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Sulfacetamide (Ophthalmic)

Pronunciation

(sul fa SEE ta mide)

Index Terms

  • Sodium Sulfacetamide
  • Sulamyd
  • Sulfacetamide Sodium

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, Ophthalmic, as sodium:

Generic: 10% (3.5 g)

Solution, Ophthalmic, as sodium:

Bleph-10: 10% (5 mL)

Generic: 10% (5 mL, 15 mL)

Brand Names: U.S.

  • Bleph-10

Pharmacologic Category

  • Antibiotic, Ophthalmic

Pharmacology

Interferes with bacterial growth by inhibiting bacterial folic acid synthesis through competitive antagonism of PABA

Onset of Action

Improvement of conjunctivitis is usually seen within 3 to 6 days

Use: Labeled Indications

Ocular infections:

Ophthalmic ointment and solution: Treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Ophthalmic solution: Treatment of trachoma as an adjunctive to systemic sulfonamide therapy

Limitations of use: Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are also completely resistant to sulfa drugs.

Contraindications

Hypersensitivity to sulfonamides or any component of the formulation.

Documentation of allergenic cross-reactivity for sulfonamides is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Conjunctivitis, other superficial ocular infections: Note: Taper dose by increasing dosage time interval as condition responds; usual duration of treatment: 7 to 10 days:

Ophthalmic solution: Instill 1 to 2 drops every 2 to 3 hours

Ophthalmic ointment: Apply ~1/2-inch ribbon every 3 to 4 hours and at bedtime

Trachoma: Ophthalmic solution: Instill 2 drops every 2 hours; must be used in conjunction with systemic therapy

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Conjunctivitis, other superficial ocular infections, or trachoma: Infants ≥2 months, Children, and Adolescents: Ophthalmic: Refer to adult dosing.

Administration

Ophthalmic: Avoid contact of tube or bottle tip with skin or eye. Instill sulfacetamide into the conjunctival sac.

Solution: Apply finger pressure to lacrimal sac during and for 1 to 2 minutes after instillation of solution to decrease risk of absorption and systemic effects. For the treatment of trachoma, use must be in conjunction with systemic therapy.

Ointment: May be used as an adjunct to the ophthalmic solution.

Storage

Solution: Store at 8°C to 25°C (46°F to 77°F); protect from light. Darkened solutions should not be used.

Ointment: Store at 20°C to 25°C (68°F to 77°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not defined.

Cardiovascular: Edema

Ocular (following ophthalmic application): Burning, conjunctivitis, conjunctival hyperemia, corneal ulcers, irritation, stinging

Miscellaneous: Allergic reactions, systemic lupus erythematosus

Warnings/Precautions

Concerns related to adverse effects:

• Blood dyscrasias: Severe reactions (rare fatalities), including agranulocytosis, aplastic anemia, and other blood dyscrasias, have occurred with sulfonamides (regardless of route). Discontinue at the first sign of serious reaction.

• Dermatologic reactions: Severe reactions (rare fatalities), including Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred with sulfonamides (regardless of route). Discontinue at first sign of rash.

• Hepatic necrosis: Fatalities (rare) associated with fulminant hepatic necrosis have occurred with sulfonamides (regardless of route). Discontinue at first sign of serious reaction.

• Sulfonamide allergy: Chemical similarities are present among sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid). Use in patients with sulfonamide allergy is specifically contraindicated in product labeling; however, a risk of cross-reaction exists in patients with allergy to any of these compounds; avoid use when previous reaction has been severe.

• Superinfection: Prolonged use may lead to overgrowth of nonsusceptible organisms, including fungi. If superinfection is suspected, institute appropriate alternative therapy.

Other warnings/precautions:

• Administration: Do not use concurrently with silver preparations.

• Appropriate use: For topical application to the eye only; not for injection. To avoid contamination, do not touch tip of container to any surface.

• Efficacy: May be inactivated by purulent exudates containing PABA.

Monitoring Parameters

Response to therapy, hypersensitivity reactions

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. Use of systemic sulfonamides during pregnancy may cause kernicterus in the newborn.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience burning or stinging. Have patient report immediately to prescriber signs of a severe sulfonamide reaction (rash; red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, or eyes; fever, chills, or sore throat; cough that is new or worse; loss of strength and energy; any bruising or bleeding; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes), vision changes, eye pain, severe eye irritation, or eye discharge (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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