Drospirenone/Estradiol Generic Name:
Drospirenone/Estradiol (droe-SPYE-re-none/ES-tra-DYE-ol)Brand Name:
Estrogen, alone or in combination with progestin hormones, should not be used to prevent heart disease or dementia. Estrogen taken alone or in combination with progestin may increase the risk of heart disease (including heart attacks), stroke, serious blood clots in the lung (pulmonary embolism) or leg (deep venous thrombosis), breast cancer, or dementia. These risks appear to depend on the length of time Drospirenone/Estradiol is used and the amount of estrogen per dose. Therefore, Drospirenone/Estradiol should be used for the shortest possible length of time at the lowest effective dose so you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Discuss any questions or concerns with your doctor.
Drospirenone/Estradiol is used for:
Treating certain moderate to severe symptoms of menopause (eg, hot flashes; dryness, itching, and burning in or around the vagina). It may also be used for other conditions as determined by your doctor.
Drospirenone/Estradiol is a combination of progestin and estrogen hormones. It works by replacing natural progestin and estrogen in women who can no longer produce enough of these hormones.
Do NOT use Drospirenone/Estradiol if:
- you are allergic to any ingredient in Drospirenone/Estradiol
- you are pregnant or think you may be pregnant
- you have kidney, liver, or adrenal gland problems
- you have a history of blood clots (eg, in the lungs, legs, eyes); endometrial, cervical, or vaginal cancer; estrogen-dependent growths; undiagnosed abnormal vaginal bleeding; or breast cancer
- you have had recent (within the past year) bleeding in the brain, stroke, heart attack, or other serious blood vessel problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using Drospirenone/Estradiol :
Some medical conditions may interact with Drospirenone/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 had your uterus removed (hysterectomy), or you have a history of endometriosis, growths in the uterus, uterine fibroids, abnormal mammograms, or lumps in the breast
- if you have a history of asthma, heart problems (eg, heart failure), high blood pressure, blood problems (eg porphyria), blood vessel problems, heart attack, stroke, high cholesterol or lipid levels, diabetes, depression, dementia, gallbladder problems, pancreas problems, cancer, growths in the liver, lupus, migraine headaches, seizures, or underactive thyroid
- if you have high blood potassium levels, low blood sodium levels, or abnormal blood calcium levels
- if you have a history of fluid retention (swelling) or tobacco use, or if you are very overweight
- if a member of your family has ever had a blood clot (eg, in the lung or leg)
- if you have a history of jaundice (yellowing of the eyes or skin) caused by pregnancy or estrogen use
- if you will be confined to a bed or chair for an extended period of time (eg, because of surgery or a long airplane ride)
Some MEDICINES MAY INTERACT with Drospirenone/Estradiol . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Troleandomycin because the risk of jaundice (yellowing of the skin of eyes) and liver problems may be increased
- Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril), angiotensin receptor blockers (eg, valsartan), heparin, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), potassium sparing diuretics (eg, triamterene), or potassium supplements because the risk of high potassium levels in the blood may be increased
- Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Drospirenone/Estradiol 's side effects
- Barbiturates (eg, phenobarbital), carbamazepine, griseofulvin, hydantoins (eg, phenytoin), penicillins (eg, amoxicillin), rifampin, St. John's wort, or tetracyclines (eg, doxycycline) because they may decrease Drospirenone/Estradiol 's effectiveness
- Corticosteroids (eg, prednisone) because the risk of their side effects may be increased by Drospirenone/Estradiol
- Lamotrigine or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Drospirenone/Estradiol
This may not be a complete list of all interactions that may occur. Ask your health care provider if Drospirenone/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/Estradiol :
Use Drospirenone/Estradiol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Drospirenone/Estradiol . Talk to your pharmacist if you have questions about this information.
- Take Drospirenone/Estradiol by mouth with or without food.
- Grapefruit and grapefruit juice may increase the risk of side effects from Drospirenone/Estradiol . Talk to your doctor before including grapefruit or grapefruit juice in your diet while taking Drospirenone/Estradiol .
- Take Drospirenone/Estradiol on a regular schedule to get the most benefit from it.
- Taking Drospirenone/Estradiol at the same time each day will help you remember to take it.
- Continue to take Drospirenone/Estradiol even if you feel well. Do not miss any doses.
- If you miss a dose of Drospirenone/Estradiol , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Drospirenone/Estradiol .
Important safety information:
- Drospirenone/Estradiol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Drospirenone/Estradiol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Check with your doctor before you use a salt substitute or a product that has potassium in it.
- Drospirenone/Estradiol may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
- Tell your doctor or dentist that you take Drospirenone/Estradiol before you receive any medical or dental care, emergency care, or surgery. Drospirenone/Estradiol should be discontinued at least 4 to 6 weeks before surgery or at any time you will be confined to a bed or chair for a long period of time (eg, a long plane flight). Talk to your doctor about the safe use of Drospirenone/Estradiol if any of these conditions apply to you.
- Drospirenone/Estradiol may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker. Ask your doctor whether you should use sunscreen or wear protective clothing when your skin is exposed to the sun, sunlamps, or tanning booths.
- If you wear contact lenses and you develop problems with them or your vision, contact your doctor as soon as possible.
- Drospirenone/Estradiol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Drospirenone/Estradiol .
- Diabetes patients - Drospirenone/Estradiol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- You should talk to your doctor regularly to determine whether or not you still need to take Drospirenone/Estradiol .
- Lab tests, including mammograms, Pap smears, blood pressure, and blood potassium levels, may be performed while you use Drospirenone/Estradiol . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- You should perform monthly self-breast exams and receive yearly breast exams from your doctor while you are taking Drospirenone/Estradiol . Talk with your doctor if you are unsure how to properly perform a self-breast exam. Report any lumps to your doctor right away.
- Use Drospirenone/Estradiol with caution in the ELDERLY; they may be more sensitive to its effects.
- Drospirenone/Estradiol should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Drospirenone/Estradiol if you are pregnant. If you think you may be pregnant, contact your doctor right away. Drospirenone/Estradiol is found in breast milk. If you are or will be breast-feeding while you use Drospirenone/Estradiol , check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Drospirenone/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:
Back pain; breast tenderness, pain, or enlargement; headache; mild hair loss; nausea; nervousness; stomach cramps, bloating, or pain; vaginal spotting or breakthrough bleeding; vomiting; weight changes.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); calf pain, swelling, or tenderness; chest pain; confusion; discharge from the nipples; fainting; irregular heartbeat; lumps in the breast; mental or mood changes (eg, depression, irritability, memory loss); numbness of an arm or leg; one-sided weakness; severe or persistent dizziness or stomach pain; severe or persistent breast pain; severe, persistent, or recurring abnormal vaginal bleeding; speech changes (eg, slurred speech); sudden severe headache, nausea, or vomiting; sudden shortness of breath; sudden weight gain; swelling of the hands or feet; unusual vaginal discharge, itching, or odor; vision changes (eg, double vision, sudden vision loss); yellowing of the skin or eyes.
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 or persistent nausea; severe or unusual vaginal bleeding.Proper storage of Drospirenone/Estradiol :
Store Drospirenone/Estradiol at room temperature, between 68 and 77 degrees F (20 and 20 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/Estradiol out of the reach of children and away from pets.
- If you have any questions about Drospirenone/Estradiol , please talk with your doctor, pharmacist, or other health care provider.
- Drospirenone/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/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.