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Prempro

[Conjugated Estrogens/Medroxyprogesterone]

Keep PREMPRO and PREMPHASE out of the reach of children.
This leaflet provides a summary of the most important information about PREMPRO and PREMPHASE. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about PREMPRO and PREMPHASE that is written for health professionals. You can get more information by calling the toll free number 800-934-5556.

What are the ingredients in PREMPRO and PREMPHASE?

PREMPRO contains the same conjugated estrogens found in Premarin which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components including sodium sulfate conjugates, 17 -dihydroequilin, 17 -estradiol and 17 -dihydroequilin. PREMPRO also contains either 1.5, 2.5, or 5 mg of medroxyprogesterone acetate.

Text Continues Below



PREMPRO also contains calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, titanium dioxide, and yellow ferric oxide or red ferric oxide or FD& C Blue No. 2.

PREMPHASE is two separate tablets. One tablet (maroon color) is 0.625 mg of Premarin which is a mixture of sodium estrone sulfate and sodium equilin sulfate and other components including sodium sulfate conjugates, 17 -dihydroequilin, 17 -estradiol and 17 -dihydroequilin. The maroon tablet also contains 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.

The second tablet (light blue color) contains 0.625 mg of the same ingredients as the maroon color tablet plus 5 mg of medroxyprogesterone acetate. The light blue tablet also contains 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 therapy consists of a single tablet to be taken once daily.
PREMPRO 0.3 mg/ 1.5 mg Each carton includes 3 EZ DIAL dispensers containing 28 tablets. One EZ DIAL dispenser contains 28 oval, cream tablets containing 0.3 mg of the conjugated estrogens found in Premarin tablets and 1.5 mg of medroxyprogesterone acetate for oral administration.

PREMPRO 0.45 mg/ 1.5 mg

Each carton includes 3 EZ DIAL dispensers containing 28 tablets. One EZ DIAL dispenser contains 28 oval, gold tablets 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

Each carton includes 3 EZ DIAL dispensers containing 28 tablets. One EZ DIAL dispenser contains 28 oval, peach tablets 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

Each carton includes 3 EZ DIAL dispensers containing 28 tablets. One EZ DIAL dispenser contains 28 oval, light-blue tablets 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; one maroon Premarin tablet taken daily on days 1 through 14 and one light-blue tablet taken on days 15 through 28.

Each carton includes 3 EZ DIAL dispensers containing 28 tablets. One EZ DIAL dispenser contains 14 oval, maroon Premarin tablets containing 0.625 mg of conjugated estrogens and 14 oval, light-blue tablets that contain 0.625 mg of the conjugated estrogens found in Premarin tablets and 5 mg of medroxyprogesterone acetate for oral administration.

The appearance of PREMPRO tablets is a trademark of Wyeth Pharmaceuticals. The appearance of Premarin tablets is a trademark of Wyeth Pharmaceuticals. The appearance of the conjugated estrogens/ medroxyprogesterone acetate combination tablets is a registered
trademark.

Store at 20 -25 ° ° ° C (68 -77 ° ° ° F); excursions permitted to 15 -30 ° ° ° C (59 -86 ° ° ° F) [see USP Controlled Room Temperature].
Wyeth Pharmaceuticals Inc.
Philadelphia, PA 19101

W10407C009
ET02
Revised June 5, 2003

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