PREMARIN® VAGINAL CREAM Highlights

(conjugated estrogens)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PREMARIN® VAGINAL CREAM safely and effectively. See full prescribing information for PREMARIN VAGINAL CREAM.

PREMARIN (conjugated estrogens) Vaginal Cream.
Initial U.S. Approval: 1946

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA

See full prescribing information for complete boxed warning.

Estrogen-Alone Therapy

•
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens (5.3)
•
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia (5.2, 5.4)
•
The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) (5.2)
•
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older (5.4)

Estrogen Plus Progestin Therapy

•
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia (5.2, 5.4)
•
The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) (5.2)
•
The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer (5.3)
•
The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older (5.4)

RECENT MAJOR CHANGES

Warnings and Precautions, Malignant Neoplasms (5.3)

02/2024

INDICATIONS AND USAGE

PREMARIN (conjugated estrogens) Vaginal Cream is a mixture of estrogens indicated for:

•
Treatment of Atrophic Vaginitis and Kraurosis Vulvae (1.1)
•
Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause (1.2)

DOSAGE AND ADMINISTRATION

•
Cyclic administration of 0.5 to 2 g intravaginally [daily for 21 days then off for 7 days] for Treatment of Atrophic Vaginitis and Kraurosis Vulvae (2. 1)
•
Cyclic administration of 0.5 g intravaginally [daily for 21 days then off for 7 days] for Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause (2. 2)
•
Twice-weekly administration of 0.5 g intravaginally [for example, Monday and Thursday] for Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause (2. 2)

DOSAGE FORMS AND STRENGTHS

•
Each gram contains 0.625 mg conjugated estrogens, USP (3)
•
Combination package: Each contains a net wt. 1.06 oz (30 g) tube with plastic applicator(s) calibrated in 0.5 g increments to a maximum of 2 g (3)

CONTRAINDICATIONS

•
Undiagnosed abnormal genital bleeding (4)
•
Known, suspected, or history of breast cancer (4, 5.3)
•
Known or suspected estrogen-dependent neoplasia (4, 5.3)
•
Active DVT, PE, or a history of these conditions (4, 5.2)
•
Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (4, 5.2)
•
Known anaphylactic reaction or angioedema to PREMARIN Vaginal Cream (5.16, 5.17)
•
Known liver dysfunction or disease (4, 5.10)
•
Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders (4)
•
Known or suspected pregnancy (4, 8.1)

WARNINGS AND PRECAUTIONS

•
Estrogens increase the risk of gallbladder disease (5.5)
•
Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (5.6, 5.7, 5.10, 5.11)
•
Monitor thyroid function in women on thyroid replacement therapy (5.12, 5.21)

ADVERSE REACTIONS

In a prospective, randomized, placebo-controlled, double-blind study, the most common adverse reactions ≥ 2 percent are headache, pelvic pain, vasodilation, breast pain, leucorrhea, metrorrhagia, vaginitis, vulvovaginal disorder (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism (7.1)

USE IN SPECIFIC POPULATIONS

•
Nursing Mothers: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk (8.3)
•
Geriatric Use: An increased risk of probable dementia in women over 65 years of age was reported in the Women's Health Initiative Memory ancillary studies of the Women's Health Initiative (5.4, 8.5)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2024

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PREMARIN® VAGINAL CREAM safely and effectively. See full prescribing information for PREMARIN VAGINAL CREAM.

PREMARIN (conjugated estrogens) Vaginal Cream.
Initial U.S. Approval: 1946

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA

See full prescribing information for complete boxed warning.

Estrogen-Alone Therapy

•
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens (5.3)
•
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia (5.2, 5.4)
•
The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) (5.2)
•
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older (5.4)

Estrogen Plus Progestin Therapy

•
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia (5.2, 5.4)
•
The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) (5.2)
•
The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer (5.3)
•
The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older (5.4)

RECENT MAJOR CHANGES

Warnings and Precautions, Malignant Neoplasms (5.3)

02/2024

INDICATIONS AND USAGE

PREMARIN (conjugated estrogens) Vaginal Cream is a mixture of estrogens indicated for:

•
Treatment of Atrophic Vaginitis and Kraurosis Vulvae (1.1)
•
Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause (1.2)

DOSAGE AND ADMINISTRATION

•
Cyclic administration of 0.5 to 2 g intravaginally [daily for 21 days then off for 7 days] for Treatment of Atrophic Vaginitis and Kraurosis Vulvae (2. 1)
•
Cyclic administration of 0.5 g intravaginally [daily for 21 days then off for 7 days] for Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause (2. 2)
•
Twice-weekly administration of 0.5 g intravaginally [for example, Monday and Thursday] for Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause (2. 2)

DOSAGE FORMS AND STRENGTHS

•
Each gram contains 0.625 mg conjugated estrogens, USP (3)
•
Combination package: Each contains a net wt. 1.06 oz (30 g) tube with plastic applicator(s) calibrated in 0.5 g increments to a maximum of 2 g (3)

CONTRAINDICATIONS

•
Undiagnosed abnormal genital bleeding (4)
•
Known, suspected, or history of breast cancer (4, 5.3)
•
Known or suspected estrogen-dependent neoplasia (4, 5.3)
•
Active DVT, PE, or a history of these conditions (4, 5.2)
•
Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (4, 5.2)
•
Known anaphylactic reaction or angioedema to PREMARIN Vaginal Cream (5.16, 5.17)
•
Known liver dysfunction or disease (4, 5.10)
•
Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders (4)
•
Known or suspected pregnancy (4, 8.1)

WARNINGS AND PRECAUTIONS

•
Estrogens increase the risk of gallbladder disease (5.5)
•
Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (5.6, 5.7, 5.10, 5.11)
•
Monitor thyroid function in women on thyroid replacement therapy (5.12, 5.21)

ADVERSE REACTIONS

In a prospective, randomized, placebo-controlled, double-blind study, the most common adverse reactions ≥ 2 percent are headache, pelvic pain, vasodilation, breast pain, leucorrhea, metrorrhagia, vaginitis, vulvovaginal disorder (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism (7.1)

USE IN SPECIFIC POPULATIONS

•
Nursing Mothers: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk (8.3)
•
Geriatric Use: An increased risk of probable dementia in women over 65 years of age was reported in the Women's Health Initiative Memory ancillary studies of the Women's Health Initiative (5.4, 8.5)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2024
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