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PREMPRO™ |
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(conjugated estrogens/medroxyprogesterone acetate tablets) |
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PREMPHASE® |
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(conjugated estrogens/medroxyprogesterone acetate tablets) |
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DESCRIPTION |
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PREMPRO therapy consists of a single tablet containing 0.625 mg of the
conjugated estrogens found in Premarin®
tablets and 2.5 mg or 5 mg of medroxyprogesterone
acetate (MPA) for oral administration. |
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PREMPHASE therapy consists of two separate tablets, a maroon Premarin tablet
containing 0.625 mg of conjugated estrogens that is taken orally on days 1
through 14 and a light-blue tablet containing 0.625 mg of the conjugated
estrogens found in Premarin tablets and 5 mg of medroxyprogesterone acetate
(MPA) that is taken orally on days 15 through 28. |
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The conjugated equine estrogens found in Premarin 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. |
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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. |
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PREMPRO 2.5 mg |
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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. |
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PREMPRO 5 mg |
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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, FD&C Blue No. 2. |
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PREMPHASE |
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Each maroon Premarin 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. |
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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. |
