Brand Names: Covaryx, Covaryx HS, EEMT, Essian H.S., Estratest, Estratest H.S., Syntest DS, Syntest HS

Generic Name: esterified estrogens and methyltestosterone (Pronunciation: ess TER if fyed ESS troe jenz and METH il tes TOS te rone)

• What is esterified estrogens and methyltestosterone (Estratest)?
• What are the possible side effects of esterified estrogens and methyltestosterone?
• What is the most important information I should know about esterified estrogens and methyltestosterone?
• What should I discuss with my health care provider before using esterified estrogens and methyltestosterone?
• How should I use esterified estrogens and methyltestosterone?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while using esterified estrogens and methyltestosterone?
• What other drugs will affect esterified estrogens and methyltestosterone?
• Where can I get more information?

What is esterified estrogens and methyltestosterone (Estratest)?

Esterified estrogens are female sex hormones necessary for many processes in the body.

Methyltestosterone is a man-made form of testosterone, a naturally occurring sex hormone that is produced in a man's testicles. Small amounts of testosterone are also produced in a woman's ovaries and adrenal system.

The combination of esterified estrogens and methyltestosterone is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

This medication may also be used for other purposes not listed in this medication guide.

Estratest HS

oblong, green, imprinted with SOLVAY 1023

Estratest

oblong, green, imprinted with SOLVAY 1026

What are the possible side effects of esterified estrogens and methyltestosterone?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• swelling, rapid weight gain;
• confusion, unusual thoughts or behavior;
• pain, swelling, or tenderness in your stomach;
• nausea, stomach pain, loss of appetite jaundice (yellowing of the skin or eyes);
• breast lump, nipple discharge;
• acne, skin color changes, increased facial hair, male pattern baldness, voice changes; or
• changes in your menstrual periods, break-through bleeding.

Less serious side effects may include:

• mild nausea, stomach upset;
• swollen or painful breasts;
• headache;
• hair loss;
• depression, anxiety; or
• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about esterified estrogens and methyltestosterone?

Do not use this medication if you have any of the following conditions: liver disease, a recent history of heart attack, stroke or circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, or if you are pregnant or breast-feeding. This medication should not be used to prevent heart disease or stroke.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Tell your doctor if you become pregnant during treatment.

Esterified estrogens and methyltestosterone increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using esterified estrogens and methyltestosterone may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are taking esterified estrogens and methyltestosterone.

Long-term esterified estrogens and methyltestosterone treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using esterified estrogens and methyltestosterone long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using esterified estrogens and methyltestosterone.