NDC 0065-0643 Tobrex

Tobramycin

NDC Product Code 0065-0643

NDC CODE: 0065-0643

Proprietary Name: Tobrex 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: Tobramycin 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 people with a certain inherited condition (cystic fibrosis) who have a persistent lung infection with a certain bacteria (Pseudomonas aeruginosa). People with cystic fibrosis produce thick, sticky mucus that can plug up the tubes, ducts and passageways in the lungs. This can result in serious breathing problems and infections in the lungs. Tobramycin belongs to a class of drugs known as aminoglycoside antibiotics. Tobramycin inhalation solution works by stopping the growth of a certain bacteria (Pseudomonas aeruginosa) that commonly infects the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, and helps to improve breathing.

NDC Code Structure

  • 0065 - Alcon Laboratories, Inc.

NDC 0065-0643-05

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 5 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Tobrex with NDC 0065-0643 is a a human prescription drug product labeled by Alcon Laboratories, Inc.. The generic name of Tobrex is tobramycin. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Alcon Laboratories, Inc.

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.

Tobrex 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.

  • TOBRAMYCIN 3 mg/mL

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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • SODIUM SULFATE (UNII: 0YPR65R21J)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • TYLOXAPOL (UNII: Y27PUL9H56)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SULFURIC ACID (UNII: O40UQP6WCF)
  • WATER (UNII: 059QF0KO0R)

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.
  • 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]

Product Labeler Information

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

Labeler Name: Alcon Laboratories, Inc.
Labeler Code: 0065
FDA Application Number: NDA050541 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: NDA - A product marketed under an approved 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: 03-15-1981 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

Tobramycin Ophthalmic

Tobramycin Ophthalmic is pronounced as (toe bra mye' sin)

Why is tobramycin ophthalmic medication prescribed?
Ophthalmic tobramycin is used to treat eye infections. Tobramycin is in a class of medications called antibiotics. It works by killing bacteria that cause infections....
[Read More]

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Tobrex 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

Description

TOBREX® (tobramycin ophthalmic solution) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.Each mL of TOBREX® (tobramycin ophthalmic solution) 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and purified water. TOBREX® (tobramycin ophthalmic solution) 0.3% has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg.Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.The chemical structure of tobramycin is:Molecular Weight = 467.52Molecular Formula: C18H37N5O9Chemical Name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine.

Clinical Pharmacology

In Vitro Data: In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

Indications And Usage

TOBREX® (tobramycin ophthalmic solution) 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX®. Clinical studies have shown tobramycin to be safe and effective for use in children.

Contraindications

TOBREX® (tobramycin ophthalmic solution) 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

Warnings

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to TOBREX® (tobramycin ophthalmic solution) 0.3% occurs, discontinue use.

General:

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.

Information For Patients:

Do not touch dropper tip to any surface, as this may contaminate the solution.

Pregnancy:

Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers:

Because of the potential for adverse reactions in nursing infants from TOBREX®, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in pediatric patients below the age of 2 months has not been established.

Geriatric Use:

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

Adverse Reactions:

The most frequent adverse reactions to TOBREX® Ophthalmic Solution are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with TOBREX®. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from TOBREX® (tobramycin ophthalmic solution) 0.3% therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

Overdosage

Clinically apparent signs and symptoms of an overdose of TOBREX® (tobramycin ophthalmic solution) 0.3% (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

Dosage And Administration

In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.

How Supplied

5 mL sterile solution is packaged in a 8 mL low density polyethylene white DROP-TAINER® bottle and natural dispensing plug and white polypropylene closure (NDC 0065-0643-05) containing tobramycin 0.3% (3 mg/mL).Storage: Store at 2°C-25°C (36°F- 77°F).Rx Only
© 2000-2003, 2012, 2018 NovartisRevised: April 2018Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAAlcon®
A Novartis companyT2018-31

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