Monograph Details
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Ob/Gyn
> Menopause and HRT
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ELESTRIN |
| Manufacturer |
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BioSante 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 0.06%; gel; contains alcohol. |
| Indications |
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Moderate-to-severe vasomotor symptoms associated with menopause. |
| Children |
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Not applicable. |
| Adults |
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Prime pump before 1st use. Use lowest effective dose. Initially: Apply 1 pump (0.87g) daily to clean, dry, unbroken skin of upper arm. Reevaluate periodically. |
| Contraindications |
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Undiagnosed abnormal genital bleeding. Thromboembolic disease (eg, stroke or MI within past year, DVT, pulmonary embolism). Thrombophlebitis. Breast or estrogen-dependent carcinoma. Liver dysfunction or disease. Pregnancy (Cat X). |
| Precautions |
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Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Renal dysfunction. Gallbladder disease. Hypertriglyceridemia. Hypothyroidism. Conditions aggravated by fluid retention. Bone disease associated with hypercalcemia. Do initial complete physical; repeat annually (include BP, mammogram, PAP smear). Discontinue if jaundice occurs and during immobilization or 2 weeks before planned mammogram or surgery associated with thromboembolism. Product is flammable. Nursing mothers. |
| Interactions |
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May be antagonized by CYP3A4 inducers. May be potentiated by CYP3A4 inhibitors. Avoid applying sunscreen to application site (increases estradiol absorption). |
| Adverse Reactions |
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See literature. Breast tenderness, metrorrhagia, vaginal discharge, nausea, nasopharyngitis, upper respiratory tract infection. Long-term use may increase risk of estrogen-dependent cancers (eg, breast and/or endometrial), dementia, others. Increased risk of thromboembolic disorders, gallbladder disease. |
| How Supplied |
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Gel—144g (100 metered 0.87g doses) |
| Additional Resources |
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• Related Prescribing Note |
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