories, Inc. 008018525 MANUFACTURE Revised: 09/2011Alcon Laboratories, Inc


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