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PREMARIN® VAGINAL CREAM (conjugated estrogens)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

PREMARIN® VAGINAL CREAM Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA

Estrogen-Alone Therapy

Endometrial Cancer...

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1 INDICATIONS AND USAGE

1.1 Treatment of Atrophic Vaginitis and Kraurosis Vulvae

1.2 Treatment of Moderate to Severe...

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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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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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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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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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6 ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Cardiovascular Disorders [see

    6.1 Clinical Trials Experience

    ...

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7 DRUG INTERACTIONS

No drug interaction studies have been conducted for PREMARIN Vaginal Cream.

7.1 Metabolic Interactions

...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

PREMARIN Vaginal Cream should not be used during pregnancy [see

8.3 Nursing Mothers

...

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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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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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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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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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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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15 REFERENCES

  1. Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA. 2007;297:1465–1477.
  2. Hsia J, et al....
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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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17 PATIENT COUNSELING INFORMATION

See

17.1 Vaginal Bleeding

Inform postmenopausal women of the importance of reporting vaginal bleeding to their healthcare provider as soon as possible...

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