Cerisa

Stratus Pharamceuticals, Inc
Sonar Products, Inc

CERISA™ WASH

FULL PRESCRIBING INFORMATION: CONTENTS*

• CERISA DESCRIPTION
• CLINICAL PHARMACOLOGY
• CERISA INDICATIONS AND USAGE
• CERISA CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Carcinogenesis, Mutagenesis an Impairment of Fertility
  • Pregnancy
  • Nursing Mothers
  • Pediatric Use
• CERISA ADVERSE REACTIONS
• CERISA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 170.1 g Carton

FULL PRESCRIBING INFORMATION

(Sodium Sulfacetamide 10% and Sulfur 1%)

Rx only

CERISA DESCRIPTION

Each gram of CERISA™ WASH contains 100mg of Sodium Sulfacetamide and 10mg of Sulfur in a wash containing Butylated Hydroxytolulene, Cetyl Alcohol, Disodium EDTA, Glyceryl Stearate and PEG-l00 Stearate, Lactic Acid, Magnesium Aluminum Silicate, Methyl Paraben, Propyl Paraben, Purified Water, Sodium C14-16 Olefin Sulfonate, Sodium Hydroxide, Sodium Thiosulfate, Stearyl alcohol, White Petrolatum and Xanthan Gum.

Sodium Sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, Sodium Sulfacetamide is N-{(4-aminophenyl) sulfony}-acetamide, monosodium salt, monohydrate.

The structural formula is:

CLINICAL PHARMACOLOGY

The most widely accepted mechanism of action of sulfonamides in 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.

The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

CERISA INDICATIONS AND USAGE

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

CERISA 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.

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. FOR EXTERNAL USE ONLY. Keep out of reach of children. Keep tube tightly closed.

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.

CERISA ADVERSE REACTIONS

Although rare, sodium sulfacetamide may cause local irritation.

CERISA 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.

HOW SUPPLIED

CERISA™ WASH is available in 170.1g (6.0 oz) tubes,NDC 58980-330-61.

Store at controlled room temperature: 15°-30° C (59°-86° F)

Distributed by
STRATUS
PHARMACEUTICALS INC

Manufactured by
Sonar Products Inc.
Carlstadt, NJ 07072
exclusively for
Stratus Pharmaceuticals Inc.
12379 Southwest 130th Street
Miami, Florida 33186-6727

Customer Service
Telephone: 1-800-442-7882
Fax: 305-254-6875

©2008 Stratus Pharmaceuticals Inc.

JG-CW-IN200811.

PRINCIPAL DISPLAY PANEL - 170.1 g Carton

NDC 58980-330-61
Net WT. 6.0 oz. (170.1g)

CERISA™ WASH
(Sodium Sulfacetamide 10% and Sulfur Wash 1%)

STRATUS
PHARMACEUTICALS INC

Rx only

Manufactured for Stratus Pharmaceuticals Inc., 12379 Southwest 130th Street, Miami, Florida 33186-6208