Sulfacetamide Sodium

Pronunciation: SUL-fa-SET-a-mide SOE-dee-um
Class: Anti-infective, topical, ophthalmic

Trade Names

Bleph-10
- Ophthalmic solution 10%

Klaron
- Topical lotion 10%

Mexar
- Topical wash 10%

Ovace
- Topical foam 10%

Ovace Plus
- Topical wash 10%

Seb-Prev
- Lotion 10%
- Wash 10%

Sulfacetamide sodium
- Ophthalmic ointment 10%

Pharmacology

By competing with paraaminobenzoic acid, sulfacetamide restricts the synthesis of folic acid required by bacteria for growth.

Indications and Usage

Topical use

Treatment of bacterial infections of the skin caused by susceptible organisms, including Propionibacterium acne ; topical control of seborrheic dermatitis of the face and scalp.

Ophthalmic use

Treatment of conjunctivitis and other superficial ocular infections caused by susceptible microorganisms; adjunctive treatment in systemic sulfonamide therapy of trachoma.

Contraindications

Known hypersensitivity to sulfonamides or any component of the product; kidney disease (medicated pads).

Dosage and Administration

Acne Vulgaris
Adults and Children 12 y and older

Topical Apply a thin film to affected areas twice daily.

Bacterial Skin Infections
Adults and Children 12 y and older Cream, gel

Topical Apply to affected areas twice daily for 8 to 10 days.

Foam

Topical Gently massage into affected areas until foam disappears. Repeat application for 8 to 10 days.

Wash

Topical Wash affected areas, massage into skin, work into a full lather, rinse thoroughly, and pat dry. Rinse with plain water. Repeat application for 8 to 10 days.

Conjunctivitis; Superficial Ocular Infections
Adults and Children 2 mo and older

Ophthalmic Instill 1 or 2 drops into the conjunctival sac(s) of the affected eye(s) every 2 to 3 h. Dosages may be tapered by increasing the time between doses as the condition responds. Usual duration of treatment is 10 days.

Seborrhea Dermatitis, Seborrhea Sicca
Adults and Children 12 y and older Cream, gel

Topical Apply to affected areas twice daily, morning and evening. Repeat application for 8 to 10 days. As the condition subsides, lengthen the interval between applications. Applications once or twice weekly or every other week may prevent recurrence. Should condition recur after stopping, reinitiate use as at the beginning of treatment.

Foam

Topical Twice daily, gently massage into affected areas of the scalp until foam disappears. Allow treated area to air dry. Do not wash the treated area immediately after applying foam. Repeat application for 8 to 10 days. As the condition subsides, lengthen the interval between applications. Applications once or twice weekly or every other week may prevent recurrence. Should condition recur after stopping, reinitiate use as at the beginning of treatment.

Wash

Topical Wash affected areas twice daily, morning and evening. Massage into skin, work into a full lather, rinse thoroughly, and pat dry. Rinse with plain water. Repeat application for 8 to 10 days. Regular shampooing is not necessary, but shampoo the hair at least once weekly. As the condition subsides, lengthen the interval between applications. Applications once or twice weekly or every other week may prevent recurrence. Should condition recur after stopping, reinitiate use as at the beginning of treatment.

Trachoma
Adults and Children

Ophthalmic Instill 2 drops into conjunctival sac(s) of the affected eye(s) every 2 h. Topical treatment must be accompanied by systemic treatment.

General Advice

  • For external use only.
  • Medicated pads or wash may darken after prolonged exposure. Slight discoloration does not affect efficacy or safety.
  • Discontinue use and inform health care provider if condition being treated becomes worse, if a rash develops in area being treated or elsewhere, or if arthritis, fever, or mouth sores develop.
  • Sulfonamide solutions will darken in color on long standing and should then be discarded.

Storage/Stability

Cream, gel, lotion

Store between 68° and 77°F. Do not freeze.

Foam

Store between 59° and 86°F.

Wash

Store at room temperature, between 59° and 86°F. Protect from freezing and excessive heat.

Ophthalmic

Store between 46° and 77°F. Protect from light.

Drug Interactions

Silver preparations

Sodium sulfacetamide is incompatible with silver preparations.

Adverse Reactions

Dermatologic

Edema, erythema, itching, Stevens-Johnson syndrome.

EENT

Bacterial and fungal corneal ulcers, conjunctival hyperemia, nonspecific conjunctivitis (ophthalmic).

Local

Burning, irritation, stinging.

Miscellaneous

Allergic reactions, local hypersensitivity progressing to systemic lupus erythematosus, and secondary infections have occurred (ophthalmic).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 12 y. Ophthalmic: Safety and efficacy not established in infants younger than 2 mo.

Hypersensitivity

Hypersensitivity reactions may occur irrespective of the route of administration.

Superinfection

Nonsusceptible organisms, including fungi, may proliferate.

Metabisulfite

The topical suspension contains metabisulfite, which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes.

Reduced efficacy

Para-aminobenzoic acid present in purulent exudates may be reduce the efficacy of sulfonamides.

Severe reactions

Rare, severe, and sometimes fatal reactions, including acute hemolytic anemia, agranulocytosis, aplastic anemia and other blood dyscrasias, drug fever, fulminant hepatic necrosis, jaundice, purpura hemorrhagica, Stevens-Johnson syndrome, and toxic epidermal necrolysis, can occur.

Systemic absorption

Absorption is greater following application to abraded, denuded, infected, large, or severely burned areas.

Overdosage

Symptoms

Oral overdose has been associated with crystalluria, hematuria, nausea, renal failure caused by precipitation of the drug, and vomiting.

Patient Information

  • Inform patients that a slight yellowish discoloration may occur when excessive amount of the product is used and comes in contact with white fabrics, and that the discoloration is readily removed by ordinary laundering without bleach.
  • Instruct patient on correct method of instilling eye drops and to avoid contamination by not touching the tip of the container to the eye, eyelid, or any surface.

Copyright © 2009 Wolters Kluwer Health.

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