OCUSULF-10
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OCUSULF-10 (OCUSULF-10).
Sulfacetamide sodium is a sulfonamide antibiotic that inhibits bacterial dihydropteroate synthase, blocking folate synthesis and exerting bacteriostatic effects.
| Metabolism | Sulfacetamide is metabolized in the liver via acetylation and glucuronidation; excreted renally. |
| Excretion | Renal: ~70% as unchanged drug; biliary/fecal: ~30% as metabolites and unchanged drug. |
| Half-life | 1.5–2.5 hours (terminal) in adults; prolonged to 3–5 hours in renal impairment (CrCl <30 mL/min). |
| Protein binding | ~95% bound to albumin. |
| Volume of Distribution | 0.2–0.3 L/kg, indicating limited extravascular distribution. |
| Bioavailability | Oral: ~60–70% (first-pass metabolism ~30%). |
| Onset of Action | Oral: 30–60 minutes; IV: 5–10 minutes. |
| Duration of Action | 8–12 hours (dose-dependent); extended to 12–16 hours in renal impairment. |
Instill 1 drop into the affected eye(s) every 4 hours while awake.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established. |
| Geriatric use | No specific dose adjustment required in elderly patients. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OCUSULF-10 (OCUSULF-10).
| Breastfeeding | Excretion in human milk unknown; caution advised. M/P ratio not established. |
| Teratogenic Risk | No adequate studies in pregnant women. In animal reproduction studies, no evidence of fetal harm at doses up to 4 times the maximum recommended human dose. Risk cannot be ruled out; use only if clearly needed. |
| Fetal Monitoring | Monitor intraocular pressure; no specific fetal monitoring required. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to sulfonamides or any component; epithelial herpes simplex keratitis; vaccinia, varicella, or other viral diseases of the cornea or conjunctiva; fungal or mycobacterial ocular infections.
| Precautions | Hypersensitivity reactions including Stevens-Johnson syndrome; use caution in patients with sulfonamide allergy; prolonged use may lead to overgrowth of nonsusceptible organisms including fungi. |
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| Fertility Effects | No studies on fertility; reproductive toxicity seen in animal studies at high doses. |