Estradioldrug info

estradiol 0.01 MG Vaginal Insert

What it is used for

Estradiol vaginal inserts are 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 April 3, 2024. 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

Estradiol vaginal inserts USP, 10 mcg, are small, white, film-coated inserts containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol, USP. Each insert of estradiol vaginal insert USP, 10 mcg contains the following excipients: corn starch, hypromellose, lactose monohydrate and magnesium stearate. The film coating contains hypromellose and polyethylene glycol. Each estradiol vaginal insert, USP is 6 mm in diameter and is placed in a disposable applicator. Each insert-filled applicator is packaged separately in a blister pack. Estradiol vaginal inserts, USP are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol, USP 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: 9ec90e26-figure-01

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective April 3, 2024. 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.

This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.

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