NDC 0404-7194 Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc

Neomycin Sulfate, Polymyxin B Sulfate And Bacitracin Zinc

NDC Product Code 0404-7194

NDC CODE: 0404-7194

Proprietary Name: Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc 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: Neomycin Sulfate, Polymyxin B Sulfate And Bacitracin Zinc 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 decrease the risk of infection after certain intestinal surgeries. Neomycin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria in the intestines. Neomycin may also be used along with a special diet to treat a certain serious brain problem (hepatic encephalopathy). This condition is caused by too much of a certain natural substance (ammonia). Normally, the liver gets rid of ammonia, but liver disease can cause too much ammonia to build up in the body. This medication helps treat encephalopathy by killing certain intestinal bacteria that make ammonia. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
  • Drug uses not available

NDC Code Structure

  • 0404 - Henry Schein Inc.
    • 0404-7194 - Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc

NDC 0404-7194-01

Package Description: 1 TUBE in 1 CARTON > 3.5 g in 1 TUBE

NDC Product Information

Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc with NDC 0404-7194 is a a human prescription drug product labeled by Henry Schein Inc.. The generic name of Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc is neomycin sulfate, polymyxin b sulfate and bacitracin zinc. The product's dosage form is ointment and is administered via ophthalmic form.

Labeler Name: Henry Schein Inc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc 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.

  • NEOMYCIN SULFATE 3.5 mg/g
  • POLYMYXIN B SULFATE 10000 [USP'U]/g
  • BACITRACIN ZINC 400 [USP'U]/g

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.

  • PETROLATUM (UNII: 4T6H12BN9U)

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.

  • Aminoglycoside Antibacterial - [EPC] (Established Pharmacologic Class)
  • Aminoglycosides - [CS]
  • Polymyxin-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • Polymyxins - [CS]
  • Decreased Cell Wall Synthesis & Repair - [PE] (Physiologic Effect)

Product Labeler Information

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

Labeler Name: Henry Schein Inc.
Labeler Code: 0404
FDA Application Number: ANDA065088 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: 05-13-2015 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 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. Values = ‘Y’ or ‘N’.

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Information for Patients

Neomycin, Polymyxin, and Bacitracin Ophthalmic

Neomycin, Polymyxin, and Bacitracin Ophthalmic is pronounced as (nee oh mye' sin) (pol i mix' in) (bass i tray' sin)

Why is neomycin, polymyxin, and bacitracin ophthalmic medication prescribed?
Neomycin, polymyxin, and bacitracin ophthalmic combination is used to treat eye and eyelid infections. Neomycin, polymyxin, and bacitracin are in a class of medications c...
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Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc Product Label Images

Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc 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 only

Description:

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is a sterile antimicrobial ointment for ophthalmic use. Each gram contains: Neomycin Sulfate (equivalent to 3.5 mg neomycin base), Polymyxin B sulfate equal to 10,000 polymyxin B units, bacitracin zinc equal to 400 bacitracin units, and white petrolatum, q.s.
Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formula are:
Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 , which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:
Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula is:

Clinical Pharmacology

A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and bacitracin.
Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic, which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.
Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.
Bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms. It interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in peptidoglycan synthesis.

Microbiology

Microbiology: Neomycin sulfate, polymyxin B sulfate, and bacitracin zinc together are considered active against the following microorganisms: Staphylococcus aureus, streptococci including Streptococcus pneumoniae, Escherichiacoli, Haemophilusinfluenzae, Klebsiella/ Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.

Indications And Usage

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment. USP is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

Contraindications

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings

NOT FOR INJECTION INTO THE EYE. Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment, USP should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing.
Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Application of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

General Precautions

General: As with other antibiotic preparations, prolonged use of Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.
Bacterial resistance to Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP may also develop. If purulent discharge, inflammation, or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.
There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers, which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).
Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Information For Patients

Information for Patients: Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.
Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).
If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician, Do not use this product if you are allergic to any of the listed ingredients.
Keep tightly closed when not in use. Keep out of reach of children.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.
Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, liter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.

Pregnancy

Pregnancy: Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with neomycin sulfate, polymyxin B sulfate, or bacitracin. It is also not known whether Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP should be given to pregnant woman only if clearly needed.

Nursing Mothers

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 Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is administered to a nursing woman.

Pediatric Use

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

Adverse reactions have occurred with the anti-infective components of Neomycin and Polymyxin B Sulfate and Bacitracin Zinc Ophthalmic Ointment, USP. The exact incidence is not known. Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.
Local irritation on instillation has also been reported.

Dosage And Administration

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

How Supplied

Tube of 1/8 oz. (3.5 g) with ophthalmic tip.
NDC 0404-7194-01

Storage And Handling

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Distributed by (in US only):HENRY SCHEIN INC.135 DURYEA ROADMELVILLE, NY 11747 USA
BNPB00N Rev. 10/15

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