Hoechst Marion Roussel
Action And Clinical Pharmacology: Sulfanilamide has been an ingredient of vaginal formulations for about four decades. It blocks certain metabolic processes essential for the growth of susceptible bacteria.
AVC Cream is buffered to the pH of the normal healthy vagina (approximately 4.3) to encourage the presence of normally occurring DSderlein bacilli of the vagina.
Indications And Clinical Uses: For the treatment of vulvovaginitis caused by C. albicans. Diagnosis of Candida should be confirmed by vaginal smears and/or cultures prior to initiating therapy.
Contra-Indications: AVC should not be used in patients known to be sensitive to the sulfonamides, or to AVC Cream.
Precautions: General: Because sulfonamides are absorbed from the vaginal mucosa, the usual precautions for oral sulfonamides apply. Patients should be observed for manifestations such as skin rash or other evidence of systemic toxicity, and if these develop, the medication should be discontinued.
If clinical symptoms persist microbiological tests should be repeated to rule out other pathogens and to confirm the diagnosis.
Deaths associated with administration of oral sulfonamides have reportedly occurred from hypersensitivity reactions, agranulocytosis, aplastic anemia, and other blood dyscrasias. Goiter production, diuresis, and hypoglycaemia have reportedly occurred rarely in patients receiving oral sulfonamides. Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration has reportedly produced thyroid malignancies in this species.
Pregnancy: Vaginal applicators should be used with caution after the seventh month of pregnancy.
It is not known whether sulfanilamide can cause fetal harm when administered to a pregnant woman or can affect reproductive capability. Sulfanilamide should be administered to a pregnant woman only if clearly needed.
Sulfonamides, including sulfanilamide, readily pass through the placenta and reach fetal circulation. The concentration in the fetus is from 50 to 90% of that in the maternal blood and if high enough, can cause toxic effects. The safe use of sulfonamides, including sulfanilamide, in pregnancy has not been established. The teratogenic potential of most sulfonamides has not been thoroughly investigated in either animals or humans. However, a significant increase in the incidence of cleft palate and other bony abnormalities of offspring has been observed when certain sulfonamides of the short, intermediate, and long-acting types (including sulfanilamide) were given to pregnant rats and mice at high oral doses (7 to 25 times the human therapeutic oral dose).
Lactation: Sulfanilamide should be avoided in nursing mothers because absorbed sulfonamides will appear in maternal milk and have caused kernicterus in the newborn. Because of the potential for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug.
Children: Safety and effectiveness of sulfanilamide in children have not been established.
Adverse Reactions: Although absorption of sulfanilamide occurs through the vaginal mucosa, systemic manifestations attributable to this drug are infrequent. Local sensitivity reactions such as increased discomfort or a burning sensation have occasionally been reported following the use of topical sulfonamides. Treatment should be discontinued if either local or systemic manifestations of sulfonamide toxicity or sensitivity occur.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: There have been no reports of accidental overdosage with sulfanilamide. The acute oral LD50 of sulfonamide is 3 700 to 4 200 mg/kg in mice. The minimum human lethal dose of sulfanilamide has not been established. It is not known if sulfanilamide is dialyzable.
Dosage And Administration: 1 applicatorful (about 6 g) intravaginally once or twice daily. Improvement will often be apparent within a few days. Exacerbation may occur during menses; therefore, it is advisable to continue the applications for 1 month, or through 1 complete menstrual cycle.
Douching with a suitable solution before insertion may be recommended for hygienic purposes. A pad may be used to protect underclothing if necessary.
Availability And Storage: Each tube contains: sulfanilamide 15%. Nonmedicinal ingredients: lactose, in a water-miscible, non-staining base made from propylene glycol, stearic acid, diglycol stearate, methylparaben, propylparaben, lactic acid and triethanolamine. Buffered with lactic acid to an acid pH of approximately 4.3. Tubes of 100 g with applicator. Store at room temperature (15 to 30°C).
AVC® Hoechst Marion Roussel Sulfanilamide Vaginitis Therapy
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