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Vagifem Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol (as hemihydrate) 10mcg; vaginal inserts.
Pharmacological Class
Estrogen.
How Supplied
Vaginal inserts—8, 18 (w. applicators)
Manufacturer
Vagifem Indications
Indications
Atrophic vaginitis due to menopause.
Vagifem Dosage and Administration
Adult
Use lowest effective dose for the shortest duration. 1 insert intravaginally once daily for 2 weeks, then 1 insert twice weekly. Reevaluate periodically.
Children
Not indicated.
Vagifem Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Known, suspected, or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE, or history of these conditions. Active arterial thromboembolic disease (eg, stroke, MI) or a history of these conditions. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known liver impairment or disease. Known angioedema. Known or suspected pregnancy.
Vagifem Boxed Warnings
Boxed Warning
Endometrial cancer. Cardiovascular disorders. Breast cancer. Probable dementia.
Vagifem Warnings/Precautions
Warnings/Precautions
Increased risk of cardiovascular disorders (eg, stroke, DVT). Endometrial, breast, or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. Consider the addition of a progestin in patients with an intact uterus to avoid endometrial hyperplasia. History of hypertriglyceridemia. Hepatic impairment. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Caution in asthma, diabetes, epilepsy, migraines, porphyria, SLE, hepatic hemangiomas. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Discontinue if jaundice, cardiac events, severe hypercalcemia or pancreatitis occurs. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Nursing mothers.
Vagifem Pharmacokinetics
See Literature
Vagifem Interactions
Interactions
May be antagonized by CYP3A4 inducers (eg, St. John's Wort, phenobarbital, carbamazepine, rifampin). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice).
Vagifem Adverse Reactions
Adverse Reactions
See full labeling. Upper respiratory tract infection, headache, abdominal pain, back pain, genital pruritus, moniliasis, vulvovaginal mycotic infection, diarrhea; increased risk of gallbladder disease, thromboembolic disorders.
Vagifem Clinical Trials
See Literature
Vagifem Note
Not Applicable
Vagifem Patient Counseling
See Literature
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