Introduction

Antibacterial; sulfonamide.

Uses for Sulfacetamide

Bacterial Ophthalmic Infections

Topical treatment of bacterial conjunctivitis and other superficial infections of the eye caused by susceptible Staphylococcus aureus, Streptococcus pneumoniae, viridans streptococci, Haemophilus influenzae, Enterobacter, Escherichia coli, and Klebsiella.

Ineffective for topical treatment of ophthalmic infections caused by Neisseria, Serratia marcescens, or Pseudomonas aeruginosa. Consider that staphylococci frequently are resistant to sulfonamides.

Mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment. Although topical ophthalmic anti-infectives may shorten time to resolution and reduce severity and risk of complications, avoid indiscriminate use of topical anti-infectives. Treatment of acute bacterial conjunctivitis generally is empiric; use of a broad-spectrum topical ophthalmic antibacterial usually recommended. In vitro staining and/or cultures of conjunctival material may be indicated in management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.

Chlamydial Ophthalmic Infections

Has been used topically as an adjunct to systemic sulfonamide therapy for treatment of conjunctivitis secondary to trachoma caused by Chlamydia trachomatis; however, systemic anti-infectives (usually oral azithromycin) recommended for treatment of ocular trachoma.

Systemic anti-infectives (e.g., oral azithromycin, doxycycline, or erythromycin) necessary for treatment of chlamydial conjunctivitis, including chlamydial ophthalmia neonatorum. Data to support use of topical anti-infectives in conjunction with systemic therapy for treatment of chlamydial conjunctivitis not available.

Ocular Inflammation

Fixed-combination ophthalmic preparations containing sulfacetamide and a corticosteroid (i.e., prednisolone): Topical treatment of corticosteroid-responsive ocular conditions when a corticosteroid indicated and superficial bacterial ocular infection or risk of such infection exists.

Although manufacturers state that use of a fixed-combination ophthalmic preparation containing an anti-infective and a corticosteroid may be indicated in ocular inflammatory conditions when risk of superficial ocular infection is high or when potentially dangerous numbers of bacteria are expected to be present in the eye, experts state avoid use of such preparations in patients with bacterial conjunctivitis because of risk of potentiating the infection.

Consider that use of fixed-combination ophthalmic preparations containing an anti-infective and a corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; and/or increase IOP. (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Sulfacetamide Dosage and Administration

Administration

Ophthalmic Administration

Apply sulfacetamide ophthalmic ointment or solution topically to the eye.

Apply fixed-combination ophthalmic preparations containing sulfacetamide and a corticosteroid (i.e., prednisolone) topically to the eye.

For topical ophthalmic use only; do not inject into the eye.

Avoid contaminating container tip with material from eye, eyelid, or other source.

Shake fixed-combination ophthalmic suspension well prior to use.

Dosage

Available as sulfacetamide sodium alone or in fixed combination with prednisolone acetate or prednisolone sodium phosphate; dosage expressed in terms of the salts.

Pediatric Patients

Bacterial Ophthalmic Infections

Ophthalmic

Sulfacetamide sodium 10% (ophthalmic ointment) in children ≥2 months of age: Apply 1.25 cm (½ inch) ribbon into conjunctival sac of affected eye(s) every 3 or 4 hours and at bedtime.

Sulfacetamide sodium 10% (ophthalmic solution) in children ≥2 months of age: Instill 1 or 2 drops into conjunctival sac of affected eye(s) every 2–3 hours initially.

When improvement occurs, taper dosage by reducing frequency until drug discontinued.

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days; some experts state 5–7 days usually adequate for mild bacterial conjunctivitis.

Chlamydial Ophthalmic Infections

Ophthalmic

Sulfacetamide sodium 10% (ophthalmic solution) in children ≥2 months of age with trachoma: Instill 2 drops into conjunctival sac of affected eye(s) every 2 hours in conjunction with systemic anti-infectives. (See Chlamydial Ophthalmic Infections under Uses.)

Ocular Inflammation

Ophthalmic

Sulfacetamide sodium 10% and prednisolone acetate 0.2% (ophthalmic ointment) in children ≥6 years of age: Apply 1.25 cm (½ inch) ribbon into conjunctival sac of affected eye(s) 3 or 4 times daily during the day and once or twice during the night.

Sulfacetamide sodium 10% and prednisolone acetate 0.2% (ophthalmic suspension) in children ≥6 years of age: Instill 2 drops into conjunctival sac of affected eye(s) every 4 hours during the day and at bedtime.

Sulfacetamide sodium 10% and prednisolone phosphate 0.23% (ophthalmic solution) in children ≥6 years of age: Instill 2 drops into affected eye(s) every 4 hours.

If no improvement after 2 days, reevaluate patient.

When treating chronic conditions, gradually taper dosage by decreasing frequency. Do not discontinue prematurely.

Adults

Bacterial Ophthalmic Infections

Ophthalmic

Sulfacetamide sodium 10% (ophthalmic ointment): Apply 1.25 cm (½ inch) ribbon into conjunctival sac of affected eye(s) every 3 or 4 hours and at bedtime.

