Perrigo Sodium Sulfacetamide and Sulfur

Perrigo New York Inc

SODIUM SULFACETAMIDE 10% AND SULFUR 5% LOTION

FULL PRESCRIBING INFORMATION: CONTENTS*

• PERRIGO SODIUM SULFACETAMIDE AND SULFUR DESCRIPTION
• CLINICAL PHARMACOLOGY
• PERRIGO SODIUM SULFACETAMIDE AND SULFUR INDICATIONS AND USAGE
• PERRIGO SODIUM SULFACETAMIDE AND SULFUR CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Carcinogenesis, Mutagenesis and Impairment of Fertility
  • Pregnancy
  • Nursing Mothers
  • Pediatric Use
• PERRIGO SODIUM SULFACETAMIDE AND SULFUR ADVERSE REACTIONS
• PERRIGO SODIUM SULFACETAMIDE AND SULFUR DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• Principal Display Panel - 30 g Carton
• Principal Display Panel - 30 g Tube
• Principal Display Panel - 60 g Carton
• Principal Display Panel - 60 g Tube

FULL PRESCRIBING INFORMATION

Sodium Sulfacetamide 10%

and Sulfur 5% Lotion

Rx Only

PERRIGO SODIUM SULFACETAMIDE AND SULFUR DESCRIPTION

Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Lotion contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a lotion containing benzyl alcohol, cetyl alcohol, edetate disodium, emulsifying wax, isopropyl myristate, monobasic sodium phosphate, PEG-8 stearate, propylene glycol, propylene glycol monostearate, purified water, and sodium thiosulfate.

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate.

The structural formula is:

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.

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.

PERRIGO SODIUM SULFACETAMIDE AND SULFUR INDICATIONS AND USAGE

Sodium Sulfacetamide 10% and Sulfur 5% Lotion is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

PERRIGO SODIUM SULFACETAMIDE AND SULFUR CONTRAINDICATIONS

Sodium Sulfacetamide 10% and Sulfur 5% Lotion 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 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 away from eyes. 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 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 epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Carcinogenesis, Mutagenesis and Impairment of Fertility

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

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% and Sulfur 5% Lotion. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% and Sulfur 5% Lotion 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 Sodium Sulfacetamide 10% and Sulfur 5% Lotion. 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.

Pediatric Use

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

PERRIGO SODIUM SULFACETAMIDE AND SULFUR ADVERSE REACTIONS

Although rare, sodium sulfacetamide may cause local irritation.

PERRIGO SODIUM SULFACETAMIDE AND SULFUR DOSAGE AND ADMINISTRATION

Apply a thin film of Sodium Sulfacetamide 10% and Sulfur 5% Lotion to affected areas 1 to 3 times daily, or as directed by a physician.

HOW SUPPLIED

Sodium Sulfacetamide 10% and Sulfur 5% Lotion is available as follows:

30 g tube (NDC 45802-946-94)

60 g tube (NDC 45802-946-96)

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

MANUFACTURED BY

STIEFEL LABORATORIES, INC.,

CORAL GABLES, FL 33134

DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010

83318

Rev. 10/07

4Y700 RC J1

Principal Display Panel - 30 g Carton

Sodium Sulfacetamide 10% and Sulfur 5% Lotion

Rx Only

Principal Display Panel - 30 g Tube

Sodium Sulfacetamide 10% and Sulfur 5% Lotion

Rx Only

Principal Display Panel - 60 g Carton

Sodium Sulfacetamide 10% and Sulfur 5% Lotion

Rx Only

Principal Display Panel - 60 g Tube

Sodium Sulfacetamide 10% and Sulfur 5% Lotion

Rx Only