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drospirenone and ethinyl estradiol

Generic Name: drospirenone and ethinyl estradiol (dro SPY re nown, ETH in il, ESS tra dy ol)
Brand Name: Gianvi, Loryna, Nikki, Ocella, Syeda, Vestura, Yasmin, Yaz, Zarah

What is drospirenone and ethinyl estradiol?

Drospirenone and ethinyl estradiol is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Drospirenone and ethinyl estradiol is used as contraception to prevent pregnancy. This medicine 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. There are many available brands of drospirenone and ethinyl estradiol. Not all brands are listed on this leaflet.

Yaz 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 purposes not listed in this medication guide.

What is the most important information I should know about drospirenone and ethinyl estradiol?

Do not use if you are pregnant or if you recently had a baby.

You should not take this medicine if you have: an adrenal gland disorder, kidney disease, uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take this medicine if you smoke and are over 35 years old.

What should I discuss with my healthcare provider before taking drospirenone and ethinyl estradiol?

Taking this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take this medicine if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss 2 menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking this medicine.

You should not take this medicine if you have:

  • an adrenal gland disorder;

  • kidney disease;

  • untreated or uncontrolled high blood pressure;

  • heart disease (coronary artery disease, history of heart attack, stroke, or blood clot);

  • an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;

  • circulation problems (especially if caused by diabetes);

  • a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;

  • unusual vaginal bleeding that has not been checked by a doctor;

  • liver disease or liver cancer;

  • severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;

  • a history of jaundice caused by pregnancy or birth control pills;

  • if you smoke and are over 35 years old; or

  • if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • heart problems, high blood pressure, or if you are prone to having blood clots;

  • high levels of potassium in your blood;

  • high cholesterol or triglycerides, or if you are overweight;

  • depression;

  • liver or kidney disease;

  • underactive thyroid, diabetes, gallbladder disease; or

  • a migraine headache.

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

How should I take drospirenone and ethinyl estradiol?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms with spermicide, when you first start using this medication.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You could get pregnant if you do not take one pill daily.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

If you need major surgery with long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Follow the patient instructions provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill increases your risk of becoming pregnant.

If you miss 1 active pill, take 2 pills on the day that you remember. Then take 1 pill per day for the rest of the pack.

If you miss 2 active pills in a row in Week 1 or 2, take 2 pills per day for 2 days in a row. Then take 1 pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss 2 active pills in a row in Week 3, throw out the rest of the pack and start a new pack 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 that day.

If you miss 3 active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack 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 that day.

If you miss 2 or more pills, you may not have a period during the month. If you miss a period for 2 months in a row, call your doctor because you might be pregnant.

If you miss a reminder pill, throw it away and keep taking 1 reminder pill per day until the pack is empty.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose may cause nausea or vaginal bleeding.

What should I avoid while taking drospirenone and ethinyl estradiol?

Do not smoke while taking this medicine, especially if you are older than 35 years of age.

This medicine 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.

Drospirenone and ethinyl estradiol side effects

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

Stop using birth control pills and call your doctor at once if you have:

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • liver problems--loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;

  • swelling in your hands, ankles, or feet;

  • a change in the pattern or severity of migraine headaches; or

  • symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • nausea, vomiting;

  • breast tenderness;

  • headache, mood changes, feeling tired or irritable;

  • weight gain; or

  • changes in your menstrual periods, decreased sex drive.

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.

Side Effects (complete list)

Drospirenone and ethinyl estradiol dosing information

Usual Adult Dose for Contraception:

Formulations with placebo tablets:
1 tablet orally once a day for 21 consecutive days, then either 1 placebo tablet OR no tablet for 7 days

Formulations without placebo tablets:
1 tablet orally once a day

Comments:
-Start either the first day of menses, or the first Sunday after onset of menses.
-When switching from a different oral contraceptive, start the day a new pack of the previous medication would have been started.
-When switching from a transdermal patch, vaginal ring, or injection, start when the next application would have been due.
-When switching from an intrauterine device, start the day the device is removed.
-Tablets should be taken in the order directed on the package.
-Take at the same time every day, preferably after the evening meal or at bedtime.
-Patients should use a non-hormonal contraceptive as back up for the first 7 days.

Usual Adult Dose for Premenstrual Dysphoric Disorder:

1 tablet orally once a day

Comments:
-Start either the first day of menses, or the first Sunday after onset of menses.
-When switching from a different oral contraceptive, start the day a new pack of the previous medication would have been started.
-When switching from a transdermal patch, vaginal ring, or injection, start when the next application would have been due.
-When switching from an intrauterine device, start the day the device is removed.
-Tablets should be taken in the order directed on the package.
-Take at the same time every day, preferably after the evening meal or at bedtime.
-Patients should use a non-hormonal contraceptive as back up for the first 7 days.


Use: Treatment of premenstrual dysphoric disorder in women who choose to use an oral contraceptive for contraception.

Usual Adult Dose for Acne:

1 tablet orally once a day

Comments:
-Start either the first day of menses, or the first Sunday after onset of menses.
-When switching from a different oral contraceptive, start the day a new pack of the previous medication would have been started.
-When switching from a transdermal patch, vaginal ring, or injection, start when the next application would have been due.
-When switching from an intrauterine device, start the day the device is removed.
-Tablets should be taken in the order directed on the package.
-Take at the same time every day, preferably after the evening meal or at bedtime.
-Patients should use a non-hormonal contraceptive as back up for the first 7 days.

Use: Treatment of moderate acne vulgaris in women at least 14 years old and have achieved menarche, with no known contraindication to oral contraceptives, who choose to use an oral contraceptive for contraception.

What other drugs will affect drospirenone and ethinyl estradiol?

Other drugs may interact with drospirenone and ethinyl estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can make this medicine less effective, which may result in pregnancy. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about drospirenone and ethinyl estradiol.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • 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 1996-2012 Cerner Multum, Inc. Version: 8.01.

Date modified: December 03, 2017
Last reviewed: October 16, 2017

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