Monograph Details
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Ob/Gyn
> Menopause and HRT
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ALORA |
| Manufacturer |
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Watson Pharmaceuticals, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Estrogen. |
| Generic Name |
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Estradiol 0.025mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day; transdermal patch. |
| Indications |
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Moderate to severe vasomotor symptoms of menopause. Vulval and vaginal atrophy. Postmenopausal osteoporosis prevention. Hypoestrogenism. |
| Children |
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Not applicable. |
| Adults |
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Apply to clean, dry area on lower abdomen, hips, or buttocks (avoid breasts, waistline). Osteoporosis: initially one 0.025mg/day patch twice weekly. Others: initially one 0.05 mg/day patch twice weekly. Maintenance: use lowest effective dose. Patients without intact uterus may use continuous schedule; otherwise use cyclically (3 weeks on, 1 week off). Transferring from other topical therapy: may start immediately or if from oral estrogens: apply 1st patch up to 1 week after last oral dose. Rotate application sites. Reevaluate periodically. |
| Contraindications |
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Undiagnosed abnormal genital bleeding. Thromboembolic disorders. Thrombophlebitis. Breast or estrogen-dependent carcinoma. Pregnancy (Cat.X). |
| Precautions |
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Patients with intact uterus should receive a progestin to avoid endometrial hyperplasia. Familial hyperlipoproteinemia or history of breast cancer. Hypercoagulability. Hepatic insufficiency. Conditions aggravated by fluid retention. Endometriosis. Gallbladder disease. Bone disease associated with hypercalcemia. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Discontinue if hypertension or jaundice occurs and during immobilization, or at least 2 weeks before surgery associated with increased risk of thromboembolism. Nursing mothers. |
| Adverse Reactions |
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See literature. Increased risk of endometrial cancer or hyperplasia, thromboembolic disorders. Headache, local irritation, fluid retention, breakthrough bleeding, mastodynia, nausea, abdominal cramps, migraine, dizziness; vaginal bleeding (at 0.1mg/day dose). |
| How Supplied |
Patch 0.05 mg/day—8, 24
0.025mg/day, 0.075 mg/day, 0.1 mg/day—8 |
| Additional Resources |
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• Related Prescribing Note |
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