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sulfacetamide sodium and
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----------Prascion® RA Cream With Sunscreens sodium sulfacetamide 10% and sulfur 5%
CLINICAL PHARMACOLOGY: The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours.
INDICATIONS AND USAGE: Prascion RA Cream With Sunscreens is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS: Prascion RA Cream With Sunscreens is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. This drug is not to be used by patients with kidney disease.
WARNINGS: Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfacetamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicated hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.
PRECAUTIONS: General - If irritation develops, use of the product should be discontinued and appropriate therapy instituted. For external use only. Keep away from eyes. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this
Carcinogenesis, Mutagenesis and Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy - Category C. Animal reproduction studies have not been conducted with Prascion® RA Cream With Sunscreens. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.
Nursing Mothers - It is not known whether sodium sulfacetamide is excreted in human milk following topical use of Prascion® RA Cream With Sunscreens. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing woman.
DOSAGE AND ADMINISTRATION: Apply a thin film of Prascion RA Cream With Sunscreens to affected areas 1 to 3 times daily.
Manufactured for: Prasco Laboratories
Revised: 12/2010 Prasco Laboratories
Reproduced with permission of U.S. National Library of Medicine
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