PREMPRO Sugar-coated tablet Ref.[10585] Active ingredients: Estrogens, conjugated Medroxyprogesterone

Source: FDA, National Drug Code (US)  Revision Year: 2017 

Product description

Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture 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 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin.

Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is:

PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide.

PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide.

PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, FD&C Blue No. 2, and black iron oxide.

Premphase

Each maroon Premarin tablets for oral administration contain 0.625 mg of conjugated estrogens and the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, titanium dioxide, FD&C Blue No. 2, and FD&C Red No. 40. These tablets comply with USP Dissolution Test 5.

Each light-blue tablet for oral administration contains 0.625 mg of conjugated estrogens, 5 mg of medroxyprogesterone acetate, and the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, FD&C Blue No. 2, and black iron oxide.

Prempro

Tablet Strength Tablet Color Contains
0.3 mg/1.5 mg Yellow iron oxide and black iron oxide
0.45 mg/1.5 mg Yellow iron oxide and black iron oxide
0.625 mg/2.5 mg Red iron oxide, yellow iron oxide, and black iron oxide
0.625 mg/5 mg FD&C Blue No. 2 and black iron oxide

Premphase

Tablet Strength Tablet Color Contains
0.625 mg FD&C Blue No. 2 and FD&C Red No. 40
0.625 mg/5 mg FD&C Blue No. 2 and black iron oxide
Dosage Forms and Strengths
PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets)
Tablet Strength Tablet Shape / Color Imprint
0.3 mg CE plus 1.5 mg MPA oval / cream PREMPRO
0.3/1.5
0.45 mg CE plus 1.5 mg MPA oval / gold PREMPRO
0.45/1.5
0.625 mg CE plus 2.5 mg MPA oval / peach PREMPRO
0.625/2.5
0.625 mg CE plus 5 mg MPA oval / light blue PREMPRO
0.625/5
PREMPHASE (conjugated estrogens/medroxyprogesterone acetate tablets)
Tablet Strength Tablet Shape/Color Imprint
0.625 mg CE oval / maroon (14 tablets) PREMARIN
0.625
0.625 mg CE plus 5 mg MPA oval / light-blue (14 tablets) PREMPRO
0.625/5
How Supplied

PREMPRO therapy consists of a single tablet to be taken once daily.

PREMPRO 0.625 mg/2.5 mg:

NDC 0046-1107-11, carton includes 1 blister card containing 28 oval, peach tablets.

NDC 69189-1107-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital

The appearance of PREMPRO tablets is a trademark of Pfizer Inc.

The appearance of PREMARIN tablets is a trademark of Pfizer Inc. The appearance of the conjugated estrogens/medroxyprogesterone acetate combination tablets is a trademark.

Drugs

Drug Countries
PREMPRO United States

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