"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.
(estradiol topical emulsion)
Read this PATIENT INFORMATION before you start taking Estrasorb and read what you get each time you refill Estrasorb, There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment
- Patient Information:
Details with Side Effects
What is the most important information I should know about Estrasorb?
- Estrogens increase the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are using Estrasorb. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes or dementia. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with or without progestins, may increase your risk of dementia, based on a study of women age 65 years or older. You and your healthcare provider should talk regularly about whether you still need treatment with Estrasorb.
What is Estrasorb?
Estrasorb contains an estrogen hormone called estradiol. When applied to the skin as directed below, Estrasorb releases estradiol, which is absorbed through the skin into the bloodstream.
What is Estrasorb used for?
Estrasorb is used after menopause to:
- reduce moderate to severe hot Hashes.
Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.”
When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Estrasorb.
Who should not use Estrasorb?
Do not start using Estrasorb if you:
- have unusual vaginal bleeding
- currently have or have had certain cancers
Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have had cancer, talk with your health care provider about whether you should use Estrasorb,
- had a stroke or heart attack in the past year
- currently have or have had blood clots
- are allergic to Estrasorb or any of its ingredients
- See the end of this leaflet for a list of ingredients in Estrasorb.
- think you may he pregnant.
Tell your healthcare provider:
- if you are breast feeding. The hormone in Estrasorb can pass into you're your breast milk.
- about all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- if you are going to have surgery or will be on bed rest. You may need to stop using Estrasorb.
What are the possible side effects of estrogens?
Less common but serious side effects include:
- Breast cancer
- Cancer of the uterus
- Heart attack
- Blood clots
- Gallbladder disease
- Ovarian cancer
These are some of the warning signs of serious side effects:
- Breast lumps
- Unusual vaginal bleeding
- Dizziness and faintness
- Changes in speech
- Severe headaches
- Chest pain
- Shortness of breath
- Pains in your legs
- Changes in vision
Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.
Common side effects include:
- Breast pain
- Irregular vaginal bleeding or spotting
- Stomach/abdominal cramps, bloating
- Nausea and vomiting
- Skin irritation, redness, or rash may occur at the site of application
- Hair loss
Other side effects include:
- High blood pressure
- Liver problems
- High blood sugar
- Fluid retention
- Enlargement of benign tumors of the uterus (“fibroids”)
- Vaginal yeast infection
These are not all of the possible side effects of Estrasorb. For more information, ask your healthcare provider or pharmacist.
What can I do to lower my chances of getting a serious side effect with Estrasorb?
- Talk with your healthcare provider regularly about v/hether you should continue using Estrasorb.
- If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you.
- See your healthcare provider right away if you get vaginal bleeding while using Estrasorb.
- Have a breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram (breast x-ray examination), you may need to have breast exams more often.
- If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances of getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.
How should I use Estrasorb?
Estrasorb should be used only as long as needed. You and your healthcare provider should talk regularly (for example every 3 to 6 months) about whether you still need treatment with Estrasorb.
Estrasorb is an emulsion that is applied each day to the skin of both thighs and calves. It is not known if Estrasorb will be absorbed as well if applied to other parts of the body. Estrasorb is packaged in foil pouches. A daily dose of Estrasorb is two foil pouches. Do not open the pouches until just before you apply Estrasorb.
Apply Estrasorb in the morning. If you shower or take a bath, be sure your skin is dry before using Estrasorb. Do not apply Estrasorb to any skin on your thighs and calves that appears to be red or irritated. Do not apply sunscreen and Estrasorb at the same time because sunscreen may affect the amount of estradiol you absorb.
How to apply Estrasorb
- Estrasorb is best applied when you are sitting comfortably. The skin on both legs should be clean and dry.
- Cut or tear the first pouch across the notches to open it (Diagram 1).
- Place the pouch flat on top of your left thigh, with the open end facing your knee. Hold the other end with one hand and use the forefinger of your other hand to push all of the contents of the pouch onto your left thigh (Diagram 2).
- With one hand or both hands rub the material into your entire left thigh and left calf for three minutes or until thoroughly absorbed (Diagram 3).
Rub any excess material remaining on the hands on your buttocks.
- Cut or tear the second pouch across the notches to open it (see Diagram 1). Place the pouch flat on top of your right thigh, with the open end facing your knee. Hold the unopened end with one hand and use the forefinger of your other hand to push all of the contents of the pouch onto your right thigh (see Diagram 2).
- With one hand or both hands rub the material into your entire right thigh and right calf for three minutes until thoroughly absorbed (see Diagram 3). Rub any excess material remaining on the hands on your buttocks.
- To reduce the chances of Estrasorb transfer to other individuals upon contact, allow the application areas to dry completely and cover with clothing.
- Wash your hands with soap and water after you have finished the applications to ensure that any excess material has been removed (Diagram 4).
If you forget to apply Estrasorb in the morning just apply Estrasorb as soon as you remember. Do not apply Estrasorb more than once each day.
General information about the sale and effective use of Estrasorb.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Estrasorb for conditions for which it was not prescribed. Do not give Estrasorb to other people, even if they have the same symptoms you have. It may harm them.
Keep Estrasorb out of the reach of children.
This leaflet provides a summary of the important information about Estrasorb. If you would like more information. talk with your healthcare provider or pharmacist. You can ask for information about Estrasorb that is written for health professionals. You can get more information by calling the toll free number (1-866-230-0375).
What are the ingredients in Estrasorb?
17β-estradiol, Soybean oil, Water, Polysorbate 80, Ethanol
Last reviewed on RxList: 7/22/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Estrasorb Information
Estrasorb - User Reviews
Estrasorb User Reviews
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