A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Prempro Online, Description, Chemistry, Ingredients - Conjugated estrogens/medroxyprogesterone acetate
Prempro Online, Description, Chemistry, Ingredients - Conjugated estrogens/medroxyprogesterone acetate
PREMPRO™
(conjugated estrogens/medroxyprogesterone acetate tablets)
PREMPHASE®
(conjugated estrogens/medroxyprogesterone acetate tablets)
Rx only
DESCRIPTION
PREMPRO 0.3 mg/1.5 mg therapy consists of a single tablet containing 0.3 mg of the conjugated estrogens (CE) found in
Premarin tablets and 1.5 mg of medroxyprogesterone acetate (MPA) for oral administration.
PREMPRO 0.45 mg/1.5 mg therapy consists of a single tablet containing 0.45 mg of the conjugated estrogens found in Premarin
tablets and 1.5 mg of medroxyprogesterone acetate for oral administration.
PREMPRO 0.625 mg/2.5 mg therapy consists of a single tablet containing 0.625 mg of the conjugated estrogens found in Premarin
tablets and 2.5 mg of medroxyprogesterone acetate for oral administration.
PREMPRO 0.625 mg/5 mg therapy consists of a single tablet containing 0.625 mg of the conjugated estrogens found in Premarin
tablets and 5 mg of medroxyprogesterone acetate for oral administration.
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 that is taken orally on days 15 through 28.
The conjugated estrogens found in Premarin tablets are a mixture of sodium estrone sulfate and sodium equilin sulfate, obtained
exclusively from natural sources and blended to represent the average composition of materials derived from pregnant mares' urine.
They contain as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and
17 ß-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
Each cream tablet for oral administration contains 0.3 mg conjugated estrogens, 1.5 mg 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,
yellow ferric oxide.
PREMPRO 0.45 mg/1.5 mg
Each gold tablet for oral administration contains 0.45 mg conjugated estrogens, 1.5 mg 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,
yellow ferric oxide.
PREMPRO 0.625 mg/2.5 mg
Each peach tablet for oral administration contains 0.625 mg conjugated estrogens, 2.5 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.
PREMPRO 0.625 mg/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, FD&C Blue No. 2.
PREMPHASE
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.
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
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