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PREMARIN® VAGINAL CREAM (conjugated estrogens)
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PREMARIN® VAGINAL CREAM Quick Finder
Highlights
Boxed Warning
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
Estrogen-Alone Therapy
Endometrial Cancer...
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Indications and Usage
1 INDICATIONS AND USAGE
1.1 Treatment of Atrophic Vaginitis and Kraurosis Vulvae
1.2 Treatment of Moderate to Severe...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
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...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Each gram contains 0.625 mg conjugated estrogens, USP.
Combination package: Each contains a net wt. 1.06 oz (30 g) tube with plastic applicator(s) calibrated in...
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Contraindications
4 CONTRAINDICATIONS
PREMARIN Vaginal Cream therapy should not be used in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding
- Known...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Risks from Systemic Absorption
Systemic absorption occurs with the use of PREMARIN Vaginal Cream. The warnings, precautions, and...
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Adverse Reactions
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see Boxed Warning, Warnings...
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Drug Interactions
7 DRUG INTERACTIONS
No drug interaction studies have been conducted for PREMARIN Vaginal Cream.
7.1 Metabolic Interactions
...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
PREMARIN Vaginal Cream should not be used during pregnancy [see Contraindications (4...
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Overdosage
10 OVERDOSAGE
Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of...
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Description
11 DESCRIPTION
Each gram of PREMARIN (conjugated estrogens) Vaginal Cream contains 0.625 mg conjugated estrogens, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate,...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term continuous administration of natural and synthetic estrogens in certain...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Effects on Vulvar and Vaginal Atrophy
A 12-week, prospective, randomized, double-blind placebo-controlled study was conducted to compare the...
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References
15 REFERENCES
- Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA. 2007;297:1465–1477.
- Hsia J, et al....
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
PREMARIN (conjugated estrogens) Vaginal Cream—Each gram contains 0.625 mg conjugated estrogens, USP.
...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (Patient Information and Instructions for Use).
17.1 Vaginal Bleeding
...
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Resources
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