HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 |
| Warnings and Precautions, Malignant Neoplasms (5.2) | 11/2017 |
INDICATIONS AND USAGEPREMARIN 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)
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
DOSAGE FORMS AND STRENGTHSTablets: 0.3, 0.45, 0.625, 0.9, and 1.25 mg (3)
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)
- 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
ADVERSE REACTIONSMost 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
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)
- 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)
- 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