Drospirenone/Ethinyl Estradiol Generic Name:
Drospirenone/Ethinyl Estradiol (droe-SPYE-re-none/ETH-i-nil ES-tra-DYE-ol)Brand Name:
Cigarette smoking increases the risk of serious heart problems associated with use of Drospirenone/Ethinyl Estradiol . This risk increases with age and with heavy smoking (15 or more cigarettes per day). Women who are older than 35 years old have a greater risk. Women who use Drospirenone/Ethinyl Estradiol should not smoke.
Drospirenone/Ethinyl Estradiol is used for:
Preventing pregnancy. It may also be used for other conditions as determined by your doctor.
Drospirenone/Ethinyl Estradiol is a progesterone and estrogen combination birth control pill. It works by preventing ovulation, thickening the mucus in the cervix, and changing the lining of the uterus.
Do NOT use Drospirenone/Ethinyl Estradiol if:
- you are allergic to any ingredient in Drospirenone/Ethinyl Estradiol
- you are pregnant or think you may be pregnant
- you have a history of blood clotting problems, severe blood clots (eg, in the lungs, legs, eyes), certain blood vessel problems (eg, bleeding in the brain, heart attack, stroke), or breast cancer
- you have certain heart problems (eg, heart valve problems, certain types of irregular heartbeat); chest pain caused by angina; certain blood problems (eg, porphyria); certain types of headaches or migraines with aura; severe or uncontrolled high blood pressure; diabetes that affects circulation; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; or undiagnosed abnormal vaginal bleeding
- you have kidney disease, adrenal disease, liver disease or liver tumors, or a history of yellowing of the eyes or skin caused by pregnancy or prior birth control use
- you have had surgery and are or will be confined to a bed or a chair for an extended period of time
- you are older than 35 years old and you smoke 15 or more cigarettes per day
Contact your doctor or health care provider right away if any of these apply to you.
Before using Drospirenone/Ethinyl Estradiol :
Some medical conditions may interact with Drospirenone/Ethinyl Estradiol . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, abnormal vaginal bleeding, a lump in the breast, or fibrocystic breast disease, or if a family member has had breast cancer
- if you have a history of diabetes or high blood sugar, gallbladder problems, migraines or severe or persistent headaches, heart problems, high blood pressure, high blood cholesterol or lipid levels, kidney or liver problems, blood or bleeding problems, mental or mood problems (eg, depression), lupus, high blood calcium or potassium levels, chorea (jerky, involuntary movements of the face, arms, or legs), varicose veins, yellowing of the eyes or skin, pancreas problems, or seizures
- if you smoke, are very overweight, have not yet had your first menstrual period, or have fluid retention or swelling problems
- if you will be having surgery or will be confined to a bed or a chair for a long period of time
Some MEDICINES MAY INTERACT with Drospirenone/Ethinyl Estradiol . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Aldosterone blockers (eg, eplerenone), angiotensin converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin receptor blockers (eg, losartan), heparin, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, naproxen), potassium supplements, or potassium-sparing diuretics (eg, spironolactone) because the risk of high blood potassium levels may be increased
- Acetaminophen, ascorbic acid (vitamin C), or atorvastatin because they may increase the risk of Drospirenone/Ethinyl Estradiol 's side effects
- Azole antifungals (eg, ketoconazole) or HIV protease inhibitors (eg, ritonavir) because they may decrease Drospirenone/Ethinyl Estradiol 's effectiveness, resulting in pregnancy or breakthrough bleeding, or they may increase the risk of Drospirenone/Ethinyl Estradiol 's side effects
- Aprepitant, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, ampicillin), phenylbutazone, rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Drospirenone/Ethinyl Estradiol 's effectiveness, resulting in breakthrough bleeding or pregnancy
- Beta-blockers (eg, propranolol), corticosteroids (eg, prednisolone), cyclosporine, theophylline, tizanidine, or troleandomycin because the risk of their side effects may be increased by Drospirenone/Ethinyl Estradiol
- Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by Drospirenone/Ethinyl Estradiol
- Clofibric acid, lamotrigine, morphine, salicylic acid, or temazepam because their effectiveness may be decreased by Drospirenone/Ethinyl Estradiol
This may not be a complete list of all interactions that may occur. Ask your health care provider if Drospirenone/Ethinyl Estradiol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Drospirenone/Ethinyl Estradiol :
Use Drospirenone/Ethinyl Estradiol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Drospirenone/Ethinyl Estradiol . Talk to your pharmacist if you have questions about this information.
- Take Drospirenone/Ethinyl Estradiol by mouth with or without food.
- Talk with your doctor about how you should start to take your first pack of Drospirenone/Ethinyl Estradiol . If you begin to take Drospirenone/Ethinyl Estradiol during the first 24 hours of your period, you do not need to use an extra form of birth control. If you begin to take Drospirenone/Ethinyl Estradiol on the Sunday after your period starts, you will need to use an extra form of birth control for 7 days after you start taking Drospirenone/Ethinyl Estradiol .
- If you are switching from another birth control pill to Drospirenone/Ethinyl Estradiol , start Drospirenone/Ethinyl Estradiol on the same day that would have started a new pack of your previous birth control pills. Talk with your doctor if you have any questions about how to switch from another form of hormonal birth control to Drospirenone/Ethinyl Estradiol .
