Perrigo Seb Prev

Perrigo New York Inc

SEB-PREV™ GEL (SODIUM SULFACETAMIDE 10%)

FULL PRESCRIBING INFORMATION: CONTENTS*

• PERRIGO SEB PREV DESCRIPTION
• CLINICAL PHARMACOLOGY
• PERRIGO SEB PREV INDICATIONS AND USAGE
• PERRIGO SEB PREV CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Information For Patients
  • Drug Interactions
  • Carcinogenesis, Mutagenesis, and Impairment of Fertility
  • Pregnancy
  • Nursing Mothers
  • Pediatric Use
• PERRIGO SEB PREV ADVERSE REACTIONS
• OVERDOSAGE
• PERRIGO SEB PREV 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

Seb-Prev Gel

(Sodium Sulfacetamide 10%)

Rx Only

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE

PERRIGO SEB PREV DESCRIPTION

Each gram of Seb-Prev™ Gel contains 100 mg of Sulfacetamide Sodium USP in a vehicle consisting of edetate disodium, glycerin, methylparaben, propylene glycol, purified water, sodium thiosulfate, and xanthan gum.

Sulfacetamide sodium is C8H9N2NaO3S•H2O with a molecular weight of 254.24. Chemically, it is Acetamide N-[(4-aminophenyl)sulfonyl]-, monosodium salt, monohydrate, with the following structural formula:

Sulfacetamide sodium is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform, and in ether.

CLINICAL PHARMACOLOGY

Sulfacetamide sodium exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There are no clinical data available on the degree and rate of systemic absorption of Seb-Prev™ Gel when applied to the skin or scalp. However, significant absorption of sulfacetamide sodium through the skin has been reported.

The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sulfacetamide sodium are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.

PERRIGO SEB PREV INDICATIONS AND USAGE

Seb-Prev™ Gel is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

PERRIGO SEB PREV CONTRAINDICATIONS

Seb-Prev™ Gel is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.

WARNINGS

Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sulfacetamide sodium 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.

PRECAUTIONS

General

Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If Seb-Prev™ Gel produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed.

Information For Patients

Patients should discontinue Seb-Prev™ Gel if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Seb-Prev™ Gel also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop. For external use only. Avoid contact with eyes and mucous membranes. Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or poison control center immediately (see OVERDOSAGE).

Drug Interactions

Seb-Prev™ Gel is incompatible with silver preparations.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies for carcinogenic potential have not been performed on Seb-Prev™ Gel to date. Studies on reproduction and fertility also have not been performed. One author detected chromosomal nondisjunction in the yeast, Saccharomyces cerevisiae, following application of sulfacetamide sodium. The significance of this finding to the topical use of sulfacetamide sodium in the human is unknown.

Pregnancy

Teratogenic effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Seb-Prev™ Gel. It also is not known whether Seb-Prev™ Gel can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Seb-Prev™ Gel should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Seb-Prev™ Gel is administered to a nursing woman.

Pediatric Use

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

PERRIGO SEB PREV ADVERSE REACTIONS

Reports of irritation and hypersensitivity to sulfacetamide sodium are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sulfacetamide sodium, 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 has been reported (see WARNINGS ).

OVERDOSAGE

The oral LD50 of sulfacetamide in mice is 16.5 g/kg. The LD50 for topical administration of sulfacetamide has not been determined. Oral overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria, and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. In the event of overdosage, call a physician or poison control center; emergency treatment should be started immediately.

Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method. However, vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of eight to twelve fluid ounces of water. If emesis does not occur within 15 minutes, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should

be performed. Isotonic and one-half isotonic saline are the lavage solutions of choice. Saline cathartics, such as milk of magnesia, draw water into the bowel by osmosis and, therefore, may be valuable for their action in rapid dilution of bowel content. After emergency treatment, the patient should continue to be medically monitored.

Observe kidney function for up to 1 week and have the patient ingest copious amounts of fluid during this period. Mannitol infusions may be helpful at the first sign of oliguria. Alkalinization of the urine by ingestion of bicarbonate is very helpful in preventing crystallization of sulfa drug in the kidney.

PERRIGO SEB PREV DOSAGE AND ADMINISTRATION

Seborrheic dermatitis including seborrhea sicca: Apply to affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Repeat application as described for eight to ten days.

As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of Seb-Prev™ Gel should be reinitiated as at the beginning of treatment.

Secondary cutaneous bacterial infections: Apply to affected areas twice daily for eight to ten days.

HOW SUPPLIED

Seb-Prev™ Gel is available as follows:

30 g tube (NDC 45802-960-94)

60 g tube (NDC 45802-960-96)

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Do not freeze.

Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration is readily removed by ordinary laundering without bleaches.

MANUFACTURED BY

STIEFEL LABORATORIES, INC.

CORAL GABLES, FL 33134

DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010

Rev. 10/07

81084

: 5P600 RC J1

Principal Display Panel - 30 g Carton

Seb-Prev™ Gel

(Sodium Sulfacetamide 10%)

For Dermatologic Use Only. Not for Ophthalmic Use.

Rx Only

Principal Display Panel - 30 g Tube

Seb-Prev™ Gel

(Sodium Sulfacetamide 10%)

For Dermatologic Use Only. Not for Ophthalmic Use.

Rx Only

Principal Display Panel - 60 g Carton

Seb-Prev™ Gel

(Sodium Sulfacetamide 10%)

For Dermatologic Use Only. Not for Ophthalmic Use.

Rx Only

Principal Display Panel - 60 g Tube

Seb-Prev™ Gel

(Sodium Sulfacetamide 10%)

For Dermatologic Use Only. Not for Ophthalmic Use.

Rx Only