Prempro Ingredients and Composition

Prempro Information

Prempro Ingredients and Composition

The conjugated equine estrogens found in Prempro tablets are a mixture of sodium estrone sulfate and sodium equilin sulfate. They contain as concomitant components, as sodium sulfate conjugates, 17a -dihydroequilin, 17a -estradiol and 17b -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-, (6a )-. Its molecular formula is C₂₄H₃₄O₄, with a molecular weight of 386.53.

Prempro 2.5 mg

Each peach tablet for oral administration contains 0.625 mg conjugated estrogens, 2.5 mg of medroxy-progesterone 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
• red ferric oxide

Prempro 5 mg

Each light-blue tablet for oral administration contains 0.625 mg 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
• red ferric oxide
• FD&C Blue No. 2

Premphase

Each maroon Premphase tablet for oral administration contains 0.625 mg of conjugated estrogens and the following inactive ingredients:

• calcium phosphate tribasic
• calcium sulfate
• carnauba wax
• cellulose
• glyceryl monooleate
• lactose
• magnesium stearate
• methylcellulose
• pharmaceutical glaze
• polyethylene glycol
• stearic acid
• sucrose
• titanium dioxide
• FD&C Blue No. 2
• D&C Red No. 27
• FD&C Red No. 40.

These tablets comply with USP Drug Release Test 1.

Each light-blue tablet for oral administration contains 0.625 mg of conjugated estrogens and 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

Prempro Information