Menstrual Disorders Medications


Definition of Menstrual Disorders: Menstrual disorders include painful, heavy or irregular periods.

Drugs associated with Menstrual Disorders

The following drugs and medications are in some way related to, or used in the treatment of Menstrual Disorders. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Menstrual Disorders Amenorrhea (20 drugs) Menorrhagia (1 drug) Period Pain (47 drugs) Premenstrual Dysphoric Disorder (31 drugs) Premenstrual Syndrome (15 drugs)
Drug List: Alyacen-1-35 Aranelle Balziva Brevicon Briellyn Cyclafem-1-35 Cyclafem-7-7-7 Estrostep-Fe Femcon-Fe-Chewable-Tablets Femhrt Genora-1-35 Gianvi Gildess-Fe-1-5-0-03 Gildess-Fe-1-0-2 Jenest Jevantique Junel-1-5-30 Junel-1-20 Junel-Fe-1-5-30 Junel-Fe-1-20 Leena Loestrin-1-20 Loestrin-21-1-5-30 Loestrin-21-1-20 Loestrin_24_Fe Loestrin-Fe-1-5-30 Loestrin-Fe-1-20 Loryna Lysteda Microgestin-1-5-30 Microgestin-1-20 Microgestin-Fe-1-5-30 Microgestin-Fe-1-20 Modicon Necon-0-5-35 Necon-1-35 Necon-10-11 Necon-7-7-7 Nelova-0-5-35 Norethin-1-35-E Norinyl-1-35 Nortrel-0-5-35 Nortrel-1-35 Nortrel-7-7-7 Ocella Ortho-Novum-1-35 Ortho-Novum-7-7-7 Ovcon-35 Ovcon-35-Fe Ovcon-50 Syeda Tilia-Fe Tri-Legest Tri-Legest-Fe Tri-Norinyl Vestura Yasmin Yaz Zenchent-Fe Zeosa


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Birth Control (Contraception) Medications


Definition of Birth Control: The prevention of conception or impregnation. More...

Drugs associated with Birth Control

The following drugs and medications are in some way related to, or used in the treatment of Birth Control. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Birth Control Emergency Contraception (14 drugs) Learn more about Birth Control (Contraception)

Medical Encyclopedia:

Birth control and family planning Emergency contraception Over-the-counter birth control
Drug List: Alesse Altavera Amethia Amethia-Lo Amethyst Apri Aranelle Aviane Balziva Beyaz Brevicon Briellyn Camila Camrese Caziant Cesia Cryselle-28 Cyclafem-1-35 Cyclafem-7-7-7 Cyclessa Demulen Depo-Provera Depo-Provera-Contraceptive-Injectable Depo-Subq-Provera-104-Injectable-Suspension-Subcutaneous Desogen Ella Emoquette Enpresse Errin Estrostep-Fe Femcon-Fe-Chewable-Tablets Femhrt Generess-Fe Genora-1-35 Gianvi Gildess-Fe-1-5-0-03 Gildess-Fe-1-0-2 Implanon Jenest Jevantique Jolessa Jolivette Junel-1-5-30 Junel-1-20 Junel-Fe-1-5-30 Junel-Fe-1-20 Kariva Kelnor Leena Lessina Levlen Levlite Levonest Levora Lo-Loestrin-Fe Lo-Ovral Lo-Ovral-28 Loestrin-1-20 Loestrin-21-1-5-30 Loestrin-21-1-20 Loestrin_24_Fe Loestrin-Fe-1-5-30 Loestrin-Fe-1-20 Loryna Loseasonique Low-Ogestrel Low-Ogestrel-28 Lunelle Lutera Lybrel Microgestin-1-5-30 Microgestin-1-20 Microgestin-Fe-1-5-30 Microgestin-Fe-1-20 Mircette Mirena Modicon Mononessa Natazia Necon-0-5-35 Necon-1-35 Necon-1-50 Necon-10-11 Necon-7-7-7 Nelova-0-5-35 Nexplanon Nor-Qd Nora-Be Nordette Norethin-1-35-E Norinyl-1-35 Norinyl-1-50 Norplant-System Nortrel-0-5-35 Nortrel-1-35 Nortrel-7-7-7 Nuvaring Ocella Ogestrel Ogestrel-28 Orsythia Ortho_Cyclen Ortho_Evra Ortho-Micronor Ortho-Tri-Cyclen Ortho-Tri-Cyclen-Lo Ortho-Cept Ortho-Novum-1-35 Ortho-Novum-1-50 Ortho-Novum-7-7-7 Ovcon-35 Ovcon-35-Fe Ovcon-50 Portia Previfem Provera Quasense-Extended-Cycle Reclipsen Safyral Seasonale Seasonique Solia Sprintec Sronyx Syeda Tilia-Fe Tri-Legest Tri-Legest-Fe Tri-Levlen Tri-Lo-Sprintec Tri-Norinyl Tri-Previfem Tri-Sprintec Trinessa Trinessa-Lo Triphasil Triphasil-21 Triphasil-28 Trivora Trivora-28 Velivet Vestura Yasmin Yaz Zarah Zenchent Zenchent-Fe Zeosa Zovia Zovia-1-35 Zovia-1-50


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Yasmin


Generic Name: drospirenone and ethinyl estradiol (Oral route)

droe-SPYE-re-none, ETH-i-nil es-tra-DYE-ol

Oral route(Tablet)

Cigarette smoking increases the risk of serious cardiovascular events from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Women who are over 35 years of age and smoke should not use oral contraceptives .

Commonly used brand name(s)

In the U.S.

Gianvi Loryna Ocella Syeda Vestura Yasmin YAZ Yaz 28 Zarah

Available Dosage Forms:

Tablet

Therapeutic Class: Monophasic Contraceptive Combination

Pharmacologic Class: Progestin

Uses For Yasmin

Drospirenone and ethinyl estradiol combination is used as an oral contraceptive. Oral contraceptives are known also as the Pill, OCs, BCs, BC tablets, or birth control pills. This medicine usually contains two types of hormones, estrogens and progestins and, when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented. Although oral contraceptives have other effects that help prevent a pregnancy from occurring, this is the main action.

This medicine is also used to treat premenstrual dysphoric disorder (PMDD). PMDD is a severe form of premenstrual syndrome (PMS). Patients with PMDD may experience severe emotional and physical symptoms 10 to 14 days before their menstrual flow starts .

