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PREMARIN®Description (conjugated estrogens)

11 DESCRIPTION

PREMARIN® (conjugated estrogens tablets, USP) for oral administration contains a mixture of conjugated estrogens purified from pregnant mares' urine and consists of 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 concomitant components as sodium sulfate conjugates, 17α-dihydroequilin, 17α estradiol, and 17β-dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg strengths of conjugated estrogens.

PREMARIN 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide. Each tablet strength contains the following colors:

Tablet strengthTablet color contains
0.3 mgD&C Yellow No. 10 and FD&C Blue No. 2
0.45 mgFD&C Blue No. 2
0.625 mgFD&C Blue No. 2 and FD&C Red No. 40
0.9 mgD&C Red No. 30 and D&C Red No. 7
1.25 mgBlack iron oxide, D&C Yellow No. 10 and FD&C Yellow No. 6

PREMARIN tablets comply with USP Dissolution Test criteria, as outlined below:

PREMARIN 1.25 mg tabletsUSP Dissolution Test 4
PREMARIN 0.3 mg, 0.45 mg and 0.625 mg tabletsUSP Dissolution Test 5
PREMARIN 0.9 mg tabletsUSP Dissolution Test 6
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