Prescription Drugs

CLINICAL PHARMACOLOGY The mode of action of SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) is not completely known. SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) Cream is a topical antibacterial preparation used intravaginally against Haemophilus (Gardnerella) vaginalis bacteria. Indirect effects, such as lowering the vaginal pH, may be equally important mechanisms.

INDICATIONS SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) Cream is indicated for the treatment of vaginitis caused by Haemophilus (Gardnerella) vaginalis bacteria. The diagnosis of a Haemophilus (Gardnerella) vaginalis vaginitis should be firmly established before initiation of treatment with SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) . DOSAGE AND ADMINISTRATION SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) Cream. One full applicator intravaginally twice daily for four to six days. This course of therapy may be repeated if necessary; the dosage may be reduced one-half to one-quarter. HOW SUPPLIED Cream 78 g tubes with the ORTHO* Measured-Dose Applicator. NDC 0062-5440-77

PATIENT INFORMATION No Information Provided.

OVERDOSE No Information Provided. CONTRAINDICATIONS SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) is contraindicated in the following circumstances: kidney disease; hypersensitivity to sulfonamides; in pregnancy at term and during the nursing period because sulfonamides cross the placenta, are excreted in breast milk and may cause Kernicterus.

SIDE EFFECTS There has been one reported case of Agranulocyctosis in a patient receiving SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) Cream. The most frequent adverse reactions to SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) are localized irritation and/or allergy including rare reports of Stevens-Johnson syndrome which may be fatal. DRUG INTERACTIONS No Information Provided.

WARNINGS Deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood dyscrasias. The presence of clinical signs such as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders. PRECAUTIONS Because sulfonamides may be absorbed from the vaginal mucosa, the usual precautions for oral sulfonamides apply. Patients should be observed for skin rash or evidence of systemic toxicity, and if these develop, the medications should be discontinued. Laboratory tests: Standard office diagnostic procedures for vaginitis are usually sufficient to establish the diagnosis of Haemophilus (Gardnerella) vaginalis and to rule out a trichomonal or monilial infection. These include noting a fish-like odor upon addition of 10% KOH to vaginal discharge and microscopic identification of "clue cells" in a wet mount preparation. If cultures are obtained, care must be taken to use appropriate media and methods for Haemophilus (Gardnerella) vaginalis. Carcinogenesis, mutagenesis, impairment of fertility: The sulfonamides bear certain chemical similarities to some goitrogens. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration has produced thyroid malignancies in this species. Pregnancy: Teratogenic Effects: Pregnancy Category C: The safe use of sulfonamides in pregnancy has not been established. The teratogenicity 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 were given to pregnant rats and mice at high oral doses (7 to 25 times the human therapeutic dose). Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. See CONTRAINDICATIONS . Pediatric use: Safety and effectiveness in children have not been established.