Bleph 10

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

Introduction

Sulfonamide anti-infective.107

Uses for Bleph 10

Bacterial Ophthalmic Infections

Treatment of conjunctivitis, corneal ulcers, and other superficial infections of the eye caused by susceptible Staphylococcus aureus, Streptococcus pneumoniae, viridans streptococci, Haemophilus influenzae, Enterobacter, Escherichia coli, and Klebsiella.107 108 f

Used alone or in fixed combination with topical corticosteroids (e.g., fluorometholone, prednisolone) when such combination therapy is indicated.b c e g

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Ineffective for treatment of infections caused by Neisseria, Serratia marcescens, or Pseudomonas aeruginosa.108 b c e f g Consider that staphylococci frequently are resistant to sulfonamides.108 b c e f g

Chlamydial Ophthalmic Infections

Has been used as an adjunct to systemic anti-infectives for treatment of trachoma; 107 108 f however, systemic anti-infectives are recommended.106 No data to support use of topical anti-infectives in conjunction with systemic therapy.106

Bleph 10 Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye(s) as an ophthalmic ointment, solution, or suspension.107 108 b c e f g

Not for injection;107 108 b c e f do not inject subconjunctivally or instill directly into the anterior chamber of the eye.g

Avoid contamination of the tip of the container.b c e f g

Shake suspension well prior to use.b g

Dosage

Available as sulfacetamide sodium; dosage expressed in terms of the salt.f

Available as fixed combinations containing sulfacetamide sodium and prednisolone acetate, prednisolone sodium phosphate, or fluorometholone; dosage expressed in terms of the salt.b c e g

Pediatric Patients

Bacterial Ophthalmic Infections
Sulfacetamide 10%
Ophthalmic Solution

Children ≥2 months of age: Initially, 1 or 2 drops into the conjunctival sac of the affected eye(s) every 2–3 hours.f Reduce dosing frequency as infection improves.f Usual duration of treatment is 7–10 days.f

Sulfacetamide 10% and Fluorometholone 0.1%
Ophthalmic Suspension

Children ≥2 years of age: 1 drop into the conjunctival sac of the affected eye(s) 4 times daily.g Reduce dosing frequency as infection improves.g

If improvement does not occur after 2 days, reevaluate the patient.g Do not discontinue prematurely.g

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.g

Sulfacetamide 10% and Prednisolone Acetate 0.2%
Ophthalmic Ointment

Children ≥6 years of age: Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 3 or 4 times daily during the day and once or twice during the night.c Reduce dosing frequency as infection improves.c

If improvement does not occur after 2 days, reevaluate the patient.b c Do not discontinue prematurely.b c

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.b c

Ophthalmic Suspension

Children ≥6 years of age: 2 drops into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.b Reduce dosing frequency as infection improves.b

If improvement does not occur after 2 days, reevaluate the patient.b c Do not discontinue prematurely.b c

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.b c

Sulfacetamide 10% and Prednisolone Sodium Phosphate 0.25%
Ophthalmic Solution

Children ≥6 years of age: 2 drops into the affected eye(s) every 4 hours.e Reduce dosing frequency as infection improves.e

If improvement does not occur after 2 days, reevaluate the patient.e Do not discontinue prematurely.e

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.e

Chlamydial Ophthalmic Infections
Trachoma
Ophthalmic Solution

Sulfacetamide 10% in children ≥2 months of age: 2 drops into the conjunctival sac of the affected eye(s) every 2 hours in conjunction with systemic anti-infectives.f

Adults

Bacterial Ophthalmic Infections
Sulfacetamide 10%
Ophthalmic Solution

Initially, 1 or 2 drops of solution into the conjunctival sac of the affected eye(s) every 2–3 hours.f Reduce dosing frequency as infection improves.f Usual duration of treatment is 7–10 days.f

Sulfacetamide 10% and Fluorometholone 0.1%
Ophthalmic Suspension

1 drop into the conjunctival sac of the affected eye(s) 4 times daily.g Reduce dosing frequency as infection improves.g

If improvement does not occur after 2 days, reevaluate the patient.g Do not discontinue prematurely.g

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.g

Sulfacetamide 10% and Prednisolone Acetate 0.2%
Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 3 or 4 times daily during the day and once or twice during the night.c Reduce dosing frequency as infection improves.c

If improvement does not occur after 2 days, reevaluate the patient.b c Do not discontinue prematurely.b c

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.b c

Ophthalmic Suspension

2 drops into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.b Reduce dosing frequency as infection improves.b

If improvement does not occur after 2 days, reevaluate the patient.b c Do not discontinue prematurely.b c

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.b c

Sulfacetamide 10% and Prednisolone Sodium Phosphate 0.25%
Ophthalmic Solution

2 drops into the affected eye(s) every 4 hours.e Reduce dosing frequency as infection improves.e

If improvement does not occur after 2 days, reevaluate the patient.e Do not discontinue prematurely.e

