ATC Class:S01AB
Sulfacetamide sodium is a sulfonamide antibacterial agent.101, 102, 103, 142
Bacterial Ophthalmic Infections
Sulfacetamide sodium ophthalmic ointment and ophthalmic solution are used for the 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 , or Klebsiella .101, 102, 103 When selecting a topical ophthalmic anti-infective, clinicians should consider that sulfacetamide sodium is ineffective for the treatment of infections caused by Neisseria , Serratia marcescens , and Pseudomonas aeruginosa and that staphylococci frequently are resistant to sulfonamides.101, 102, 103
Although mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment,135, 136, 137, 141 topical ophthalmic anti-infectives may shorten the time to resolution and reduce severity and risk of complications.135, 136, 137, 141 Treatment of acute bacterial conjunctivitis generally is empiric and use of a broad-spectrum topical ophthalmic antibacterial usually is recommended;135, 136, 141 however, indiscriminate use of topical anti-infectives should be avoided.135, 141 In vitro staining and/or cultures of conjunctival material may be indicated in the management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.135, 136, 141
Chlamydial Ophthalmic Infections
Sulfacetamide sodium ophthalmic solution has been used topically as an adjunct to oral sulfonamide therapy for the treatment of conjunctivitis secondary to trachoma caused by Chlamydia trachomatis .101, 103
Systemic anti-infective therapy (usually oral azithromycin) is recommended for the treatment of ocular trachoma.136, 292 In addition, systemic anti-infective therapy (e.g., oral azithromycin, doxycycline, or erythromycin) is necessary for the treatment of chlamydial conjunctivitis, including chlamydial ophthalmia neonatorum.135, 136, 292 Data to support use of topical anti-infectives in conjunction with systemic therapy for treatment of chlamydial conjunctivitis are not available.135, 136
Topical ophthalmic preparations containing sulfacetamide sodium in fixed combination with a corticosteroid (i.e., prednisolone acetate or prednisolone sodium phosphate) are used for the treatment of corticosteroid-responsive ocular conditions when a corticosteroid is indicated and superficial bacterial ocular infection or risk of such infection exists.105, 106, 107
Ophthalmic corticosteroids may be indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation.105, 106, 107 Ophthalmic corticosteroids also may be indicated in the treatment of chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies.105, 106, 107 Topical corticosteroids are not effective in mustard gas keratitis and Sjögren's keratoconjunctivitis.106
Although the 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 the risk of superficial ocular infection is high or when there is an expectation that potentially dangerous numbers of bacteria will be present in the eye,105, 106, 107 experts state that such preparations should be avoided in patients with bacterial conjunctivitis because of the risk of potentiating the infection.136
Clinicians should consider that use of fixed-combination ophthalmic preparations containing an anti-infective and a corticosteroid may mask the clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; and/or increase intraocular pressure.105, 106, 107 (See Precautions Related to Use of Fixed Combinations Containing Corticosteroids under Cautions: Precautions and Contraindications.)
For systemic uses of sulfonamides, see Sulfonamides 8:12.20.
Sulfacetamide sodium is applied topically to the eye as a 10% ophthalmic ointment102 or 10% ophthalmic solution.101, 103
Sulfacetamide sodium also is commercially available in fixed combination with a corticosteroid (i.e., prednisolone acetate or prednisolone sodium phosphate) for topical application to the eye.105, 106, 107
Sulfacetamide sodium ophthalmic preparations and fixed-combination ophthalmic preparations containing sulfacetamide sodium and a corticosteroid are for topical ophthalmic use only ;101, 102, 103, 105, 106, 107 these preparations should not be injected into the eye.101, 102, 103, 105, 106, 107
Care should be taken to avoid contaminating the container tip with material from eye, eyelid, or any other source.101, 102, 103, 105, 106, 107
The fixed-combination ophthalmic suspension containing sulfacetamide sodium and prednisolone acetate should be shaken well prior to use.105
Dosage of sulfacetamide sodium is expressed in terms of the salt.101, 102, 103
Dosage of fixed-combination preparations containing sulfacetamide sodium and prednisolone acetate or prednisolone sodium phosphate are expressed in terms of the salts.105, 106, 107
Bacterial Ophthalmic Infections
For the topical treatment of bacterial conjunctivitis or other superficial ocular infections in adults and children 2 months of age and older, a ribbon of sulfacetamide sodium 10% ophthalmic ointment approximately 1.25 cm (½ inch) in length should be placed into the conjunctival sac of the affected eye(s) every 3-4 hours and at bedtime.102
If sulfacetamide sodium 10% ophthalmic solution is used for the topical treatment of bacterial conjunctivitis or other superficial ocular infections in adults and children 2 months of age and older, 1 or 2 drops of the ophthalmic solution should be instilled into the conjunctival sac of the affected eye(s) every 2-3 hours initially.101, 103