No contraceptive method is 100 percent effective. Discuss with your health care professional your options for birth control .

Drospirenone and ethinyl estradiol combination is also used to treat acne in women at least 14 years of age, who have already started menstruating and choose to use a birth control pill to prevent pregnancy .

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

Before Using Yasmin

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

This medicine is not intended for use in children or teenagers who have not yet started menstruating. This medicine is frequently used for birth control in teenage females and has not been shown to cause different side effects or problems than it does in adults. Some teenagers may need extra information on the importance of taking this medication exactly as prescribed.

Pregnancy Pregnancy Category Explanation All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. Breast Feeding Drospirenone

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Ethinyl Estradiol

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

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.

Boceprevir

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.

Boceprevir Felbamate Isotretinoin Paclitaxel Paclitaxel Protein-Bound Theophylline Tizanidine Tranexamic Acid

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.

Alprazolam Amoxicillin Ampicillin Amprenavir Aprepitant Atazanavir Bacampicillin Betamethasone Bexarotene Bosentan Carbamazepine Colesevelam Cyclosporine Darunavir Delavirdine Doxycycline Efavirenz Etravirine Fosamprenavir Fosaprepitant Fosphenytoin Ginseng Griseofulvin Lamotrigine Licorice Minocycline Modafinil Mycophenolate Mofetil Mycophenolic Acid Nelfinavir Nevirapine Oxcarbazepine Oxytetracycline Phenobarbital Phenytoin Pioglitazone Prednisolone Primidone Rifabutin Rifampin Rifapentine Ritonavir Roflumilast Rosuvastatin Rufinamide Selegiline St John's Wort Telaprevir Tetracycline Tipranavir Topiramate Troglitazone Troleandomycin Valdecoxib Voriconazole Warfarin 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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine Grapefruit Juice 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:

Abnormal changes in menstrual or uterine bleeding or Fibroid tumors of the uterus—Oral contraceptives usually improve these female conditions but sometimes they can make them worse or make the diagnosis of these problems more difficult. Adrenal insufficiency or Liver problems or Kidney problems—These conditions may increase the risk of retaining too much potassium in the blood. Blood clots (or history of) or Heart or circulation disease or Stroke (or history of)—If these conditions are already present, oral contraceptives may have a greater chance of causing blood clots or circulation problems, especially in women who smoke tobacco. Otherwise, oral contraceptives may help prevent circulation and heart disease if you are healthy and do not smoke. Cancer, including breast cancer (or history of or family history of)—Oral contraceptives may worsen some cancers, especially when breast, cervical, or uterine cancers already exist. Use of oral contraceptives is not recommended if you have any of these conditions. If you have a family history of breast disease, oral contraceptives may still be a good choice but you may need to be tested more often. Gallbladder disease or gallstones (or history of) or High blood cholesterol or High blood potassium or Liver disease (or history of, including jaundice during pregnancy) or Mental depression (or history of)—Oral contraceptives may make these conditions worse or, rarely, cause them to occur again. Oral contraceptives may still be a good choice but you may need to be tested more often. High blood pressure (hypertension) or Migraine headaches—Oral contraceptives may cause fluid build-up and may cause these conditions to become worse; however, some people have fewer migraine headaches when they use oral contraceptives. Proper Use of drospirenone and ethinyl estradiol

This section provides information on the proper use of a number of products that contain drospirenone and ethinyl estradiol. It may not be specific to Yasmin. Please read with care.

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

A paper with information for the patient will be given to you with your filled prescription, and will provide many details concerning the use of oral contraceptives. Read this paper carefully and ask your health care professional if you need additional information or explanation.

When you begin to use oral contraceptives, your body will require at least 7 days to adjust before a pregnancy will be prevented. You will need to use an additional birth control method for at least 7 days. Some doctors recommend using an additional method of birth control for the first cycle (or 3 weeks) to ensure full protection. Follow the advice of your doctor or other health care professional.

Try to take the doses no more than 24 hours apart to reduce the possibility of side effects and to prevent pregnancy. Since one of the most important factors in the proper use of oral contraceptives is taking every dose exactly on schedule, you should never let your tablet supply run out. When possible, try to keep an extra month's supply of tablets on hand and replace it monthly.

It is very important that you keep the tablets in their original container and take the tablets in the same order that they appear in the container. The containers help you keep track of which tablets to take next. Different colored tablets in the same package contain different amounts of hormones or are placebos (tablets that do not contain hormones). The effectiveness of the medicine is reduced if the tablets are taken out of order.

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.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on Sunday after your period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even when you miss a dose. Do not change your schedule on your own. If the schedule that you have been put on is not convenient, check with your doctor about changing schedules. For Sunday start you need to use another form of birth control for the first 7 days.

For Yasmin(R) and Yaz(R), begin next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule .

For oral dosage form (tablets): For contraception or treatment of acne: Adults and teenagers (after menarche) — Yasmin(R), 1 yellow tablet by mouth every day for 21 consecutive days followed by 1 white (inert) tablet daily for 7 days per menstrual cycle Adults and teenagers (after menarche)— Yaz(R), 1 pink tablet by mouth every day for 24 consecutive days followed by 1 white (inert) tablet daily for 4 days per menstrual cycle Missed Dose

Call your doctor or pharmacist for instructions.

Storage

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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Yasmin

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.

This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor .

Tell the medical doctor or dentist in charge that you are taking this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue taking this medicine .

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier. If this should occur:

Continue on your regular dosing schedule. The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week. After you have been taking oral contraceptives on schedule and for more than 3 months and bleeding continues, check with your doctor.

Missed menstrual periods may occur:

If you have not taken the medicine exactly as scheduled. Pregnancy must be considered as a possibility. If the medicine is not the right strength or type for your needs. If you stop taking oral contraceptives, especially if you have taken oral contraceptives for 2 or more years.

Check with your doctor if you miss any menstrual periods so that the cause may be determined.

If you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor.

