Sodium Sulfacetamide Scalp Treatment

Dosage Form: topical lotion

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10% Sulfacetamide Sodium USP Scalp Treatment Lotion

DESCRIPTION:

River’s Edge Scalp Treatment Lotion contains in each gram: 100mg Sulfacetamide Sodium, in an emulsion base containing Urea 10%, Polyethylene Glycol 400 Monostearate, Isopropyl Myristate, Propylene Glycol Monostearate, Propylene Glycol, Sodium Thiosulfate, Methyl Paraben, Tetrasodium EDTA and Purified Water. This bland lotion, containing surface active agents which allow the medication to come into intimate contact with the skin, is greaseless and disappears when rubbed into the skin or scalp. The hair can be combed and arranged as usual after application. The lotion rinses easily from the scalp with water.

Sulfacetamide sodium is C8H9N2NaO3S H20 with a molecular weight of 254.24. Chemically it is Acetamide, N-[(4-aminophenyl) sulfonyl]-, monosodium salt, monohydrate, with the following structural formula:

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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 River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion 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.

INDICATIONS AND USAGE:

River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion is intended for topical appliccaton 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.

CONTRAINDICATIONS:

River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion is contraindicated in persons with known or susceptible hypersensitivity to sulfonamides or to any of the ingredients of the preparation.

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 River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is grater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially ay 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 River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop.

Drug Interactions: River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion is incompatible with silver preparations.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion to date. Studies on reproduction and fertility also have not been performed. One author detected chromosomal nondisjuntion 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 Category C: Animal reproduction studies have not been conducted with River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion. It also is not known whether River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion should be sued by 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 River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children blow the age of 12 years have not been established.

ADVERSE REACTIONS:

Reports or 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 erythematous; in one case a fatal outcome has been reported. (See WARNINGS.)

OVERDOSAGE:

The oral LD50 of sulfacetamide in mice is 16.5g/kg. In the event of overdosage, emergency treatment should be started immediately.

Manifestations: Overdosage may cause nausea and vomiting. Large doses may cause hematuria, crystalluria, and renal shutdown due to precipitation of sulfa crystals in the renal tubules and urinary tract.

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.

DOSAGE AND ADMINISTRATION:

Seborrheic dermatitis including seborrhea sicca – In mild cases involving the scalp and adjacent skin areas, including noninflammatory types with scaling (dandruff), the lotion should be applied as directed by a physician with best results occurring when applied at bedtime and allowed to remain overnight. Its application should be preceded by a shampoo if the hair and scalp are oily or greasy or if there is considerable debris. In severe cases with crusting, heavy scaling, and inflammation involving the scalp or the scalp and other skin, the lotion should be applied twice daily. Initially, the hair and scalp should be cleansed with a nonirritating shampoo, such as, River’s Edge 10% Urea Deep Cleansing Shampoo. To ensure intimate contact of the medication with the affected skin, cleansing should be repeated as frequently as necessary thereafter.

The applicator tip of the plastic tube is convenient for applying River’s Edge 10% Sufacetamide Sodium USP Scalp Treatment Lotion, especially for patients with thick hair. Part hair one section at a time and apply a small amount of lotion along part line. Repeat until scalp is moistened, then massage into scalp thoroughly with fingers. Remove excess lotion or large scales by gently brushing scalp. Leave lotion on overnight or as directed by physician. Shampooing following treatment is not necessary but hair should washed at least once a week. (A thorough brushing or rinsing with plain water will remove any excess medication.) The application of the lotion, as described, should be repeated 8 to 10 times. As the eruption subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the eruption recur after stopping therapy, the application of River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion should be reinitiated as at the beginning of treatment.

Secondary Cutaneous Bacterial Infections – The lotion should be applied to affected areas 2 to 4 time daily until the infection has cleared.

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing. The lotion may tend to darken slightly on prolonged standing. Slight discoloration does not impair the efficacy or safety of the product. Occasionally, a slightly yellowish discoloration may occur when an excessive amount of the lotion is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches.

HOW SUPPLIED:

River’s Edge 10% Sulfacetamide Sodium USP Scalp Treatment Lotion is supplied in an 85 g (3 oz.) tube, NDC 68032-109-03. It is also available in the Scalp Treatment Kit, NDC 110-01.

Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Rev.08/09 110-11

PACKAGING:

Rx Only
NDC 68032-110-01
Scalp Treatment KIT
For the Topical Treatment of Seborrheic Dermatitis, Scaling Dermatoses, and Seborrhea Sicca (including Common Dandruff).

CONTENTS:
10% Sulfacetamide Sodium, USP
SCALP TREATMENT LOTION
3 oz. Tube

10% Urea Deep Cleansing Antibacterial Shampoo

Scalp Treatment Brush

See inside for full Prescribing Information.
Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

River’s Edge Scalp Treatment Kit (Rx Only) contains a 3 oz. tube of River’s Edge Scalp Treatment Lotion, a 4 oz. bottle of River’s Edge Deep Cleansing Antibacterial Shampoo, and a River’s Edge Scalp  Treatment brush.
A brief description of each component of the River’s Edge Scalp Treatment Kit follows:
1.    River’s Edge Scalp Treatment Lotion with 10% Sufacetamide Sodium (an antibacterial) is in a bland greaseless lotion which disappears when rubbed into the scalp. Urea 10% (a skin softener) and surface-active agent, allow for intimate contact of the drug with the scalp. INGREDIENTS: River’s Edge Scalp Treatment Lotion contains in each gram: 100mg Sulfacetamide Sodium, in an emulsion base containing Urea 10%, Polyethylene Glycol 400 Monostearate, Isopropyl Myristate, Propylene Glycol Monostearate, Propylene Glycol, Sodium Thiosulfate, Methyl Paraben, Tetrasodium EDTA and Purified Water.
2.    River’s Edge Deep Cleansing Antibacterial Shampoo is used to wash hair before applying the River’s Edge Scalp Treatment Lotion and if necessary, after completion of the treatment. INGREDIENTS: River’s Edge 10% Urea Deep Cleansing Antibacterial Shampoo consists of 10% Urea, TEA Lauryl Sulfate, Lauramide DEA, Ethoxydiglycol, Carbomer, PEG-12 Distearate, Disodium EDTA, Triclosan, Trolamine, Menthol, DC Yellow #8 and Purified Water.
3.    River’s Edge Scalp Treatment Brush is a convenient way of working the lotion into the scalp to help massage the medication into the skin, without irritating the scalp.

Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Rev. 08/09 110-31

SULFACETAMIDE SODIUM 
sulfacetamide sodium scalp treatment lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-110
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 g
Packaging
# Item Code Package Description
1 NDC:68032-110-01 85 g in 1 KIT
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2009
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2009
 
River's Edge Pharmaceuticals, LLC



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