When improvement occurs, dosage should be tapered by decreasing the frequency of application until the drug is discontinued.101, 102, 103
The usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5-10 days;101, 102, 103, 135, 136, 141 some experts state that 5-7 days of such therapy usually is adequate for mild bacterial conjunctivitis.135
Chlamydial Ophthalmic Infections
If sulfacetamide sodium 10% ophthalmic solution is used as an adjunct to systemic anti-infective therapy in the treatment of trachoma (see Uses: Chlamydial Ophthalmic Infections), the manufacturers recommend that 2 drops of the ophthalmic solution be instilled into the conjunctival sac of the affected eye(s) every 2 hours.101, 103
When the fixed-combination ophthalmic ointment containing sulfacetamide sodium and prednisolone acetate (sulfacetamide sodium 10% and prednisolone acetate 0.2%) is used in adults and children 6 years of age and older, a ribbon of the ointment approximately 1.25 cm (½ inch) in length should be placed into the conjunctival sac of the affected eye(s) 3 or 4 times daily during the day and once or twice during the night.106
When the fixed-combination ophthalmic suspension containing sulfacetamide sodium and prednisolone acetate (sulfacetamide sodium 10% and prednisolone acetate 0.2%) is used in adults and children 6 years of age and older, 2 drops of the ophthalmic suspension should be instilled into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.105
When the fixed-combination ophthalmic solution containing sulfacetamide sodium and prednisolone sodium phosphate (sulfacetamide sodium 10% and prednisolone phosphate 0.23%) is used in adults and children 6 years of age and older, 2 drops of the ophthalmic solution may be instilled into the affected eye(s) every 4 hours.107
If there is no improvement after 2 days of treatment with the fixed-combination ophthalmic preparation, the patient should be reevaluated.105, 106, 107 When treating chronic conditions, dosage may be tapered gradually by decreasing the frequency of administration; however, the drug should not be discontinued prematurely.105, 106, 107
The most frequently reported adverse effects following topical application of sulfacetamide sodium ophthalmic preparations are local irritation, stinging, and burning.101, 102, 103 Nonspecific conjunctivitis, conjunctival hyperemia, and secondary infections have been reported less frequently.101, 102, 103
Bacterial and fungal corneal ulcers have developed during treatment with sulfonamide ophthalmic preparations.101, 102, 103
Severe reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, and aplastic anemia or other blood dyscrasias, have been reported rarely with sulfonamides; fatalities have occurred.101, 102, 103
Sensitization may recur when a sulfonamide is readministered, irrespective of the route of administration.101, 102, 103 Sensitivity reactions have been reported in individuals with no history of sulfonamide hypersensitivity.101, 102, 103 Cross-sensitivity may occur among the various sulfonamides.101, 102, 103
Precautions and Contraindications
Sulfacetamide sodium ophthalmic ointment and ophthalmic solution are contraindicated in patients hypersensitive to sulfonamides or any ingredient in the formulation.101, 102, 103
Fixed-combination ophthalmic preparations containing sulfacetamide sodium and a corticosteroid (i.e., prednisolone acetate or prednisolone sodium phosphate) are contraindicated in patients with known or suspected hypersensitivity to sulfacetamide sodium or other sulfonamides, prednisolone or other corticosteroids, or any ingredient in the formulation.105, 106, 107 In addition, these fixed-combination preparations are contraindicated in 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.105, 106, 107
Patients should be advised to immediately discontinue sulfacetamide sodium ophthalmic preparations, including fixed-combination ophthalmic preparations containing sulfacetamide sodium and a corticosteroid, at the first sign of hypersensitivity, rash, or other serious reaction.101, 102, 103, 105, 106, 107 Patients also should be advised to discontinue the ophthalmic preparation and contact a clinician if there is an increase in purulent discharge or aggravation of inflammation or pain.101, 102, 103
Prolonged use of topical sulfonamides may result in the overgrowth of nonsusceptible organisms, including fungi.101, 102, 103, 105, 106, 107 Bacterial resistance to sulfonamides may also develop.101, 102, 103
The manufacturers caution that p -aminobenzoic acid (PABA) present in purulent exudates may compete with sulfonamides and reduce effectiveness of topical ophthalmic preparations containing sulfacetamide sodium.101, 102, 103, 105, 106, 107
The manufacturers caution that ophthalmic ointments may retard corneal wound healing.102, 106
Precautions Related to Use of Fixed Combinations Containing Corticosteroids
When ophthalmic preparations containing sulfacetamide sodium in fixed combination with a corticosteroid (i.e., prednisolone acetate or prednisolone sodium phosphate) are used, the usual cautions, precautions, and contraindications associated with the corticosteroid also must be considered.105, 106, 107
