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ESTRATEST® (esterified estrogens and methyltestosterone) Tablets
ESTRATEST® and ESTRATEST® H.S. are indicated for the management of moderate to severe vasomotor symptoms associated with menopause in patients who do not respond to estrogens alone. (There is no evidence that estrogens are effective for nervous systems or depression without associated vasomotor symptoms, and they should not be used to treat such conditions).
Estrogens should not be used for the prevention of cardiovascular disease. The Women's Health Initiative (WHI) reported increased risks of certain cardiovascular and embolic events and some gynecological cancers in postmenopausal women. While ESTRATEST® brand Tablets were not studied in the WHI, in the absence of conclusive data, a conservative view would assume the risks to be similar.
Estrogens are contraindicated for patients with known or suspected pregnancy, breast cancer, active thrombophlebitis, or thromboembolic disorders. Methyltestosterone is contraindicated in pregnant and lactating women, and patients with severe liver damage. Methyltestosterone should be prescribed with caution in women with a current or past history of hyperandrogenic states. The most commonly reported adverse events are those typical of estrogen therapy (such as breast tenderness, headache, nausea, edema and abdominal pain) and of androgen treatment (including alopecia, acne, and hirsutism).
Safety and efficacy for this class of compounds was confirmed by the National Academy of Sciences. This product has not obtained FDA pre-market approval applicable for new drugs.
Please see link below for complete safety and prescribing information.
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