If you are scheduled for any laboratory tests, tell your doctor that you are taking birth control pills.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

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

Yasmin Side Effects

Healthy women who do not smoke cigarettes have almost no chance of having a severe side effect from taking oral contraceptives. For most women, more problems occur because of pregnancy than will occur from taking oral contraceptives. But for some women who have special health problems, oral contraceptives can cause some unwanted effects. Some of these unwanted effects include benign (not cancerous) liver tumors, liver cancer, or blood clots or related problems, such as a stroke. Although these effects are very rare, they can be serious enough to cause death. You may want to discuss these effects with your doctor.

Smoking cigarettes during the use of oral contraceptives has been found to greatly increase the chances of these serious side effects occurring. To reduce the risk of serious side effects, do not smoke cigarettes while you are taking oral contraceptives.

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

Rare Abdominal or stomach pain (sudden, severe, or continuing) anxiety burning pain in lower abdomen changes in skin color chill convulsions coughing up blood feeling of heat feeling of warmth in lips and tongue fever headache (severe or sudden) loss of coordination (sudden) loss of vision or change in vision (sudden) nervousness numbness of the fingertips pain in lower back, pelvis, or stomach pains in chest, groin, or leg (especially in calf of leg) ringing in the ears shortness of breath (sudden or unexplained) slurring of speech (sudden) sudden loss of consciousness swelling of foot or leg weakness, numbness, or pain in arm or leg (unexplained)

Check with your doctor as soon as possible if any of the following side effects occur:

More common—usually less common after the first 3 months of oral contraceptive use Changes in the uterine bleeding pattern at menses or between menses, such as decreased bleeding at menses, breakthrough bleeding or spotting between periods, prolonged bleeding at menses, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes. Less common Headaches or migraines (although headaches may lessen in many users, in others, they may increase in number or become worse) increased blood pressure vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge RareFor women who smoke tobacco Pains in stomach, side, or abdomen yellow eyes or skin For women with a history of breast disease Lumps in breast Mental depression swelling, pain, or tenderness in upper abdominal area

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 Abdominal cramping or bloating acne (usually less common after first 3 months and may improve if acne already exists) breast pain, tenderness, or swelling dizziness nausea swelling of ankles and feet unusual tiredness or weakness vomiting Less common Brown, blotchy spots on exposed skin gain or loss of body or facial hair increased or decreased interest in sexual intercourse weight gain or loss

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: Yasmin side effects (in more detail)

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More Yasmin resources Yasmin Side Effects (in more detail) Yasmin Use in Pregnancy & Breastfeeding Drug Images Yasmin Drug Interactions Yasmin Support Group 46 Reviews for Yasmin - Add your own review/rating Yasmin Consumer Overview Yasmin MedFacts Consumer Leaflet (Wolters Kluwer) Yasmin Prescribing Information (FDA) Gianvi Prescribing Information (FDA) Loryna Prescribing Information (FDA) Ocella Prescribing Information (FDA) Syeda Prescribing Information (FDA) YAZ MedFacts Consumer Leaflet (Wolters Kluwer) Yaz Prescribing Information (FDA) Yaz Consumer Overview Zarah Prescribing Information (FDA) Compare Yasmin with other medications Acne Birth Control Menstrual Disorders Premenstrual Dysphoric Disorder


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Contraceptives


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.

Contraceptives are used to prevent unwanted pregnancy. Hormonal contraceptives consist of one or more synthetic female sex hormones (estrogen and progestin or progestin only). These sex hormones prevent pregnancy by blocking the normal process of ovulation. They may also alter the lining of the uterus (endometrium) so that it is unable to support a fertilized egg and they change the mucus in the cervix so that it is hard for the sperm to travel hence conception is less likely should ovulation occur.

These hormones are either taken as regular doses in pill form (oral contraceptives), or are administered through the skin by means of a patch impregnated with hormones. They can also be given by three monthly injections of a long acting progestin, or by subcutaneous implants of progestin. They are also available as hormonal intrauterine devices and vaginal rings.

See also

Medical conditions associated with contraceptives:

Abnormal Uterine Bleeding Acne Amenorrhea Birth Control Emergency Contraception Endometrial Cancer Endometrial Hyperplasia, Prophylaxis Endometriosis Gonadotropin Inhibition Menstrual Disorders Ovarian Cysts Polycystic Ovary Syndrome Postmenopausal Symptoms Premenstrual Dysphoric Disorder Premenstrual Syndrome Prevention of Osteoporosis Renal Cell Carcinoma Drug List: Junel-1-5-30 Nordette Norinyl-1-35 Zeosa Plan-B Triphasil Ortho-Novum-1-35 Loestrin-1-20 Plan-B-One-Step Demulen Zarah Ovcon-35 Trivora Lybrel Low-Ogestrel-28 Necon-1-35 Ortho-Novum-7-7-7 Aranelle Gildess-Fe-1-5-0-03 Modicon Nexplanon Next-Choice Tri-Legest-Fe Ortho_Cyclen Lutera Ortho_Evra Junel-1-20 Seasonale Yasmin Femcon-Fe-Chewable-Tablets Lo-Ovral Mircette Desogen Lo-Loestrin-Fe Low-Ogestrel Nora-Be Microgestin-1-20 Camila Kelnor Mirena Nuvaring Portia Provera Aviane Quasense-Extended-Cycle Trinessa Jolessa Lo-Ovral-28 Mononessa Yaz Alesse Beyaz Cryselle-28 Kariva Levlen Ocella Depo-Provera-Contraceptive-Injectable Loestrin_24_Fe Microgestin-Fe-1-5-30 Apri Aygestin Implanon Zovia-1-35 Depo-Provera Femhrt Ortho-Tri-Cyclen Ortho-Tri-Cyclen-Lo Tri-Lo-Sprintec Levora Natazia Sronyx Junel-Fe-1-5-30 Junel-Fe-1-20 Tri-Sprintec Seasonique Sprintec Cyclessa Microgestin-Fe-1-20 Safyral Necon-7-7-7 Ortho-Cept Loseasonique Ortho-Micronor Gianvi Jolivette Reclipsen Errin Lessina Zovia Tri-Previfem Briellyn Nortrel-7-7-7 Velivet Ogestrel-28 Loestrin-Fe-1-20 Nortrel-1-35 Loestrin-21-1-20 Orsythia Triphasil-28 Altavera Amethia Amethia-Lo Amethyst Balziva Brevicon Camrese Caziant Cesia Cyclafem-1-35 Cyclafem-7-7-7 Depo-Subq-Provera-104-Injectable-Suspension-Subcutaneous Emoquette Enpresse Estrostep-Fe Generess-Fe Genora-1-35 Gildess-Fe-1-0-2 Jenest Jevantique Jinteli Leena Levlite Levonest Loestrin-21-1-5-30 Loestrin-Fe-1-5-30 Loryna Lunelle Microgestin-1-5-30 Necon-0-5-35 Necon-1-50 Necon-10-11 Nelova-0-5-35 Nor-Qd Norethin-1-35-E Norinyl-1-50 Norplant-System Nortrel-0-5-35 Ogestrel Ortho-Novum-1-50 Ovcon-35-Fe Ovcon-50 Preven-Ec Previfem Solia Syeda Tilia-Fe Tri-Legest Tri-Levlen Tri-Norinyl Trinessa-Lo Triphasil-21 Trivora-28 Vestura Zenchent Zenchent-Fe Zovia-1-50