Sulfacetamide sodium 10% (ophthalmic solution): Instill 1 or 2 drops of solution into conjunctival sac of affected eye(s) every 2–3 hours initially.

When improvement occurs, taper dosage by reducing frequency until drug discontinued.

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days; 5–7 days usually adequate for mild bacterial conjunctivitis.

Chlamydial Ophthalmic Infections

Trachoma

Sulfacetamide sodium 10% (ophthalmic solution): Instill 2 drops into conjunctival sac of affected eye(s) every 2 hours in conjunction with systemic anti-infectives. (See Chlamydial Ophthalmic Infections under Uses.)

Ocular Inflammation

Ophthalmic

Sulfacetamide sodium 10% and prednisolone acetate 0.2% (ophthalmic ointment): Apply 1.25 cm (½ inch) ribbon into conjunctival sac of affected eye(s) 3 or 4 times daily during the day and once or twice during the night.

Sulfacetamide sodium 10% and prednisolone acetate 0.2% (ophthalmic suspension): Instill 2 drops into conjunctival sac of affected eye(s) every 4 hours during the day and at bedtime.

Sulfacetamide sodium 10% and prednisolone phosphate 0.23% (ophthalmic solution): Instill 2 drops into affected eye(s) every 4 hours.

If no improvement after 2 days, reevaluate patient.

When treating chronic conditions, gradually taper dosage by decreasing frequency. Do not discontinue prematurely.

Special Populations

No special population dosage recommendations.

Contraindications

• Sulfacetamide ophthalmic ointment or solution: Hypersensitivity to sulfonamides or any ingredient in the formulation.

• Fixed-combination ophthalmic preparations containing sulfacetamide and a corticosteroid (i.e., prednisolone): Known or suspected hypersensitivity to sulfacetamide or other sulfonamides, prednisolone or other corticosteroids, or any ingredient in the formulation. Also, patients with viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; mycobacterial infections of the eye; or fungal diseases of ocular structures.

Warnings/Precautions

Warnings

Severe Reactions

Severe reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, and aplastic anemia or other blood dyscrasias, reported rarely with sulfonamides; fatalities have occurred.

Sensitivity Reactions

Hypersensitivity Reactions

Severe hypersensitivity reactions reported with sulfonamides. (See Severe Reactions under Cautions.)

Sensitization may recur when a sulfonamide is readministered, irrespective of route of administration.

Sensitivity reactions reported in individuals with no history of sulfonamide hypersensitivity.

Cross-sensitivity may occur among the various sulfonamides.

Immediately discontinue at first sign of hypersensitivity, rash, or other serious reaction.

Other Warnings and Precautions

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.

Bacterial resistance to sulfonamides may develop.

Precautions Related to Ophthalmic Administration

Manufacturers caution that p-aminobenzoic acid (PABA) present in purulent exudates may compete with sulfonamides and reduce effectiveness of topical ophthalmic preparations containing sulfacetamide.

Manufacturers caution that ophthalmic ointments may retard corneal wound healing.

Use of Fixed Combinations Containing Corticosteroids

When ophthalmic preparations containing sulfacetamide in fixed combination with a corticosteroid (i.e., prednisolone) used, consider cautions, precautions, and contraindications associated with the EENT corticosteroid.

Provide initial prescriptions for fixed-combination ophthalmic preparations containing a corticosteroid or renewal prescriptions (beyond 8 g of ophthalmic ointment or beyond 20 mL of ophthalmic solution or suspension) only after examining patient with slit lamp microscopy and, when appropriate, fluorescein staining.

Prolonged use of fixed-combination ophthalmic preparations containing a corticosteroid may result in posterior subcapsular cataract formation and may increase IOP in susceptible individuals, resulting in ocular hypertension/glaucoma with damage to the optic nerve and defects in visual acuity and fields of vision. If such preparations used for ≥10 days, routinely monitor IOP, even though this may be difficult in children and uncooperative patients. Use fixed combinations containing a corticosteroid with caution in patients with glaucoma; check IOP frequently in such patients.

Use of fixed-combination ophthalmic preparations containing a corticosteroid after cataract surgery may delay healing and increase incidence of bleb formation.

Perforation reported when topical ophthalmic corticosteroids were used in patients with diseases that cause corneal or scleral thinning.

Acute anterior uveitis may occur in susceptible individuals, primarily blacks.

Use ophthalmic preparations containing a corticosteroid with caution in patients with severe dry eye.

Prolonged use of fixed-combination ophthalmic preparations containing a corticosteroid may suppress host responses and increase risk of secondary ocular infections. Use in patients with acute purulent conditions of the eye may mask infection or enhance existing infection.

May prolong course and exacerbate severity of many viral infections of the eye (including herpes simplex). Use with great caution in patients with herpes simplex.

Consider possibility of fungal infections of the cornea after prolonged use of ophthalmic preparations containing a corticosteroid. Perform fungal cultures when appropriate.

If signs and symptoms persist or recur after treatment with a fixed-combination preparation containing sulfacetamide and a corticosteroid, eyelid cultures and tests to determine sulfacetamide susceptibility may be indicated.

