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ACTIVELLA 0.5mg/0.1mg
Menopause and HRT
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Drug Name:

ACTIVELLA 0.5mg/0.1mg Rx

Generic Name and Formulations:
Estradiol 0.5mg, norethindrone acetate 0.1mg; tabs.

Company:
Novo Nordisk

Therapeutic Use:

Indications for ACTIVELLA 0.5mg/0.1mg:

In women with an intact uterus: moderate to severe vasomotor symptoms of menopause; vulvar and vaginal atrophy; prevention of postmenopausal osteoporosis.

Adult:

1 tab daily. Vasomotor symptoms, postmenopausal osteoporosis: 1mg/0.5mg or 0.5mg/0.1mg strength. Vulvar and vaginal atrophy: 1mg/0.5mg strength. Reevaluate periodically.

Children:

Not applicable.

Contraindications:

Breast or estrogen-dependent carcinoma. Thromboembolic disorders. Undiagnosed abnormal genital bleeding. Liver dysfunction or disease. Pregnancy (Cat.X).

Warnings/Precautions:

Use for shortest duration and lowest dose consistent with treatment goals and risks. Not for prevention of cardiovascular disease or dementia. Endometrial hyperplasia. Gallbladder disease. Hypercoagulability. Familial hypercholesterolemia. Bone disease associated with hypercalcemia. Do initial complete physical (include BP, mammogram, PAP smear) and repeat annually. Conditions aggravated by fluid retention. Discontinue if visual disturbances or jaundice occurs and during immobilization, or at least 2 weeks before surgery associated with thromboembolism. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. May aggravate asthma, diabetes, epilepsy, migraine, porphyria, SLE, hepatic hemangiomas. May interfere with lab tests (eg, thyroid, PT, glucose tolerance, HDL-C/LDL-C). Nursing mothers.

See Also:

ACTIVELLA 1mg/0.5mg

Pharmacological Class:

Estrogen + progestin.

Adverse Reactions:

See full labeling. Increased risk of gallbladder disease, thromboembolic disorders, dementia, breast and ovarian cancer. GI upset/pain, irregular bleeding, headache, edema, hypertension, mastodynia, chloasma, others.

How Supplied:

Packs (28 tabs)—1

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