Estrogel Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol 0.06%; topical gel; contains alcohol.
Pharmacological Class
Estrogen.
How Supplied
Metered-dose pump (50g)—1
Manufacturer
Generic Availability
NO
Estrogel Indications
Indications
Moderate to severe vasomotor symptoms of menopause. Vulvar and vaginal atrophy due to menopause.
Estrogel Dosage and Administration
Adult
Prime pump before 1st use. Apply 1 pump (1.25g) daily to clean, dry, intact skin over one arm; allow to dry for 5mins.
Children
Not applicable.
Estrogel Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency or other thrombophilic disorders.
Estrogel Boxed Warnings
Boxed Warning
Endometrial cancer. Breast cancer. Cardiovascular disorders. Probable dementia.
Estrogel 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. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or hypercalcemia occurs. Monitor thyroid function. Monitor conditions that may predispose to fluid retention (eg, cardiac or renal impairment); discontinue if medically concerning fluid retention occurs. 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: not recommended.
Estrogel Pharmacokinetics
See Literature
Estrogel Interactions
Interactions
May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John's wort). Concomitant thyroid replacement; may need to increase thyroid dose. May be affected by application of topical lotion (increases estradiol absorption). May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Estrogel Adverse Reactions
Adverse Reactions
Headache, flatulence, breast pain, rash, pruritus; thromboembolism, neoplasms.
Estrogel Clinical Trials
See Literature
Estrogel Note
Not Applicable
Estrogel Patient Counseling
See Literature