Sulfacetamide Sodium

Trade Names:
AK-Sulf
- Ophthalmic solution 10%
- Ophthalmic ointment 10%

Trade Names:
Bleph-10
- Ophthalmic solution 10%

Trade Names:
Carmol Scalp Treatment
- Lotion 10%

Trade Names:
Klaron
- Topical lotion 10%

Trade Names:
Mexar
- Topical wash 10%

Trade Names:
Ocusulf-10
- Ophthalmic solution 10%

Trade Names:
Ovace
- Topical foam 10%

Trade Names:
Ovace Plus
- Topical wash 10%

Trade Names:
Rosula NS
- Topical pads 10%

Trade Names:
Seb-Prev
- Topical cream 10%
- Gel 10%
- Wash 10%

Trade Names:
Storz Sulf
- Ophthalmic solution 10%

Trade Names:
Sulfacetamide Sodium
- Ophthalmic solution 30%

Pharmacology

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

Indications and Usage

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

Treatment of acne vulgaris.

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

Topical

Apply to affected areas 1 to 2 times daily.

Apply a thin film to affected areas twice daily

Topical

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

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

Apply to affected areas 2 to 4 times daily until the infection has cleared.

Apply to affected areas 1 to 2 times daily.

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.

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.

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.

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.

For best results, apply at bedtime and allow to remain overnight. Precede application with a shampoo if the hair or scalp is oily or greasy or if there is considerable debris. In severe cases with crusting, heavy scaling, and inflammation, apply lotion twice daily. 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.

Apply to affected areas 1 to 2 times daily.

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.

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

• Shake suspension well before using.
• 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

Store at 68° to 77°F. Do not freeze.

Store at 59° to 86°F. Protect lotion and medicated pads from freezing.

Store at 68° to 77°F. Keep tightly closed.

Store at room temperature (59° to 86°F). Protect from freezing and excessive heat.

Store at 46° to 77°F. Protect from light.

Drug Interactions

Sodium sulfacetamide is incompatible with silver preparations.

Laboratory Test Interactions

None well documented.

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 yr of age. Ophthalmic: Safety and efficacy not established in infants younger than 2 mo of age.

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.

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