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) should be made only after examining the patient with slit lamp microscopy and, when appropriate, fluorescein staining.105, 106, 107
Patients should be advised to discontinue the fixed-combination ophthalmic preparation and contact a clinician if inflammation or pain persists longer than 48 hours or becomes aggravated.105, 106, 107
Prolonged use of fixed-combination ophthalmic preparations containing a corticosteroid may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in ocular hypertension/glaucoma with damage to the optic nerve and defects in visual acuity and fields of vision.105, 106, 107 If an ophthalmic preparation containing a corticosteroid is used for 10 days or longer, intraocular pressure should be routinely monitored, even though this may be difficult in children and uncooperative patients.105, 106, 107 Such preparations should be used with caution in patients with glaucoma, and intraocular pressure should be checked frequently in such patients.105, 106, 107
Use of fixed-combination ophthalmic preparations containing a corticosteroid after cataract surgery may delay healing and increase the incidence of bleb formation.105, 106, 107
Perforation has occurred when topical ophthalmic corticosteroids were used in patients with diseases that cause thinning of the cornea or sclera.105, 106, 107
Acute anterior uveitis may occur in susceptible individuals, primarily blacks.105, 106, 107
Ophthalmic preparations containing a corticosteroid should be used with caution in patients with severe dry eye.105, 106
Prolonged use of fixed-combination ophthalmic preparations containing a corticosteroid may suppress host responses and increase the risk of secondary ocular infections.105, 106, 107 Use of such preparations in patients with acute purulent conditions of the eye may mask infection or enhance existing infection.105, 106, 107
Use of ophthalmic preparations containing a corticosteroid may prolong the course and exacerbate severity of many viral infections of the eye (including herpes simplex).105, 106, 107 Such preparations should be used with great caution in patients with herpes simplex.105, 106, 107
The possibility of fungal infections of the cornea should be considered after prolonged use of ophthalmic preparations containing a corticosteroid.105, 106, 107 Fungal cultures should be taken when appropriate.105, 106, 107
Eyelid cultures and tests to determine susceptibility to sulfacetamide may be indicated if signs and symptoms persist or recur after treatment with a fixed-combination preparation containing sulfacetamide sodium and a corticosteroid.105, 106, 107
Safety and efficacy of sulfacetamide sodium ophthalmic ointment and ophthalmic solution have not been established in infants younger than 2 months of age.101, 102, 103
Safety and efficacy of fixed-combination ophthalmic preparations containing sulfacetamide sodium and a corticosteroid (i.e., prednisolone acetate or prednisolone sodium phosphate) have not been established in children younger than 6 years of age.105, 106, 107
Mutagenicity and Carcinogenicity
Studies have not been conducted in animals or humans to evaluate the mutagenic or carcinogenic potential of sulfacetamide sodium ophthalmic preparations.101, 102, 103 Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term oral administration of sulfonamides has resulted in thyroid malignancies in these animals.101, 102, 103
Pregnancy, Fertility, and Lactation
Animal reproduction studies have not been performed using sulfacetamide ophthalmic preparations.101, 102, 103, 105
There are no adequate and well-controlled studies using sulfonamide ophthalmic preparations in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to pregnant women.101, 102, 103 Use of oral sulfonamides in pregnant women at term may result in kernicterus in neonates.101, 102, 103
Sulfacetamide sodium ophthalmic preparations, including fixed-combination preparations containing sulfacetamide sodium and a corticosteroid, should be used during pregnancy only if potential benefits justify potential risks to the fetus.101, 102, 103, 105, 106, 107
Systemically administered sulfonamides are capable of producing kernicterus in breast-fed infants.101, 102, 103
Because of the potential for development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the woman.101, 102, 103, 105, 106, 107
Sulfacetamide sodium is incompatible with preparations containing silver.101, 102, 103, 105, 106, 107 (See Chemistry and Stability: Stability)
Because the antibacterial activity of sulfonamides involves competitive inhibition of p -aminobenzoic acid (PABA), antagonism may occur between sulfonamides and local anesthetics that are PABA derivatives.105, 106, 107
Sulfonamides are usually bacteriostatic in action.101, 102, 103, 142 Sulfonamides interfere with utilization of p -aminobenzoic or p -aminobenzoic glutamic acids by bacteria, thus inhibiting the biosynthesis of folic acid which is essential for the growth of susceptible organisms. Only organisms that synthesize their own folic acid are inhibited by sulfonamides; animal cells and bacteria that are capable of utilizing folic acid precursors or preformed folic acid are not affected by these drugs. The antibacterial activity of the sulfonamides is decreased in the presence of blood or purulent exudates which contain p -aminobenzoic acid.
