Label: TOBRAMYCIN- tobramycin solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 03/12

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin Ophthalmic Solution USP, 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.

    Tobramycin Ophthalmic Solution USP, 0.3% has a pH range between 7.0 and 8.0.

    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

    MW=467.2

    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-ribohexopyranosyl-(1→6) }-2-deoxystreptamine.

    Close
  • 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.

    Close
  • 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 children.

    Close
  • CONTRAINDICATIONS

    Tobramycin Ophthalmic Solution USP, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

    Close
  • 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.

    Close
  • 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.

    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 Tobramycin Ophthalmic Solution USP, 0.3%, 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 other adult patients.

    Close
  • ADVERSE REACTIONS

    The most frequent adverse reactions to Tobramycin Ophthalmic Solution USP, 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 Tobramycin Ophthalmic Solution USP, 0.3%. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from Tobramycin Ophthalmic Solution USP, 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.

    Close
  • OVERDOSAGE

    Clinically apparent signs and symptoms of an overdose of Tobramycin Ophthalmic Solution USP, 0.3% (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

    Close
  • 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.

    Close
  • HOW SUPPLIED

    5 mL sterile solution is packaged in a 5 mL white plastic DROP-TAINER* bottle with a plastic dispensing plug and white plastic closure (NDC 61314-643-05) containing tobramycin 0.3% (3 mg/mL).

    Storage: Store at 2° - 25°C (36° - 77°F).

    Rx Only

    *DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.

    Close
  • SPL UNCLASSIFIED SECTION

    9007228-1011

    SANDOZ

    Manufactured by
    Alcon Laboratories, Inc.
    Fort Worth, Texas 76134 for
    Sandoz Inc.
    Princeton, NJ 08540
    Printed in USA

    Close
  • PRINCIPAL DISPLAY PANEL

    NDC 61314-643-05

    Tobramycin
    Ophthalmic
    Solution USP
    0.3%

    Rx only

    STERILE
    5 mL

    SANDOZ

    Carton
    Label
    Close
  • INGREDIENTS AND APPEARANCE
    TOBRAMYCIN 
    tobramycin solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61314-643
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE  
    BORIC ACID  
    SODIUM SULFATE  
    SODIUM CHLORIDE  
    TYLOXAPOL  
    SODIUM HYDROXIDE  
    SULFURIC ACID  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61314-643-05 5 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA062535 01/09/1995
    Labeler - Sandoz Inc. (005387188)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    Name Address ID/FEI Business Operations
    Alcon Laboratories, Inc. 008018525 MANUFACTURE
    Close