Monograph Details
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Ob/Gyn
> Menopause and HRT
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ESTROGEL |
| Manufacturer |
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Ascend Therapeutics |
| 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 0.75mg/1.25g; gel; contains alcohol. |
| Indications |
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Moderate to severe vasomotor symptoms of menopause. Vulvar and vaginal atrophy. |
| Children |
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Not applicable. |
| Adults |
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Prime pump before 1st use. Apply 1 pump (1.25g) daily to clean, dry, intact skin over one arm; allow to dry for 5 minutes. |
| 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. 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. Product is flammable. Nursing mothers. |
| Interactions |
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Plasma levels reduced by CYP3A4 inducers. Potentiated by CYP3A4 inhibitors. |
| Adverse Reactions |
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See literature. Increased risk of endometrial cancer or hyperplasia, thromboembolic disorders, gallbladder disease. Headache, rash, pruritus, fluid retention, mastodynia, metrorrhagia. |
| How Supplied |
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Gel (64 X 1.25g doses)—1 |
| Additional Resources |
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• Related Prescribing Note |
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