Premarin

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR PREMARIN® (conjugated estrogens tablets, USP)

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.

The Women’s Health Initiative (WHI) estrogen alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women with daily oral conjugated estrogens (CE) alone. The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism, stroke, and myocardial infarction in postmenopausal women with daily oral CE combined with medroxyprogesterone acetate (MPA).

The WHI Memory Study (WHIMS) reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older, in both the estrogen alone and estrogen plus progestin arms. It is unknown whether these findings apply to younger postmenopausal women.

The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer.

Estrogens with or without progestins should be prescribed at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.

PREMARIN should not be used in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or a history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or a history of these conditions; active arterial thromboembolic disease (eg, stroke, myocardial infarction), or a history of these conditions; anaphylactic reaction or angioedema with PREMARIN; liver impairment or disease; thrombophilic disorders; pregnancy.

Estrogens increase the risk of gallbladder disease. Discontinue estrogen if loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs. Monitor thyroid function in women on thyroid replacement therapy, because estrogens may be associated with increased thyroid binding globulin (TBG) levels.

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.

INDICATIONS

PREMARIN is indicated in the treatment of moderate to severe vasomotor symptoms due to menopause, treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, and the prevention of postmenopausal osteoporosis.

When prescribing solely for the symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.

Please see Full Prescribing Information including BOXED WARNING.

STUDY DESCRIPTIONS:

Utian et al: HOPE trial. Data from the Women’s Health, Osteoporosis, Progestin, Estrogen (HOPE) study: a 2-year trial of 2673 healthy, postmenopausal women (average age 53.3 years) with a uterus. This study reflects the results from the first year of the trial in the efficacy-evaluable population (n=241), which examined the effects of 3 dosage combinations of conjugated equine estrogen (CEE) therapy (including 2 lower dosages) with and without medroxyprogesterone acetate (MPA) on vulvovaginal atrophy (VVA) and vasomotor symptoms. Within each treatment group, the number of patients included in the analyses ranged from 25 to 34 during weeks 1 through 12.2

Lindsay et al: HOPE trial substudy. Data from the Health, Osteoporosis, Progestin, Estrogen (HOPE) study: a 2-year trial of 2673 healthy, postmenopausal women (average age 53.3 years +/- 4.9 years). This study reflects the results from the second half of the study, which examined the effects of 3 dosage combinations of conjugated equine estrogen (CEE) therapy (including 2 lower dosages) with and without medroxyprogesterone acetate (MPA) on bone density and biochemical markers of bone turnover in 695 postmenopausal women. In addition to estrogen, all patients received 600 mg of calcium carbonate daily.4

REFERENCES:

1.Premarin [prescribing information]. New York, NY: Pfizer Inc; 2014.

2.Utian WH, Shoupe D, Bachmann G, Pinkerton JV, Pickar JH. Relief of vasomotor symptoms and vaginal atrophy with lower doses of conjugated equine estrogens and medroxyprogesterone acetate. Fertil Steril. 2001;75(6):1065-1079.

3.Data on file. Pfizer Inc; New York, NY.

4.Lindsay R, Gallagher J, Kleerekoper M, Pickar JH. Effect of lower doses of conjugated equine estrogens with and without medroxyprogesterone acetate on bone in early postmenopausal women. JAMA. 2002;287(20):2668-2676.

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