Sulfacetamide (topical)

Sulfacetamide (topical)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

Sulfacetamide (topical) is a antiacne, antibacterial that is FDA approved for the treatment of acne vulgaris. Common adverse reactions include application site irritation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Sulfacetamide sodium lotion is indicated in the topical treatment of acne vulgaris.

• Apply a thin film to affected areas twice daily.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sulfacetamide (topical) in adult patients.

Non–Guideline-Supported Use

• Bacterial keratitis

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Sulfacetamide (topical) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sulfacetamide (topical) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulfacetamide (topical) in pediatric patients.

Contraindications

• Sulfacetamide sodium lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation.

Warnings

• Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section).

• Sulfacetamide sodium lotion contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

PRECAUTIONS

General

• For external use only. Keep away from eyes. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sodium sulfacetamide can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

• Keep out of the reach of children.

Adverse Reactions

Clinical Trials Experience

• In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Sulfacetamide sodium lotion was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Sulfacetamide sodium lotion had adverse reactions of erythema, itching and edema. It has been reported that sodium sulfacetamide may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of medication has to be discontinued.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Sulfacetamide (topical) in the drug label.

Drug Interactions

There is limited information regarding Drug Interactions of Sulfacetamide (topical) in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• Animal reproduction studies have not been conducted with Klaron® Lotion. It is also not known whether Sulfacetamide sodium lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide sodium lotion should be given to a pregnant woman only if clearly needed.

• Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Sulfacetamide sodium lotion in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sulfacetamide (topical) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sulfacetamide (topical) during labor and delivery.

Nursing Mothers

• It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sulfacetamide sodium lotion . Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.

Pediatric Use

• Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Geriatic Use

There is no FDA guidance on the use of Sulfacetamide (topical) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Sulfacetamide (topical) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sulfacetamide (topical) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sulfacetamide (topical) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sulfacetamide (topical) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sulfacetamide (topical) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sulfacetamide (topical) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Topical

Monitoring

There is limited information regarding Monitoring of Sulfacetamide (topical) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Sulfacetamide (topical) in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Sulfacetamide (topical) in the drug label.

Pharmacology

Mechanism of Action

• The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth.

Structure

• Each mL of Klaron® (sodium sulfacetamide lotion) Lotion, 10% contains 100 mg of sodium sulfacetamide in a vehicle consisting of purified water; propylene glycol; lauramide DEA (and) diethanolamine; polyethylene glycol 400, monolaurate; hydroxyethyl cellulose; sodium chloride; sodium metabisulfite; methylparaben; xanthan gum; EDTA and simethicone.

This image is provided by the National Library of Medicine.

Pharmacodynamics

• While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.

Pharmacokinetics

• The pharmacokinetics of sulfacetamide and its major metabolite sulfaniliamide in Sulfacetamide sodium lotion was evaluated in adult subjects (N=14) with acne vulgaris. The subjects applied Sulfacetamide sodium lotion to their face, back, chest and shoulders every 12 hours for 28 days. The percentage of the applied dose of Sulfacetamide sodium lotion excreted in the urine as sulfacetamide plus sulfanilamide, ranged from 0.08 to 0.33%.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Sulfacetamide (topical) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Sulfacetamide (topical) in the drug label.

How Supplied

4 FL OZ (118 mL) bottles (NDC 0187-5198-04).

Storage

• Store at Controlled Room Temperature 20 to 25°C (68 to 77°F)

• Shake well before using. Keep tightly closed.

Images

Drug Images

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Package and Label Display Panel

PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON

NDC 0187-5198-04

Klaron®

sodium sulfacetamide lotion

Lotion, 10%

FOR TOPICAL USE ONLY

One 4 fl oz (118 mL) Bottle

VALEANT Pharmaceuticals North America LLC

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Sulfacetamide (topical) in the drug label.

Precautions with Alcohol

• Alcohol-Sulfacetamide (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Carmol Scalp Treatment®
• Klaron®
• Ovace®
• S.O.S.S.®
• Sodium Sulamyd®
• Sulf-10®

Look-Alike Drug Names

There is limited information regarding Sulfacetamide (topical) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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