Sulfonamides have a broad spectrum of activity and are active against both gram-positive and gram-negative aerobic bacteria; however, the increasing incidence of resistance in organisms formerly susceptible to the sulfonamides has decreased the range of clinical usefulness of these anti-infective agents.142
Sulfacetamide sodium is active against some gram-positive bacteria involved in ophthalmic infections, including Staphylococcus aureus , Streptococcus pneumoniae , and viridans streptococci; however, many staphylococci are resistant to sulfonamides.101, 102, 103
Sulfacetamide sodium also is active against some gram-negative bacteria involved in ophthalmic infections, including Haemophilus influenzae , Enterobacter , Escherichia coli , and Klebsiella .101, 102, 103
Resistance may develop in vitro and in vivo in organisms initially susceptible to sulfonamides. Bacteria resistant to sulfonamides may have altered dihydropteroate synthetase (the enzyme inhibited by sulfonamides), altered folate biosynthesis, increased production of p -aminobenzoic acid, or decreased uptake or enhanced metabolism of sulfonamides.142 Resistance may also result from chromosomal alterations or may be plasmid-mediated and transferable.142 High-level resistance to sulfonamides is usually permanent and irreversible.142
Organisms resistant to one sulfonamide are usually cross-resistant to other sulfonamides.142
Following topical application of sulfacetamide sodium to the eye, the drug penetrates into ocular tissues and fluids and may be absorbed systemically in patients with inflamed conjunctiva.142
Systemically administered sulfonamides cross the placenta and are distributed into human milk in low concentrations.140
Sulfonamides are synthetic derivatives of p -aminobenzenesulfonamide (sulfanilamide). Sulfacetamide sodium is suitable for ophthalmic use because it is freely soluble in water and less alkaline, and therefore less irritating to the conjunctiva, than are other sulfonamides.
Sulfacetamide sodium occurs as a white, odorless, crystalline powder and is freely soluble in water and sparingly soluble in alcohol.102
Sulfacetamide sodium is commercially available for topical ophthalmic use as a 10% ophthalmic ointment102 or 10% ophthalmic solution.101, 103 Sulfacetamide sodium also is commercially available for topical ophthalmic use in fixed combination with a corticosteroid (i.e., prednisolone acetate or prednisolone sodium phosphate).105, 106, 107
Sulfacetamide sodium 10% ophthalmic ointment contains sulfacetamide sodium in a white petrolatum and mineral oil ointment base.102
Sulfacetamide sodium 10% ophthalmic solution has a pH of 6.8-8 and contains benzalkonium chloride as a preservative or contains methylparaben and propylparaben as preservatives.101, 103
The fixed combination of sulfacetamide sodium and prednisolone acetate (sulfacetamide sodium 10% and prednisolone acetate 0.2%) is commercially available as an ophthalmic ointment105 and an ophthalmic suspension.106 The fixed-combination ophthalmic ointment contains sulfacetamide sodium and prednisolone acetate in an ointment base of mineral oil, petrolatum and lanolin alcohol, and white petrolatum and contains phenylmercuric acetate as a preservative.106 The fixed-combination ophthalmic suspension contains benzalkonium chloride as a preservative and has a pH of 6.6-7.2.105
The fixed combination of sulfacetamide sodium and prednisolone sodium phosphate (sulfacetamide sodium 10% and prednisolone phosphate 0.23%) is commercially available as an ophthalmic solution that has a pH of 6.5-7.5 and contains thimerosal as a preservative.107
Sulfacetamide sodium 10% ophthalmic ointment should be stored at 20-25°C.102
Sulfacetamide sodium 10% ophthalmic solution should be stored at 8-25°C101, 103 and protected from light.101
