Monograph Details
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Ob/Gyn
> Menopause and HRT
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ENJUVIA |
| Manufacturer |
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Duramed 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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Synthetic conjugated estrogens, B, 0.3mg, 0.45mg, 0.625mg, 0.9mg, 1.25mg; tabs. |
| Indications |
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Moderate to severe vasomotor symptoms of menopause. Moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. |
| Children |
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Not applicable. |
| Adults |
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Use lowest effective dose. Initially 0.3mg once daily. Reevaluate periodically. |
| Contraindications |
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Breast or estrogen-dependent carcinoma. Undiagnosed abnormal vaginal bleeding. Thromboembolic disorders (eg, stroke or MI within one year, DVT, pulmonary embolism). Thrombophlebitis. 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. Familial hyperlipoproteinemia. 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. Nursing mothers. |
| Interactions |
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May be antagonized by CYP3A4 inducers. May be potentiated by CYP3A4 inhibitors. |
| Adverse Reactions |
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GI upset, abdominal pain, irregular bleeding, vaginitis, dysmenorrhea, headache, edema, hypertension, mastodynia, chloasma, visual abnormalities (reevaluate if occur), leg cramps, hypertriglyceridemia. 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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Tabs—100 |
| Additional Resources |
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• Related Prescribing Note |
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