Drospirenone/ethinyl estradiol (By mouth)
Drospirenone (droe-SPYE-re-none), Ethinyl Estradiol (ETH-i-nil es-tra-DYE-ol)
Used to prevent pregnancy. Also treats premenstrual dysphoric disorder (PMDD) and acne. This medicine is a birth control pill.
YAZ, Ocella, Zarah, Yasmin, Syeda, Yaz 28, Gianvi, Loryna, VesturaThere may be other brand names for this medicine.
When This Medicine Should Not Be Used:Do not use this medicine if you have had an allergic reaction to drospirenone or ethinyl estradiol, or if you are pregnant or have unusual vaginal bleeding. Do not use this medicine if you have uncontrolled high blood pressure, certain heart problems, or diabetes with kidney, eye, nerve, or blood vessel damage. Do not use this medicine if you have adrenal problems, breast cancer, kidney disease, liver disease, or certain types of headaches. Do not use this medicine if you have a history of blood clots, heart attack, or stroke. Do not use this medicine if you smoke cigarettes and you are older than 35 years of age.
How to Use This Medicine:
- Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
- This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
- Take this medicine at the same time each day, preferably after your evening meal or at bedtime. Birth control pills work best when no more than 24 hours pass between doses.
- Swallow the tablet whole. Do not crush, break, or chew it.
- Your body will need at least 7 days to adjust before a pregnancy will be prevented when you first use this medicine. Use a second form of birth control, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.
- Keep your pills in the blister pack you receive from the pharmacy. Take the pills in the order they appear in the container.
- You may feel sick or nauseated, especially during the first few months that you take this medicine. Call your doctor if your nausea does not go away.
- Follow the instructions in the patient leaflet or call your doctor if you vomit or have diarrhea within 3 to 4 hours of taking this medicine.
If a dose is missed:
- This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.
- Use a second form of birth control for 7 days after you miss a dose, to prevent pregnancy.
- Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.
- You may not have a period for that month if you miss more than one dose or change your schedule.
- You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.
How to Store and Dispose of This Medicine:
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are using acetaminophen (Tylenol), ascorbic acid (Vitamin C), atorvastatin (Lipitor), bosentan (Tracleer), felbamate (Felbatol), rifampin (Rifadin, Rimactane), St John's wort, certain blood pressure medicine (such as eplerenone, Inspra, benazepril, enalapril, lisinopril, Lotrel, Vasotec, Zestril, Zestoretic, Avalide, Avapro, Benicar, Cozaar, Diovan, Micardis), a diuretic (water pill, such as spironolactone, triamterene, Aldactone), or NSAID pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen, Advil, Aleve, Celebrex, Voltaren).
- Tell your doctor if you are also using heparin, potassium supplements, medicine for seizures (such as lamotrigine, Lamictal, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, topiramate, Depakene, Dilantin, Luminal, or Tegretol), medicine for HIV/AIDS (such as atazanavir, lopinavir, ritonavir, Crixivan, Kaletra, Lexiva, Norvir, Prezista, Reyataz, delavirdine, efavirenz, Atripla, Sustiva, Rescriptor), an antifungal (such as griseofulvin, itraconazole, ketoconazole, Grifulvin V, Nizoral, Sporanox), or thyroid medicine (such as levothyroxine, Synthroid).
Warnings While Using This Medicine:
- Tell your doctor right away if you think you are pregnant. This medicine could harm your unborn baby if you take it while you are pregnant.
- Make sure your doctor knows if you are breastfeeding, or if you have had a baby within 4 weeks before you start using this medicine. Tell your doctor if you have inherited angioedema (swelling of the face, tongue, or throat), breast cancer, diabetes, high blood pressure, high cholesterol, high potassium in the blood, or a history of depression or chloasma gravidarum (a skin disorder during pregnancy). Tell your doctor if you have ever had cholestasis (jaundice) caused by pregnancy or birth control pills.
- Birth control pills may increase your risk for blood clots, especially in the first 6 months of use. This medicine contains drospirenone and ethinyl estradiol, which may increase your risk for blood clots more than other birth control pills. Stop using this medicine and check with your doctor right away if you have pain in your chest, groin, or legs (especially your calves), a sudden or severe headache, slurred speech, unexplained shortness of breath, or a sudden loss of coordination.
- Your risk of a blood clot, heart attack, or stroke increases if you smoke while you use birth control pills. Your risk is even higher if you are older than 35, or if you have diabetes, high blood pressure, high cholesterol, or if you are overweight.
- Stop using this medicine and tell your doctor right away if you have dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain or tenderness in your upper stomach, or yellow eyes or skin. These could be symptoms of a serious liver problem.
- This medicine will not protect you from HIV/AIDS or other sexually transmitted diseases. Talk with your doctor if this is a concern for you.
- Tell your doctor right away if you have blurred vision, trouble reading, or any other vision changes, or if you wear contact lens and start to have trouble with them. Your doctor may refer you to an eye doctor.
- Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
- Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
- Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.Your doctor may also want to check your blood pressure while you take this medicine.
Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Chest pain, trouble breathing, coughing up blood
- Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
- Heavy vaginal bleeding
- Irregular, late, or missed menstrual period
- Lumps in breast
- Numbness or weakness in your arm or leg, or on one side of your body
- Pain in your lower leg (calf)
- Severe stomach pain with nausea, vomiting
- Sudden or severe headache, problems with vision, speech, walking
If you notice these less serious side effects, talk with your doctor:
- Rapid weight gain, swelling in your hands, ankles, or feet
- Breast pain, tenderness, swelling, discharge
- Depression, mood changes
- Mild headache
- Vaginal spotting, light bleeding, itching, discharge
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
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