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Premarin Vaginal Cream

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Premarin Vaginal Cream

Indications
Dosage
How Supplied

INDICATIONS

Treatment of Atrophic Vaginitis and Kraurosis Vulvae

Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause

DOSAGE AND ADMINISTRATION

General Dosing Information

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer.

A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see WARNINGS AND PRECAUTIONS].

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 reevaluated periodically as clinically appropriate to determine if treatment is still necessary.

Treatment of Atrophic Vaginitis and Kraurosis Vulvae

PREMARIN Vaginal Cream is administered intravaginally in a cyclic regimen (daily for 21 days and then off for 7 days). Generally, women should be started at the 0.5 g dosage strength. Dosage adjustments (0.5 to 2 g) may be made based on individual response [see Dosage Forms and Strengths].

Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause

PREMARIN Vaginal Cream (0.5 g) is administered intravaginally in a twice-weekly (for example, Monday and Thursday) continuous regimen or in a cyclic regimen of 21 days of therapy followed by 7 days off of therapy [see Dosage Forms and Strengths].

HOW SUPPLIED

Dosage Forms And Strengths

Each gram contains 0.625 mg conjugated estrogens, USP.

Combination packages

Each contains a net wt.1.5 oz (42.5 g) tube with plastic applicator calibrated in 0.5 g increments to a maximum of 2 g; or a net wt. 1.06 oz (30 g) tube with plastic applicator calibrated in 0.5 g increments to a maximum of 2 g.

PREMARIN (conjugated estrogens) Vaginal Cream — Each gram contains 0.625 mg conjugated estrogens, USP.

Combination packages

NDC 0046-0872-21 – Each tube contains a net wt. of 1.06 oz (30 g) with plastic applicator calibrated in 0.5 g increments to a maximum of 2 g.

NDC 0046-0872-93 – Each tube contains a net wt. of 1.5 oz (42.5 g) with plastic applicator calibrated in 0.5 g increments to a maximum of 2 g.

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. Philadelphia, PA 19101. Rev Apr 2011

Last reviewed on RxList: 6/7/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Premarin Vaginal Cream - User Reviews

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