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PREMARIN® (conjugated estrogens) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

PREMARIN® (conjugated estrogens) Tablets, USP for oral use
Initial U.S. Approval: 1942

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 (5.2)
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia (5.1, 5.3)
  • Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) (5.1)
  • 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 (5.3)

Estrogen Plus Progestin Therapy

  • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia (5.1, 5.3)
  • The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) (5.1)
  • The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer (5.2)
  • 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 (5.3)

RECENT MAJOR CHANGES

Warnings and Precautions, Malignant Neoplasms (5.2)11/2017

INDICATIONS AND USAGE

PREMARIN is a mixture of estrogens indicated for:

  • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1)
  • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2)
  • Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure (1.3)
  • Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease (1.4)
  • Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) (1.5)
  • Prevention of Postmenopausal Osteoporosis (1.6)

DOSAGE AND ADMINISTRATION

  • Daily administration of 0.3, 0.45, 0.625, 0.9, and 1.25 mg (2.1, 2.2, 2.3, 2.5, 2.6)
  • Cyclic administration of 0.3, 0.625, and 1.25 mg (2.1, 2.2, 2.3)

DOSAGE FORMS AND STRENGTHS

Tablets: 0.3, 0.45, 0.625, 0.9, and 1.25 mg (3)

CONTRAINDICATIONS

  • Undiagnosed abnormal genital bleeding (4)
  • Known, suspected, or history of breast cancer except in appropriately selected patients being treated for metastatic diseases (4, 5.2)
  • Known or suspected estrogen-dependent neoplasia (4, 5.2)
  • Active DVT, PE, or a history of these conditions (4, 5.1)
  • Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (4, 5.1)
  • Known anaphylactic reaction or angioedema with PREMARIN (5.7)
  • Known liver impairment or disease (4, 5.12)
  • 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 (5.4)
  • Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (5.5, 5.6, 5.11, 5.12)
  • Monitor thyroid function in women on thyroid replacement therapy (5.13, 5.18)

ADVERSE REACTIONS

Most common adverse reactions (≥ 5 percent) are: abdominal pain, asthenia, pain, back pain, headache, flatulence, nausea, depression, insomnia, breast pain, endometrial hyperplasia, leucorrhea, vaginal hemorrhage, and vaginitis. (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 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 (5.3, 8.5)

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

Revised: 9/2018

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