- Take Drospirenone/Ethinyl Estradiol at the same time every day, not more than 2 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.
- For Drospirenone/Ethinyl Estradiol to be effective, it must be taken every day. Do not skip doses even if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseated. If you have these side effects and they do not go away, check with your doctor.
- If you miss 1 dose of Drospirenone/Ethinyl Estradiol , take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup form of birth control if you only miss 1 pill. If you miss more than 1 dose, read the extra patient leaflet that comes with Drospirenone/Ethinyl Estradiol or contact your doctor for instructions. You must use a backup form of birth control if you miss more than 1 dose. If you are not sure how to handle missed doses, use an extra form of birth control (eg, condoms) until you talk with your doctor.
Ask your health care provider any questions you may have about how to use Drospirenone/Ethinyl Estradiol .
Important safety information:
- Drospirenone/Ethinyl Estradiol may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk is greater if you smoke. Do not smoke or use other tobacco products while taking Drospirenone/Ethinyl Estradiol .
- Bleeding or spotting may occur while you are taking Drospirenone/Ethinyl Estradiol . Do not stop taking Drospirenone/Ethinyl Estradiol if this occurs. If bleeding or spotting continues or is heavy, contact your doctor.
- If your period does not occur when expected, or if you experience unusual breast tenderness or symptoms of morning sickness, call your doctor right away. These symptoms may indicate that you are pregnant.
- The effectiveness of Drospirenone/Ethinyl Estradiol may be decreased by certain medicines (eg, antibiotics, medicines for seizures, St. John's wort) or conditions (eg, vomiting or diarrhea). This could cause breakthrough bleeding or increase the risk of an unplanned pregnancy if you have sex. To prevent pregnancy, use an additional form of birth control (eg, condoms). Talk with your doctor or pharmacist for more information.
- Tell your doctor or dentist that you take Drospirenone/Ethinyl Estradiol before you receive any medical or dental care, emergency care, or surgery. If possible, Drospirenone/Ethinyl Estradiol should be stopped at least 4 weeks before surgery or any time you might be confined to a bed or chair for a long period of time (eg, long plane flight, bedrest, or lengthy illness).
- You should usually not take Drospirenone/Ethinyl Estradiol within 4 to 6 weeks after giving birth. Discuss any questions or concerns with your doctor.
- Drospirenone/Ethinyl Estradiol may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
- If you wear contact lenses and you develop problems with them or other vision changes, contact your doctor.
- You may experience a delay in being able to become pregnant after stopping Drospirenone/Ethinyl Estradiol . This effect may be greater in patients who had irregular periods before starting Drospirenone/Ethinyl Estradiol . Discuss any concerns with your doctor or pharmacist.
- Drospirenone/Ethinyl Estradiol does not stop the spread of HIV and other sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD.
- When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not run out of medicine. Your chance of becoming pregnant may be increased if you do not take Drospirenone/Ethinyl Estradiol every day as directed.
- Diabetes patients - Drospirenone/Ethinyl Estradiol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including breast exams, Pap tests, physicals, and blood pressure, may be performed while you use Drospirenone/Ethinyl Estradiol . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Examine your breasts monthly as directed by your doctor. Report any lumps right away.
- Drospirenone/Ethinyl Estradiol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Drospirenone/Ethinyl Estradiol .
- Drospirenone/Ethinyl Estradiol should not be used in CHILDREN who have not yet had their first menstrual period; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not take Drospirenone/Ethinyl Estradiol if you are pregnant. If you think you may become pregnant, contact your doctor right away. Drospirenone/Ethinyl Estradiol is found in breast milk. Do not breast-feed while you are taking Drospirenone/Ethinyl Estradiol .
Possible side effects of Drospirenone/Ethinyl Estradiol :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Breast tenderness; bleeding or spotting between menstrual periods; nausea; stomach cramps or bloating; vomiting; weight gain.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); breast lump or discharge; calf or leg pain, swelling, or tenderness; change in the amount of urine produced; chest pain or heaviness; confusion; coughing of blood; fainting; irregular heartbeat; left-sided jaw, neck, shoulder, or arm pain; mental or mood changes (eg, depression); migraines; missed menstrual period; numbness of an arm or leg; one-sided weakness; persistent, severe, or recurring headache or dizziness; persistent vaginal spotting; severe or persistent trouble sleeping; severe stomach pain or tenderness; shortness of breath; slurred speech; sudden severe vomiting; swelling of the fingers, hands, legs, or ankles; symptoms of liver problems (eg, yellowing of the skin or eyes, fever, dark urine, pale stools, loss of appetite); unusual or severe vaginal bleeding; unusual tiredness or weakness; vaginal irritation or discharge; vision changes (eg, sudden vision loss, double vision).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include severe nausea; unexplained vaginal bleeding.Proper storage of Drospirenone/Ethinyl Estradiol :
Store Drospirenone/Ethinyl Estradiol at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Drospirenone/Ethinyl Estradiol out of the reach of children and away from pets.
- If you have any questions about Drospirenone/Ethinyl Estradiol , please talk with your doctor, pharmacist, or other health care provider.
- Drospirenone/Ethinyl Estradiol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Drospirenone/Ethinyl Estradiol . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.