Indications And Clinical Uses:
Postoperative vaginitis or cervicitis, nonspecific vaginitis, ulcerative vaginitis and related gynecological conditions.
Sulfonamide sensitivity; kidney disease.
Although some absorption of sulfonamide may occur through the vaginal mucosa, systemic reactions attributable to this are infrequent, as are local sensitivity reactions such as increased discomfort or a burning sensation following the use of this product. However, as with all sulfonamides, the usual precautions 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.
Pregnancy: Teratogenic Effects: 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, 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).
Lactation: Because of the potential for serious adverse reactions in nursing infants from triple sulfa, 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.
Children: Safety and effectiveness in children have not been established.
Dosage And Administration:
1 applicatorful (approximately 5 mL) intravaginally before retiring and again in the morning, decreasing to 50 or 25% after a period of 4 to 6 days if desired. Course of treatment may be repeated if necessary.
Availability And Storage:
Each g of white, water dispersible, absorptive vaginal cream contains: sulfabenzamide 3.7%, sulfathiazole 3.42%, sulfacetamide 2.86%, compounded with cetyl alcohol, cholesterol, diethylaminoethyl stearamide, glyceryl monostearate, lanolin, lecithin, methylparaben, peanut oil, phosphoric acid, propylene glycol, propylparaben, purified water, stearic acid and urea. Tubes of 78 g with applicator.
SULTRIN® Janssen-Ortho Triple Sulfa Vaginitis Therapy
Posted by RxMed