ESTRATEST® and ESTRATEST® H.S. (esterified estrogens and methyltestosterone) Tablets Combination of estrogens and androgens in one pill indicated for the management of moderate to severe vasomotor symptoms associated with menopause, in patients who do not respond to estrogen alone Product Information 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. They combine Esterified Estrogens (a type of estrogen) with Methyltestosterone (a type of androgen) in one pill. 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 should not be used in 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. ESTRATEST® and ESTRATEST® H.S. Prescribing and Safety Information ESTRATEST ® is available by prescription only. Ask your doctor if ESTRATEST® is right for you.