YAZ

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

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

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. 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

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 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 side effects (in more detail)

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More YAZ resources

• YAZ Side Effects (in more detail)
• YAZ Use in Pregnancy & Breastfeeding
• YAZ Drug Interactions
• YAZ Support Group
• 237 Reviews for YAZ - Add your own review/rating

• YAZ MedFacts Consumer Leaflet (Wolters Kluwer)


• Gianvi Prescribing Information (FDA)


• Loryna Prescribing Information (FDA)


• Ocella Prescribing Information (FDA)


• Syeda Prescribing Information (FDA)


• Yasmin Prescribing Information (FDA)


• Yasmin Consumer Overview


• Yasmin MedFacts Consumer Leaflet (Wolters Kluwer)


• Yaz Prescribing Information (FDA)


• Yaz Consumer Overview


• Zarah Prescribing Information (FDA)

Compare YAZ with other medications

• Acne
• Birth Control
• Menstrual Disorders
• Premenstrual Dysphoric Disorder