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) |
| Molecular Weight | 244.22 |
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 | Use only if clearly needed; no well-controlled studies in pregnant women. Potential risk of kernicterus in neonates if used near term. |
| 2nd trimester | Use only if clearly needed; no known teratogenic risk. |
| 3rd trimester | Avoid near term due to risk of kernicterus; sulfonamides displace bilirubin from albumin. |
Clinical note
Comprehensive clinical and safety monograph for SODIUM SULAMYD (SODIUM SULAMYD).
| Placental transfer | Crosses placenta; achieves fetal serum levels approximately 50-90% of maternal levels. |
| Breastfeeding | Excreted in breast milk in small amounts. Use with caution in nursing mothers, especially in infants with hyperbilirubinemia or G6PD deficiency. May cause hemolytic anemia in G6PD-deficient infants. |
■ 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 componentErythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis due to sulfonamidesInfants < 2 months of age (oral use)
| 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. |
| Food/Dietary | No clinically significant food interactions. Avoid taking with alcohol as may increase sulfonamide side effects. No dietary restrictions. |
Loading safety data…
| Lactation Rating |
| L3 (Moderately Safe). |
| 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. |
| 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. |
| Clinical Pearls | Sodium sulfacetamide (Sodium Sulamyd) is a sulfonamide antibiotic used topically for ophthalmic infections. It is bacteriostatic and effective against many gram-positive and gram-negative bacteria. Due to sulfonamide cross-reactivity, avoid in patients with sulfa allergies. May cause stinging upon instillation. Ineffective against fungi and viruses. Diluted forms (e.g., 10% solution) are used for conjunctivitis; higher concentrations (30% solution) for corneal ulcers. Must be used with caution in patients with G6PD deficiency due to risk of hemolysis. |
| Patient Advice | Wash hands before and after use. Do not touch tube tip to eye or any surface to avoid contamination. · Shake suspension well before using. · Remove contact lenses before application and wait at least 15 minutes before reinserting. · Apply as directed, typically 1-2 drops into affected eye(s) every 2-3 hours during waking hours for acute infections. · Complete full course even if symptoms improve to prevent recurrence. · Report any signs of allergy (rash, itching, swelling) or worsening symptoms to your doctor immediately. · May cause temporary blurred vision; avoid driving until vision clears. · Do not use if solution is discolored or contains particles. · Store at room temperature, away from moisture and heat; keep bottle tightly closed. |