Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is available as follows: 4 FL OZ (118mL) bottles (NDC 45802- 896 -26); PRINCIPAL DISPLAY PANEL NDC 45802-896-26 Rx Only Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) For Topical Use Only Shake Well Before Using 4 FL OZ (118 mL) label
- HOW SUPPLIED Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is available as follows: 4 FL OZ (118mL) bottles (NDC 45802- 896 -26)
- PRINCIPAL DISPLAY PANEL NDC 45802-896-26 Rx Only Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) For Topical Use Only Shake Well Before Using 4 FL OZ (118 mL) label
Overview
Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) contains 100 mg of sulfacetamide sodium in a vehicle consisting of diethanolamine; EDTA; hydroxyethyl cellulose; lauramide DEA; methylparaben; polyethylene glycol 400, monolaurate; propylene glycol; purified water; simethicone; sodium chloride; sodium metabisulfite and xanthan gum. Sulfacetamide sodium is a sulfonamide with antibacterial activity. Chemically, sulfacetamide sodium is N'-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Image 1
Indications & Usage
INDICATIONS Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is indicated in the topical treatment of acne vulgaris .
Dosage & Administration
Apply a thin film to affected areas twice daily.
Warnings & Precautions
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 Topical Suspension USP, 10% (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 (see CONTRAINDICATIONS section).
Contraindications
Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).
Adverse Reactions
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 sulfacetamide sodium may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of medication has to be discontinued.
Storage & Handling
STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Shake well before using. Keep tightly closed.
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