Menopause and HRT:
Indications for: ESTROGEL
Moderate to severe vasomotor symptoms of menopause. Vulvar and vaginal atrophy due to menopause.
Adult Dosage:
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 Dosage:
Not applicable.
ESTROGEL 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.
Boxed Warning:
Endometrial cancer. Breast cancer. Cardiovascular disorders. Probable dementia.
ESTROGEL 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 Classification:
Estrogen.
ESTROGEL 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).
Adverse Reactions:
Headache, flatulence, breast pain, rash, pruritus; thromboembolism, neoplasms.
Generic Drug Availability:
NO
How Supplied:
Metered-dose pump (50g)—1
