Menopause and HRT:

Indications for ACTIVELLA 1mg/0.5mg:

Moderate to severe vasomotor symptoms of menopause. Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Prevention of postmenopausal osteoporosis.

Adult Dosage:

Vasomotor symptoms, osteoporosis: 1mg/0.5mg or 0.5mg/0.1mg tab once daily. Vulvar and vaginal atrophy: 1mg/0.5mg tab once daily.

Children Dosage:

Not applicable.

ACTIVELLA 1mg/0.5mg 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.

Boxed Warning:

Cardiovascular disorders. Endometrial cancer and breast cancer. Probable dementia.

ACTIVELLA 1mg/0.5mg 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.

ACTIVELLA 1mg/0.5mg Classification:

Estrogen + progestin.

ACTIVELLA 1mg/0.5mg 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).

Adverse Reactions:

Back pain, headache, pain in the extremity, nausea, diarrhea, gastroenteritis, insomnia, emotional lability, upper RTI, sinusitis, nasopharyngitis, weight increase, breast pain, post-menopausal bleeding, uterine fibroid, vaginal hemorrhage, ovarian cyst, endometrial thickening, viral infection, moniliasis genital, accidental injury; thromboembolism, neoplasms.

How Supplied:

Packs (28 tabs)—1