Specific Populations

Pregnancy

No adequate and well-controlled studies using ophthalmic preparations containing sulfacetamide in pregnant women. Use of oral sulfonamides in pregnant women at term may result in kernicterus in neonates.

Use sulfacetamide ophthalmic preparations, including fixed-combination preparations containing sulfacetamide and a corticosteroid, during pregnancy only if potential benefits justify potential risks to fetus.

Lactation

Systemically absorbed sulfonamides can cause kernicterus in breast-fed infants.

Discontinue nursing or the drug, taking into account importance of the drug to the woman.

Pediatric Use

Sulfacetamide ophthalmic ointment and solution: Safety and efficacy not established in infants <2 months of age.

Fixed-combination ophthalmic preparations containing sulfacetamide and a corticosteroid (i.e., prednisolone): Safety and efficacy not established in children <6 years of age.

Common Adverse Effects

Local irritation, transient stinging or burning.

Administration

Ophthalmic Administration

Apply sulfacetamide ophthalmic ointment or solution topically to the eye.

Apply fixed-combination ophthalmic preparations containing sulfacetamide and a corticosteroid (i.e., prednisolone) topically to the eye.

For topical ophthalmic use only; do not inject into the eye.

Avoid contaminating container tip with material from eye, eyelid, or other source.

Shake fixed-combination ophthalmic suspension well prior to use.

Dosage

Available as sulfacetamide sodium alone or in fixed combination with prednisolone acetate or prednisolone sodium phosphate; dosage expressed in terms of the salts.

Pediatric Patients

Bacterial Ophthalmic Infections

Ophthalmic

Sulfacetamide sodium 10% (ophthalmic ointment) in children ≥2 months of age: Apply 1.25 cm (½ inch) ribbon into conjunctival sac of affected eye(s) every 3 or 4 hours and at bedtime.

Sulfacetamide sodium 10% (ophthalmic solution) in children ≥2 months of age: Instill 1 or 2 drops into conjunctival sac of affected eye(s) every 2–3 hours initially.

When improvement occurs, taper dosage by reducing frequency until drug discontinued.

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days; some experts state 5–7 days usually adequate for mild bacterial conjunctivitis.

Chlamydial Ophthalmic Infections

Ophthalmic

Sulfacetamide sodium 10% (ophthalmic solution) in children ≥2 months of age with trachoma: Instill 2 drops into conjunctival sac of affected eye(s) every 2 hours in conjunction with systemic anti-infectives. (See Chlamydial Ophthalmic Infections under Uses.)

Ocular Inflammation

Ophthalmic

Sulfacetamide sodium 10% and prednisolone acetate 0.2% (ophthalmic ointment) in children ≥6 years of age: Apply 1.25 cm (½ inch) ribbon into conjunctival sac of affected eye(s) 3 or 4 times daily during the day and once or twice during the night.

Sulfacetamide sodium 10% and prednisolone acetate 0.2% (ophthalmic suspension) in children ≥6 years of age: Instill 2 drops into conjunctival sac of affected eye(s) every 4 hours during the day and at bedtime.

Sulfacetamide sodium 10% and prednisolone phosphate 0.23% (ophthalmic solution) in children ≥6 years of age: Instill 2 drops into affected eye(s) every 4 hours.

If no improvement after 2 days, reevaluate patient.

When treating chronic conditions, gradually taper dosage by decreasing frequency. Do not discontinue prematurely.

Adults

Bacterial Ophthalmic Infections

Ophthalmic

Sulfacetamide sodium 10% (ophthalmic ointment): Apply 1.25 cm (½ inch) ribbon into conjunctival sac of affected eye(s) every 3 or 4 hours and at bedtime.

Sulfacetamide sodium 10% (ophthalmic solution): Instill 1 or 2 drops of solution into conjunctival sac of affected eye(s) every 2–3 hours initially.

When improvement occurs, taper dosage by reducing frequency until drug discontinued.

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days; 5–7 days usually adequate for mild bacterial conjunctivitis.

Chlamydial Ophthalmic Infections

Trachoma

Sulfacetamide sodium 10% (ophthalmic solution): Instill 2 drops into conjunctival sac of affected eye(s) every 2 hours in conjunction with systemic anti-infectives. (See Chlamydial Ophthalmic Infections under Uses.)

Ocular Inflammation

Ophthalmic

Sulfacetamide sodium 10% and prednisolone acetate 0.2% (ophthalmic ointment): Apply 1.25 cm (½ inch) ribbon into conjunctival sac of affected eye(s) 3 or 4 times daily during the day and once or twice during the night.

Sulfacetamide sodium 10% and prednisolone acetate 0.2% (ophthalmic suspension): Instill 2 drops into conjunctival sac of affected eye(s) every 4 hours during the day and at bedtime.

Sulfacetamide sodium 10% and prednisolone phosphate 0.23% (ophthalmic solution): Instill 2 drops into affected eye(s) every 4 hours.

If no improvement after 2 days, reevaluate patient.

When treating chronic conditions, gradually taper dosage by decreasing frequency. Do not discontinue prematurely.

Special Populations

No special population dosage recommendations.

Specific Drugs