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Bijuva Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol, progesterone; 0.5mg/100mg, 1mg/100mg; caps.
Pharmacological Class
Estrogen + progestin.
How Supplied
Caps—30
Manufacturer
Generic Availability
NO
Bijuva Indications
Indications
Moderate to severe vasomotor symptoms due to menopause in women with a uterus.
Bijuva Dosage and Administration
Adult
Use lowest effective dose for the shortest duration. Take with food. Initially 0.5mg/100mg daily in the evening; adjust based on response. Attempt to taper or discontinue at 3–6 month intervals.
Children
Not applicable.
Bijuva Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Breast or other estrogen-dependent neoplasms. Active DVT, PE, or history of. Active arterial thromboembolic disease, or history of. Known hepatic impairment or disease. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
Bijuva Boxed Warnings
Boxed Warning
Cardiovascular disorders. Breast cancer. Endometrial cancer. Probable dementia.
Bijuva Warnings/Precautions
Warnings/Precautions
Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs or suspected. Manage risk factors for cardiovascular disease and/or venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of endometrial cancer in women with intact uterus (adding progestins has been shown to reduce endometrial hyperplasia risk). Breast or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, papilledema, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Perform yearly breast exams (including mammography). Reevaluate periodically. Elderly. Nursing mothers.
Bijuva Pharmacokinetics
See Literature
Bijuva Interactions
Interactions
May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John's wort). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Bijuva Adverse Reactions
Adverse Reactions
Breast tenderness, headache, nausea, vaginal bleeding, vaginal discharge, pelvic pain; thromboembolism, neoplasms.
Bijuva Clinical Trials
See Literature
Bijuva Note
Not Applicable
Bijuva Patient Counseling
See Literature
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