Your browser does not support JavaScript! TOBREX (TOBRAMYCIN) SOLUTION [ALCON LABORATORIES, INC.]
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TOBREX (tobramycin) solution
[Alcon Laboratories, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL New Drug Application
Drug Label Sections

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® solution 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:


chemical

Molecular Weight = 467.52

Molecular Formula: C18H37N5O9

Chemical 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 hyper sensitivity 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.

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.

Information For Patients

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

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.

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° - 25°C (36° - 77°F).

Rx Only
© 2000-2003, 2012 Novartis
Revised: June 2012

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Printed in USA

9008199-0712

PRINCIPAL DISPLAY PANEL

NDC 0065-0643-05

Alcon®

Tobrex®
(tobramycin ophthalmic solution) 0.3%

5mL Sterile

Carton
Label

TOBREX  
tobramycin solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0065-0643
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BORIC ACID 
SODIUM SULFATE 
SODIUM CHLORIDE 
TYLOXAPOL 
SODIUM HYDROXIDE 
SULFURIC ACID 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0065-0643-055 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA05054103/15/1981
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Laboratories, Inc.008018525MANUFACTURE(0065-0643)

Revised: 11/2012
 
Alcon Laboratories, Inc.

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