sulfacetamide sodium
Dosage Form: shampoo
Ovace® Plus Shampoo
ACTIVE INGREDIENT:
Sodium Sulfacetamide 10% w/w.
INACTIVE INGREDIENTS:
Citric Acid, Cocamide MEA, Ethoxydiglycol, Fragrance, Glycol Distearate, Magnesium Aluminum Silicate, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-150 Distearate, Purified Water (Aqua), Sodium Chloride, Sodium Laureth Sulfate, Xanthan Gum.
Sulfacetamide sodium is C8H9N2NaO3S·H2O with 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 or 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 Ovace® Plus Shampoo 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 that show susceptibility to sulfacetamide sodium are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae,Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.
INDICATIONS AND USAGE:
Ovace® Plus Shampoo is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). Shake well before using.
CONTRAINDICATIONS:
Ovace® Plus Shampoo 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.
Keep out of reach of children.
PRECAUTIONS:
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 Ovace® Plus Shampoo 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 Ovace® Plus Shampoo if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Ovace® Plus Shampoo also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop.
Drug Interactions:Ovace® Plus Shampoo is incompatible with silver preparations.
Pharmacology:Ovace® Plus Shampoo has a bacteriostatic effect against Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections.
Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on Ovace® Plus Shampoo to date. Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction in the yeast, Saccharomyces cerevisiae, following application of sulfacetamide sodium has been reported. 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 Ovace® Plus Shampoo. It is also not known whether Ovace® Plus Shampoo can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ovace® Plus Shampoo 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 Ovace® Plus Shampoo is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in children under the age of 12 years have not been established.
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 was reported. (See WARNINGS.)
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
OVERDOSAGE:
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 oral overdosage may cause hematuria, crystalluria, and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center or your doctor.
DOSAGE AND ADMINISTRATION:
Apply to wet hair and massage vigorously into scalp. Rinse thoroughly. For best results use at least twice a week or as directed by a doctor. Avoid contact with eyes or mucous membranes. Do not give to an infant less than 2 months of age.
HOW SUPPLIED:
Ovace® Plus Shampoo is available in a 8 fl. oz. NDC 23589-035-08 bottle and as a 5 g. NDC 23589-035-15 sample packet.
STORAGE:
Store at controlled room temperature 20°-25°C (68°-77°F).
Note: Protect from freezing and excessive heat. The shampoo 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 shampoo 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.
Manufactured for:
TIBER LABORATORIES
Suwanee, GA 30024
Patent Pending
PACKAGING:
NDC 23589-035-08
Rx Only
OVACE® Plus Shampoo
(Sodium Sulfacetamide 10%)
Net 8 fl. oz. (237 mL)
ACTIVE INGREDIENT: Sodium Sulfacetamide 10% w/w
INACTIVE INGREDIENTS: Citric Acid, Cocamide MEA, Ethoxydiglycol, Fragrance, Glycol Distearate, Magnesium Aluminum Silicate, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-150 Distearate, Purified Water (Aqua), Sodium Chloride, Sodium Laureth Sulfate, Xanthan Gum.
INDICATIONS AND USAGE: Intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). Shake well before using.
DOSAGE AND ADMINISTRATION: Apply to wet hair and massage vigorously into scalp. Rinse thoroughly. For best results use at least twice a week or as directed by a doctor. Avoid contact with eyes or mucous membranes. Do not give to an infant less than 2 months of age.
WARNING: For external use only. Keep this and all drugs out of reach of children.
STORAGE: Store at controlled room temperature 20°-25°C (68°-77°F).
Protect from freezing and excessive heat.
Manufactured for:
TIBER LABORATORIES
Suwanee, GA 30024
Patent Pending
Sample Carton:
Sample Label:
| OVACE PLUS sulfacetamide sodium shampoo | ||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 01/01/2009 | ||
| Labeler - Tiber Laboratories, LLC. (008913939) |
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