Drug Information for Vagifem (estradiol vaginal tablets) Initial U.S. Approval: 1999 (Novo Nordisk): 11 DESCRIPTION

Vagifem 10 mcg (estradiol vaginal tablets) are small, white, film-coated tablets containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. Vagifem 25 mcg (estradiol vaginal tablets) are small, white, film-coated tablets containing 25.8 mcg of estradiol hemihydrate equivalent to 25 mcg of estradiol. Each tablet of Vagifem 10 mcg and 25 mcg contains the following excipients: hypromellose, lactose monohydrate, maize starch and magnesium stearate. The film coating contains hypromellose and polyethylene glycol. Each Vagifem tablet is 6 mm in diameter and is placed in a disposable applicator. Each tablet-filled applicator is packaged separately in a blister pack. Vagifem tablets are used intravaginally. When the tablet comes in contact with the vaginal mucosa, estradiol is released into the vagina.

Estradiol hemihydrate is a white, almost white or colorless crystalline solid, chemically described as estra-1,3,5 (10)-triene-3,17ß-diol. The chemical formula is C₁₈H₂₄O₂ • ½ H₂O with a molecular weight of 281.4.

The structural formula is: