Rx only
DESCRIPTION
Premarin® (conjugated estrogens tablets, USP) for oral administration contains a mixture of conjugated 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, 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, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, and titanium dioxide.
— 0.3 mg tablets also contain: D&C Yellow No. 10 and FD&C Blue No. 2.
— 0.45 mg tablets also contain: FD&C Blue No. 2.
— 0.625 mg tablets also contain: FD&C Blue No. 2 and FD&C Red No. 40.
— 0.9 mg tablets also contain: D&C Red No. 30 and D&C Red No. 7.
— 1.25 mg tablets also contain: black 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 tablets | USP Dissolution Test 4 |
| Premarin 0.3 mg, 0.45 mg and 0.625 mg tablets | USP Dissolution Test 5 |
| Premarin 0.9 mg tablets | USP Dissolution Test 6 |