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Gianvi


drospirenone and ethinyl estradiol
Dosage Form: tablets
Gianvi™
(drospirenone and ethinyl estradiol tablets)
Rev. D 6/2010
11001685

Rx only

PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES

Gianvi Description

Gianvi™ (drospirenone and ethinyl estradiol tablets) 3 mg/0.02 mg provides an oral contraceptive regimen consisting of 24 active film-coated tablets each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol and 4 inert film-coated tablets. Other ingredients are anhydrous lactose, corn starch, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch and titanium dioxide. The inert tablets contain anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose.

Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11, 12,13,14,15,15a,16 - hexadecahydro - 10,13 - dimethylspiro - [17H - dicyclopropa - [6,7:15,16]cyclopenta[a]phenanthrene - 17,2’(5H) - furan] - 3,5’(2H) - dione) is a synthetic progestational compound. Ethinyl estradiol (19-nor-17?-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound. The structural formulas are as follows:

Drospirenone

C24H30O3 Molecular Weight: 366.5

Ethinyl Estradiol

C20H24O2 Molecular Weight: 296.4

Gianvi - Clinical Pharmacology Pharmacodynamics Oral Contraception

Combination oral contraceptives (COCs) act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increases the difficulty of sperm entry into the uterus) and the endometrium (which reduces the likelihood of implantation).

Drospirenone is a spironolactone analogue with antimineralocorticoid activity. Preclinical studies in animals and in vitro have shown that drospirenone has no androgenic, estrogenic, glucocorticoid, or antiglucocorticoid activity. Preclinical studies in animals have also shown that drospirenone has antiandrogenic activity.

Acne

Acne vulgaris is a skin condition with a multifactorial etiology including androgen stimulation of sebum production. While the combination of ethinyl estradiol and drospirenone increases sex hormone binding globulin (SHBG) and decreases free testosterone, the relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this skin condition has not been established. The impact of the antiandrogenic activity of drospirenone on acne is not known.

Pharmacokinetics Absorption

The absolute bioavailability of drospirenone (DRSP) from a single entity tablet is about 76%. The absolute bioavailability of ethinyl estradiol (EE) is approximately 40% as a result of presystemic conjugation and first-pass metabolism.  The absolute bioavailability of drospirenone and ethinyl estradiol tablets,  which is a combination tablet of drospirenone and ethinyl estradiol stabilized by betadex as a clathrate (molecular inclusion complex), has not been evaluated. The bioavailability of EE is similar when dosed via a betadex clathrate formulation compared to when it is dosed as a free steroid. Serum concentrations of DRSP and EE reached peak levels within 1 to 2 hours after administration of drospirenone and ethinyl estradiol tablets.

The pharmacokinetics of DRSP are dose proportional following single doses ranging from 1 to 10 mg. Following daily dosing of drospirenone and ethinyl estradiol tablets, steady-state DRSP concentrations were observed after 8 days. There was about 2 to 3 fold accumulation in serum Cmax and AUC (0-24h) values of DRSP following multiple dose administration of drospirenone and ethinyl estradiol tablets  (see Table I).

For EE, steady-state conditions are reported during the second half of a treatment cycle. Following daily administration of drospirenone and ethinyl estradiol tablets  serum Cmax and AUC (0-24h) values of EE accumulate by a factor of about 1.5 to 2 (see Table I).

TABLE I: TABLE OF PHARMACOKINETIC PARAMETERS OF DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS (Drospirenone 3 mg and Ethinyl Estradiol 0.02 mg) * geometric mean (geometric coefficient of variation) † median (range) Drospirenone

Cycle /

Day

No. of

Subjects

Cmax * 

(ng/mL)

Tmax†

(h)

AUC (0-24h)*

(ng•h/mL)

t1/2*

(h) 1/1 23 38.4 (25) 1.5 (1 to 2) 268 (19) NA 1/21 23 70.3 (15) 1.5 (1 to 2) 763 (17) 30.8 (22) Ethinyl Estradiol

Cycle /

Day

No. of

Subjects

Cmax*

(pg/mL)

Tmax†

(h)

AUC (0-24h)*

(pg•h/mL)

t1/2*

(h) 1/1 23 32.8 (45) 1.5 (1 to 2) 108 (52) NA 1/21 23 45.1 (35) 1.5 (1 to 2) 220 (57) NA NA = Not available Effect of Food

The rate of absorption of DRSP and EE following single administration of a formulation similar to drospirenone and ethinyl estradiol tablets was slower under fed (high fat meal) conditions with the serum Cmax being reduced about 40% for both components. The extent of absorption of DRSP, however, remained unchanged. In contrast, the extent of absorption of EE was reduced by about 20% under fed conditions.

Distribution

DRSP and EE serum levels decline in two phases. The apparent volume of distribution of DRSP is approximately 4 L/kg and that of EE is reported to be approximately 4 to 5 L/kg.

DRSP does not bind to sex hormone binding globulin (SHBG) or corticosteroid binding globulin (CBG) but binds about 97% to other serum proteins. Multiple dosing over 3 cycles resulted in no change in the free fraction (as measured at trough levels).  EE is reported to be highly but non-specifically bound to serum albumin (approximately 98.5%) and induces an increase in the serum concentrations of both SHBG and CBG. EE induced effects on SHBG and CBG were not affected by variation of the DRSP dosage in the range of 2 to 3 mg.

