Generic Name and Formulations:
Estradiol (as hemihydrate) 10mcg; vaginal tabs.

Company:
Novo Nordisk
Indications for VAGIFEM:
Atrophic vaginitis due to menopause.

Adult:
1 tab intravaginally once daily for 2 weeks, then 1 tab twice weekly. Reeva luate periodically.

Children:
Not recommended.

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 (Cat.X).

Warnings/Precautions:
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 at least 4–6 weeks before surgery associated with thromboembolism. Monitor thyroid function. Hereditary angioedema. Nursing mothers.

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).

Pharmacological Class:
Estrogen.

Adverse Reactions:
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 Supplied:
Vaginal tabs—8, 18 (w. applicators)