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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:
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.
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.
| 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 |
| 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 |
Sources
Premphase Manufacturers
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Physicians Total Care, Inc.
![Premphase (Conjugated Estrogens And Medroxyprogesterone Acetate) Kit [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Premphase | Physicians Total Care, Inc.
2.1 General Dosing InformationUse 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 MenopausePREMPRO 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 MenopausePREMPRO 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 OsteoporosisPREMPRO 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.
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Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
Premphase | Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
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.
2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to MenopausePREMPRO 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.
2.2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to MenopausePREMPRO therapy consists of a single tablet to be taken orally once daily.
PREMPHASE therapy consists of two separate tablets: one maroon 0.625 mg CE tablet taken daily on days 1 through 14 and one light-blue tablet containing 0.625 mg CE and 5 mg 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.
2.3 Prevention of Postmenopausal OsteoporosisPREMPRO therapy consists of a single tablet to be taken orally once daily.
PREMPHASE therapy consists of two separate tablets: one maroon 0.625 mg CE tablet taken daily on days 1 through 14 and one light-blue tablet containing 0.625 mg CE and 5 mg of MPA taken on days 15 through 28.
When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
![Premphase (Conjugated Estrogens And Medroxyprogesterone Acetate) Kit Prempro (Conjugated Estrogens And Medroxyprogesterone Acetate) Tablet, Sugar Coated [Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fd0c0836-5d23-2183-da81-9dc7f4287052&name=prempro-07.jpg)
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