Metabolism

The two main metabolites of DRSP found in human plasma were identified to be the acid form of DRSP generated by opening of the lactone ring and the 4,5-dihydrodrospirenone-3-sulfate. These metabolites were shown not to be pharmacologically active. In in vitro studies with human liver microsomes, DRSP was metabolized only to a minor extent mainly by Cytochrome P450 3A4 (CYP3A4).

EE has been reported to be subject to presystemic conjugation in both small bowel mucosa and the liver. Metabolism occurs primarily by aromatic hydroxylation but a wide variety of hydroxylated and methylated metabolites are formed. These are present as free metabolites and as conjugates with glucuronide and sulfate. CYP3A4 in the liver is responsible for the 2-hydroxylation which is the major oxidative reaction. The 2-hydroxy metabolite is further transformed by methylation and glucuronidation prior to urinary and fecal excretion.

Excretion

DRSP serum levels are characterized by a terminal disposition phase half-life of approximately 30 hours after both single and multiple dose regimens. Excretion of DRSP was nearly complete after ten days and amounts excreted were slightly higher in feces compared to urine. DRSP was extensively metabolized and only trace amounts of unchanged DRSP were excreted in urine and feces. At least 20 different metabolites were observed in urine and feces. About 38 to 47% of the metabolites in urine were glucuronide and sulfate conjugates. In feces, about 17 to 20% of the metabolites were excreted as glucuronides and sulfates.

For EE the terminal disposition phase half-life has been reported to be approximately 24 hours. EE is not excreted unchanged. EE is excreted in the urine and feces as glucuronide and sulfate conjugates and undergoes enterohepatic circulation.

Special Populations Ethnic Groups

No clinically significant difference was observed between the pharmacokinetics of DRSP or EE in Japanese versus Caucasian women (age 20 to 35) when drospirenone and ethinyl estradiol tablets were administered daily for 21 days. Other ethnic groups have not been studied.

Hepatic Dysfunction

Drospirenone and ethinyl estradiol tablets are contraindicated in patients with hepatic dysfunction (see CONTRAINDICATIONS and BOLDED WARNING).  The mean exposure to DRSP in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. Drospirenone and ethinyl estradiol tablets have not been studied in women with severe hepatic impairment.

Renal Insufficiency

Drospirenone and ethinyl estradiol tablets are contraindicated in patients with renal insufficiency (see CONTRAINDICATIONS and BOLDED WARNING).

The effect of renal insufficiency on the pharmacokinetics of DRSP (3 mg daily for 14 days) and the effect of DRSP on serum potassium levels were investigated in female subjects (n = 28, age 30 to 65) with normal renal function and mild and moderate renal impairment. All subjects were on a low potassium diet. During the study 7 subjects continued the use of potassium sparing drugs for the treatment of the underlying illness. On the 14th day (steady-state) of DRSP treatment, serum DRSP levels in the group with mild renal impairment (creatinine clearance CLcr, 50 to 80 mL/min) were comparable to those in the group with normal renal function (CLcr, >80 mL/min). The serum DRSP levels were on average 37% higher in the group with moderate renal impairment (CLcr, 30 to 50 mL/min) compared to those in the group with normal renal function. DRSP treatment was well tolerated by all groups. DRSP treatment did not show any clinically significant effect on serum potassium concentration. Although hyperkalemia was not observed in the study, in five of the seven subjects who continued use of potassium sparing drugs during the study, mean serum potassium levels increased by up to 0.33 mEq/L. Therefore, potential exists for hyperkalemia to occur in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs.

Indications and Usage for Gianvi

Gianvi™ (drospirenone and ethinyl estradiol tablets) 3 mg/0.02 mg is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.

Oral contraceptives are highly effective. Table II lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and contraceptive implants and IUDs, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Gianvi™ (drospirenone and ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Gianvi™ (drospirenone and ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR: UNITED STATES. * Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. † Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. ‡ Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly). The percentage who experience an accidental pregnancy during the first year if they do not stop use for any reason. § The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. ¶ Foams, creams, gels, vaginal suppositories, and vaginal film. # Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. ? With spermicidal cream or jelly. ? Without spermicides. ? The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills). ? However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.

 

  % of Women Experiencing an Unintended Pregnancy Within the First Year of Use % of Women Continuing Use at One Year* Method (1) Typical Use†  (2) Perfect Use‡  (3) (4) Chance§  85 85 40 Spermicides¶  26 6 63 Periodic abstinence 25 Calendar 9 Ovulation method 3 Sympto-thermal# 2 Post-ovulation 1 Withdrawal 19 4 Cap? Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nulliparous women 20 9 56 Diaphragm? 20 6 56 Condom?  Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 progestin only 0.5 combined 0.1 IUD Progesterone T 2 1.5 81 Copper T 380A 0.8 0.6 78 Lng 20 0.1 0.1 81 Depo Provera 0.3 0.3 70 Norplant and Norplant-2 0.05 0.05 88 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.1 100 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.?  Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.?  Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Guest F, Kowal D, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. Oral Contraceptive Clinical Trial

In the primary contraceptive efficacy study of drospirenone and ethinyl estradiol tablets (3 mg DRSP/0.02 mg EE) of up to 1 year duration, 1,027 subjects were enrolled and completed 11,480 28-day cycles of use. The age range was 17 to 36 years. The racial demographic was: 87.8% Caucasian, 4.6% Hispanic, 4.3% Black, 1.2% Asian, and 2.1% other. Women with a BMI greater than 35 were excluded from the trial. The pregnancy rate (Pearl Index) was 1.41 per 100 woman-years of use based on 12 pregnancies that occurred after the onset of treatment and within 14 days after the last dose of drospirenone and ethinyl estradiol tablets in women 35 years of age or younger during cycles in which no other form of contraception was used.

