Divigel Generic Name & Formulations
Mechanism of Action
Divigel Dosage and Administration
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.
Divigel Boxed Warnings
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, or hypercalcemia. Permanently discontinue if papilledema 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). Flammable. Reevaluate periodically. Pregnancy: not indicated. Nursing mothers.
Cmax: 14 pg/mL for 0.25 g; 28.4 pg/mL for 0.5 g; 51.5 pg/mL for 1.0 g.
Median Tmax: 16 hours (range: 0, 72) for 0.25 g; 10 hours (range: 0, 72) for 0.5 g; 8 hours (range: 0, 48) for 1.0 g.
Steady-state serum concentration is reached by day 12.
Estrogens circulate in the blood largely bound to SHBG and albumin.
- Renal. Half-life: ~10 hours.
Divigel Adverse Reactions
Divigel Clinical Trials
Divigel Patient Counseling