Yaz 3mg/0.02mg

Generic Name: Drospirenone/Ethinyl Estradiol 3mg/0.02mg
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About Yaz

What Yaz is used for

  • To prevent pregnancy

  • To treat moderate acne vulgaris in women 14 years of age and older who are able to use birth control pills and have achieved menarche. Your first menstrual period is referred to as menarche.

What Yaz does

YAZ is a birth control pill (oral contraceptive) that contains two female sex hormones, the progestin drospirenone (3.0 mg) and a low dose of the estrogen ethinyl estradiol (0.020 mg). Both hormones are synthetic and similar to those that occur naturally in your body. The YAZ pill pack has 24 light pink “active” pills (with hormones) to be taken for 24 days, followed by 4 white “reminder” pills (without hormones) to be taken for four days. It has also been shown to be highly effective in preventing pregnancy and in treating moderate acne vulgaris when taken as prescribed by your doctor. Pregnancy is always more risky than taking birth control pills, except in smokers older than age 35.

Birth control pills work in two ways:

  1. They inhibit the monthly release of an egg by the ovaries.

  2. They change the mucus produced by the cervix. This slows the movement of the sperm through the mucus and through the uterus (womb).

Drospirenone in YAZ helps with androgen- (male sex hormone) related skin problems. Androgen circulates naturally within the female body. Androgens can cause glands in the skin to over-produce oil. This results in acne. YAZ works by lowering androgen levels in the body and by blocking the effects of androgens at the gland. As a result, a reduction in the number of acne breakouts is associated with YAZ treatment.

Effectiveness of Birth Control Pills

Combination birth control pills are more than 99 percent effective in preventing pregnancy when:

  • the pill is TAKEN AS DIRECTED, and

  • the amount of estrogen is 20 micrograms or more.

A 99 percent effectiveness rate means that if 100 women used birth control pills for one year, one woman in the group would get pregnant.

The chance of becoming pregnant increases with incorrect use.

Other Ways to Prevent Pregnancy

Other methods of birth control are available to you. They are usually less effective than birth control pills. When used properly, however, other methods of birth control are effective enough for many women.

The following table gives reported pregnancy rates for various forms of birth control, including no birth control. The reported rates represent the number of women out of 100 who would become pregnant in one year.

Reported Pregnancies per 100 Women per Year
Combination pill less than 1 to 2
Intrauterine device (IUD) less than 1 to 6
Condom with spermicidal foam or gel 1 to 6
Mini-pill 3 to 6
Condom 2 to 12
Diaphragm with spermicidal foam or gel 3 to 18
Spermicide 3 to 21
Sponge with spermicide 3 to 28
Cervical cap with spermicide 5 to 18
Periodic abstinence (rhythm), all types 2 to 20
No birth control 60 to 85

Pregnancy rates vary widely because people differ in how carefully and regularly they use each method. (This does not apply to IUDs since they are implanted in the uterus.) Regular users may achieve pregnancy rates in the lower ranges. Others may expect pregnancy rates more in the middle ranges.

The effective use of birth control methods other than birth control pills and IUDs requires more effort than taking a single pill every day. It is an effort that many couples undertake successfully.

When Yaz should not be used

The birth control pill is not suitable for every woman. In a small number of women, serious side effects may occur. Your doctor can advise you if you have any conditions that would pose a risk to you. The use of the birth control pill always should be supervised by your doctor.

You should not use YAZ if you have or have had any of the following conditions:

  • blood clots in the legs, lungs, eyes, or elsewhere, or thrombophlebitis (inflammation or swelling of the veins)

  • stroke, heart attack, or coronary artery disease (e.g., angina pectoris), or a condition that may be a first sign of a stroke (such as a transient ischemic attack or small reversible stroke)

  • disease of the heart valves with complications

  • severe high blood pressure

  • diabetes with complications

  • known abnormalities of the blood clotting system that increases your risk for developing blood clots

  • very high blood cholesterol or triglyceride levels

  • heavy smoking (>15 cigarettes per day) and over age 35

  • migraine headache

  • you are scheduled for major surgery

  • prolonged bed rest

  • jaundice (yellowing of the eyes or skin), liver disease, or liver tumor

  • known or suspected cancer of the breast or uterus (womb) or other estrogen-dependent cancer

  • unusual vaginal bleeding without a known reason

  • loss of vision due to blood vessel disease of the eye

  • you are pregnant or suspect you may be pregnant

  • pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in your blood

  • allergy (hypersensitivity) to ethinyl estradiol, drospirenone or to any of the other ingredients in YAZ (see What the medicinal ingredients are: and What the important nonmedicinal ingredients are:).

In addition, you should not use YAZ if you have any of the following conditions:

  • kidney disease

  • liver disease

  • adrenal disease

Tell your doctor if you have ever had any of the above conditions (your doctor can recommend another method of birth control).

What the medicinal ingredients for Yaz are

Drospirenone and ethinyl estradiol.

What the important nonmedicinal ingredients for Yaz are

Cornstarch, hydroxypropylmethyl cellulose, lactose monohydrate, magnesium stearate, povidone, talc, titanium dioxide, red ferric oxide and β-cyclodextrin.

What dosage forms Yaz comes in

YAZ (drospirenone and ethinyl estradiol) tablets are available in a 28-day regimen.

Each blister pack contains 24 light pink and 4 white, film-coated, round tablets. Each light pink, film-coated tablet contains 3.0 mg drospirenone and 0.020 mg ethinyl estradiol. The white tablets are inactive.


Warnings and Precautions

Serious Warnings and Precautions

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. This risk increases with age and becomes significant in hormonal contraceptive users older than 35 years of age. Women should not smoke.

Birth control pills DO NOT PROTECT against sexually transmitted infections (STIs), including HIV/AIDS.

For protection against STIs, it is advisable to use latex or polyurethane condoms IN COMBINATION WITH birth control pills.

YAZ is a birth control pill containing estrogen and progestin. The progestin in YAZ is known as drospirenone and it may increase the levels of potassium in your blood. Therefore, you should not take YAZ if you have kidney, liver, or adrenal disease (a disease that may alter the body’s fluid and mineral balance) because this could cause serious heart and health problems. Other drugs may also increase potassium (see BEFORE you use YAZ, talk to your doctor or pharmacist if you:). During the first month that you take YAZ, you should have a blood test to check your potassium level.

BEFORE you use YAZ, talk to your doctor or pharmacist if you

  • smoke

  • are overweight

  • have a history of breast disease (e.g., breast lumps) or a family history of breast cancer

  • have high blood pressure

  • have high cholesterol

  • have diabetes

  • have heart or kidney disease

  • have a history of seizures/epilepsy

  • have a history of depression

  • have a history of liver disease or jaundice

  • wear contact lenses

  • have uterine fibroids (benign tumors of the uterus)

  • may be pregnant or are breast-feeding

  • have systemic lupus erythematosus

  • have inflammatory bowel disease such as Crohn’s disease or ulcerative colitis

  • have haemolytic uremic syndrome

  • have sickle cell disease

  • have any problems with the valves in your heart and/or have an irregular heart rhythm

  • have been told that you have a condition called hereditary angioedema or if you have had episodes of swelling in body parts such as hands, feet, face, or airway passages

  • you are currently on daily, long-term treatment for a chronic condition with any of the medications listed below:

    • Non steroidal anti-inflammatory drugs (NSAIDs) when taken long-term and for treatment of arthritis or other problems (e.g., ibuprofen, naproxen, or others)

    • Potassium-sparing diuretics (spironolactone and others)

    • Potassium supplements

    • ACE inhibitors and Angiotensin-II receptor antagonists for the treatment of high blood pressure (e.g., captopril, enalapril, lisinopril, losartan, valsartan, irbesartan, or others)

    • Heparin

You should also inform your doctor about a family history of blood clots, heart attacks, or strokes.

If you see a different doctor, inform him or her that you are using YAZ.

Tell your doctor if you are scheduled for any laboratory tests since certain blood tests may be affected by hormonal contraceptives.

Also tell your doctor if you are scheduled for MAJOR surgery. You should consult your doctor about stopping the use of YAZ four weeks before surgery and not using YAZ for a time period after surgery or during bed rest.

YAZ should be used only under the supervision of a doctor, with regular follow-up to identify side effects associated with its use. Your visits may include a blood pressure check, a breast exam, an abdominal exam and a pelvic exam, including a Pap smear. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year. Use YAZ only on the advice of your doctor and carefully follow all directions given to you. You must use the birth control pill exactly as prescribed. Otherwise, you may become pregnant.

If you and your doctor decide that, for you, the benefits of YAZ outweigh the risks, you should be aware of the following:

The Risks of Using YAZ

  1. Circulatory disorders (including blood clot in legs, lungs, heart, eyes, or brain)

    Women who use hormonal contraceptives have a higher incidence of blood clots. Blood clots are the most common serious side effects of birth control pills. The risk of developing blood clots is especially high during the first year a woman ever uses a hormonal contraceptive. Clots can occur in many parts of the body.

    Be alert for the following symptoms and signs of serious adverse effects. Call your doctor immediately if they occur:

    • sharp pain in the chest, coughing blood, or sudden shortness of breath. These symptoms could indicate a possible blood clot in the lung.

    • pain and/or swelling in the calf. These symptoms could indicate a possible blood clot in the leg.

    • crushing chest pain or heaviness. These symptoms could indicate a possible heart attack.

    • sudden severe or worsening headache or vomiting, dizziness or fainting, disturbances of vision or speech, or weakness or numbness in an arm or leg. These symptoms could indicate a possible stroke.

