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Prempro 0.45mg/1.5mg Generic Name & Formulations
Legal Class
Rx
General Description
Conjugated estrogens 0.45mg, medroxyprogesterone acetate 1.5mg; tabs.
Pharmacological Class
Estrogen + progestin.
How Supplied
Blister card (28 tabs)—1
Manufacturer
Prempro 0.45mg/1.5mg Indications
Indications
Moderate-to-severe vasomotor symptoms of menopause. Moderate-to-severe vulvar and vaginal atrophy due to menopause. Prevention of postmenopausal osteoporosis.
Prempro 0.45mg/1.5mg Dosage and Administration
Adult
1 tab once daily.
Children
Not applicable.
Prempro 0.45mg/1.5mg Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Breast 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.
Prempro 0.45mg/1.5mg Boxed Warnings
Boxed Warning
Endometrial cancer. Breast cancer. Cardiovascular disorders. Probable dementia.
Prempro 0.45mg/1.5mg 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.
Prempro 0.45mg/1.5mg Pharmacokinetics
See Literature
Prempro 0.45mg/1.5mg 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. Concomitant aminoglutethimide: may reduce bioavailability of medroxyprogesterone. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Prempro 0.45mg/1.5mg Adverse Reactions
Adverse Reactions
Abdominal pain, asthenia, back pain, headache, flatulence, nausea, depression, pruritus, breast pain, dysmenorrhea, leukorrhea; thromboembolism, neoplasms, anaphylaxis, angioedema (permanently discontinue if occurs).
Prempro 0.45mg/1.5mg Clinical Trials
See Literature
Prempro 0.45mg/1.5mg Note
Not Applicable
Prempro 0.45mg/1.5mg Patient Counseling
See Literature
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