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Prempro

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Prempro, Premphase

Prempro, Premphase

INDICATIONS

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

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

Prevention of Postmenopausal Osteoporosis

DOSAGE AND ADMINISTRATION

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.

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 (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.

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 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.

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 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.

HOW SUPPLIED

Dosage Forms and Strengths

PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets)
Tablet Strength Tablet Shape/Color Imprint
0.3 mg CE plus 1.5 mg MPA oval / cream PREMPRO 0.3/1.5
0.45 mg CE plus 1 .5 mg MPA oval / gold PREMPRO 0.45/1.5
0.625 mg CE plus 2.5 mg MPA oval / peach PREMPRO 0.625/2.5
0.625 mg CE plus 5 mg MPA oval / light blue PREMPRO 0.625/5
0.625 mg CE oval / maroon (14 tablets) PREMARIN 0.625
0.625 mg CE plus 5 mg MPA oval / light-blue (14 tablets) PREMPRO 0.625/5

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

PREMPRO 0.3 mg/1.5 mg

NDC 0046-1105-11, carton includes 1 blister card containing 28 oval, cream tablets.

PREMPRO 0.45 mg/1.5 mg

NDC 0046-1106-11, carton includes 1 blister card containing 28 oval, gold tablets.

PREMPRO 0.625 mg/2.5 mg

NDC 0046-1107-11, carton includes 1 blister card containing 28 oval, peach tablets.

PREMPRO 0.625 mg/5 mg

NDC 0046-1108-11, carton includes 1 blister card containing 28 oval, light-blue tablets.

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.

NDC 0046-2575-12, carton includes 1 blister card containing 28 tablets (14 oval, maroon Premarin tablets and 14 oval, light-blue tablets).

Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Wyeth Pharmaceuticals Inc, A subsidiary Pfizer Inc, Philadelphia, PA, 19101

Last reviewed on RxList: 2/21/2012
This monograph has been modified to include the generic and brand name in many instances.

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