Acne Clinical Trials

In two multicenter, double blind, randomized, placebo-controlled studies, 889 subjects, ages 14 to 45 years, with moderate acne received drospirenone and ethinyl estradiol tablets or placebo for six 28 day cycles. The primary efficacy endpoints were the percent change in inflammatory lesions, non-inflammatory lesions, total lesions, and the percentage of subjects with a “clear” or “almost clear” rating on the Investigator’s Static Global Assessment (ISGA) scale on day 15 of cycle 6, as presented in Table III:

TABLE III: EFFICACY RESULTS FOR ACNE TRIALS* * Evaluated at day 15 of cycle 6, last observation carried forward for the Intent to treat population Study 1 Study 2 Drospirenone and Ethinyl Estradiol Tablets N=228 Placebo N=230 Drospirenone and Ethinyl Estradiol Tablets N=218 Placebo N=213 ISGA Success Rate 35 (15%) 10 (4%) 46 (21%) 19 (9%)

Inflammatory Lesions

Mean Baseline Count

Mean Absolute (%) Reduction

33

15 (48%)

33

11 (32%)

32

16 (51%)

32

11 (34%)

Non-inflammatory Lesions

Mean Baseline Count

Mean Absolute (%) Reduction

47

18 (39%)

47

10 (18%)

44

17 (42%)

44

11 (26%)

Total lesions

Mean Baseline Count

Mean Absolute (%) reduction

80

33 (42%)

80

21 (25%)

76

33 (46%)

76

22 (31%) Contraindications

Gianvi™ (drospirenone and ethinyl estradiol tablets) should not be used in women who have the following:

Renal insufficiency Hepatic dysfunction Adrenal insufficiency Thrombophlebitis or thromboembolic disorders A past history of deep-vein thrombophlebitis or thromboembolic disorders Cerebral-vascular or coronary-artery disease (current or history) Valvular heart disease with thrombogenic complications Severe hypertension Diabetes with vascular involvement Headaches with focal neurological symptoms Major surgery with prolonged immobilization Known or suspected carcinoma of the breast Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Known or suspected pregnancy Liver tumor (benign or malignant) or active liver disease Heavy smoking (? 15 cigarettes per day) and over age 35 Hypersensitivity to any component of this product Warnings

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Gianvi™ (drospirenone and ethinyl estradiol tablets) contains 3 mg of the progestin drospirenone that has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25 mg dose of spironolactone. Gianvi™ (drospirenone and ethinyl estradiol tablets) should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction and adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium level checked during the first treatment cycle. Medications that may increase serum potassium include ACE inhibitors, angiotensin – II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs.

The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and hypertension. The risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is based principally on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiologic studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population. For further information, the reader is referred to a text on epidemiologic methods.

1. Thromboembolic Disorders and Other Vascular Problems a. Myocardial Infarction

An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary-artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six. The risk is very low under the age of 30.

Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older with smoking accounting for the majority of excess cases. Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and nonsmokers over the age of 40 (Table IV) among women who use oral contraceptives.

TABLE IV: CIRCULATORY DISEASE MORTALITY RATES PER 100,000 WOMAN- YEARS BY AGE, SMOKING STATUS AND ORAL CONTRACEPTIVE USE (Adapted from P.M. Layde and V. Beral) AGE EVER-USERS
NON-SMOKERS

EVER-USERS

SMOKERS

CONTROLS

NON-SMOKERS

CONTROL

SMOKERS 15 to 24 0 10.5 0 0 25 to 34 4.4 14.2 2.7 4.2 35 to 44 21.5 63.4 6.4 15.2 45+ 52.4 206.7 11.4 27.9

Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity. In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism. Oral contraceptives have been shown to increase blood pressure among users (see section 9 in WARNINGS). Similar effects on risk factors have been associated with an increased risk of heart disease. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

b. Thromboembolism

An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to nonusers to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease. Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization. The risk of thromboembolic disease due to oral contraceptives is not related to length of use and disappears after pill use is stopped.

A two- to four-fold increase in the relative risk of post-operative thromboembolic complications has been reported with the use of oral contraceptives. The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions. If feasible, oral contraceptives should be discontinued from at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization. Since the immediate postpartum period is also associated with an increased risk of thromboembolism, combined oral contraceptives should be started no earlier than four to six weeks after delivery and at that time only in women who elect not to breast feed.

Several studies have investigated the relative risks of thromboembolism in women using a different drospirenone-containing COC (Yasmin, which contains 0.030 mg of ethinyl estradiol and 3 mg of drospirenone) compared to those in women using COCs containing other progestins. Two prospective cohort studies, both evaluating the risk of venous and arterial thromboembolism and death, were initiated at the time of Yasmin approval.1, 2 The first (EURAS) showed the risk of thromboembolism (particularly venous thromboembolism) and death in Yasmin users to be comparable to that of other oral contraceptive preparations, including those containing levonorgestrel (a so-called second generation COC). The second prospective cohort study (Ingenix) also showed a comparable risk of thromboembolism in Yasmin users compared to users of other COCs, including those containing levonorgestrel. In the second study, COC comparator groups were selected based on their having similar characteristics to those being prescribed Yasmin.

Two additional epidemiological studies, one case-control study (van Hylckama Vlieg et al.3) and one retrospective cohort study (Lidegaard et al.4) suggested that the risk of venous thromboembolism occurring in Yasmin users was higher than that for users of levonorgestrel-containing COCs and lower than that for users of desogestrel/gestodene-containing COCs (so-called third generation COCs). In the case-control study, however, the number of Yasmin cases was very small (1.2% of all cases) making the risk estimates unreliable. The relative risk for Yasmin users in the retrospective cohort study was greater than that for users of other COC products when considering women who used the products for less than one year. However, these one-year estimates may not be reliable because the analysis may include women of varying risk levels. Among women who used the product for 1 to 4 years, the relative risk was similar for users of Yasmin to that for users of other COC products.

c. Cerebrovascular Diseases

Oral contraceptives have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years), hypertensive women who also smoke. Hypertension was found to be a risk factor, for both users and nonusers, for both types of strokes, while smoking interacted to increase the risk for hemorrhagic strokes.

In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normotensive users to 14 for users with severe hypertension. The relative risk of hemorrhagic stroke is reported to be 1.2 for nonsmokers who used oral contraceptives, 2.6 for smokers who did not use oral contraceptives, 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users and 25.7 for users with severe hypertension. The attributable risk is also greater in older women. Oral contraceptives also increase the risk for stroke in women with other underlying risk factors such as certain inherited or acquired thrombophilias, hyperlipidemias, and obesity. Women with migraine (particularly migraine with aura) who take combination oral contraceptives may be at an increased risk of stroke.

d. Dose-Related Risk of Vascular Disease From Oral Contraceptives

A positive association has been observed between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease. A decline in serum high-density lipoproteins (HDL) has been reported with many progestational agents. A decline in serum high-density lipoproteins has been associated with an increased incidence of ischemic heart disease. Because estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between doses of estrogen and progestogen and the nature and absolute amount of progestogen used in the contraceptive. The amount of both hormones should be considered in the choice of an oral contraceptive.

Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. For any particular estrogen/progestogen combination, the dosage regimen prescribed should be one which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and the needs of the individual patient. New acceptors of oral contraceptive agents should be started on preparations containing the lowest estrogen content that is judged appropriate for the individual patient.

e. Persistence of Risk of Vascular Disease

There are two studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives. In a study in the United States, the risk of developing myocardial infarction after discontinuing oral contraceptives persists for at least 9 years for women aged 40 to 49 years who had used oral contraceptives for five or more years, but this increased risk was not demonstrated in other age groups. In another study in Great Britain, the risk of developing cerebrovascular disease persisted for at least 6 years after discontinuation of oral contraceptives, although excess risk was very small. However, both studies were performed with oral contraceptive formulations containing 50 micrograms or higher of estrogens.

2. Estimates of Mortality From Contraceptive Use

One study gathered data from a variety of sources which have estimated the mortality rate associated with different methods of contraception at different ages (Table V). These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Each method of contraception has its specific benefits and risks. The study concluded that with the exception of oral contraceptive users 35 and older who smoke and 40 and older who do not smoke, mortality associated with all methods of birth control is below that associated with childbirth.


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Yaz 28


Generic Name: drospirenone and ethinyl estradiol (Oral route)

droe-SPYE-re-none, ETH-i-nil es-tra-DYE-ol

Oral route(Tablet)

Cigarette smoking increases the risk of serious cardiovascular events from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Women who are over 35 years of age and smoke should not use oral contraceptives .

Commonly used brand name(s)

In the U.S.

Gianvi Loryna Ocella Syeda Vestura Yasmin YAZ Yaz 28 Zarah

Available Dosage Forms:

Tablet

Therapeutic Class: Monophasic Contraceptive Combination

Pharmacologic Class: Progestin

Uses For Yaz 28

Drospirenone and ethinyl estradiol combination is used as an oral contraceptive. Oral contraceptives are known also as the Pill, OCs, BCs, BC tablets, or birth control pills. This medicine usually contains two types of hormones, estrogens and progestins and, when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented. Although oral contraceptives have other effects that help prevent a pregnancy from occurring, this is the main action.

This medicine is also used to treat premenstrual dysphoric disorder (PMDD). PMDD is a severe form of premenstrual syndrome (PMS). Patients with PMDD may experience severe emotional and physical symptoms 10 to 14 days before their menstrual flow starts .

No contraceptive method is 100 percent effective. Discuss with your health care professional your options for birth control .

Drospirenone and ethinyl estradiol combination is also used to treat acne in women at least 14 years of age, who have already started menstruating and choose to use a birth control pill to prevent pregnancy .

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

Before Using Yaz 28

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

This medicine is not intended for use in children or teenagers who have not yet started menstruating. This medicine is frequently used for birth control in teenage females and has not been shown to cause different side effects or problems than it does in adults. Some teenagers may need extra information on the importance of taking this medication exactly as prescribed.

Pregnancy Pregnancy Category Explanation All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. Breast Feeding Drospirenone

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Ethinyl Estradiol

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

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.

Boceprevir

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.

Boceprevir Felbamate Isotretinoin Paclitaxel Paclitaxel Protein-Bound Theophylline Tizanidine Tranexamic Acid

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.

Alprazolam Amoxicillin Ampicillin Amprenavir Aprepitant Atazanavir Bacampicillin Betamethasone Bexarotene Bosentan Carbamazepine Colesevelam Cyclosporine Darunavir Delavirdine Doxycycline Efavirenz Etravirine Fosamprenavir Fosaprepitant Fosphenytoin Ginseng Griseofulvin Lamotrigine Licorice Minocycline Modafinil Mycophenolate Mofetil Mycophenolic Acid Nelfinavir Nevirapine Oxcarbazepine Oxytetracycline Phenobarbital Phenytoin Pioglitazone Prednisolone Primidone Rifabutin Rifampin Rifapentine Ritonavir Roflumilast Rosuvastatin Rufinamide Selegiline St John's Wort Telaprevir Tetracycline Tipranavir Topiramate Troglitazone Troleandomycin Valdecoxib Voriconazole Warfarin 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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine Grapefruit Juice 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:

Abnormal changes in menstrual or uterine bleeding or Fibroid tumors of the uterus—Oral contraceptives usually improve these female conditions but sometimes they can make them worse or make the diagnosis of these problems more difficult. Adrenal insufficiency or Liver problems or Kidney problems—These conditions may increase the risk of retaining too much potassium in the blood. Blood clots (or history of) or Heart or circulation disease or Stroke (or history of)—If these conditions are already present, oral contraceptives may have a greater chance of causing blood clots or circulation problems, especially in women who smoke tobacco. Otherwise, oral contraceptives may help prevent circulation and heart disease if you are healthy and do not smoke. Cancer, including breast cancer (or history of or family history of)—Oral contraceptives may worsen some cancers, especially when breast, cervical, or uterine cancers already exist. Use of oral contraceptives is not recommended if you have any of these conditions. If you have a family history of breast disease, oral contraceptives may still be a good choice but you may need to be tested more often. Gallbladder disease or gallstones (or history of) or High blood cholesterol or High blood potassium or Liver disease (or history of, including jaundice during pregnancy) or Mental depression (or history of)—Oral contraceptives may make these conditions worse or, rarely, cause them to occur again. Oral contraceptives may still be a good choice but you may need to be tested more often. High blood pressure (hypertension) or Migraine headaches—Oral contraceptives may cause fluid build-up and may cause these conditions to become worse; however, some people have fewer migraine headaches when they use oral contraceptives. Proper Use of drospirenone and ethinyl estradiol

This section provides information on the proper use of a number of products that contain drospirenone and ethinyl estradiol. It may not be specific to Yaz 28. Please read with care.

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

A paper with information for the patient will be given to you with your filled prescription, and will provide many details concerning the use of oral contraceptives. Read this paper carefully and ask your health care professional if you need additional information or explanation.

