Monograph Details
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Ob/Gyn
> Menopause and HRT
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ESTRASORB |
| Manufacturer |
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Graceway Pharmaceuticals |
| 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 hemihydrate 2.5mg/g; topical emulsion. |
| Indications |
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Moderate to severe vasomotor symptoms of menopause. |
| Children |
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Not applicable. |
| Adults |
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Rub contents of 2 pouches (3.48g) onto legs daily over 3 minutes (1 pouch per leg); rub excess on hands onto buttocks. |
| Contraindications |
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Undiagnosed abnormal genital bleeding. Thromboembolic disorders. Thrombophlebitis. Breast or estrogen-dependent carcinoma, unless palliative. Pregnancy (Cat X). |
| Precautions |
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Patients with intact uterus should receive a progestin to avoid endometrial hyperplasia. Reevaluate periodically. Familial hyperlipoproteinemia or history of breast cancer. Hypercoagulability. Endometriosis. Severe hypocalcemia. Bone disease associated with hypercalcemia. Do initial complete physical and repeat annually (include BP, mammogram, Pap smear). Discontinue if jaundice or hypercalcemia occurs, and during immobilization or at least 2 weeks before surgery associated with increased risk of thromboembolism. Nursing mothers. |
| Interactions |
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Plasma levels reduced by CYP3A4 inducers (eg, St. John's wort, rifampin). Potentiated by CYP3A4 inhibitors (eg, ketoconazole). Avoid applying near sunscreen (increases estradiol absorption). May interfere with lab tests. |
| Adverse Reactions |
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See literature. Increased risk of endometrial cancer or hyperplasia, thromboembolic disorders, gallbladder disease. Headache, pruritus, fluid retention, mastodynia, breakthrough bleeding. |
| How Supplied |
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Emulsion (1.74g/pouch)—56 |
| Additional Resources |
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• Related Prescribing Note |
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