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ESTRATEST®^‡ (esterified estrogens and methyltestosterone) and ESTRATEST® H.S.^‡
(Esterified Estrogens and Methyltestosterone) Tablets

Read this PATIENT INFORMATION before you start taking ESTRATEST (esterified estrogens and methyltestosterone) ® and ESTRATEST (esterified estrogens and methyltestosterone) ® H.S. Tablets and read what you get each time you refill ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets. 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.

What is ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets?

ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets are medicines that contain estrogen and androgen hormones.

What is ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets used for?

ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets are 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 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 ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets.

• treat moderate to severe dryness, itching, and burning in and around the vagina. You and your healthcare provider should talk regularly about whether you still need treatment with ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets to control these problems. If you use ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

Who should not take ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets?

Do not start taking ESTRATEST (esterified estrogens and methyltestosterone) or ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets 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 had cancer, talk with your healthcare provider about whether you should take ESTRATEST (esterified estrogens and methyltestosterone) or ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets.
• 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 ESTRATEST (esterified estrogens and methyltestosterone) or ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets or any of their ingredients. See the end of this leaflet for a list of ingredients in ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets.
• think you may be pregnant.

Tell your healthcare provider:

• if you are breastfeeding. The hormones in ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets 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 ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets work. ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets 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 take ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets?

Estrogens should be used at the lowest dose possible for your treatment only as long as needed. The lowest effective dose of ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets has not been determined. 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 ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets.

What are the possible side effects of estrogens?

Less common but serious side effects include:

• Breast cancer
• Cancer of the uterus
• Stroke
• Heart attack
• Blood clots
• Dementia
• 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
• Vomiting

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 pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps, bloating
• Nausea and vomiting
• 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 the possible side effects of ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets. For more information, ask your healthcare provider or pharmacist.

What can I do to lower my chance of a serious side effect with ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets?

• Talk with your healthcare provider regularly about whether you should continue taking ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets.
• 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 taking ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets.
• 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 ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets for conditions for which it was not prescribed. Do not give ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets to other people, even if they have the same symptoms you have. It may harm them.

Keep ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets out of the reach of children.

This leaflet provides a summary of the most important information about ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets that is written for health professionals. You can get more information by calling the toll free number 1-800-241-1643.

What are the ingredients in ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets?

ESTRATEST H.S. is a combination of Esterified Estrogens and Methyltestosterone. Each capsule-shaped, light green, sugar-coated tablet contains the following active ingredients: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP.

ESTRATEST is a combination of Esterified Estrogens and Methyltestosterone. Each capsule-shaped, dark green, sugar-coated tablet contains the following active ingredients: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP.

ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets contain the following inactive ingredients: acacia, acetylated monoglycerides, calcium carbonate, carboxymethylcellulose sodium, carnauba wax NF, citric acid, colloidal silicon dioxide, gelatin, iron oxide, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, pharmaceutical glaze, povidone, propylene glycol, propylparaben, shellac glaze, sodium benzoate, sodium bicarbonate, sorbic acid, starch, sucrose, talc, titanium dioxide, and tribasic calcium phosphate.

ESTRATEST (esterified estrogens and methyltestosterone) Tablets also include: FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, and D&C Yellow No. 10 Lake.

ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets also include: D&C Yellow No. 10 Lake, FD&C Blue No. 1 Lake, FD&C Blue No. 2 Lake, FD&C Yellow No. 6 Lake, and FD&C Red No. 40 Lake.

Store at controlled room temperature 15° to 30°C (59° to 86°F).

^‡This product has not obtained FDA pre-market approval applicable for new drugs.

Last reviewed on RxList: 7/18/2008
This monograph has been modified to include the generic and brand name in many instances.