Prempro label

Prempro

Prempro Recall

Get an alert when a recall is issued.

Add Info

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Add Info

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Add Info

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

Add Info

FDA Labeling Changes

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

Add Info

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

Add Info

History

There is currently no drug history available for this drug.

Add Info

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
Add Info
Add to My Alerts
Report Side Effect
Leave a Review
Navigate to :
Prempro Recall
Side Effects & Adverse Reactions
Legal Issues
FDA Safety Alerts
Manufacturer Warnings
FDA Labeling Changes
Uses
History
Other Information
Manufacturers
Trending Topics

Prempro Manufacturers

  • Physicians Total Care, Inc.
    Prempro | Physicians Total Care, Inc.
    No Recall

    Prempro | Physicians Total Care, Inc.

    Prempro | Physicians Total Care, Inc.
    2.1 General Dosing Information

    Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

    2.2 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

    PREMPRO therapy consists of a single tablet to be taken orally once daily.

    PREMPHASE therapy consists of two separate tablets: one maroon 0.625 mg Premarin (conjugated estrogens) tablet taken daily on days 1 through 14 and one light-blue tablet containing 0.625 mg conjugated estrogens and 5 mg of medroxyprogesterone acetate taken on days 15 through 28.

    2.3 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause

    PREMPRO therapy consists of a single tablet to be taken orally once daily.

    PREMPHASE therapy consists of two separate tablets: one maroon 0.625 mg Premarin [conjugated estrogens (CE)] tablet taken daily on days 1 through 14 and one light-blue tablet containing 0.625 mg CE and 5 mg of medroxyprogesterone acetate (MPA) taken on days 15 through 28.

    When prescribing solely for the treatment of moderate to severe vulvar and vaginal atrophy, topical vaginal products should be considered.

    2.4 Prevention of Postmenopausal Osteoporosis

    PREMPRO therapy consists of a single tablet to be taken orally once daily.

    PREMPHASE therapy consists of two separate tablets: one maroon 0.625 mg Premarin (conjugated estrogens) tablet taken daily on days 1 through 14 and one light-blue tablet containing 0.625 mg conjugated estrogens and 5 mg of medroxyprogesterone acetate taken on days 15 through 28.

  • Dispensing Solutions, Inc.
    Prempro | Dispensing Solutions, Inc.
    No Recall

    Prempro | Dispensing Solutions, Inc.

    Prempro | Dispensing Solutions, Inc.
    2.1 General Dosing Information

    Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

    2.2 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

    PREMPRO therapy consists of a single tablet to be taken orally once daily.

    PREMPHASE therapy consists of two separate tablets: one maroon 0.625 mg Premarin (conjugated estrogens) tablet taken daily on days 1 through 14 and one light-blue tablet containing 0.625 mg conjugated estrogens and 5 mg of medroxyprogesterone acetate taken on days 15 through 28.

    2.3 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause

    PREMPRO therapy consists of a single tablet to be taken orally once daily.

    PREMPHASE therapy consists of two separate tablets: one maroon 0.625 mg Premarin [conjugated estrogens (CE)] tablet taken daily on days 1 through 14 and one light-blue tablet containing 0.625 mg CE and 5 mg of medroxyprogesterone acetate (MPA) taken on days 15 through 28.

    When prescribing solely for the treatment of moderate to severe vulvar and vaginal atrophy, topical vaginal products should be considered.

    2.4 Prevention of Postmenopausal Osteoporosis

    PREMPRO therapy consists of a single tablet to be taken orally once daily.

    PREMPHASE therapy consists of two separate tablets: one maroon 0.625 mg Premarin (conjugated estrogens) tablet taken daily on days 1 through 14 and one light-blue tablet containing 0.625 mg conjugated estrogens and 5 mg of medroxyprogesterone acetate taken on days 15 through 28.

Login To Your Free Account