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Premarin Vaginal Cream Generic Name & Formulations
Legal Class
Rx
General Description
Conjugated estrogens 0.625mg/g.
Pharmacological Class
Estrogen.
See Also
How Supplied
Tabs 0.3mg, 0.625mg, 1.25mg—100, 1000; 0.45mg, 0.9mg—100; Cream—30g (w. applicator)
Manufacturer
Premarin Vaginal Cream Indications
Indications
Atrophic vaginitis. Kraurosis vulvae. Moderate-to-severe dyspareunia due to menopause.
Premarin Vaginal Cream Dosage and Administration
Adult
Atrophic vaginitis, kraurosis vulvae: 0.5–2g/day intravaginally given cyclically (3 weeks on, 1 week off). Dyspareunia: 0.5g intravaginally twice weekly (eg, Mon. & Thurs.) given continuously or cyclically (3 weeks on, 1 week off).
Children
Not applicable.
Premarin Vaginal Cream Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Breast cancer (except in select patients being treated for metastatic disease) or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency, or other thrombophilias. Hepatic impairment or disease. Pregnancy.
Premarin Vaginal Cream Boxed Warnings
Boxed Warning
Endometrial cancer. Breast cancer. Cardiovascular disorders. Probable dementia.
Premarin Vaginal Cream Warnings/Precautions
Warnings/Precautions
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Nursing mothers: not recommended.
Premarin Vaginal Cream Pharmacokinetics
See Literature
Premarin Vaginal Cream Interactions
Interactions
May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Premarin Vaginal Cream Adverse Reactions
Adverse Reactions
Abdominal pain, asthenia, back pain, headache, flatulence, nausea, depression, insomnia, breast pain, endometrial hyperplasia, leucorrhea, vaginal hemorrhage, vaginitis; thromboembolism, neoplasms, anaphylaxis, angioedema (permanently discontinue if occurs).
Premarin Vaginal Cream Clinical Trials
See Literature
Premarin Vaginal Cream Note
Not Applicable
Premarin Vaginal Cream Patient Counseling
See Literature
