Estradioldrug info
estradiol 0.01 MG Vaginal Insert [Vagifem]
What it is used for
Vagifem is an estrogen indicated for the treatment of atrophic vaginitis due to menopause.
1.1 Treatment of
Atrophic Vaginitis due to Menopause
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective February 10, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Vagifem 10 mcg (estradiol vaginal inserts) are small, white, film-coated inserts containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. Each insert of Vagifem 10 mcg contains the following excipients: hypromellose, lactose monohydrate, maize starch and magnesium stearate. The film coating contains hypromellose and polyethylene glycol. Each Vagifem insert is 6 mm in diameter and is placed in a disposable applicator. Each insert-filled applicator is packaged separately in a blister pack. Vagifem inserts are used intravaginally. When the insert 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 -triene-3,17β-diol. The chemical formula is C 18 H 24 O 2
½ H 2 O with a molecular weight of 281.4. The structural formula is: Structural Formula for Vagifem
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective February 10, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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