VAGIFEM

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Generic Name for VAGIFEM

Estradiol (as hemihydrate) 10micrograms, 25micrograms; vaginal tabs.

Legal Classification:

Rx

Pharmacological Class for VAGIFEM

Estrogen.

Manufacturer of VAGIFEM

Novo Nordisk

Indications for VAGIFEM

Atrophic vaginitis.

Adult dose for VAGIFEM

1 tab intravaginally once daily for 2 weeks, then 1 tab twice weekly. Reevaluate periodically.

Children's dosing for VAGIFEM

Not recommended.

Contraindications for VAGIFEM

Breast or estrogen-dependent carcinoma. Undiagnosed abnormal vaginal bleeding. Thromboembolic disorders (eg, stroke or MI, DVT, pulmonary embolism). Thrombophlebitis. Liver dysfunction or disease. Pregnancy (Cat.X).

Precautions for VAGIFEM

See literature. Endometrial hyperplasia. Gallbladder disease. Do initial complete physical and repeat annually (include BP, mammogram, Pap smear). Severely atrophic vaginal mucosa or other trauma risk. Familial hyperlipoproteinemia. Discontinue if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs, and 2 weeks before surgery associated with thromboembolism. Monitor thyroid function. Nursing mothers.

Interactions for VAGIFEM

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).

Adverse Reactions for VAGIFEM

See literature. Upper respiratory tract infection, headache, abdominal pain, back pain, genital pruritus, moniliasis, vulvovaginal mycotic infection, diarrhea; increased risk of gallbladder disease, thromboembolic disorders.

How is VAGIFEM supplied?

Vaginal tabs—8, 18 (w. applicators)

Related Disease:

Menopausal disorders

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Vagifem 10mcg approved for atrophic vaginitis due to menopause

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The FDA has approved a 10mcg formulation of Vagifem (estradiol vaginal tablets, from Novo Nordisk) for the treatment of atrophic vaginitis due to menopause.

Phase 3 study of Ophena for treatment of dyspareunia associated with postmenopausal vaginal atrophy

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