SODIUM SULAMYD
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SODIUM SULAMYD (SODIUM SULAMYD).
Sodium sulfacetamide is a sulfonamide antibiotic that inhibits bacterial dihydropteroate synthase, blocking folate synthesis.
| Metabolism | Hepatic acetylation; excreted renally as unchanged drug and metabolites. |
| Excretion | Renal excretion of unchanged drug (approximately 70-100%) via glomerular filtration and tubular secretion; minor biliary/fecal elimination (<5%) |
| Half-life | 7-13 hours (prolonged in renal impairment; in anuria up to 22-50 hours) |
| Protein binding | 10-20% (principally to albumin) |
| Volume of Distribution | Systemic absorption negligible after ophthalmic administration; if absorbed, estimated 0.15-0.2 L/kg (distributes into extracellular fluid) |
| Bioavailability | Ophthalmic: approximately 0.5-5% (systemic absorption through nasolacrimal duct and conjunctival vessels); oral: not applicable |
| Onset of Action | Ophthalmic: within 15-30 minutes; systemic: not applicable (topical use only) |
| Duration of Action | Ophthalmic: 4-6 hours (corneal penetration achieves therapeutic concentrations for susceptible organisms) |
1-2 drops of 10% or 15% solution into affected eye(s) every 2-3 hours initially, tapered as infection resolves; ophthalmic ointment: apply 0.5-inch ribbon into conjunctival sac every 3-4 hours and at bedtime.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No specific GFR-based dose adjustments required for ophthalmic use; systemic absorption is minimal. |
| Liver impairment | No specific Child-Pugh based adjustments required for ophthalmic use. |
| Pediatric use | Infants and children: same ophthalmic dosing as adults; use 10% solution in neonates to avoid higher systemic exposure. |
| Geriatric use | No specific dose adjustment required; use with caution in elderly with dry eye syndrome or pre-existing corneal pathology. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SODIUM SULAMYD (SODIUM SULAMYD).
| Breastfeeding | Systemic absorption after ocular administration is minimal; sulfacetamide is excreted in breast milk in small amounts after oral administration. M/P ratio not established. Considered compatible with breastfeeding due to negligible systemic levels; however, monitor infant for rash or GI disturbance. |
| Teratogenic Risk | Ocular administration results in negligible systemic absorption; no well-controlled studies in pregnant women. Animal studies show no teratogenic effects. FDA Pregnancy Category C. Risk cannot be ruled out, but systemic exposure is minimal; use only if clearly needed. |
■ FDA Black Box Warning
Sulfonamides have been associated with severe adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis, agranulocytosis, and aplastic anemia.
| Serious Effects |
Hypersensitivity to sulfonamides or any component of the formulation.
| Precautions | May cause hypersensitivity reactions; discontinue if rash or serious adverse reaction occurs. Use with caution in patients with prior sulfonamide allergy. Prolonged use may result in overgrowth of nonsusceptible organisms. |
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| Fetal Monitoring | No specific monitoring required due to low systemic absorption. For extended use, monitor maternal renal function and signs of hypersensitivity. Fetal monitoring not indicated. |
| Fertility Effects | No reported effects on fertility. Systemic exposure is minimal with ocular use; reproductive animal studies are not available for ophthalmic formulations. |