Premarin

[Conjugated Estrogens]

Drug Description
DESCRIPTION

Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture of conjugated equine estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 -dihydroequilin, 17 -estradiol, and 17 -dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, 1. 25 mg, and 2.5 mg strengths of conjugated estrogens.

Premarin tablets contain the following inactive ingredients: calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, stearic acid (not present in 0.45 mg tablet), sucrose, and titanium dioxide.

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- 0.3 mg tablets also contain: D& C Yellow No. 10, FD& C Blue No. 1,
FD& C Blue No. 2, FD& C Yellow No. 6; these tablets comply with USP Drug Release
Test 1.

- 0.45 mg tablets also contain: FD& C Blue No. 2; these tablets comply with USP Drug Release Test 1.

- 0.625 mg tablets also contain: FD& C Blue No. 2, D& C Red No. 27, FD& C Red No. 40; these tablets comply with USP Drug Release Test 1.

- 0.9 mg tablets also contain: D& C Red No. 6, D& C Red No. 7; these tablets comply with USP Drug Release Test 2.

- 1.25 mg tablets also contain: black iron oxide, D& C Yellow No. 10, FD& C Yellow No. 6; these tablets comply with USP Drug Release Test 3.

- 2.5 mg tablets also contain: FD& C Blue No. 2, D& C Red No. 7; these tablets comply with USP Drug Release Test 3.

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER

Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose.

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