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Bleph 10

Generic Name: Sulfacetamide
Class: Antibacterials
ATC Class: S01AB
VA Class: OP210
CAS Number: 6209-17-2
Brands: Bleph 10

Sulfacetamide is also contained as an ingredient in the following combinations:
Sulfacetamide Sodium and Prednisolone Acetate

Medically reviewed on Jul 30, 2018

Introduction

Antibacterial; sulfonamide.101 102 103 142

Uses for Bleph 10

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.101 102 103

Ineffective for topical treatment of ophthalmic infections caused by Neisseria, Serratia marcescens, or Pseudomonas aeruginosa.101 102 103 Consider that staphylococci frequently are resistant to sulfonamides.101 102 103

Mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment.135 136 137 141 Although topical ophthalmic anti-infectives may shorten time to resolution and reduce severity and risk of complications,135 136 137 141 avoid indiscriminate use of topical anti-infectives.135 141 Treatment of acute bacterial conjunctivitis generally is empiric;135 136 141 use of a broad-spectrum topical ophthalmic antibacterial usually recommended.135 136 141 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.135 136 141

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;101 103 however, systemic anti-infectives (usually oral azithromycin) recommended for treatment of ocular trachoma.136 292

Systemic anti-infectives (e.g., oral azithromycin, doxycycline, or erythromycin) necessary for 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 not available.135 136

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.105 106 107

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,105 106 107 experts state avoid use of such preparations in patients with bacterial conjunctivitis because of risk of potentiating the infection.136

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.105 106 107 (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Bleph 10 Dosage and Administration

Administration

Ophthalmic Administration

Apply sulfacetamide ophthalmic ointment or solution topically to the eye.101 102 103

Apply fixed-combination ophthalmic preparations containing sulfacetamide and a corticosteroid (i.e., prednisolone) topically to the eye.105 106 107

For topical ophthalmic use only; do not inject into the eye.101 102 103 105 106 107

Avoid contaminating container tip with material from eye, eyelid, or other source.101 102 103 105 106 107

Shake fixed-combination ophthalmic suspension well prior to use.105

Dosage

Available as sulfacetamide sodium alone101 102 103 or in fixed combination with prednisolone acetate or prednisolone sodium phosphate;105 106 107 dosage expressed in terms of the salts.101 102 103 105 106 107

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.102

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.101 103

When improvement occurs, taper dosage by reducing frequency until drug discontinued.101 102 103

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days;101 102 103 135 136 141 some experts state 5–7 days usually adequate for mild bacterial conjunctivitis.135

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.101 103 (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.106

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.105

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.107

If no improvement after 2 days, reevaluate patient.105 106 107

When treating chronic conditions, gradually taper dosage by decreasing frequency.105 106 107 Do not discontinue prematurely.105 106 107

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.102

Sulfacetamide sodium 10% (ophthalmic solution): Instill 1 or 2 drops of solution into conjunctival sac of affected eye(s) every 2–3 hours initially.101 103

When improvement occurs, taper dosage by reducing frequency until drug discontinued.101 102 103

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days;101 102 103 135 136 141 5–7 days usually adequate for mild bacterial conjunctivitis.135

Chlamydial Ophthalmic Infections
Trachoma
Ophthalmic

Sulfacetamide sodium 10% (ophthalmic solution): Instill 2 drops into conjunctival sac of affected eye(s) every 2 hours in conjunction with systemic anti-infectives.101 103 (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.106

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.105

Sulfacetamide sodium 10% and prednisolone phosphate 0.23% (ophthalmic solution): Instill 2 drops into affected eye(s) every 4 hours.107

If no improvement after 2 days, reevaluate patient.105 106 107

When treating chronic conditions, gradually taper dosage by decreasing frequency.105 106 107 Do not discontinue prematurely.105 106 107

Special Populations

No special population dosage recommendations.101 102 103 105 106 107

Cautions for Bleph 10

Contraindications

  • Sulfacetamide ophthalmic ointment or solution: Hypersensitivity to sulfonamides or any ingredient in the formulation.101 102 103

  • 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.105 106 107 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.105 106 107

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.101 102 103

Sensitivity Reactions

Hypersensitivity Reactions

Severe hypersensitivity reactions reported with sulfonamides.101 102 103 (See Severe Reactions under Cautions.)

