"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
METHYLTESTOSTERONE W/ ESTROGEN - ORAL
COMMON BRAND NAME(S): Estratest
WARNING: Estrogens given alone and with another hormone (progestin) for replacement therapy after menopause have sometimes caused rare but very serious side effects. Discuss the risks and benefits of hormone treatment and your personal health history with your doctor.
Estrogens have been reported to increase the chance of cancer of the uterus (endometrial cancer). Taking a progestin with estrogen decreases this risk. Tell your doctor immediately if you have any unusual vaginal bleeding.
Estrogens may also increase your risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs. Estrogen given in combination with progestin can infrequently cause heart disease (e.g., heart attacks), stroke, serious blood clots (pulmonary embolism and deep venous thrombosis), dementia, and cancer of the breast. 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 reduce 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 to 6 months) to see if you still need to take this medication.
Estrogen treatment alone does not appear to increase your risk of breast cancer when used for up to 7 years after menopause. However, talk to your doctor about the risks if you need to take estrogen for a longer period.
Products that contain estrogen should not be used to prevent heart disease or dementia.
If you use this drug for an extended period, you should have a complete physical exam at regular intervals (e.g., once a year) or as directed by your doctor. See Notes section.
USES: This medication is used for the short-term treatment of 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 produces the usual amount of female hormone (estrogen) at the age when monthly menstrual periods normally stop. This medication is a combination of 2 hormones, a female hormone (estrogen) and a male hormone (methyltestosterone).
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.
HOW TO USE: 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 on a cycle, usually once a day for 21 days followed by no medication for 7 days, or as directed by your doctor. Follow your dosing schedule carefully. This drug should be used for the shortest possible length of time. See also Warning section.
This medication may be taken with or without food. You may take it with food or immediately after a meal to prevent stomach upset.
Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day as directed. Dosage is based on your medical condition and response to therapy.
Inform your doctor if your condition does not improve or worsens.
Additional Estratest Information
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