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.e

Chlamydial Ophthalmic Infections
Trachoma
Ophthalmic Solution

Sulfacetamide 10%: 2 drops into the conjunctival sac of the affected eye(s) every 2 hours, in conjunction with systemic anti-infectives.f

Special Populations

No special population dosage recommendations at this time.a b c e f g

Cautions for Bleph 10

Contraindications

  • Known or suspected hypersensitivity to sulfonamides or to any ingredient in the formulation.107 108 b c e f g

Warnings/Precautions

Warnings

Severe Reactions

Severe, fatal reactions to sulfonamides have occurred rarely, including dermatologic reactions, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, or other blood dyscrasias.107 108 f g

Adverse reactions reported with systemic sulfonamides could occur with topical application.107

Sensitivity Reactions

Hypersensitivity

Topical application of sulfonamides may produce sensitization and preclude later systemic use of these drugs.107 a f g In addition, patients who have been sensitized by systemic sulfonamide administration may exhibit hypersensitivity reactions following topical application of the drugs.107 a f g

Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely following topical application in individuals with a history of hypersensitivity to systemic sulfonamides.107 108 f g

Cross-sensitivity occurs among the various sulfonamides.108 f

Discontinue sulfonamide therapy immediately at the first sign of hypersensitivity, rash, or other serious reaction.107 108 f g

General Precautions

Superinfection

Use of sulfonamides may result in the overgrowth of nonsusceptible organisms, including fungi.107 108 f g Bacterial and fungal corneal ulcers have developed during use of ophthalmic sulfonamide preparations.108

Discontinue drug and institute appropriate therapy if superinfection occurs.107

Ophthalmic Ointments

Ophthalmic ointments may delay corneal healing.c

Use of Fixed Combinations Containing Corticosteroids

Concomitant topical corticosteroids may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the antibiotic; or suppress hypersensitivity reactions to sulfonamides or other ingredients in the formulation.107 c

When sulfacetamide is used in fixed combination with a corticosteroid, consider the cautions, precautions, and contraindications associated with EENT corticosteroids.b c e g

Specific Populations

Pregnancy

Category C.108 f

Lactation

Systemically absorbed sulfonamides can cause kernicterus in neonates and infants.108 f g Discontinue nursing or the drug.108 f g

Pediatric Use

Safety and efficacy of ophthalmic sulfacetamide sodium not established in infants <2 months of age.107 108 f

Safety and efficacy of fixed-combination ophthalmic sulfacetamide and prednisolone not established in children <6 years of age.b c e

Safety and efficacy of fixed-combination ophthalmic sulfacetamide and fluorometholone not established in children <2 years of age.g

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.g

Common Adverse Effects

Local irritation, transient stinging or burning.107 a f

Interactions for Bleph 10

Specific Drugs

Drug

Interaction

Comments

Anesthetics, local (p-aminobenzoic acid related

Possible antagonism of action of sulfonamides107

Gentamicin

In vitro antagonismb c e

Do not use concomitantlyb c e

Bleph 10 Pharmacokinetics

Absorption

Extent

Sulfonamides do not appear to be appreciably absorbed from mucous membranes.107

Distribution

Extent

Systemic sulfonamides cross the placenta and are distributed into human milk in low concentrations.h

Stability

Storage

Ophthalmic

Sulfonamide preparations darken on prolonged standing and exposure to heat and light.b e f Discard preparations that have darkened; yellow discoloration does not affect activity.b e f

Ointment

Sulfacetamide sodium and prednisolone acetate: Tightly closed containers at 15–25°C.c

Solution

Sulfacetamide sodium: 8–25°C; protect from light and freezing.f

Sulfacetamide sodium and prednisolone sodium phosphate: 15–25°C; protect from light.e

Suspension

Sulfacetamide sodium and fluorometholone: 15–30°C; protect from light and freezing.g

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

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Ophthalmic

Ointment or Solution

Sulfacetamide sodium is incompatible with preparations containing silver.107 108 f

Precipitation may occur if zinc sulfate is added to sulfacetamide sodium solutions, depending on the concentration of each drug.107

Actions and Spectrum

  • Usually bacteriostatic,f but may be bactericidal at very high concentrations.107 108

  • Sulfonamides interfere with utilization of aminobenzoic or aminobenzoic glutamic acids by susceptible organisms, thus inhibiting biosynthesis of folic acid which is essential for growth.107 a f 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.107

  • Antibacterial activity is decreased in the presence of blood or purulent exudates containing p-aminobenzoic acid.107 108 a f

  • Spectrum of activity includes some aerobic gram-positive and -negative bacteria.107 a

  • Gram-positive aerobic bacteria: Active against S. aureus, S. pneumoniae, and viridans streptococci.107 108 a f g Many staphylococci are resistant.107 108 g

  • Gram-negative aerobic bacteria: Active against H. influenzae, Enterobacter, E. coli, and Klebsiella.108 a f g

