Clenia Plus Topical Cleanser (Sodium Sulfacetamide 9% and Sulfur 4.25% Suspension)

Clenia Plus is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

INDICATIONS AND USAGE 

Clenia Plus is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. 

Important Safety Information 

CONTRAINDICATIONS 

Clenia Plus is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Clenia Plus 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 sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved. 

Sulfonamides are known to cause Stevens- Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. 

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 

Avoid contact with eyes, lips and mucous membranes. 

KEEP OUT OF REACH OF CHILDREN. Keep container tightly closed. 

PRECAUTIONS 

General:

Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. 

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.

Drug Interactions:

This product is incompatible with silver preparations. 

ADVERSE REACTIONS

Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported.

Clenia Plus Topical Cleanser (Sodium Sulfacetamide 9% and Sulfur 4.25% Suspension)

Clenia Plus is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

INDICATIONS AND USAGE 

Clenia Plus is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. 

Important Safety Information 

CONTRAINDICATIONS 

Clenia Plus is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Clenia Plus 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 sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved. 

Sulfonamides are known to cause Stevens- Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. 

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 

Avoid contact with eyes, lips and mucous membranes. 

KEEP OUT OF REACH OF CHILDREN. Keep container tightly closed. 

PRECAUTIONS 

General:

Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. 

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.

Drug Interactions:

This product is incompatible with silver preparations. 

ADVERSE REACTIONS

Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported.