What is drospirenone-ethinyl estradiol?

Drospirenone and ethinyl estradiol prevent ovulation (the release of an egg from an ovary) and also cause changes in your cervical and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

The combination of drospirenone and ethinyl estradiol is used as contraception to prevent pregnancy. It is also used to treat moderate acne in women who are at least 14 years old and have started having menstrual periods, and who wish to use birth control pills to prevent pregnancy.

This medication is also used to treat the symptoms of premenstrual dysphoric disorder (PMDD), such as anxiety, depression, irritability, trouble concentrating, lack of energy, sleep or appetite changes, breast tenderness, joint or muscle pain, headache, and weight gain.

Drospirenone and ethinyl estradiol may also be used for other purposes not listed in this medication guide.

Precautions

Do not take this medication if you are allergic to drospirenone or ethinyl estradiol, or if you have:

  • uncontrolled high blood pressure, migraine headaches, or a heart valve disorder;
  • a history of stroke, blood clot, or circulation problems of diabetes;
  • kidney or liver disease;
  • adrenal gland disorder;
  • unusual vaginal bleeding;
  • any type of breast, uterine, or hormone-dependent cancer; or
  • a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions.

  • high blood pressure or heart disease;
  • high cholesterol or if you are overweight;
  • liver cancer;
  • gallbladder disease;
  • diabetes;
  • seizures or epilepsy; or
  • a history of depression, irregular menstrual cycles, or history of breast or uterine cancer.

FDA pregnancy category X. This medication can cause birth defects. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

The hormones in this medication can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

Drospirenone may raise potassium levels in your blood. Other medical conditions can also affect potassium levels, including liver disease, kidney disease, and adrenal gland disorders. Before using drospirenone and ethinyl estradiol, tell your doctor if you have any of these conditions.

Do not smoke while using this medication, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Drospirenone and ethinyl estradiol will not protect you from sexually transmitted diseases—including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

Missing a pill increases your risk of becoming pregnant.

If you miss one"active" pill, take the dose as soon as you remember or take two pills at the time of your next regularly scheduled dose. You do not need to use backup birth control.

If you miss two"active" tablets in a row in week one or two, take two tablets each for the next two regularly scheduled doses (one missed tablet plus one regularly scheduled tablet for 2 days in a row). Use another form of birth control for at least 7 days following the missed tablets.

If you miss two "active" tablets in a row in week three, or if you miss three tablets in a row during any of the first 3 weeks, throw out the rest of the pack and start a new package on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday.

On Sunday, throw out the rest of the pack and start a new pack of pills that same day. You may not have a period that month, but this is expected. However, if you miss your period 2 months in a row, call your doctor because you might be pregnant.

If you miss one of the reminder pills in week four, skip that dose and take the next one as directed.

If you miss a pill, you may become pregnant if you have sex in the 7 days after your missed pill. You MUST use another birth control method (such as condoms or spermicides) as a back-up for those 7 days.

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Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a change in the pattern or severity of migraine headaches;
  • stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes);
  • a breast lump; or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

  • breast pain, tenderness, or swelling;
  • freckles or darkening of facial skin, increased hair growth, or loss of scalp hair;
  • changes in weight or appetite, swelling of your hands or feet;
  • problems with contact lenses;
  • vaginal itching or discharge; or
  • changes in your menstrual periods.

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

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Interactions

Some drugs can make drospirenone and ethinyl estradiol less effective, which may result in pregnancy. Other drugs may be affected by drospirenone and ethinyl estradiol. Before using this medication, tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Other Names

Yasmin, Yaz, drospirenone-ethinyl estradiol, ethinyl estradiol-drospirenone, and Ocella

Available Strengths & Dosages


Route Form Strength
oral tablet 3 mg-0.02 mg

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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