Sulfanilamide clinical pharmacology

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Sulfanilamide
AVC VAGINAL® FDA Package Insert
Description
Clinical Pharmacology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mohamed Moubarak, M.D. [2]

Clinical Pharmacology

Sulfanilamide has been a useful ingredient of vaginal formulations for about four decades. It blocks certain metabolic processes essential for the growth of susceptible bacteria. In AVC, the sulfanilamide is in a specially compounded base buffered to the pH (about 4.3) of the normal vagina to encourage the presence of the normally occurring Döderlein’s bacilli of the vagina.

The use of AVC for the treatment of vulvovaginitis caused by Candida albicans is supported by three clinical investigations. The three studies show AVC with sulfanilamide to be significantly more effective (p ≤ 0.01) than placebo as follows:

In Study I, the ratio of effectiveness was 71% for the AVC with sulfanilamide versus 49% for placebo with 30 days of treatment;

In Study II, the percentages were 48% and 24%, respectively, with 15 days of treatment;

In Study III, the percentages were 66% versus 33%, respectively, with 30 days of treatment.[1]

References

  1. "AVC VAGINAL (SULFANILAMIDE) CREAM [JAZZ PHARMACEUTICALS COMMERCIAL CORP.]". Text " accessdate" ignored (help)

Adapted from the FDA Package Insert.