Rarely, very serious side effects have occurred when estrogen-only and combination hormone replacement therapies (estrogen and progestin HRT) are used after menopause. Discuss the risks and benefits of hormone treatment and your personal health history with your doctor.
Combination HRT should not be used to prevent heart disease or dementia. Combination HRT can rarely cause heart disease (e.g., heart attacks), stroke, serious blood clots (pulmonary embolism and deep venous thrombosis), dementia, and breast cancer. The risk for stroke and breast cancer increases with age, especially for women older than 75. Estrogens may also increase the risk of cancer of the ovaries. Some of these risks appear to depend on the length of time this drug is used and the amount of estrogen per dose. Therefore, this medication should be used for the shortest possible length of time at the lowest effective dose, so you can obtain the benefits and minimize the chance of serious side effects from long-term treatment. Discuss the details with your doctor and check with him/her regularly (e.g., every 3-6 months) to see if you still need to take this medication.
If you use this drug for an extended time, you should have a complete physical exam at regular intervals (e.g., once a year) or as directed by your doctor. See Notes section.Who should not take drospirenone-estradiol?
This medication is used to reduce menopause symptoms. It helps reduce episodes of flushing and sweating of the upper body and face, commonly called hot flashes. It also helps treat dryness, itching, and burning around the vagina. These symptoms occur when a woman's body no longer makes the usual amount of female hormone (estrogen). This medication is a combination of 2 types of female hormones: an estrogen (estradiol) and a progestin (drospirenone). A progestin is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. A woman who has had her uterus removed does not need progestin and should not be treated with this combination medication.
If you need treatment only for vaginal menopause symptoms, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
Certain combination HRT products may also be used to prevent bone loss (osteoporosis) in people at high risk who cannot take other drugs that are safe and effective to prevent or treat bone loss (e.g., raloxifene, bisphosphonates such as alendronate). These medicines should be considered for use before estrogen/progestin HRT therapy for osteoporosis.
Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth, usually once daily or as directed by your doctor. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
Inform your doctor if your condition does not improve or if it worsens.
Dizziness, lightheadedness, headache, stomach upset, bloating, irritability, changes in sleep patterns, nausea, weight changes, increased/decreased interest in sex, change in vaginal discharge, or breast tenderness may occur. If any of these persist or worsen, tell your doctor promptly.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, memory loss), breast lumps, nipple discharge, swelling of the hands/feet, unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged/returning bleeding), yellowing eyes/skin, stomach/abdominal pain, worsening of a seizure condition, muscle weakness, signs of worsening diabetes control (e.g., increased thirst and urination), symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).
This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, pulmonary embolism, stroke, heart attack). Get medical help right away if you experience: pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, sudden shortness of breath, coughing up blood, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, confusion, slurred speech, weakness on one side of the body, sudden vision changes (such as partial/complete blindness), unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
In the US -
Before taking this medication, tell your doctor or pharmacist if you are allergic to drospirenone or estradiol; or to spironolactone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: vaginal bleeding of unknown cause, certain types of cancer (breast, ovary, uterus), blood clotting disorders (such as protein C or protein S deficiency), current/history of blood clots (such as in the legs, eyes, lungs), history of stroke or heart attack, liver disease, kidney disease, adrenal gland problems.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (including blood clots, breast lumps/cancer, angioedema), asthma, diabetes, seizures, migraine headaches, heart disease (e.g., high blood pressure, congestive heart failure), underactive thyroid (hypothyroidism), a certain hormone problem (hypoparathyroidism), mineral imbalance (high or low calcium blood level, high potassium blood level, low sodium blood level), mental/mood disorders (e.g., depression, memory loss), high blood pressure during pregnancy (toxemia), yellowing eyes/skin (cholestatic jaundice) during pregnancy or with past estrogen use, uterus problems (e.g., uterine fibroids, endometriosis), high blood cholesterol/fat (triglyceride) levels, gallbladder disease, obesity, a certain metabolic disorder (porphyria), lupus.
This drug may make you dizzy or lightheaded. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.
If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Consult your eye doctor if these problems occur.
This drug may cause a patchy darkening of the skin on the face (melasma). Sunlight may worsen this darkening. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Do not smoke cigarettes or use tobacco. Smoking/using tobacco while taking this medication further increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35.
If you will be having surgery or will be confined to a chair or bed for a long time (e.g., a long plane flight), tell your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking this drug because of the increased risk for blood clots.
This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.
This medication is not effective for preventing a miscarriage and should not be used for this purpose.
Small amounts of this medication pass into breast milk. This drug may reduce the quality and amount of breast milk. Consult your doctor before breast-feeding.
See also Precautions section.
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
This drug should not be used with the following medications because very serious interactions may occur: aromatase inhibitors (e.g., anastrozole, exemestane), tranexamic acid.
If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting drospirenone/estradiol.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: corticosteroids (e.g., prednisone), ospemifene, raloxifene, tamoxifen, tizanidine, warfarin, drugs affecting liver enzymes that remove estrogens from your body (such as azole antifungals including itraconazole, macrolide antibiotics including erythromycin, rifamycins including rifabutin, St. John's wort, certain anti-seizure medications including carbamazepine, phenobarbital, phenytoin).
Drospirenone may increase the level of potassium in your blood. Before taking drospirenone/estradiol, tell your doctor or pharmacist if you are taking other medications that can raise potassium blood levels. A potassium level in the blood that is too high may cause serious side effects. Follow your doctor's instructions carefully, and continue taking medications for your condition as directed. Keep all medical/laboratory appointments so your doctor can monitor your potassium levels. Check with your doctor or pharmacist if you are taking any of the following: aliskiren, ACE inhibitors (e.g., benazepril, lisinopril), angiotensin receptor blockers (e.g., losartan, valsartan), heparin, nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, naproxen), certain "water pills" (potassium-sparing diuretics such as amiloride, eplerenone, spironolactone, triamterene).
This product can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting, unusual vaginal bleeding in females.
Do not share this medication with others. Keep all medical and laboratory appointments. You should have a complete physical examination that includes blood pressure measurements and breast/pelvic examinations at regular intervals (e.g., once a year) or as directed by your doctor. Follow your doctor's instructions on how to examine your own breasts and report any lumps immediately. You should also be regularly screened for cervical cancer (e.g., Pap test) and have periodic mammograms as determined by your doctor. Consult your doctor for more details.
Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.
Additional lifestyle changes (e.g., reducing stress, eating a low fat/low salt diet, losing weight if you are overweight) to control or prevent high blood pressure, high cholesterol, and diabetes help to prevent heart disease and strokes. Keep your mind active with mental exercises to help prevent dementia. Discuss with your doctor lifestyle changes that might benefit you.
You can also manage hot flashes by keeping a cool body temperature (e.g., using a fan, drinking cool beverages, dressing lightly/in layers, avoiding hot/spicy foods). Limiting caffeine and alcohol, exercising regularly, and learning relaxation techniques may help reduce hot flashes. Vaginal lubricants can help lessen discomfort during intercourse.
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised June 2014. Copyright(c) 2014 First Databank, Inc.
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