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Drug Information for Vagifem (estradiol vaginal tablets) Initial U.S. Approval: 1999 (Novo Nordisk): 11 DESCRIPTION
- WARNING: CARDIOVASCULAR DISORDERS, ENDOMETRIAL CANCER, BREAST CANCER and PROBABLE DEMENTIA
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 6 ADVERSE REACTIONS
- 7 DRUG INTERACTIONS
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 15 REFERENCES
- 17 PATIENT COUNSELING INFORMATION
- 17.5 FDA-Approved Patient Labeling
- Principal Display panel - VAGIFEM 25 µg
- Principal Display panel - VAGIFEM 10 µg
- External Links Related to Vagifem (estradiol vaginal tablets) Initial U.S. Approval: 1999 (Novo Nordisk)
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:
- Drug Information Provided by National Library of Medicine (NLM).