NDC 24208-670 Sulfacetamide Sodium

Sulfacetamide Sodium

NDC Product Code 24208-670

NDC CODE: 24208-670

Proprietary Name: Sulfacetamide Sodium What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sulfacetamide Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat bacterial eye infections (such as conjunctivitis). It belongs to a class of drugs known as sulfa antibiotics. Sulfacetamide works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

NDC Code Structure

  • 24208 - Bausch & Lomb Incorporated

NDC 24208-670-04

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

Price per Unit: $2.26909 per ML

NDC Product Information

Sulfacetamide Sodium with NDC 24208-670 is a a human prescription drug product labeled by Bausch & Lomb Incorporated. The generic name of Sulfacetamide Sodium is sulfacetamide sodium. The product's dosage form is solution/ drops and is administered via ophthalmic form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1006120.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sulfacetamide Sodium Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • METHYLCELLULOSE (100 MPA.S) (UNII: 4GFU244C4J)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM THIOSULFATE (UNII: HX1032V43M)
  • SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Sulfonamide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Sulfonamides - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bausch & Lomb Incorporated
Labeler Code: 24208
FDA Application Number: ANDA040066 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 12-28-1994 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Sulfacetamide Ophthalmic

Sulfacetamide Ophthalmic is pronounced as (sul fa see' ta mide)

Why is sulfacetamide ophthalmic medication prescribed?
Ophthalmic sulfacetamide stops the growth of bacteria that cause certain eye infections. It is used to treat eye infections and to prevent them after injuries....
[Read More]

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Sulfacetamide Sodium Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx onlyFOR TOPICAL EYE USE ONLY

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:C8H9N2NaO3S • H2O Mol. Wt. 254.24Chemical 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.

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.

Contraindications

Sulfacetamide Sodium Ophthalmic Solution, USP 10% is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.

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

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 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.

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 24208-670-04DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW IS NOT INTACT.

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 ofValeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA©Bausch & Lomb IncorporatedRevised June 20169113202 (Folded)9113302 (Flat)

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