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DESCRIPTION: Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8 H 9 N 2 NaO 3 S·H 2 O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Sodium sulfacetamide 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. image structure

CLINICAL PHARMACOLOGY: Sodium sulfacetamide 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 is no clinical data available on the degree and rate of systemic absorption of this product when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported. The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.

INDICATIONS: This product 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.

PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. 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. If the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. 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. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. The use of this product also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop. Avoid contact with eyes, lips and mucous membranes. Drug Interactions: This product is incompatible with silver preparations. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction has been reported in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide. The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown. Pregnancy: Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product 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 this product is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children under the age of 12 years have not been established.

DOSAGE AND ADMINISTRATION: Seborrheic dermatitis including seborrhea sicca - Shake well before using. 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 this product should be reinitiated as at the beginning of treatment. Secondary cutaneous bacterial infections - Shake well before using. Apply to affected areas twice daily for eight to ten days.

STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep bottle tightly closed. Occasionally, a slight discoloration of fabric may occur when an excessive amount of the product 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: This product is supplied in the following size(s): 2 oz. (57 g) bottles, NDC 0178-0495-02 To report a serious adverse event or obtain product information, call 1-800-298-1087. Manufactured by: MISSION PHARMACAL COMPANY San Antonio, TX 78230 1355 R0222

DESCRIPTION Sulfacetamide Sodium Ophthalmic Solution, USP 10% is a sterile, topical antibacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula: C 8 H 9 N 2 NaO 3 S • H 2 O Mol. Wt. 254.24 Chemical name: N -Sulfanilylacetamide monosodium salt monohydrate. Each mL contains: ACTIVE: Sulfacetamide Sodium, 100 mg/mL (10%); INACTIVES: Methylcellulose, Purified Water, Sodium Thiosulfate. Sodium Phosphate Monobasic may be added to adjust pH (6.8 - 8.0). PRESERVATIVES ADDED: Methylparaben 0.05% and Propylparaben 0.01%. The osmolality range is 700-1300 mOsm/kg. Sulfacetamide Sodium (structural formula)

CLINICAL PHARMACOLOGY Microbiology: The sulfonamides are bacteriostatic agents and the spectrum of activity is similar for all. Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase. Resistant strains have altered dihydropteroate synthetase with reduced affinity for sulfonamides or produce increased quantities of aminobenzoic acid. Topically applied sulfonamides are considered active against susceptible strains of the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa . A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

INDICATIONS AND USAGE Sulfacetamide Sodium Ophthalmic Solution, USP 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa . A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

WARNINGS FOR TOPICAL EYE USE ONLY - NOT FOR INJECTION. FATALITIES HAVE OCCURRED, ALTHOUGH RARELY, DUE TO SEVERE REACTIONS TO SULFONAMIDES INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS. Sensitizations may recur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other serious reaction, discontinue use of this preparation.

PRECAUTIONS General Prolonged use of topical antibacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to sulfonamides may also develop. The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in purulent exudates. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. At the first sign of hypersensitivity, increase in purulent discharge, or aggravation of inflammation or pain, the patient should discontinue use of the medication and consult a physician (see WARNINGS ). Information for Patients To avoid contamination, do not touch tip of container to the eye, eyelid or any surface. Drug Interactions Sulfacetamide preparations are incompatible with silver preparations. Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted in animals or in humans to evaluate the possibility of these effects with ocularly administered sulfacetamide. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term oral administration of sulfonamides has resulted in thyroid malignancies in these animals. Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with sulfonamide ophthalmic preparations. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamides. There are no adequate and well-controlled studies of sulfonamide ophthalmic preparations in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in infants below the age of two months have not been established.

General Prolonged use of topical antibacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to sulfonamides may also develop. The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in purulent exudates. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. At the first sign of hypersensitivity, increase in purulent discharge, or aggravation of inflammation or pain, the patient should discontinue use of the medication and consult a physician (see WARNINGS ).

Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted in animals or in humans to evaluate the possibility of these effects with ocularly administered sulfacetamide. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term oral administration of sulfonamides has resulted in thyroid malignancies in these animals.