The fixed-combination ophthalmic ointment containing sulfacetamide sodium and prednisolone acetate (sulfacetamide sodium 10% and prednisolone acetate 0.2%) should be stored at 15-25°C.106
The fixed-combination ophthalmic suspension containing sulfacetamide sodium and prednisolone acetate (sulfacetamide sodium 10% and prednisolone acetate 0.2%) should be stored in an upright position at 8-24°C and protected from light and freezing.105
The fixed-combination ophthalmic solution containing sulfacetamide sodium and prednisolone sodium phosphate (sulfacetamide sodium 10% and prednisolone phosphate 0.23% ) should be stored in a tightly closed container at 15-25°C and protected from light and freezing.107
Sulfonamide solutions darken on prolonged standing and exposure to heat and light.101, 103, 105, 107 Sulfacetamide preparations should not be used if they have darkened;101, 103, 105, 107 yellow discoloration does not affect activity.105
Sulfacetamide sodium is incompatible with preparations containing silver.101, 102, 103, 105, 106, 107 Precipitation may occur if zinc sulfate is added to sulfacetamide sodium solutions, depending on the concentration of each drug.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | 10%* | Sulfacetamide Sodium Ophthalmic Ointment | |
Solution | 10%* | Bleph® 10 | Allergan | |
Sulfacetamide Sodium Ophthalmic Solution |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | 10% Sulfacetamide Sodium and Prednisolone Acetate 0.2% | Blephamide® | Allergan |
Suspension | 10% Sulfacetamide Sodium and Prednisolone Acetate 0.2% | Blephamide® | Allergan |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Solution | 10% with 0.25% Prednisolone Sodium Phosphate (0.23% prednisolone phosphate)* | Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions July 30, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
Only references cited for selected revisions after 1984 are available electronically.
101. Allergan. Bleph®-10 (sulfacetamide sodium) ophthalmic solution, USP 10% prescribing information. Irvine, CA; 2017 Sep.
102. Paddock Laboratories. Sulfacetamide sodium ophthalmic ointment, USP 10% prescribing information. Minneapolis, MN; 2013 Sept.
103. Bausch & Lomb. Sulfacetamide sodium ophthalmic solution, USP 10%. prescribing information. Bridgewater, NJ; 2016 Jun.
105. Allergan. Blephamide® (sulfacetamide sodium and prednisolone acetate) suspension, USP 10%/0.2% prescribing information. Irvine, CA; 2017 Jul.
106. Allergan. Blephamide® (sulfacetamide sodium and prednisolone acetate) ophthalmic ointment, USP 10%/0.2% prescribing information. Irvine, CA; 2014 Mar.
107. Bausch & Lomb. Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution 10%/0.23% (prednisolone phosphate) (sterile) prescribing information. Bridgewater, NJ; 2016 Jul.
135. American Academy of Ophthalmology. Preferred practice pattern (PPP) guidelines: conjunctivitis PPP - 2013. From American Academy of Ophthalmology website. Accessed 20 Dec 2017. [Web]
136. Azari AA, Barney NP. Conjunctivitis: a systematic review of diagnosis and treatment. JAMA . 2013; 310:1721-9. [PubMed 24150468]
137. Sheikh A, Hurwitz B, van Schayck CP et al. Antibiotics versus placebo for acute bacterial conjunctivitis. Cochrane Database Syst Rev . 2012; :CD001211. [PubMed 22972049]
140. Briggs CC, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation, 7th ed. Philadelphia, PA: Lippincott, Williams, & Wilkins; 2005: 1508-10.
141. Barnes SD, Kumar NM, Pavin-Langston D et al. Microbial Conjunctivitis. In: Bennett JE, Dolin R, and Blaser MJ, eds. Mandell, Douglas, and Bennett's principles and practices of infectious diseases. 8th ed. Philadelphia, PA: Elsevier Saunders; 2015:1392-1401.
142. Sweetman S, ed. Martindale: the complete drug reference. London: Pharmaceutical Press. Electronic version. Accessed 2018 Jan 11.
292. Committee on Infectious Diseases, American Academy of Pediatrics. Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015.