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Clenia (Sulfacetamide Sodium / Sulfur Topical) - Warnings and Precautions

 
 



WARNINGS

Although rare, hypersensitivity reactions to products containing sodium sulfacetamide may occur, including Stevens-Johnson syndrome and exfoliative dermatitis. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura, hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

FOR EXTERNAL USE ONLY
Keep away from eyes. Keep out of reach of children.

PRECAUTIONS

General

Although the object of this therapy is to achieve desquamation without irritation, this product poses a low potential for irritation, which may include reddening and scaling of the epidermis. Uncommon adverse reactions such as dryness, erythema, itching and edema may occur. Therefore, patients should be monitored for possible local irritation or sensitization. Use of the product should be discontinued if excessive irritation develops.

Information for Patients

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with CLENIA® (sodium sulfacetamide 10% and sulfur 5%) Foaming Wash or CLENIA® (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream. It is not known whether CLENIA® Foaming Wash and CLENIA® Emollient Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CLENIA® Foaming Wash and CLENIA® Emollient Cream should be used during pregnancy only if the potential benefit outweighs the potential risk.

Nursing Mothers

It is not known whether sodium sulfacetamide is excreted in human milk following topical use of CLENIA® Foaming Wash and CLENIA® Emollient Cream. However, small amounts of orally administered sulfonamides have been detected in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when CLENIA® Foaming Wash and CLENIA® Emollient Cream is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children under the age of 12 have not been established.

Page last updated: 2009-09-02

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