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Sulfacetamide (ophthalmic): Pediatric drug information

Sulfacetamide (ophthalmic): Pediatric drug information
(For additional information see "Sulfacetamide (ophthalmic): Drug information" and see "Sulfacetamide (ophthalmic): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Bleph-10
Brand Names: Canada
  • Odan-Sulfacetamide;
  • Sodium Sulamyd [DSC]
Therapeutic Category
  • Antibiotic, Ophthalmic;
  • Antibiotic, Sulfonamide Derivative
Dosing: Pediatric

Conjunctivitis: Infants ≥2 months, Children, and Adolescents: Ophthalmic:

Ointment: Instill 1/2 inch ribbon into the lower conjunctival sac of affected eye(s) every 3 to 4 hours and at bedtime; increase dosing interval as condition responds. Ointment may be used as an adjunct to the solution; usual duration of treatment: 7 to 10 days

Solution: Instill 1 to 2 drops into the lower conjunctival sac of affected eye(s) every 2 to 3 hours initially; increase dosing interval as condition responds; usual duration of treatment: 7 to 10 days

Trachoma: Infants ≥2 months, Children, and Adolescents: Ophthalmic: Solution: Instill 2 drops into the conjunctival sac of affected eye(s) every 2 hours; must be used in conjunction with systemic therapy

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Adult

(For additional information see "Sulfacetamide (ophthalmic): Drug information")

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 ointment: Apply ~1/2-inch ribbon into the conjunctival sac of affected eye(s) every 3 to 4 hours and at bedtime.

Ophthalmic solution: Instill 1 to 2 drops into the conjunctival sac(s) of affected eye(s) every 2 to 3 hours.

Trachoma: Ophthalmic solution: Instill 2 drops into the conjunctival sac(s) of affected eye(s) every 2 hours; must be used in conjunction with systemic therapy.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosage Forms: US

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)

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Ophthalmic, as sodium:

Sodium Sulamyd: 10% ([DSC])

Generic: 10% (15 mL)

Administration: Pediatric

For topical application to the eye only; not for injection. Avoid contact of tube or bottle tip with skin or eye. Apply gentle pressure to lacrimal sac during and immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration, to decrease systemic absorption of ophthalmic drops (Urtti 1993; Zimmerman 1982).

Administration: Adult

Ophthalmic: For topical ophthalmic use only; not for injection. Avoid contact of tube or bottle tip with skin or eye.

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

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.

Storage/Stability

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).

Use

Ophthalmic: Treatment of conjunctivitis and other superficial ocular infections due to susceptible organisms (Ointment; solution: FDA approved in ages ≥2 months and adults); adjunctive treatment with systemic sulfonamides for therapy of trachoma (Solution: FDA approved in ages ≥ 2 months and adults)

Medication Safety Issues
Sound-alike/look-alike issues:

Bleph-10 may be confused with Blephamide

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined.

Cardiovascular: Edema

Hypersensitivity: Hypersensitivity reaction

Neuromuscular & skeletal: Systemic lupus erythematosus

Ophthalmic: Burning sensation of eyes, conjunctival hyperemia, conjunctivitis, corneal ulcer, eye irritation, stinging of eyes

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.

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.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

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

Monitoring Parameters

Response to therapy

Mechanism of Action

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

Pharmacokinetics (Adult data unless noted)

Onset of action: Improvement of conjunctivitis is usually seen within 3 to 6 days

Pricing: US

Ointment (Sulfacetamide Sodium Ophthalmic)

10% (per gram): $18.82

Solution (Bleph-10 Ophthalmic)

10% (per mL): $33.51

Solution (Sulfacetamide Sodium Ophthalmic)

10% (per mL): $3.71 - $4.07

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Acetopt (NZ);
  • Albucid (AE, BF, BH, BJ, CI, CY, EG, ET, GH, GM, GN, ID, IN, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW);
  • Antebor (BE);
  • Apisulfa (BH, QA, SA);
  • Apisulpha-20 (AE);
  • Blef-10 (CO, PE);
  • Blef-10 con lagrifilm (CR, DO, GT, HN, NI, PA, SV);
  • Bleph-10 (AE, BB, BH, CY, EG, IQ, IR, JO, KW, LB, LY, NZ, OM, SA, SY, YE);
  • Bleph-30 (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE);
  • Dermaseb (AR);
  • Dermaser (PY);
  • Facetam (PH);
  • Isopto Cetamide (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE);
  • Locula (IN);
  • Optal (TH);
  • Queimalive (BR);
  • Riacetamid (AE);
  • Senocet (PH);
  • Sivex (TR);
  • Sulfa 10 (BE);
  • Sulfacet Sodium (VE);
  • SulfacidE (IL);
  • Sulfaclan (KR);
  • Sulfacyl (UA);
  • Sulfex (HK, SG);
  • Synsul (CO);
  • Vitasul (PH)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. Bleph-10 (sulfacetamide) [prescribing information]. Irvine, CA: Allergan; September 2017.
  2. Sulfacetamide Sodium [prescribing information]. Minneapolis, MN: Perrigo; September 2013.
  3. Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol. 1993;37(6):435-456. [PubMed 8100087]
  4. Zimmerman TJ, Kooner KS, Kandarakis AS, Ziegler LP. Improving the therapeutic index of topically applied ocular drugs. Arch Ophthalmol. 1984;102(4):551-553. [PubMed 6704011]
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