Tobramycin

Henry Schein Inc.
Human Prescription Drug
NDC 0404-7196

Tobramycin is a human prescription drug labeled by 'Henry Schein Inc.'. National Drug Code (NDC) number for Tobramycin is 0404-7196. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Tobramycin drug includes Tobramycin - 3 mg/mL . The currest status of Tobramycin drug is Active.

Drug Information:

Drug NDC:	0404-7196
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:	Tobramycin
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:	Henry Schein 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:	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 May, 2015
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	21 Jan, 2026
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:	ANDA064096
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:	Henry Schein Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	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:	0304047196017
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
0404-7196-01	1 BOTTLE, DROPPER in 1 CARTON (0404-7196-01) / 5 mL in 1 BOTTLE, DROPPER	13 May, 2015	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.

Other medicines with the same generic name

Tobrex

Tobramycin

Solution/ Drops
Alcon Laboratories, Inc.
NDC: 0065-0643

Tobramycin

Injection
Baxter Healthcare Corporation
NDC: 36000-242

Tobramycin

Injection
Baxter Healthcare Corporation
NDC: 36000-244

Product Elements:

Tobramycin tobramycin tobramycin tobramycin boric acid sodium chloride sodium sulfate tyloxapol sodium hydroxide sulfuric acid water benzalkonium chloride

Indications and Usage:

Indications and usage: tobramycin ophthalmic solution usp, 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 tobramycin ophthalmic solution usp, 0.3%. clinical studies have shown tobramycin to be safe and effective for use in pediatric patients.

Warnings:

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 tobramycin ophthalmic solution usp, 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 conjunctivitis.

Dosage and Administration:

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.

Contraindications:

Contraindications: tobramycin ophthalmic solution usp, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

Adverse Reactions:

Adverse reactions: the most frequent adverse reactions to tobramycin 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 tobramycin. similar reactions may occur with the topical use of other aminoglycoside antibiotics. other adverse reactions have not been reported from tobramycin therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

Use in Pregnancy:

Pregnancy category b: 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.

Pediatric Use:

Pediatric use: safety and effectiveness in pediatric patients below the age of two months has not been established.

Geriatric Use:

Geriatric use: no overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

Overdosage:

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

Description:

Description: tobramycin ophthalmic solution usp, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. tobramycin is a water soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. the molecular formula is c 18 h 37 n 5 o 9 , the molecular weight is 467.52 and the structural formula is: chemical name: o-{3-amino-3-deoxy-Î±-d-gluco-pyranosyl-(1 â 4)}-o-{2,6-diamino-2,3,6-trideoxy-Î±-d-ribohexo-pyranosyl-(1 â 6)}-2-deoxystreptamine. each ml contains: active: tobramycin 3 mg (0.3%). inactives: boric acid, sodium chloride, sodium sulfate, tyloxapol, sodium hydroxide and/or sulfuric acid to adjust ph (7.0 to 8.0), and water for injection. preservative: benzalkonium chloride 0.1 mg (0.01%). tobramycin structural formula

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: tobramycin ophthalmic solution usp, 0.3% is supplied as a sterile solution in plastic dropper bottles in two sizes: ndc 0404-7196-01 . . . . . . . . . . . . 5 ml storage: store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. keep container tightly closed. protect from excessive heat. distributed by (in us only): henry schein inc. 135 duryea road melville, ny 11747 usa btm00n rev. 08/14

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 text for container label: henry schein logo ndc 0404-7196-01 112-7196 tobramycin ophthalmic solution, usp 0.3% sterile 5 ml rx only principal display panel text for container label

Principal display panel text for carton label: henry schein logo ndc 0404-7196-01 112-7196 tobramycin ophthalmic solution, usp 0.3% sterile rx only 5 ml principal display panel text for carton label

Comments/ Reviews:

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