    • sudden partial or complete loss of vision. This symptom could indicate a blood clot in the eye.

    Any of these conditions can cause death or disability. Clots also occur rarely in the blood vessels of the eye, resulting in blindness or impaired vision or in a blood vessel leading to an arm or leg, resulting in damage to or loss of a limb.

    The risk of clotting seems to increase with higher estrogen doses. It is important, therefore, to use as low a dosage of estrogen as possible.

  1. Breast cancer

    The most significant risk factors for breast cancer are increasing age and a strong history of breast cancer in the family (mother or sister). Other established risk factors include obesity, never having children, and having your first full-term pregnancy at a late age.

    Some women who use hormonal contraceptives may be at increased risk of developing breast cancer before menopause, which occurs around age 50. These women may be long-term users of birth control pills (more than eight years) or women who start using birth control pills at an early age. In a few women, the use of birth control pills may accelerate the growth of an existing but undiagnosed breast cancer. Early diagnosis, however, can reduce the effect of breast cancer on a woman’s life expectancy. The potential risks related to birth control pills seem to be small, however. A yearly breast examination by a health care professional is recommended for all women.

    ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS ON REGULAR SELF-EXAMINATION OF YOUR BREASTS.

  2. Cervical cancer

    Some studies have found an increase of cancer of the cervix in women who use hormonal contraceptives, although this finding may be related to factors other than the use of oral contraceptives. However, there is insufficient evidence to rule out the possibility that oral contraceptives may cause such cancers.

  3. Liver tumors

    The short and long-term use of birth control pills have also been linked with the growth of liver tumors. Such tumors are extremely rare.

    Contact your doctor immediately if you experience severe pain or a lump in the abdomen.

  4. Gallbladder disease

    Users of birth control pills have a greater risk of developing gallbladder disease requiring surgery within the first year of use. The risk may double after four or five years of use.

  5. Use in pregnancy

    Birth control pills should not be taken by pregnant women. There is no evidence, however, that the birth control pill can damage a developing child. You should check with your doctor about risks to your unborn child from any medication taken during pregnancy.

  6. Use after pregnancy, miscarriage or an abortion

    Your doctor will advise you of the appropriate time to start the use of YAZ after childbirth, miscarriage, or therapeutic abortion.

  7. Pregnancy after stopping YAZ

    You will have a menstrual period when you stop using YAZ. You should delay pregnancy until another menstrual period occurs within four to six weeks. In this way the pregnancy can be more accurately dated. Contact your doctor for recommendations on alternate methods of contraception during this time.

  8. Use while breast-feeding

    If you are breast-feeding, consult your doctor before starting the birth control pill. The hormones in birth control pills are known to appear in breast milk. These hormones may decrease the flow of breast milk. If birth control pills are not resumed until nursing is established, however, the quantity and quality of breast milk does not seem to be affected. Adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. You should use another method of contraception and only consider starting the birth control pill once you have weaned your child completely.


Interactions with Yaz

Certain drugs may interact with birth-control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Please inform your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription. Also tell any other doctor or dentist (or the dispensing pharmacist) who prescribes another drug that you use YAZ. They can tell you if you need to use an additional method of contraception and if so, for how long.


Drugs that may interact with YAZ include:

  • drugs used for the treatment of epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate); tuberculosis (e.g., rifampin, rifabutin) and HIV infections (e.g., ritonavir, nevirapine)

  • antibiotics (e.g., penicillins, tetracyclines, erythromycin) for infectious diseases

  • cyclosporine

  • antifungals (griseofulvin, ketoconazole)

  • the herbal remedy St. John’s Wort (primarily used for the treatment of depressive moods)

  • cholesterol-lowering drugs (e.g., clofibrate)

  • antihypertensive drugs (for high blood pressure)

  • antidiabetic drugs and insulin (for diabetes)

  • prednisone

  • sedatives and hypnotics (e.g., benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate)

  • pain medication (meperidine)

  • antidepressants (e.g., clomipramine)

  • some nutritional supplements (e.g., Vitamin B12, folic acid)

  • antacids (use 2 hours before of after taking YAZ)

The pill may also interfere with the working of other drugs.

This is not a complete list of possible drug interactions with YAZ. Talk to your doctor for more information about drug interactions.


Proper Use of Yaz

Usual dose

How to Take YAZ

  1. READ THESE DIRECTIONS

    • before you start taking your pills, and

    • any time you are not sure what to do.

  2. LOOK AT YOUR PILL PACK, it has 28 pills.

    The YAZ pill pack has 24 light pink “active” pills (with hormones) to be taken for 24 days, followed by 4 white “reminder” pills (without hormones) to be taken for four days. (See package inserts for illustrations.)

