Monograph Details
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Ob/Gyn
> Menopause and HRT
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COMBIPATCH 0.05/0.14mg |
| Manufacturer |
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Novartis Pharmaceuticals Corp |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Estrogen + progestin. |
| Generic Name |
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Estradiol 0.05mg + norethindrone acetate 0.14mg; per day; transdermal system. |
| Also |
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• COMBIPATCH 0.05/0.25mg
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| Indications |
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In women with an intact uterus: moderate-to-severe vasomotor symptoms of menopause, vulvar and vaginal atrophy, hypoestrogenism. |
| Children |
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Not applicable. |
| Adults |
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Apply to smooth, clean, dry area of lower abdomen (avoid breasts, waistline). Continuous combined regimen: 1 CombiPatch twice weekly for 28-day cycle; repeat. Continuous sequential regimen (use with 0.05mg/day estrogen patch): Use estrogen-only patch for first 14 days of cycle, then 1 CombiPatch twice-weekly for second 14 days of 28-day cycle; repeat. Rotate application site. Reevaluate periodically. |
| Contraindications |
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Undiagnosed abnormal genital bleeding. Thrombophlebitis. Thromboembolic disease. Stroke. Breast or estrogen-dependent neoplasia. Pregnancy (Cat.X). |
| Precautions |
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Familial hypertriglyceridemia. Bone disease associated with hypercalcemia. Conditions aggravated by fluid retention. Hepatic dysfunction. History of thrombotic disorders. Do initial complete physical exam and repeat annually (include Pap smear, mammogram, and BP). Hypercoagulation states. Discontinue if visual abnormalities or thrombotic disorders occur. May interfere with lab tests (see literature). Nursing mothers. |
| Adverse Reactions |
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See literature. May increase risk of breast cancer, gallbladder disease, thromboembolic disorders, others. Dysmenorrhea, menstrual disorders, back pain, asthenia, application site reactions, nervousness, uterine bleeding, mastodynia. |
| How Supplied |
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Patches—8 |
| Additional Resources |
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• Related Prescribing Note |
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