Klaron Drug Information

    Generic name: SULFACETAMIDE SODIUM

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    Uses of Klaron

    Klaron Lotion is indicated in the topical treatment of acne vulgaris.

    Dosage & Administration of Klaron

    Apply a thin film to affected areas twice daily.

    Side Effects of Klaron

    In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Klaron 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 Klaron 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. To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Warnings & Cautions for Klaron

    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 ). Klaron 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 ).

    Pediatric Use of Klaron

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

    Contraindications for Klaron

    Klaron Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS ).

    Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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