Monograph Details
|
|
Ob/Gyn
> Menopause and HRT
|
|
ACTIVELLA |
| Manufacturer |
|
Novo Nordisk |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Estrogen + progestin. |
| Generic Name |
|
Estradiol 1mg, norethindrone acetate 0.5mg; tabs. |
| Indications |
|
In women with an intact uterus: moderate to severe vasomotor symptoms of menopause; genital tract atrophy; prevention of postmenopausal osteoporosis. |
| Children |
|
Not applicable. |
| Adults |
|
1 tab daily. Reevaluate periodically. |
| Contraindications |
|
Breast or estrogen-dependent carcinoma. Undiagnosed abnormal vaginal bleeding. Thromboembolic disorders. Thrombophlebitis. Liver dysfunction. Pregnancy (Cat.X). |
| Precautions |
|
Endometrial hyperplasia. Gallbladder disease. Familial hyperlipoproteinemia. Hypercoagulability. Bone disease associated with hypercalcemia. Do initial complete physical (include BP, mammogram, and Pap smear) and repeat annually. Conditions aggravated by fluid retention. Discontinue if jaundice occurs or at least 2 weeks before surgery associated with thromboembolism. May interfere with lab tests. Nursing mothers. |
| Adverse Reactions |
|
See literature. Increased risk of gallbladder disease, thromboembolic disorders. GI effects, irregular bleeding, headache, insomnia, edema, hypertension, weight changes, mastodynia, intolerance to contact lenses, chloasma. |
| How Supplied |
|
Packs (28 tabs)—1 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
