Generic Name: drospirenone/estradiol (droe-SPYE-re-none/ES-tra-DYE-ol)
Brand Name: Angeliq
Drospirenone/estradiol should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens may increase the risk of heart disease (including heart attacks), stroke, serious blood clots (eg, in the lungs or legs) cancer of the uterus, breast cancer, or dementia in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use drospirenone/estradiol. Talk with your doctor if you have questions about the benefits and risks of using drospirenone/estradiol.
Drospirenone/estradiol should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use drospirenone/estradiol.
Drospirenone/ estradiol is used for:
Treating moderate to severe hot flashes caused by menopause. Certain doses of drospirenone/estradiol are also used to treat moderate to severe dryness, itching, and burning in or around the vagina. Drospirenone/estradiol 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 have had a severe reaction (eg, swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness) after taking drospirenone/estradiol
- you are pregnant, think you may be pregnant, or plan to become pregnant
- you have kidney, liver, or adrenal gland problems
- you have known or suspected breast cancer or another estrogen-dependent cancer, or you have a history of breast cancer
- you have abnormal vaginal bleeding of an unknown cause
- you have active blood clots (eg, of the legs or lungs), a history of blood clots, or a condition which may increase your risk of blood clots
- you have had a stroke or heart attack within the past year
- you have had your uterus removed (hysterectomy)
- you are taking boceprevir
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 a condition called hereditary angioedema
- if you have a history of uterus problems (eg, endometriosis, fibroids, abnormal vaginal bleeding)
- if you have a history of abnormal mammograms or lumps in the breast, or if a member of your family has had breast cancer
- if you have a history of asthma; heart problems (eg, heart failure); high blood pressure; the blood problem porphyria; blood vessel problems; heart attack; stroke; high cholesterol or triglyceride levels; diabetes; depression; gallbladder problems; pancreas problems; cancer; growths in the liver; kidney, liver, or adrenal gland problems; lupus; memory problems; migraine headaches; seizures; thyroid problems; or chorea (jerky, involuntary movements of the face, arms, or legs)
- if you have high blood potassium levels, low blood sodium levels, low parathyroid gland function, or high blood calcium levels
- if you have a history of jaundice (yellowing of the eyes or skin) caused by pregnancy or estrogen use
- if you drink alcohol, smoke, use tobacco, are very overweight, will be having surgery, or will be confined to a bed or chair for a period of time
- if a member of your family has a history of blood clots (eg, in the leg or lungs), lupus, or has been very overweight
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 or eyes) may be increased
- Tranexamic acid because the risk of blood clots may be increased
- Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril), angiotensin receptor blockers (eg, valsartan), eplerenone, 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, itraconazole, ketoconazole), macrolide antibiotics (eg, clarithromycin, erythromycin), or protease inhibitors (eg, boceprevir, ritonavir) because they may increase the risk of drospirenone/estradiol's side effects
- Aprepitant, barbiturates (eg, phenobarbital, primidone), carbamazepine, clobazam, efavirenz, felbamate, fosaprepitant, griseofulvin, hydantoins (eg, phenytoin), mifepristone, penicillins (eg, amoxicillin), rifamycins (eg, rifampin), rufinamide, 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, thyroid hormones (eg, levothyroxine), or valproic acid 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.
- Swallow drospirenone/estradiol whole with some liquid. Do not break, crush, dissolve, or chew before swallowing. If you cannot swallow drospirenone/estradiol whole, tell your doctor. You may need a different medicine.
- 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 more than 24 hours have passed since you missed a dose of drospirenone/estradiol, 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:
- 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. If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor at least 4 to 6 weeks beforehand. You may need to stop using drospirenone/estradiol or take other special precautions for a period of time.
- 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 (eg, every 3 to 6 months) to determine whether or not you still need to take drospirenone/estradiol.
- Lab tests, including blood pressure and blood potassium levels, may be performed while you use drospirenone/estradiol. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. 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 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 is not approved for use 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Breast tenderness, pain, or enlargement; diarrhea; headache; mild fluid retention; nausea; stomach cramps, bloating, or pain; vaginal spotting or breakthrough bleeding; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bulging eyes; calf or leg pain, swelling, redness, or tenderness; chest, jaw, or arm pain; confusion; coughing up blood; discharge from the nipples; fainting; irregular heartbeat; lumps in the breast; mental or mood changes; migraine headache; new or worsening memory problems; one-sided weakness; severe or persistent dizziness or stomach pain; severe or persistent breast pain; severe, persistent, or 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, ankles, or feet; unusual sweating; unusual tiredness or weakness; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include breast tenderness; nausea or vomiting; severe or unusual vaginal bleeding; severe stomach pain; unusual drowsiness or tiredness.Proper storage of drospirenone/estradiol:
Store drospirenone/estradiol at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take drospirenone/estradiol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about drospirenone/estradiol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to drospirenone/estradiol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using drospirenone/estradiol.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
More about drospirenone/estradiol
- Other brands: Angeliq