Tobrex
Tobramycin
Alcon Laboratories, Inc.
Human Prescription Drug
NDC 0065-0643Tobrex also known as Tobramycin is a human prescription drug labeled by 'Alcon Laboratories, Inc.'. National Drug Code (NDC) number for Tobrex is 0065-0643. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Tobrex drug includes Tobramycin - 3 mg/mL . The currest status of Tobrex drug is Active.
Drug Information:
| Drug NDC: | 0065-0643 |
| 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: | Tobrex |
| 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: | Tobramycin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alcon Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| 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: | TOBRAMYCIN - 3 mg/mL
|
| 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: | NDA |
| 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: | 15 Mar, 1981 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Mar, 2023 |
| 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: | NDA050541 |
| 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: | 19 Dec, 2025 |
| 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: | Alcon Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 207846
313415
|
| 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. |
| UPC: | 0300650643054
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175477
M0000946
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | VZ8RRZ51VK
|
| 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 EPC: | Aminoglycoside Antibacterial [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Aminoglycosides [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Aminoglycoside Antibacterial [EPC]
Aminoglycosides [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 |
|---|
| 0065-0643-05 | 1 BOTTLE, PLASTIC in 1 CARTON (0065-0643-05) / 5 mL in 1 BOTTLE, PLASTIC | 15 Mar, 1981 | 31 Mar, 2023 | 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. |
Product Elements:
Tobrex tobramycin tobramycin tobramycin benzalkonium chloride boric acid sodium sulfate sodium chloride tyloxapol sodium hydroxide sulfuric acid water carton
Indications and Usage:
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.
Warnings:
Warnings for topical ophthalmic use. not for injection into the eye. sensitivity to topically applied aminoglycosides may occur in some patients. severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. if a sensitivity reaction to tobrex ® (tobramycin ophthalmic solution) 0.3% occurs, discontinue use.
General Precautions:
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.
Dosage and Administration:
Dosage and administration in mild to moderate disease, instill 1 or 2 drops into the affected eye(s) every 4 hours. in severe infections, instill 2 drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.
Contraindications:
Contraindications tobrex (tobramycin ophthalmic solution) 0.3% is contraindicated in patients with known hypersensitivity to any of its components.
Adverse Reactions:
Adverse reactions: the most frequent adverse reactions to tobrex (tobramycin ophthalmic solution) 0.3% 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 ® . postmarketing experience: additional adverse reactions identified from post-marketing use include anaphylactic reaction, stevens-johnson syndrome, and erythema multiforme. the following additional adverse reactions have been reported with systemic aminoglycosides: neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or parkinsonâs disease, because of their potential effect on neuromuscular function.
Use in Pregnancy:
Pregnancy: reproduction studies in 3 types of animals at doses up to 33 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.
Pediatric Use:
Pediatric use: safety and effectiveness in pediatric patients below the age of 2 months has not been established.
Geriatric Use:
Geriatric use: no overall differences in safety or effectiveness have been observed between elderly and younger patients.
Description:
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, purified water, sodium chloride, sodium hydroxide and/or sulfuric acid (to adjust ph), sodium sulfate, and tyloxapol. 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 = 467.52 molecular formula: c 18 h 37 n 5 o 9 chemical name: 0-{3-amino-3-deoxy-α-d-gluco-pyranosyl-(1â4) }-0-{2,6-diamino-2,3,6-trideoxy-α-d-ribohexo-pyranosyl-(1â6)}-2-deoxystreptamine. chemical
Clinical Pharmacology:
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.
How Supplied:
How supplied tobrex (tobramycin ophthalmic solution) 0.3% is supplied as a 5 ml sterile solution, packaged in a 8 ml low density polyethylene white bottle and natural dispensing plug and white polypropylene closure as follows: 5 ml containing tobramycin 0.3% (3 mg/ml) ndc 0065-0643-05 storage: store at 2°c to 25°c (36°f to 77°f). after opening, tobrex (tobramycin ophthalmic solution) 0.3% can be used until the expiration date on the bottle. distributed by: novartis pharmaceuticals corporation east hanover, new jersey 07936 © novartis t2021-65 may 2021
Information for Patients:
Information for patients: do not touch dropper tip to any surface, as this may contaminate the solution.
Package Label Principal Display Panel:
Principal display panel ndc 0065-0643-05 alcon ® tobrex ® (tobramycin ophthalmic solution) 0.3% 5ml sterile