Icid

Approved Indications:

• Bacterial Conjunctivitis: For the treatment of acute and chronic conjunctivitis caused by susceptible strains of bacteria.
• Blepharitis: Effective in managing superficial infections of the eyelids due to susceptible organisms.
• Trachoma (as adjunct): Used in combination therapy for trachoma with systemic antibiotics.
• Acne Vulgaris (Topical Form): Indicated in the treatment of inflammatory acne lesions, especially papulopustular acne.
• Seborrheic Dermatitis (Topical): Used topically to manage seborrheic dermatitis with secondary bacterial infection.
• Rosacea (Topical): As an adjunctive topical treatment for inflammatory rosacea.

Off-label/Clinically Accepted Uses:

• Prevention of Post-Surgical Eye Infections: Occasionally used prophylactically after eye surgery when antibiotic prophylaxis is required.
• Superficial Skin Infections: In mild cases, used topically on localized skin infections caused by sensitive bacteria.

Ophthalmic Use (Eye Drops 10% Solution):

• Adults & Children (≥2 years): Instill 1–2 drops into the affected eye(s) every 2 to 3 hours initially, then reduce frequency as the condition improves. Continue for 5–10 days or as directed.
• Administration: For topical ocular use only. Avoid contamination of dropper.

Topical Dermatological Use (10% Lotion or Wash):

• Acne, Rosacea, Seborrheic Dermatitis: Apply a thin film to affected area 1 to 3 times daily after washing and drying skin.
• Duration: Use for several weeks or as directed depending on response.
• Pediatric Use: Safety not established below 12 years for topical acne/rosacea formulations.

Renal/Hepatic Impairment:

• No specific dose adjustments; however, caution advised in severe renal dysfunction due to potential systemic absorption with topical overuse.

Sulfacetamide sodium is a sulfonamide antibacterial that competitively inhibits bacterial dihydropteroate synthase. This enzyme is crucial for synthesizing dihydrofolic acid, a precursor of folic acid needed for bacterial growth and replication. By mimicking para-aminobenzoic acid (PABA), Sulfacetamide prevents the conversion of PABA to dihydrofolic acid, thereby blocking bacterial DNA and protein synthesis. This results in a bacteriostatic effect, limiting the proliferation of susceptible gram-positive and gram-negative bacteria in infected tissues.

• Absorption: Topically administered Sulfacetamide Sodium may be systemically absorbed, especially when applied over broken skin or mucosa. Ophthalmic formulations have minimal systemic absorption.
• Bioavailability: Limited systemic availability via topical or ophthalmic use.
• Distribution: Localized to the site of application; negligible plasma protein binding when applied topically.
• Metabolism: Systemically absorbed portion is metabolized in the liver.
• Half-Life: Not clinically relevant for topical/ocular formulations due to minimal systemic exposure.
• Excretion: Primarily excreted via kidneys as unchanged drug and metabolites.

• Pregnancy:
• FDA Category C (for ophthalmic and topical use): Animal reproduction studies are lacking or inadequate. Use only if the potential benefit justifies the potential risk to the fetus.
• Topical use in limited areas is generally considered low risk during pregnancy.
• Lactation:
• Small amounts may be absorbed systemically and excreted in breast milk.
• Due to limited systemic exposure with topical or ophthalmic use, it is considered compatible with breastfeeding, but caution is advised, especially with prolonged or extensive application.

• Primary Class: Sulfonamide Antibacterial Agent
• Subclass: Topical/Ophthalmic Sulfonamide
• Generation: Older, first-generation sulfonamide derivative

• Known hypersensitivity to sulfonamides or any component of the formulation
• History of Stevens-Johnson Syndrome or other severe skin reactions to sulfonamides
• Advanced chronic kidney disease (in systemic use or extensive topical application)
• Use in neonates <2 months (risk of kernicterus with systemic absorption)

• Hypersensitivity Reactions: May cause severe allergic or dermatologic reactions (rash, itching, SJS).
• Avoid Systemic Absorption: Use minimal quantity on intact skin; avoid prolonged use on large surface areas.
• Cross-sensitivity: Potential cross-allergy with other sulfonamides.
• Ocular Use: Prolonged use may lead to overgrowth of non-susceptible organisms (e.g., fungi).
• Contact Lens Wearers: Should not wear lenses during active eye infections.
• Renal Impairment: Use cautiously due to potential systemic accumulation.

Common Adverse Effects (Topical & Ophthalmic):

• Ocular: Burning, stinging, redness, itching, blurred vision, eyelid swelling
• Dermatologic: Dryness, erythema, scaling, mild local irritation

Less Common/Serious:

• Hypersensitivity reactions: Rash, urticaria, pruritus
• Stevens-Johnson Syndrome (rare)
• Photosensitivity reactions
• Superinfection with prolonged use

Timing & Severity:

• Ocular side effects typically occur within minutes of instillation and are usually mild.
• Dermatologic irritation may emerge after days of use, often mild and self-limiting. Severe reactions are rare but require discontinuation.

• Topical/Ophthalmic: Low risk of systemic interactions due to minimal absorption.
• Systemic Sulfonamide Interactions (if absorbed):
• Warfarin: Potential enhancement of anticoagulant effect.
• Methotrexate: Competes for renal excretion—risk of toxicity.
• Oral Hypoglycemics (e.g., sulfonylureas): Risk of potentiation.
• Enzyme System: Not a significant CYP450 substrate or inhibitor in topical/ophthalmic form.

• No major changes in FDA or EMA guidelines in the last 3 years for Sulfacetamide sodium formulations.
• Recent clinical guidance reaffirms its limited but useful role in ocular infections and inflammatory acne.
• Topical use in rosacea has become more commonly accepted, especially when combined with sulfur.

• Ophthalmic Solution:
• Store at 15°C to 25°C (59°F to 77°F)
• Protect from light and freezing
• Do not use if the solution becomes discolored
• Topical Lotion or Cream:
• Store at 20°C to 25°C (68°F to 77°F)
• Protect from moisture and heat
• Keep cap tightly closed after use
• Do not refrigerate unless specified