Sensitization may recur when a sulfonamide is readministered, irrespective of route of administration.101 102 103

Sensitivity reactions reported in individuals with no history of sulfonamide hypersensitivity.101 102 103

Cross-sensitivity may occur among the various sulfonamides.101 102 103

Immediately discontinue at first sign of hypersensitivity, rash, or other serious reaction.101 102 103 105 106 107

Other Warnings and Precautions

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.101 102 103 105 106 107

Bacterial resistance to sulfonamides may develop.101 102 103

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.101 102 103 105 106 107

Manufacturers caution that ophthalmic ointments may retard corneal wound healing.102 106

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.105 106 107

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.105 106 107

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.105 106 107 If such preparations used for ≥10 days, routinely monitor IOP, even though this may be difficult in children and uncooperative patients.105 106 107 Use fixed combinations containing a corticosteroid with caution in patients with glaucoma;105 106 107 check IOP frequently in such patients.105 106 107

Use of fixed-combination ophthalmic preparations containing a corticosteroid after cataract surgery may delay healing and increase incidence of bleb formation.105 106 107

Perforation reported when topical ophthalmic corticosteroids were used in patients with diseases that cause corneal or scleral thinning.105 106 107

Acute anterior uveitis may occur in susceptible individuals, primarily blacks.105 106 107

Use ophthalmic preparations containing a corticosteroid 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 risk of secondary ocular infections.105 106 107 Use in patients with acute purulent conditions of the eye may mask infection or enhance existing infection.105 106 107

May prolong course and exacerbate severity of many viral infections of the eye (including herpes simplex).105 106 107 Use with great caution in patients with herpes simplex.105 106 107

Consider possibility of fungal infections of the cornea after prolonged use of ophthalmic preparations containing a corticosteroid.105 106 107 Perform fungal cultures when appropriate.105 106 107

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.105 106 107

Specific Populations

Pregnancy

No adequate and well-controlled studies using ophthalmic preparations containing sulfacetamide in pregnant women.101 102 103 Use of oral sulfonamides in pregnant women at term may result in kernicterus in neonates.101 102 103

Use sulfacetamide ophthalmic preparations, including fixed-combination preparations containing sulfacetamide and a corticosteroid, during pregnancy only if potential benefits justify potential risks to fetus.101 102 103 105 106 107

Lactation

Systemically absorbed sulfonamides can cause kernicterus in breast-fed infants.101 102 103

Discontinue nursing or the drug, taking into account importance of the drug to the woman.101 102 103 105 106 107

Pediatric Use

Sulfacetamide ophthalmic ointment and solution: Safety and efficacy not established in infants <2 months of age.101 102 103

Fixed-combination ophthalmic preparations containing sulfacetamide and a corticosteroid (i.e., prednisolone): Safety and efficacy not established in children <6 years of age.105 106 107

Common Adverse Effects

Local irritation, transient stinging or burning.101 102 103 105

Interactions for Bleph 10

Specific Drugs

Drug

Interaction

Comments

Anesthetics, local (p-aminobenzoic acid derivatives)

Possible antagonism with sulfonamides since mechanism of antibacterial action involves inhibition of p-aminobenzoic acid105 106 107

Silver

Incompatible with sulfacetamide101 102 103 105 106 107

Bleph 10 Pharmacokinetics

Absorption

Extent

Following topical application of sulfacetamide to the eye, the drug penetrates into ocular tissues and fluids and may be absorbed systemically in patients with inflamed conjunctiva.142

Distribution

Extent

Systemically administered sulfonamides cross the placenta and are distributed into human milk in low concentrations.140

