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Estrasorb

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Estrasorb

PATIENT INFORMATION

ESTRASORB®
(es-truh-sawrb)
(estradiol) Topical Emulsion

Read this Patient Information before you start using ESTRASORB and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.

What is the most important information I should know about ESTRASORB (an estrogen hormone)?

  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
  • 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 estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function).
  • Using estrogen-alone may increase your chances of getting strokes or blood clots.
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia.
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
  • You and your healthcare provider should talk regularly about whether you still need treatment with ESTRASORB.

What is ESTRASORB?

ESTRASORB is a prescription medicine that contains estradiol (an estrogen hormone). When applied to the skin, estradiol is absorbed through the skin into the bloodstream.

What is ESTRASORB used for?

ESTRASORB is used after menopause to:

  • Reduce moderate to severe hot flashes
    Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 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 get 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 to use 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
    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.
  • currently have or have had certain cancers
    Estrogens may increase the chances of getting certain types of cancer, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use ESTRASORB.
  • had a stroke or heart attack
  • currently have or have had blood clots
  • currently have or have had liver problems
  • have been diagnosed with a bleeding disorder
  • are allergic to ESTRASORB or any of its ingredients

See the list of ingredients in ESTRASORB at the end of this leaflet.

  • think you may be pregnant
    ESTRASORB is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use ESTRASORB if the test is positive and talk to your healthcare provider.

What should I tell my healthcare provider before I use ESTRASORB?

Before you use ESTRASORB, tell your healthcare provider if you:

  • have any unusual vaginal bleeding
    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.
  • have any other medical conditions
    Your healthcare provider may need to check you more carefully if you have certain conditions such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
  • are going to have surgery or will be on bed rest
    Your healthcare provider will let you know if you need to stop using ESTRASORB.
  • are breast feeding
    The hormone in ESTRASORB can pass into your breast milk.

Tell your healthcare provider about all the medicine you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Some medicines may affect how ESTRASORB works. ESTRASORB may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use ESTRASORB?

See the “Instructions for Use” at the end of this Patient Information.

  • Use ESTRASORB exactly as your healthcare provider tells you to use it.
  • ESTRASORB is for skin use only. Do not apply ESTRASORB to your face or to your breasts.
  • Apply ESTRASORB to clean, dry skin on both legs each morning.
  • You will use 2 pouches of ESTRASORB each morning: 1 pouch for the right leg and 1 pouch for the left leg.
  • Apply 1 ESTRASORB pouch of medicine to the left thigh and calf then apply 1 ESTRASORB pouch of medicine to the right thigh and calf.
  • Do not apply sunscreen at the same time you apply ESTRASORB. Sunscreen may affect the way ESTRASORB works and cause you to get too much ESTRASORB.
  • You and your healthcare provider should talk regularly (every 3 to 6 months) about whether you still need treatment with ESTRASORB.

What are the possible side effects of ESTRASORB?

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

  • new breast lumps
  • unusual vaginal bleeding
  • changes in vision or speech
  • sudden new severe headaches
  • severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
  • Less serious, but common side effects include:
  • headache
  • breast pain
  • irregular vaginal bleeding or spotting
  • stomach or abdominal cramps, bloating
  • nausea and vomiting
  • hair loss
  • fluid retention
  • vaginal yeast infection

These are not all of the possible side effects of ESTRASORB. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have side effects that bother you or does not go away. You may report side effects to Medicis, The Dermatology Company at 1-800-900-6389, or to FDA at 1-800FDA-1088.

What can I do to lower my chances of a serious side effect with ESTRASORB?

  • Talk with your healthcare provider regularly about whether you should continue using ESTRASORB.
  • If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you.
  • The addition of progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus (womb).
  • See your healthcare provider right away if you get vaginal bleeding while using ESTRASROB.
  • Have a pelvic exam, 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 had breast lumps or an abnormal mammogram, 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 a higher chance of getting heart disease.
  • Ask your healthcare provider for ways to lower your chances of getting heart disease.

How should I store ESTRASORB?

  • Store ESTRASORB at room temperature between 68°F to 77°F (20°C to 25°C).

Keep ESTRASORB and all other medicines out of the reach of children.

General information about safe and effective use of ESTRASORB

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ESTRASORB for a condition 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.

This leaflet summarizes the most important information about ESTRASORB. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about ESTRASORB that is written for health professionals.

For more information call 1-800-550-5115.

What are the ingredients in ESTRASORB?

Active ingredient: estradiol

Inactive ingredients: soy bean oil, water, polysorbate 80, and ethanol

Instructions for Use

ESTRASORB
(es-truh-sawrb)
(estradiol topical emulsion)

Read these Instructions for Use before you start using ESTRASORB and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.

To apply ESTRASORB you will need 2 pouches of ESTRASORB, 1 pouch for each leg: See Figure A

Figure A

2 pouches of ESTRASORB - Illustration

Note:

  • ESTRASORB should be applied to clean, dry skin of both legs each morning.
  • Every morning you will apply 2 pouches of ESTRASORB.
  • You should only open 1 ESTRASORB pouch at a time.

Step 1. Open 1 ESTRASORB pouch.

  • Cut or tear the ESTRASORB pouch at the notches indicated at the top of the pouch. See Figure B.

Figure B

Cut or tear the ESTRASORB pouch - Illustration

Step 2. Apply ESTRASORB to your left thigh.

  • Apply ESTRASORB to the top of your left thigh, being careful to remove all the medicine by pushing the cream (emulsion) from the bottom of the pouch, up through the opening of the pouch. See Figure C.

Figure C

Apply ESTRASORB to the top of your left thigh - Illustration

Step 3. Rub ESTRASORB into the skin of your left leg.

  • Using 1 hand or 2 hands, rub ESTRASORB into the skin of your entire left thigh and calf (lower back leg) until it is completely rubbed into your skin. See Figures D and E.

Figure D

Rub ESTRASORB into the skin - Illustration

Figure E

Rub ESTRASORB into the skin - Illustration

Step 4. Open the second ESTRASORB pouch.

  • Cut or tear the second ESTRASORB pouch at the notches indicated near the top of the pouch. See Figure B.

Step 5. Apply ESTRASORB to your right thigh.

  • Apply ESTRASORB to the top of your right thigh, being careful to remove all of the medicine by pushing the cream (emulsion) from the bottom of the pouch through the opening of the pouch. See Figure F.

Figure F

Apply ESTRASORB to your right thigh - Illustration

Step 6. Rub ESTRASORB into the skin of your right leg.

  • Using 1 hand or 2 hands, rub ESTRASORB into the skin of your entire right thigh and right calf (lower back leg) until it is completely rubbed into your skin. See Figures G and H.

Figure G

Rub ESTRASORB into the skin - Illustration

Figure H

Rub ESTRASORB into the skin - Illustration

Step 7. Allow the application areas to dry completely before covering with clothing to avoid transfer to other individuals.

Step 8. Wash your hands.

  • After you finish applying ESTRASORB to both of your legs, be sure to wash hands well with soap and water to remove any remaining ESTRASORB. See Figure I.

Figure I

Wash your hands - Illustration

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 3/23/2015
This monograph has been modified to include the generic and brand name in many instances.

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