Sulfacetamide Sodium

Padagis Us Llc
Human Prescription Drug
NDC 0574-4190

Sulfacetamide Sodium is a human prescription drug labeled by 'Padagis Us Llc'. National Drug Code (NDC) number for Sulfacetamide Sodium is 0574-4190. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Sulfacetamide Sodium drug includes Sulfacetamide Sodium - 100 mg/g . The currest status of Sulfacetamide Sodium drug is Active.

Drug Information:

Drug NDC:	0574-4190
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Sulfacetamide Sodium
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Sulfacetamide Sodium
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Padagis Us Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Ointment
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	SULFACETAMIDE SODIUM - 100 mg/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	OPHTHALMIC
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	13 Aug, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	18 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA080029
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Padagis US LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1000673
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	4NRT660KJQ
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Sulfonamide Antibacterial [EPC] Sulfonamides [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0574-4190-35	1 TUBE in 1 CARTON (0574-4190-35) / 3.5 g in 1 TUBE	13 Aug, 2014	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

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Product Elements:

Sulfacetamide sodium sulfacetamide sodium sulfacetamide sodium sulfacetamide petrolatum mineral oil

Drug Interactions:

Drug interactions: sulfacetamide preparations are incompatible with silver preparations.

Indications and Usage:

Indications and usage: for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms: escherichia coli, staphylococcus aureus, staphylococcus pneumonia, 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 aeroginosa . a significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

Warnings:

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.

General Precautions:

General: prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. bacterial resistance to sulfonamides may also develop. ophthalmic ointments may retard corneal wound healing. the effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in the 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 ).

Dosage and Administration:

Dosage and administration: for conjunctivitis and other superficial ocular infections: apply a small amount (approximately one-half inch ribbon) into the conjunctival sac(s) of the affected eye(s) every three to four hours and at bedtime. dosages may be tapered by increasing the time interval between doses as the condition responds. the ointment may be used as adjunct to the solution. the usual duration of treatment is seven to ten days.

Contraindications:

Contraindications: hypersensitivity to sulfonamides or to any ingredient of the preparation.

Adverse Reactions:

Adverse reactions: bacterial and fungal corneal ulcers have been 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 perrigo at 1-866-634-9120 , or fda at 1-800-fda-1088 or www.fda.gov/medwatch .

Drug Interactions:

Drug interactions: sulfacetamide preparations are incompatible with silver preparations.

Use in Pregnancy:

Pregnancy: teratorgenic effects. 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.

Pediatric Use:

Pediatric use: safety and effectiveness in children below the age of two months have not been established.

Description:

Description: sulfacetamide sodium ointment usp, 10%, is a sterile, topical anti-bacterial agent for ophthalmic use. each gram contains sulfacetamide sodium usp, 100 mg in an ointment base of white petrolatum and mineral oil. sulfacetamide sodium is an odorless, white, crystalline powder. it is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in benzene, chloroform, and ether. chemically it is n -sulfanilylacetamide monosodium salt monohydrate, and is represented by the following structural formula: chemical structure

Clinical Pharmacology:

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 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 aeroginosa . a significant percentage of staphylococcal isolates are completely resistant Read more...

to sulfa drugs.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

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.

How Supplied:

How supplied: sulfacetamide sodium ophthalmic ointment usp, 10%, is supplied in 3.5 gram (1/8 oz) sterile, tamper evident tubes, ndc 0574- 4190 -35 store at 20Â°-25Â°c (68Â°-77Â°f) [see usp controlled room temperature].

Information for Patients:

Information for patients: to avoid contamination, do not touch tip of container to eye, eyelid or any surface.

Package Label Principal Display Panel:

Package/label principal display panel - carton rx only ndc 0574- 4190 -35 sterile sulfacetamide sodium ophthalmic ointment usp, 10% net wt 3.5 g (1/8 oz) the following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation 1z7rc-sulfacetamide-sodium-ophthalmic-ointment.jpg serialization-template.jpg

Comments/ Reviews:

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