"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.
ESTRADIOL SPRAY - TRANSDERMAL
COMMON BRAND NAME(S): Evamist
WARNING: Estrogens, either used alone or with another hormone (progestin), have rarely caused very serious side effects. Discuss the risks and benefits of hormone treatment with your doctor. Estrogens should not be used to prevent heart disease or dementia.
Estrogens can increase the risk of cancer of the uterus (endometrial cancer). Taking a progestin as directed by your doctor can help decrease this risk. Tell your doctor right away if you have any unusual vaginal bleeding.
In postmenopausal women, estrogens can increase the risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs. Estrogens alone do not appear to increase the risk of breast cancer when used for up to 7 years. Estrogen, when used with a progestin, can increase the risk of heart disease (such as heart attacks), stroke, serious blood clots in the lungs/legs, dementia, and cancer of the breast/ovaries.
The risk for serious side effects may depend on the dose of estrogen and the length of time it is used. Therefore, this medication should be used at the lowest effective dose and for the shortest amount of time. Discuss the use of this medication with your doctor regularly (for example, every 3 to 6 months) to see if you still need to use it. If you will be taking this medication long-term, you should have regular complete physical exams (for example, once a year) as directed by your doctor. See also Notes section.
Do not let other people, especially children, come into contact with this medication. They may be accidentally exposed to this medication through contact with your forearm where you sprayed it. If this occurs, a child may have unwanted side effects. Tell the doctor right away if you notice unexpected signs of puberty in a child such as an increase in breast or nipple size. These side effects usually go away when exposure to this medication stops. To decrease this risk, carefully follow all directions for the proper use of this drug. See also the How to Use section.
USES: This medication is a female hormone (estrogen). It is absorbed through the skin and enters into the bloodstream. It is used by women to help reduce a certain symptom of menopause (hot flashes). Symptoms of menopause are caused by the body making less estrogen. If you are using estrogens to treat only vaginal symptoms of menopause (such as vaginal dryness/burning/itching), 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 estrogen products may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen treatment.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. Learn how to use the spray correctly. If you have any questions, ask your doctor or pharmacist.
Follow the instructions for priming the spray if you are using it for the first time.
Keep the spray upright when using. Spray this medication on clean, dry skin of the inside area of your forearm (between the elbow and the wrist) as directed by your doctor, usually once daily in the morning. If your dose is for more than 1 spray, do not use more than 1 spray on the same area of the skin. The application sites should be next to each other but not overlapping. Avoid applying this medication to broken, irritated skin. Do not apply this medication to other areas of the body, including the breast, face, or in or around the vagina.
The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this medication more often than prescribed.
Replace the cap on the spray after each use. After applying this medication, wash your hands thoroughly with soap and water. Wait at least 2 minutes for the application site to dry completely before dressing. Do not rub the medication into the skin. Cover the application site with clothing (such as a long-sleeve shirt) to prevent others from touching the application area and being exposed to the drug. If someone accidentally touches the application site, have them wash the area of contact on their body with soap and water as soon as possible. Also, keep pets from coming into contact with the application site.
To get the best effect, wait at least 1 hour before washing the application site to allow the drug to be absorbed through the skin.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.
Avoid getting this medication in the eyes. If this medication gets in the eyes, rinse them right away with warm water. Tell your doctor if you get any eye irritation.
This medication is flammable until dry. Let the medication dry before smoking or going near an open flame.
Keep track of the number of sprays you use. Discard the container after you have used the labeled number of sprays on the product package, even if there is medication left in the container.
Tell your doctor if your condition does not improve or if it worsens.
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