Stability

Storage

Ophthalmic

Sulfonamide solutions darken on prolonged standing and exposure to heat and light.101 103 105 107 Discard preparations that have darkened;101 103 105 107 yellow discoloration does not affect activity.105 107

Ointment

Sulfacetamide sodium 10%: 20–25°C.102

Sulfacetamide sodium 10% and prednisolone acetate 0.2%: 15–25°C.106

Solution

Sulfacetamide sodium 10%: 8–25°C;101 103 protect from light.101

Sulfacetamide sodium 10% and prednisolone phosphate 0.23%: Tightly closed container at 15–25°C; protect from light and freezing.107

Suspension

Sulfacetamide sodium 10% and prednisolone acetate 0.2%: Upright position at 8–24°C; protect from light and freezing.105

Actions and Spectrum

  • Sulfonamide anti-infectives are synthetic derivatives of p-aminobenzenesulfonamide (sulfanilamide).a

  • Usually bacteriostatic.101 102 103 142

  • Sulfonamides interfere with utilization of p-aminobenzoic or p-aminobenzoic glutamic acids by susceptible organisms, thus inhibiting biosynthesis of folic acid which is essential for growth.a 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.a

  • Spectrum of activity includes some aerobic gram-positive and -negative bacteria.101 102 103 142

  • Gram-positive bacteria: Active against Staphylococcus aureus, Streptococcus pneumoniae, and viridans streptococci.101 102 103 a Many staphylococci are resistant to sulfonamides.101 102 103

  • Gram-negative bacteria: Active against Haemophilus influenzae, Enterobacter, Escherichia coli, and Klebsiella.101 102 103 a

  • Cross-resistance usually occurs among the various sulfonamides.142

Advice to Patients

  • Advise patients to avoid contaminating container tip with material from the eye, eyelid, or other source.101 102 103 105 106 107 Keep container tightly closed when not in use;106 do not share with others.106

  • Advise patients to immediately discontinue sulfacetamide ophthalmic preparation and contact a clinician at first sign of hypersensitivity, rash, or other serious reaction.101 102 103 105 106 107 Also discontinue and contact a clinician if there is an increase in purulent discharge or aggravation of inflammation or pain.101 102 103

  • Advise patients using fixed-combination ophthalmic preparation containing a corticosteroid to contact clinician for reevaluation if there is no improvement after 2 days of treatment.105 106 107

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.101 102 103 105 106 107

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.101 102 103 105 106 107

  • Importance of informing patients of other important precautionary information.101 102 103 105 106 107 (See Cautions.)

Preparations

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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sulfacetamide Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

10%*

Sulfacetamide Sodium Ophthalmic Ointment

Solution

10%*

Bleph 10

Allergan

Sulfacetamide Sodium Ophthalmic Solution

Sulfacetamide Sodium and Prednisolone Acetate

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Other Sulfacetamide Sodium Combinations

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

AHFS DI Essentials™. © Copyright 2018, Selected Revisions July 30, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

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) ophthalmic 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. http://www.aao.org/preferred-practice-pattern/conjunctivitis-ppp--2013

136. Azari AA, Barney NP. Conjunctivitis: a systematic review of diagnosis and treatment. JAMA. 2013; 310:1721-9. http://www.ncbi.nlm.nih.gov/pubmed/24150468?dopt=AbstractPlus

137. Sheikh A, Hurwitz B, van Schayck CP et al. Antibiotics versus placebo for acute bacterial conjunctivitis. Cochrane Database Syst Rev. 2012; :CD001211. http://www.ncbi.nlm.nih.gov/pubmed/22972049?dopt=AbstractPlus

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.

140. Briggs CC, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation, 7th ed. Philadelphia, PA: Lippincott, Williams, & Wilkins; 2005: 1508-10.

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; 2015:288-94.

a. AHFS drug information 2018. McEvoy, GK, ed. Sulfacetamide sodium. Bethesda, MD: American Society of Health-System Pharmacists; 2018.

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