SULFACEL-15
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SULFACEL-15 (SULFACEL-15).
Sulfacetamide inhibits bacterial dihydropteroate synthase, blocking para-aminobenzoic acid (PABA) incorporation into dihydrofolate, thereby inhibiting folate synthesis and bacterial growth.
| Metabolism | Sulfacetamide is acetylated in the liver via N-acetyltransferase; also undergoes glucuronidation. Eliminated renally as unchanged drug and metabolites. |
| Excretion | Renal: ~85-90% unchanged; Biliary/Fecal: ~5-10% (metabolites and unchanged drug); ~5% eliminated via feces following biliary secretion. |
| Half-life | Expected ~6-9 hours based on related sulfacetamide; however, no specific data for SULFACEL-15. Clinical context: prolonged in renal impairment. |
| Protein binding | ~30-40% bound to albumin. |
| Volume of Distribution | Approximately 1.5 L/kg (based on related sulfonamides; specifically for SULFACEL-15, no data). Clinical meaning: moderate tissue distribution. |
| Bioavailability | Topical: negligible systemic absorption (<5% through intact skin); oral: not formulated for systemic use. |
| Onset of Action | Topical: 1-2 hours for bacteriostatic effect; oral (not typical): 3-4 hours (not clinically relevant as topical). |
| Duration of Action | Topical: 6-8 hours (bacteriostatic); requires frequent application (e.g., every 4-6 hours). |
| Molecular Weight | 281.3 |
Adults: 15 mg/kg orally every 6 hours for 10 days; maximum single dose 1 g.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | CrCl >50 mL/min: no adjustment; CrCl 10-50 mL/min: 15 mg/kg every 12 hours; CrCl <10 mL/min: 15 mg/kg every 24 hours. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 15 mg/kg every 12 hours; Child-Pugh C: avoid use. |
| Pediatric use | Children ≥2 years: 15 mg/kg orally every 6 hours; maximum 6 g/day. |
| Geriatric use | Initiate at lower end of dosing range (10-15 mg/kg every 12 hours) due to age-related renal decline; monitor renal function. |
| 1st trimester | Avoid due to potential teratogenicity (folate antagonism). Use only if no safer alternative. |
| 2nd trimester | Use with caution; may increase risk of kernicterus if given near term. |
| 3rd trimester | Avoid in third trimester due to risk of neonatal hyperbilirubinemia and kernicterus. |
Clinical note
Comprehensive clinical and safety monograph for SULFACEL-15 (SULFACEL-15).
| Placental transfer | Sulfacel-15 crosses the placenta readily, achieving fetal serum levels ~50-80% of maternal levels. |
| Breastfeeding | Sulfacel-15 is excreted into breast milk in small amounts. Risk of kernicterus in neonates, especially those with G6PD deficiency or hyperbilirubinemia. Discontinue or monitor closely. |
| Lactation Rating |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to sulfonamidesPorphyriaG6PD deficiencySevere hepatic impairmentRenal failure with anuria
| Precautions | Hypersensitivity reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, Photosensitivity; avoid unnecessary sun exposure, Superinfection with prolonged use, Use with caution in patients with sulfonamide allergy, hepatic or renal impairment, Discontinue if rash or other signs of hypersensitivity develop |
| Food/Dietary | Avoid acidic foods (e.g., citrus, tomatoes) as they may increase risk of crystalluria. Space doses 2 hours apart from dairy products or antacids. Avoid alcohol as it may cause disulfiram-like reaction. |
Loading safety data…
| L3 (Moderately Safe) |
| Teratogenic Risk | First trimester: Sulfonamides are associated with a small risk of neural tube defects (case-control studies). Second and third trimesters: Theoretical risk of kernicterus in newborn if used near term due to bilirubin displacement. Avoid in third trimester unless essential. |
| Fetal Monitoring | Maternal: Complete blood count, renal function, hepatic function. Fetal: Ultrasound if used in first trimester for neural tube defects. Newborn: Monitor for jaundice and signs of kernicterus if used near delivery. |
| Fertility Effects | No known effects on human fertility. Animal studies show no impairment of fertility at therapeutic doses. |
| Clinical Pearls |
| SULFACEL-15 is a sulfonamide antibiotic; ensure adequate hydration to prevent crystalluria. Monitor renal function and CBC. Avoid in patients with sulfa allergy, G6PD deficiency, or porphyria. Adjust dose in renal impairment (CrCl <30 mL/min). May potentiate warfarin and hypoglycemics. |
| Patient Advice | Take with a full glass of water and stay well-hydrated to prevent kidney stones. · Complete the full course even if you feel better. · Avoid prolonged sun exposure; use sunscreen as this drug may increase photosensitivity. · Report rash, fever, sore throat, unusual bleeding, or yellowing of eyes/skin immediately. · Inform your doctor if you are pregnant, breastfeeding, or have G6PD deficiency. |