When you begin to use oral contraceptives, your body will require at least 7 days to adjust before a pregnancy will be prevented. You will need to use an additional birth control method for at least 7 days. Some doctors recommend using an additional method of birth control for the first cycle (or 3 weeks) to ensure full protection. Follow the advice of your doctor or other health care professional.

Try to take the doses no more than 24 hours apart to reduce the possibility of side effects and to prevent pregnancy. Since one of the most important factors in the proper use of oral contraceptives is taking every dose exactly on schedule, you should never let your tablet supply run out. When possible, try to keep an extra month's supply of tablets on hand and replace it monthly.

It is very important that you keep the tablets in their original container and take the tablets in the same order that they appear in the container. The containers help you keep track of which tablets to take next. Different colored tablets in the same package contain different amounts of hormones or are placebos (tablets that do not contain hormones). The effectiveness of the medicine is reduced if the tablets are taken out of order.

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.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on Sunday after your period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even when you miss a dose. Do not change your schedule on your own. If the schedule that you have been put on is not convenient, check with your doctor about changing schedules. For Sunday start you need to use another form of birth control for the first 7 days.

For Yasmin(R) and Yaz(R), begin next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule .

For oral dosage form (tablets): For contraception or treatment of acne: Adults and teenagers (after menarche) — Yasmin(R), 1 yellow tablet by mouth every day for 21 consecutive days followed by 1 white (inert) tablet daily for 7 days per menstrual cycle Adults and teenagers (after menarche)— Yaz(R), 1 pink tablet by mouth every day for 24 consecutive days followed by 1 white (inert) tablet daily for 4 days per menstrual cycle Missed Dose

Call your doctor or pharmacist for instructions.

Storage

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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Yaz 28

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.

This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor .

Tell the medical doctor or dentist in charge that you are taking this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue taking this medicine .

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier. If this should occur:

Continue on your regular dosing schedule. The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week. After you have been taking oral contraceptives on schedule and for more than 3 months and bleeding continues, check with your doctor.

Missed menstrual periods may occur:

If you have not taken the medicine exactly as scheduled. Pregnancy must be considered as a possibility. If the medicine is not the right strength or type for your needs. If you stop taking oral contraceptives, especially if you have taken oral contraceptives for 2 or more years.

Check with your doctor if you miss any menstrual periods so that the cause may be determined.

If you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor.

If you are scheduled for any laboratory tests, tell your doctor that you are taking birth control pills.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

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

Yaz 28 Side Effects

Healthy women who do not smoke cigarettes have almost no chance of having a severe side effect from taking oral contraceptives. For most women, more problems occur because of pregnancy than will occur from taking oral contraceptives. But for some women who have special health problems, oral contraceptives can cause some unwanted effects. Some of these unwanted effects include benign (not cancerous) liver tumors, liver cancer, or blood clots or related problems, such as a stroke. Although these effects are very rare, they can be serious enough to cause death. You may want to discuss these effects with your doctor.

Smoking cigarettes during the use of oral contraceptives has been found to greatly increase the chances of these serious side effects occurring. To reduce the risk of serious side effects, do not smoke cigarettes while you are taking oral contraceptives.

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

Rare Abdominal or stomach pain (sudden, severe, or continuing) anxiety burning pain in lower abdomen changes in skin color chill convulsions coughing up blood feeling of heat feeling of warmth in lips and tongue fever headache (severe or sudden) loss of coordination (sudden) loss of vision or change in vision (sudden) nervousness numbness of the fingertips pain in lower back, pelvis, or stomach pains in chest, groin, or leg (especially in calf of leg) ringing in the ears shortness of breath (sudden or unexplained) slurring of speech (sudden) sudden loss of consciousness swelling of foot or leg weakness, numbness, or pain in arm or leg (unexplained)

Check with your doctor as soon as possible if any of the following side effects occur:

More common—usually less common after the first 3 months of oral contraceptive use Changes in the uterine bleeding pattern at menses or between menses, such as decreased bleeding at menses, breakthrough bleeding or spotting between periods, prolonged bleeding at menses, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes. Less common Headaches or migraines (although headaches may lessen in many users, in others, they may increase in number or become worse) increased blood pressure vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge RareFor women who smoke tobacco Pains in stomach, side, or abdomen yellow eyes or skin For women with a history of breast disease Lumps in breast Mental depression swelling, pain, or tenderness in upper abdominal area

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 Abdominal cramping or bloating acne (usually less common after first 3 months and may improve if acne already exists) breast pain, tenderness, or swelling dizziness nausea swelling of ankles and feet unusual tiredness or weakness vomiting Less common Brown, blotchy spots on exposed skin gain or loss of body or facial hair increased or decreased interest in sexual intercourse weight gain or loss

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: Yaz 28 side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Brevoxyl-Creamy-Wash-Complete-Pack-Wash-And-Cleansing-Bar Brevoxyl-4-Wash Brevoxyl-8-Wash Breze Briellyn Cerisa-Wash Claravis Clarifoam-Ef-Foam Cleanse-Treat Clear-Away-Wart-Removal-System-Topical Clearplex Clearskin-Cream Clenia-Emollient-Cream Clenia-Foaming-Wash Cleocin-T-Gel Clinac-Bpo Clinda-Derm-Topical Clindacin-P Clindagel Clindareach-Pledget Clindets-Swab Co-Trimoxazole Compound-W Cotrim Cyclafem-1-35 Cyclafem-7-7-7 Del-Aqua-Topical Delos-Liquid Dermalzone Dermarest-Psoriasis-Skin-Treatment Desquam-E Desquam-X-10 Desquam-X-5 Desquam-X-Wash Dhs-Sal-Topical Differin Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 Dr-Scholl-S-Callus-Removers Dr-Scholl-S-Clear-Away-Wart-Remover Dr-Scholl-S-Corn-Removers Dr-Scholl-S-Corn-Callous-Remover-Solution Dr-Scholl-S-Zino-Soft-Corn-Remover-Pads Duac-Cs-Kit-Gel Dulcolax-Milk-Of-Magnesia-Suspension Duofilm-Solution Duoplant-Gel Durasal-Topical Dynacin Emcin-Clear-Pad Emgel-Gel Epiduo Ery-Pads-Pad Erycette Eryderm-Solution Erygel Erymax 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