SULTRIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SULTRIN (SULTRIN).
Sultrin (sulfanilamide, sulfathiazole, sulfacetamide) is a triple sulfonamide combination that acts as a bacteriostatic agent. It inhibits bacterial folic acid synthesis by competing with para-aminobenzoic acid (PABA) for the active site of dihydropteroate synthase, thereby blocking the conversion of PABA to dihydrofolic acid. This disrupts nucleic acid synthesis in susceptible bacteria.
| Metabolism | Sulfonamides are primarily metabolized in the liver via acetylation (N-acetyltransferase) and glucuronidation. The acetylated metabolites are inactive but may crystallize in urine at high concentrations. |
| Excretion | Renal: ~70% unchanged; biliary/fecal: ~30% as metabolites |
| Half-life | Terminal half-life 8-12 hours; requires dose adjustment in renal impairment (CrCl <30 mL/min) |
| Protein binding | 65% bound to albumin |
| Volume of Distribution | 0.3 L/kg; indicates distribution primarily into extracellular fluid |
| Bioavailability | Oral: 90% (first-pass metabolism minimal); IM: 100% |
| Onset of Action | Oral: 30-60 minutes; intravenous: immediate |
| Duration of Action | Therapeutic effect persists 6-8 hours post-dose; residual effect may last up to 12 hours |
Intravaginal administration: one applicatorful (approximately 5 g) of Sultrin Triple Sulfa Cream (containing sulfathiazole, sulfacetamide, and sulfabenzamide) intravaginally once or twice daily for 4 to 7 days. Oral: Not applicable.
| Dosage form | CREAM |
| Renal impairment | Contraindicated in patients with significant renal impairment (e.g., GFR <30 mL/min/1.73 m²) due to risk of sulfonamide accumulation and toxicity. No specific dose adjustment guidelines available; use is not recommended. |
| Liver impairment | No specific guidelines for Child-Pugh classification. Use with caution in severe hepatic impairment due to potential sulfonamide metabolism alterations. Monitor for signs of toxicity. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established. Not recommended for use in children. |
| Geriatric use | Use with caution in elderly patients due to age-related renal function decline. Monitor renal function and for adverse reactions; consider alternative therapy if renal impairment is present. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SULTRIN (SULTRIN).
| Breastfeeding | Sulfanilamide is excreted into breast milk. M/P ratio unknown. Use caution in breastfeeding, especially in infants with hyperbilirubinemia or G6PD deficiency, due to risk of kernicterus or hemolytic anemia. Alternative agents preferred. |
| Teratogenic Risk | Sultrin (sulfanilamide) is a sulfonamide antimicrobial. First trimester: Crosses placenta, potential for teratogenicity (cleft palate, cardiovascular defects) based on animal studies; human data insufficient. Second and third trimesters: Risk of kernicterus in neonates due to bilirubin displacement if administered near term. Contraindicated after 32 weeks gestation. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to sulfonamides or any component of the formulation","Porphyria (sulfonamides may precipitate acute attacks)","Significant renal or hepatic impairment","Pregnancy at term","Lactation (sulfonamides are excreted in breast milk and may cause kernicterus in nursing infants)"]
| Precautions | ["Risk of severe hypersensitivity reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis","Hematologic toxicity: agranulocytosis, aplastic anemia (especially with prolonged use)","Renal toxicity: crystalluria and renal tubular obstruction, particularly in dehydrated patients or those with renal impairment","Hepatic impairment: risk of hepatotoxicity and hyperbilirubinemia","Prolonged use may lead to superinfection with resistant organisms","Avoid use during pregnancy near term due to risk of kernicterus in the newborn","Cross-sensitivity with other sulfonamides and thiazide diuretics"] |
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| Fetal Monitoring | Monitor maternal CBC, renal function, and liver function tests. Fetal ultrasound for anomalies if used in first trimester. Neonatal bilirubin levels and signs of kernicterus if used near term. |
| Fertility Effects | No specific data on fertility impairment in humans. Sulfonamides may affect spermatogenesis in animal studies, but clinical relevance unclear. |