Data from FDA - Curated by EPG Health - Last updated 27 July 2017

Indication(s)

INDICATIONS AND USAGE CERISA™ WASH is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

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Advisory information

contraindications
CONTRAINDICATIONS CERISA™ WASH is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. CERISA™ WASH is not to be used by patients with kidney disease.
Special warnings and precautions
PRECAUTIONS General If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be very carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Carcinogenesis, Mutagenesis an 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 CERISA™ WASH. It is also not known whether CERISA™ WASH can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CERISA™ WASH 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 CERISA™ WASH. 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 CERISA™ WASH is administered to a nursing woman. Pediatric Use Safety and effectiveness in children under the age of 12 have not been established.
Adverse reactions
ADVERSE REACTIONS Although rare, sodium sulfacetamide may cause local irritation.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Wash affected areas once or twice daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be treated, massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. If dying occurs, it may be controlled by rinsing wash off sooner or using less often.
Pregnancy and lactation
Nursing Mothers It is not known whether sodium sulfacetamide is excreted in human milk following topical use of CERISA™ WASH. 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 CERISA™ WASH is administered to a nursing woman.

More information

Category Value
Agency product number 70FD1KFU70
Orphan designation No
Product NDC 58980-330
Date Last Revised 26-10-2009
Type HUMAN PRESCRIPTION DRUG
RXCUI 999604
Storage and handling Store at controlled room temperature: 15°-30° C (59°-86° F)
Marketing authorisation holder Stratus Pharamceuticals, Inc