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with sulfonamide ophthalmic preparations. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamides. There are no adequate and well-controlled studies of sulfonamide ophthalmic preparations in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

ADVERSE REACTIONS Bacterial and fungal corneal ulcers have developed during treatment with sulfonamide ophthalmic preparations. The most frequently reported reactions are local irritation, stinging and burning. Less commonly reported reactions include non-specific conjunctivitis, conjunctival hyperemia, secondary infections and allergic reactions. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see WARNINGS ). To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

DOSAGE AND ADMINISTRATION For conjunctivitis and other superficial ocular infections: Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days. For trachoma: Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

HOW SUPPLIED Sulfacetamide Sodium Ophthalmic Solution, USP 10% is supplied in a plastic squeeze bottle with a controlled drop tip in the following size: 15 mL bottle - NDC 68071-5123-5 DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW IS NOT INTACT. symbol Storage: Store between 2°-25°C (36°-77°F). Sulfonamide solutions, on long standing, will darken in color and should be discarded. KEEP OUT OF REACH OF CHILDREN. Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA ©Bausch & Lomb Incorporated Revised June 2016 9113202 (Folded) 9113302 (Flat)

Storage: Store between 2°-25°C (36°-77°F). Sulfonamide solutions, on long standing, will darken in color and should be discarded. KEEP OUT OF REACH OF CHILDREN. Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA ©Bausch & Lomb Incorporated Revised June 2016 9113202 (Folded) 9113302 (Flat)

DESCRIPTION Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) contains 100 mg of sulfacetamide sodium in a vehicle consisting of diethanolamine; EDTA; hydroxyethyl cellulose; lauramide DEA; methylparaben; polyethylene glycol 400, monolaurate; propylene glycol; purified water; simethicone; sodium chloride; sodium metabisulfite and xanthan gum. Sulfacetamide sodium is a sulfonamide with antibacterial activity. Chemically, sulfacetamide sodium is N'-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Image 1

CLINICAL PHARMACOLOGY The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of paraminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours. The pharmacokinetics of sulfacetamide and its major metabolite sulfanilamide in sulfacetamide sodium lotion was evaluated in adult subjects (N=14) with acne vulgaris. The subjects applied sulfacetamide sodium lotion to their face, back, chest and shoulders every 12 hours for 28 days. The percentage of the applied dose of sulfacetamide sodium lotion excreted in the urine as sulfacetamide plus sulfanilamide ranged from 0.08 to 0.33%.

CONTRAINDICATIONS Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).

WARNINGS Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section). Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS section).

PRECAUTIONS General - For external use only. Keep away from eyes. 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. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sulfacetamide sodium can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded. Keep out of the reach of children. Carcinogenesis, Mutagenesis, 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 Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion). It is also not known whether Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) should be given to a pregnant woman only if clearly needed. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. Nursing Mothers - It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion). Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women. Pediatric Use - Safety and effectiveness in pediatric patients under the age of 12 have not been established.

General - For external use only. Keep away from eyes. 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. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sulfacetamide sodium can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded. Keep out of the reach of children.

Pregnancy Teratogenic Effects: Pregnancy Category C - Animal reproduction studies have not been conducted with Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion). It is also not known whether Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) should be given to a pregnant woman only if clearly needed. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

Nursing Mothers - It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion). Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.

ADVERSE REACTIONS In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of sulfacetamide sodium lotion was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with sulfacetamide sodium lotion had adverse reactions of erythema, itching and edema. It has been reported that sulfacetamide sodium may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of medication has to be discontinued.

DESCRIPTION: Each gram contains 98 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8 H 9 N 2 NaO 3 S·H 2 O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Sodium sulfacetamide 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. structure

HOW SUPPLIED: This product is supplied in the following size(s): 2 oz. (57 g) bottles, NDC 0178-0620-02 To report a serious adverse event or obtain product information, call 1-800-298-1087. Manufactured by: MISSION PHARMACAL COMPANY San Antonio, TX 78230 1355 R0222