SODIUM SULFACETAMIDE - sulfacetamide sodium liquid
Kylemore Pharmaceuticals, LLC
----------Sodium Sulfacetamide 10% Wash
Sodium Sulfacetamide 10% Wash 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.
Sodium Sulfacetamide 10% Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.
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.
For external use only.
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 Sodium Sulfacetamide 10% Wash 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 Sodium Sulfacetamide 10% Wash if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Sodium Sulfacetamide 10% Wash also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop.
Drug Interactions:Sodium Sulfacetamide 10% Wash is incompatible with silver preparations.
Pharmacology: Sodium Sulfacetamide 10% Wash has bacteriostatic effect against gram-positive and gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Longterm animal studies for carcinogenic potential have not been performed on Sodium Sulfacetamide 10% Wash 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 Category C: Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% Wash. It also is not known whether Sodium Sulfacetamide 10% Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% Wash should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
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 Sodium Sulfacetamide 10% Wash is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in children under the age of 12 years have not been established.
The oral LD50 of sulfacetamide in mice is 16.5 g/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.
Sodium Sulfacetamide 10% Wash is available in a 6 oz. bottle. NDC 49769-100-06 and a 12 oz. bottle. NDC 49769-100-12 bottle.
Note: Store at controlled room temperature. 20°-25°C (68°– 77°F) The wash may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product.
Occasionally, a slight yellowish discoloration may occur when an excessive amount of the wash 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.
Port St. Joe, FL 32456
REORDER NO. 49769-100-06 (6 oz. bottle) and 49769-100-12 (12 oz. bottle)
Iss. 02/10 100-10 P0551
Below is a the current packaging being used:
sodium sulfacetamide liquid
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|unapproved drug other||03/01/2010||04/19/2011|
|Labeler - Kylemore Pharmaceuticals, LLC (831892471)|