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AVC Cream (Sulfanilamide Vaginal) - Description and Clinical Pharmacology

 
 



AVC (sulfanilamide)

Vaginal Cream

DESCRIPTION

AVC is a preparation for vaginal administration for
the treatment of Candida albicans infections and available in the following forms:

AVC Cream

Each tube contains:

Sulfanilamide………………....................……..15.0% in a water-miscible, non-staining base made from
lactose, propylene glycol, stearic acid, diglycol stearate, methylparaben, propylparaben, trolamine, and water; buffered with lactic acid to an acid pH of approximately 4.3.

Sulfanilamide is an anti-infective agent. It is p -amino-benzenesulfonamide with the chemical structure:

Sulfanilamide occurs as a white odorless crystalline powder with a slightly bitter taste and sweet aftertaste. It is slightly soluble in water, alcohol, acetone, glycerin, propylene glycol, hydrochloric acid, and solutions of potassium and sodium hydroxide. It is practically insoluble in chloroform, ether, benzene, and petroleum ether.

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.

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