Monograph Details

Ob/Gyn > Menopause and HRT
PREMARIN VAGINAL CREAM
Manufacturer
Wyeth Pharmaceuticals
Legal Classification
Rx
Pharmacological Class
Estrogen.
Generic Name
Conjugated estrogens 0.625mg/g.
Also
PREMARIN
Indications
Vulvar or vaginal atrophy. Kraurosis vulvae.
Children
Not applicable.
Adults
0.5–2g/day intravaginally cyclically (3 weeks on, 1 week off). Reevaluate periodically.
Contraindications
Breast or estrogen-dependent carcinoma, unless palliative. Undiagnosed abnormal genital bleeding. Pulmonary embolism/DVT (active or history of). Arterial thromboembolism (eg, stroke, MI; active or recent). Pregnancy (Cat.X).
Precautions
Not for prevention of cardiovascular disease. Use for shortest duration consistent with treatment goals and risks. Reevaluate periodically. Patients with an intact uterus should almost always receive a progestin with systemic estrogens to avoid endometrial hyperplasia. Discontinue if cardiovascular events occur or are suspected; if jaundice occurs; and during immobilization or at least 2 weeks before surgery associated with thromboembolism. Hepatic dysfunction. Conditions aggravated by fluid retention. Gallbladder disease. Bone disease associated with hypercalcemia. Do initial complete physical and repeat annually (include BP, mammogram, PAP smear). Adolescents. Nursing mothers: not recommended.
Adverse Reactions
See literature. Increased risk of cardiovascular events, estrogen-dependent carcinoma, gallbladder disease, thromboembolic disorders, hepatic tumors. GI upset, breakthrough bleeding, edema, weight changes, mastodynia, hypertension, depression, intolerance to contact lenses.
How Supplied
Tabs 0.3mg, 0.625mg, 1.25mg—100, 1000
0.45mg, 0.9mg—100
Cream—42.5g (w. applicator)
Additional Resources
Related Prescribing Note