  • Cross-resistance usually occurs among the various sulfonamides.107 a f

Advice to Patients

  • Importance of not touching tip of container to eye, eyelid, or any other surface.108 b c e f g Advise patient to keep container tightly closed when not in use.g

  • Importance of discontinuing use and contacting clinician at first sign of hypersensitivity, increase in discharge, or if pain or swelling worsen.108 b c f

  • Advise patient not to share the drug with any other person.c g

  • Importance of removing soft contact lenses prior to administering preparations containing benzalkonium chloride and of delaying reinsertion of the lenses for ≥5 minutes after administration.b i

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.f

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.f

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

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

Sulfacetamide Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder

Ophthalmic

Ointment

10%*

Sulfacetamide Sodium Ophthalmic Ointment

Fougera

Solution

10%*

Bleph 10 (with benzalkonium chloride)

Allergan

Sulfacetamide Sodium Ophthalmic Solution

Bausch & Lomb, Falcon

Sulfacetamide Sodium and Prednisolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

10% Sulfacetamide Sodium and Prednisolone Acetate 0.2%

Blephamide (with phenylmercuric acetate)

Allergan

Suspension

10% Sulfacetamide Sodium and Prednisolone Acetate 0.2%

Blephamide (with benzalkonium chloride)

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% of prednisolone phosphate)*

Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution

Bausch & Lomb, Falcon

Ophthalmic

Suspension

10% with Fluorometholone 0.1%

FML-S (with benzalkonium chloride and povidone)

Allergan

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Bleph-10 10% Solution (ALLERGAN): 5/$29.39 or 15/$65.07

Blephamide 10-0.2% Suspension (ALLERGAN): 5/$70.99 or 15/$199.97

Blephamide 10-0.2% Suspension (ALLERGAN): 10/$105.99 or 30/$295.96

Sulfacetamide Sodium 10% Solution (SANDOZ): 15/$12.99 or 30/$18.98

Sulfacetamide-Prednisolone 10-0.23% Solution (BAUSCH &amp; LOMB): 5/$25.99 or 15/$56.97

Sulfacetamide-Prednisolone 10-0.23% Solution (BAUSCH &amp; LOMB): 10/$30.99 or 20/$53.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

101. Allergan, Inc. Bleph-10 (sulfacetamide sodium) ophthalmic ointment prescribing information. In: Physicians’ desk reference for ophthalmic medicines. 34th ed. Montvale, NJ: Thomson PDR; 2006:219-20.

102. Fougera. Sulfacetamide sodium ophthalmic ointment USP, 10% prescribing information. Melville, NY; 1998 Mar.

103. Falcon Pharmaceuticals, Ltd. Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution. Fort Worth, TX; 2003 Nov.

104. Allergan. FML-S (fluorometholone and sulfacetamide sodium ophthalmic suspension, USP) 0.1%/10% prescribing information. In: Physicians’ desk reference for ophthalmic medicines. 34th ed. Montevale, NJ: Thomson PDR; 2006:226-7.

105. American Academy of Pediatrics. Red book: 2006 Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006;252-7.

106. American Academy of Ophthalmology. Preferred Practice Pattern: Conjunctivitis. 2003. From the American Academy of Ophthalmology website. Accessed 11 May 2006.

107. AHFS Drug Information 2003. McEvoy, GK, ed. Sulfonamides (ophthalmic). Bethesda, MD: American Society of Health-System Pharmacists; 2003:2613-4.

108. Akorn. AK-Sulf (sulfacetamide sodium) ophthalmic solution prescribing information. Buffalo Grove, IL: 2000 May.

109. Committee on Infectious Diseases, American Academy of Pediatrics. 2000 Red book: report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000:210.

110. Anon. The choice of antibacterial drugs. Med Lett Drugs Ther. 2001; 43:69-78. [PubMed 11518876]

111. Allergan, Inc. Bleph-10 (sulfacetamide sodium) ophthalmic ointment prescribing information. Irvine, CA; 1993 Sept.

a. AHFS drug information 2008. McEvoy, GK, ed. Sulfacetamide sodium. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2855-6.

b. Allergan, Inc. Blephamide (sulfacetamide sodium and prednisolone acetate, USP ophthalmic suspension) 10%/0.2% prescribing information. Irvine, CA; 2004 Jun.

c. Allergan, Inc. Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% prescribing information. Irvine, CA; 2004 Sept.

e. Falcon Pharmaceuticals, Ltd. Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution prescribing information. Fort Worth, TX; 2007 Jul.

f. Allergan, Inc. Bleph-10 (sulfacetamide sodium ophthalmic solution, USP) 10% prescribing information. Irvine, CA; 2005 Feb.

g. Allergan, Inc. FML-S (fluorometholone and sulfacetamide sodium ophthalmic suspension, USP) 0.1%/10% prescribing information. Irvine, CA; 2005 Feb.

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

i. Christensen MT, Barry JR, Turner FD. Five-minute removal of soft lenses prevents most absorption of a topical ophthalmic solution. CLAO J. 1998; 24:227-31. [PubMed 9800062]

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