    ALSO CHECK the pill pack for: 1) where to start, and 2) direction to take pills in (follow the arrows).

  3. You should use a second method of birth control (e.g., latex condoms and spermicidal foam or gel) for the first seven days of the first cycle of pill use. This will provide a back-up in case pills are forgotten while you are getting used to taking them.

  4. When receiving any medical treatment, be sure to tell your doctor that you are using birth control pills.

  5. IF YOU EXPERIENCE VOMITING OR DIARRHEA, OR IF YOU TAKE CERTAIN MEDICINES, such as antibiotics, your pills may not work as well. Use a back-up method, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or clinic.

  6. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year.

  7. Take the pills only on the advice of your doctor and carefully follow all directions given to you. You must take the pills exactly as prescribed. Otherwise, you may become pregnant.

  8. Your doctor will advise you of the appropriate time to start the use of birth control pills after childbirth, miscarriage, or therapeutic abortion.

  9. THERE IS NO NEED TO STOP TAKING BIRTH CONTROL PILLS FOR A REST PERIOD.

  10. IF YOUR QUESTIONS ARE NOT ANSWERED HERE, CALL YOUR DOCTOR OR CLINIC.

When to Start the First Pack of Pills

BE SURE TO READ THESE INSTRUCTIONS:

  • before you start taking your pills, and

  • any time you are not sure what to do.

Decide with your doctor or clinic what is the best day for you to start taking your first pack of pills. Pick a time of day which will be easy to remember.

  1. THE FIRST DAY OF YOUR MENSTRUAL PERIOD (BLEEDING) IS DAY 1 OF YOUR CYCLE. Your doctor may advise you to start taking the pills on Day 1 or on the first Sunday after your period begins. If your period starts on Sunday, start that same day.

  2. Take one pill at approximately the same time every day for 28 days. Begin a new pack the next day, NOT MISSING ANY DAYS. Your period should occur during the last four days of using that pill pack.

What to Do During the Month

  1. TAKE A PILL AT APPROXIMATELY THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.

    • Try to associate taking your pill with some regular activity, such as eating a meal or going to bed.

    • Do not skip pills even if you have bleeding between monthly periods or feel sick to your stomach (nausea).

    • Do not skip pills even if you do not have sex very often.

  2. WHEN YOU FINISH A PACK

    Start the next pack on the day after your last white “reminder” pill. Take one pill every day. Do not wait any days between packs.

Technical Information

Breast Cancer

Gastrointestinal

Jaundice

Carcinogenesis and Mutagenesis

Hepatocellular Carcinoma

Other Risk Factors for Venous Thromboembolism

Pediatrics

Lipid and Other Metabolic Effects

Psychiatric

Geriatrics

Special Populations

Hematologic

Immune

Monitoring and Laboratory Tests

Skin

Fluid Retention

Nursing Women

Cardiovascular



Storage and Stability

Store in original packaging between 15 and 30°C.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Action and Clinical Pharmacology

Hepatic Insufficiency

Geriatrics

Distribution

Special Populations and Conditions

Absorption

Mechanism of Action

Race

Excretion

Renal Insufficiency

Metabolism

Effect of Food

YAZ

Summary of Pharmacokinetic Parameters
a (drospirenone 3 mg and ethinyl estradiol 0.020 mg) in Healthy Young Women

Pharmacodynamics

Pediatrics



Contraindications

YAZ should not be used in women with:


  • a history of or actual thrombophlebitis or thromboembolic disorders


  • a history of or actual cerebrovascular disorders


  • a history of or actual myocardial infarction or coronary artery disease


  • valvular heart disease with complications


  • a history of or actual prodromi of a thrombosis (e.g., transient ischemic attack, angina pectoris)


  • active liver disease or history of, or actual benign or malignant liver tumors


  • known or suspected carcinoma of the breast


  • carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia


  • undiagnosed abnormal vaginal bleeding


  • steroid-dependent jaundice, cholestatic jaundice, history of jaundice in pregnancy


  • any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields


  • known or suspected pregnancy


  • current or history of migraine with focal aura


  • history of or actual pancreatitis if associated with severe hypertriglyceridemia


  • renal insufficiency


  • hepatic dysfunction


  • adrenal insufficiency


  • presence of severe or multiple risk factor(s) for arterial or venous thrombosis:


    • severe hypertension (persistent values of ≥160/100 mmHg)


    • hereditary or acquired predisposition for venous or arterial thrombosis, such as Factor V Leiden mutation and activated protein C (APC-) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin antibodies, lupus anticoagulant)


    • severe dyslipoproteinemia


    • heavy smoking (>15 cigarettes per day) and over age 35


    • diabetes mellitus with vascular involvement


    • major surgery associated with an increased risk of postoperative thromboembolism


    • prolonged immobilization


  • hypersensitivity to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see Dosage Forms, Composition and Packaging.