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). |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SULFACEL-15 (SULFACEL-15).
| Breastfeeding | Sulfacetamide enters breast milk (M/P ratio approximately 0.1). Small amounts unlikely to cause adverse effects in term infants. Caution in premature, ill, or hyperbilirubinemic infants due to theoretical risk of kernicterus. |
| 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. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to sulfonamides or any component of the formulation","Sulfonamide allergy (cross-sensitivity with other sulfonamides)"]
| 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"] |
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| 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. |