esterified estrogens and methyltestosterone, Estratest, Estratest HS

Notice: Solvay Pharmaceuticals, Inc. announced on March 10, 2009, that it would discontinue supplying the marketplace with ESTRATEST® (Esterified Estrogens and Methyltestosterone) Tablets and ESTRATEST® HS (Esterified Estrogens and Methyltestosterone) Tablets. Effective March 31, 2009, the company will no longer accept orders for new product from its customers.

GENERIC NAME: esterified estrogens and methyltestosterone

BRAND NAME: Estratest

DRUG CLASS AND MECHANISM: Esterified estrogens are a mixture of related estrogens. Estrogens, when taken alone or in combination with a progestin, have been shown to reduce the risk for hip fracture due toosteoporosis by 25% as well as the risk of heart attack (myocardial infarction) and stroke by 40-50%. Esterified estrogens are used for numerous medical situations. Estrogens cause growth and development of female sex organs and the maintain sex characteristics, including growth of underarm and pubic hair and shaping of body contours and skeleton. Estrogens also increase secretions from the cervix and growth of the inner lining of the uterus (endometrium). Estrogens reduce LDL-cholesterol ("bad"cholesterol) and increase HDL-cholesterol ("good" cholesterol) concentrations.

Testosterone is the major male sex hormone that is responsible for many male sexual characteristics, but women also produce small amounts of testosterone. Following menopause, a woman's production of testosterone decreases. When testosterone in the form of methyltestosterone is added to estrogens, there may be a further alleviation of the hot flashes seen aftermenopause, and there also may be an improvement in a woman's sexual function.

GENERIC AVAILABLE: no

PRESCRIPTION: yes

PREPARATIONS: Estratest tablets: esterified estrogens 0.625mg plus methyltestosterone 1.25mg; esterified estrogens 1.25mg plus methyltestosterone 2.5mg. Estratest HS is one-half the strength of Estratest.

STORAGE: Tablets should be stored at 36-86°F (20-30°C).

PRESCRIBED FOR: Estratest is prescribed for the treatment of the common symptoms associated with menopause (e.g., hot flashes, vaginal dryness).

DOSING: Estratest usually is prescribed as 1 or 2 tablets daily for 21 consecutive days followed by 7 days without medication.

DRUG INTERACTIONS: For drug interactions for esterified estrogens, please read the esterified estrogens article.

Methyltestosterone can increase the effects of warfarin (Coumadin), increasing the risk of bleeding. Taking methyltestosterone and imipramine(Tofranil) together has led to paranoia in a few patients. Methyltestosterone can increase blood concentrations of cyclosporine (Sandimmune; Neoral), which can increase the risk of kidney damage.

PREGNANCY: Both methyltestosterone and estrogens should not be used during pregnancy due to an increased risk of fetal abnormalities.

NURSING MOTHERS: Estrogens are secreted in milk and cause unpredictable effects in the infant. They should not be used during breast-feeding.

SIDE EFFECTS: For side effects, please read the esterified estrogensarticle.

Methyltestosterone can have masculinizing effects in women, the development of acne, growth of facial hair, enlargement of the clitoris, reduction in breast size, and deepening of the voice. If treatment is discontinued when these symptoms first appear, they usually diminish or disappear; however, prolonged treatment can cause irreversible masculinizing effects.

Reference: FDA Prescribing Information