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Estrace Vaginal Cream

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Estrace Vaginal Cream

PATIENT INFORMATION

NOTE: The number of doses per tube will vary with dosage requirements and patient handling.

Read this PATIENT INFORMATION before you start using ESTRACE® Vaginal Cream and read what you get each time you refill ESTRACE Vaginal Cream (estradiol vaginal cream) . There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ESTRACE VAGINAL CREAM (AN ESTROGEN HORMONE)?

  • Estrogens increase the chances of getting cancer of the uterus.

Report any unusual vaginal bleeding right away while you are taking estrogens. 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, or strokes.

Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with ESTRACE Vaginal Cream (estradiol vaginal cream) .

What is ESTRACE Vaginal Cream (estradiol vaginal cream) ?

ESTRACE Vaginal Cream (estradiol vaginal cream) is a medicine that contains estrogen hormones.

What is ESTRACE Vaginal Cream (estradiol vaginal cream) used for?

ESTRACE Vaginal Cream (estradiol vaginal cream) is used to:

  • treat moderate to severe dryness, itching, and burning in and around the vagina due to menopause. You and your healthcare provider should talk regularly about whether you still need treatment with ESTRACE Vaginal Cream (estradiol vaginal cream) to control these problems.

Who should not use ESTRACE Vaginal Cream (estradiol vaginal cream) ?

Do not start using ESTRACE Vaginal Cream (estradiol vaginal cream) 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 or have had cancer, talk with your healthcare provider about whether you should use ESTRACE Vaginal Cream (estradiol vaginal cream) .

  • had a stroke or heart attack in the past year
  • currently have or have had blood clots
  • currently have or have had liver problems
  • are allergic to ESTRACE Vaginal Cream (estradiol vaginal cream) or any of its ingredients

See the end of this leaflet for a list of ingredients in ESTRACE Vaginal Cream (estradiol vaginal cream)

  • think you may be pregnant

Tell your healthcare provider:

  • if you are breastfeeding

The hormone in ESTRACE Vaginal Cream (estradiol vaginal cream) can pass into your 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.

  • about all the medicines you take

This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how ESTRACE Vaginal Cream (estradiol vaginal cream) works. ESTRACE Vaginal Cream (estradiol vaginal cream) may also affect how your other medicines work.

  • if you are going to have surgery or will be on bed rest.

You may need to stop taking estrogens.

How should I use ESTRACE Vaginal Cream (estradiol vaginal cream) ?

  1. Remove cap from tube. (There is no seal on tube)
  2. Do not separate plunger from applicator.
  3. Screw threaded end of applicator onto the opened tube until secure.
  4. Position upright in order to view the calibrated gram amounts.
  5. Gently squeeze tube from the bottom to expel the prescribed amount of ESTRACE Vaginal Cream into the applicator. As cream is squeezed out, plunger will rise to indicate amount of grams.
  6. Unscrew applicator from tube.
  7. Replace cap onto tube.
  8. Lie on back with knees drawn up. To deliver medication, gently insert applicator deeply into the vagina and press plunger downward to its original position.
  9. To cleanse applicator: Pull plunger to remove it from barrel. Wash with mild soap and warm water. DO NOT BOIL OR USE HOT WATER.

ESTRACE Vaginal Cream (estradiol vaginal cream) should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with ESTRACE Vaginal Cream (estradiol vaginal cream) .

What are the possible side effects of ESTRACE Vaginal Cream (estradiol vaginal cream) ?

Although ESTRACE Vaginal Cream (estradiol vaginal cream) is only used in and around the vagina, the risks associated with oral estrogens should be taken into account.

Less common but serious side effects include:

These are some of the warning signs of serious side effects:

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:

  • Headache
  • Breast tenderness
  • Irregular vaginal bleeding or spotting
  • Stomach/abdominal cramps, bloating
  • Nausea and vomiting
  • Hair loss
  • Vaginal burning, irritation, and itching

Other side effects include:

These are not all the possible side effects of ESTRACE Vaginal Cream (estradiol vaginal cream) . For more information, ask your healthcare provider or pharmacist.

What can I do to lower my chances of a serious side effect with ESTRACE Vaginal Cream?

Talk with your healthcare provider regularly about whether you should continue using ESTRACE Vaginal Cream (estradiol vaginal cream) . See your healthcare provider right away if you get vaginal bleeding while using ESTRACE Vaginal Cream (estradiol vaginal cream) . 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, 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 for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about safe and effective use of ESTRACE Vaginal Cream (estradiol vaginal cream)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ESTRACE Vaginal Cream (estradiol vaginal cream) for conditions for which it was not prescribed. Do not give ESTRACE Vaginal Cream (estradiol vaginal cream) to other people, even if they have the same symptoms you have. It may harm them.

Keep ESTRACE Vaginal Cream (estradiol vaginal cream) out of the reach of children.

This leaflet provides a summary of the most important information about ESTRACE Vaginal Cream (estradiol vaginal cream) . If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about ESTRACE Vaginal Cream (estradiol vaginal cream) that is written for health professionals. You can get more information by calling the toll free number 1-800-521-8813.

What are the ingredients in ESTRACE Vaginal Cream (estradiol vaginal cream) ?

Each gram of ESTRACE Vaginal Cream contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary-butylhydroquinone.

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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