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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
1.2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause
1.3 Prevention of Postmenopausal Osteoporosis

History

There is currently no drug history available for this drug.

Other Information

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:

Chemical Structure

PREMPRO 0.3 mg/1.5 mg, 0.45 mg/1.5 mg, and 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, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, 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, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, 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

Premphase Manufacturers


  • Physicians Total Care, Inc.
    Premphase (Conjugated Estrogens And Medroxyprogesterone Acetate) Kit [Physicians Total Care, Inc.]
  • Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
    Premphase (Conjugated Estrogens And Medroxyprogesterone Acetate) Kit Prempro (Conjugated Estrogens And Medroxyprogesterone Acetate) Tablet, Sugar Coated [Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]

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