Label: TOBRAMYCIN AND DEXAMETHASONE - tobramycin and dexamethasone suspension/ drops

  • NDC Code(s): 61314-647-05, 61314-647-10, 61314-647-25
  • Packager: Sandoz Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated October 15, 2015

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

  • DESCRIPTION

    Tobramycin and Dexamethasone Ophthalmic Suspension is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use.

    The chemical structures for tobramycin and dexamethasone are presented below:

    
tobramycin-chemical
    
tobramycin-chemical-text

    
dex-chemical
    
dex-chemical-text

    Each mL of Tobramycin and Dexamethasone Ophthalmic Suspension contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg). Preservative: benzalkonium chloride 0.01%. Inactives: tyloxapol, edetate disodium, sodium chloride, hydroxyethyl cellulose, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH) and purified water.

    Close
  • CLINICAL PHARMACOLOGY

    Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant. Dexamethasone is a potent corticoid.

    The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that 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 remain susceptible to tobramycin.

    No data are available on the extent of systemic absorption from Tobramycin and Dexamethasone Ophthalmic Suspension; however, it is known that some systemic absorption can occur with ocularly applied drugs. If the maximum dose of Tobramycin and Dexamethasone Ophthalmic Suspension is given for the first 48 hours (two drops in each eye every 2 hours) and complete systemic absorption occurs, which is highly unlikely, the daily dose of dexamethasone would be 2.4 mg. The usual physiologic replacement dose is 0.75 mg daily. If Tobramycin and Dexamethasone Ophthalmic Suspension is given after the first 48 hours as two drops in each eye every 4 hours, the administered dose of dexamethasone would be 1.2 mg daily.

    Close
  • INDICATIONS AND USAGE

    Tobramycin and Dexamethasone Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

    Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

    The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

    The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:

    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.

    Close
  • CONTRAINDICATIONS

    Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

    Close
  • WARNINGS

    NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction does occur, discontinue use.

    Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Intraocular pressure should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

    Close
  • PRECAUTIONS

    General

    The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. When multiple prescriptions are required, or whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

    Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

    Information for Patients

    Do not touch dropper tip to any surface, as this may contaminate the contents. Contact lenses should not be worn during the use of this product.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No studies have been conducted to evaluate the carcinogenic or mutagenic potential. No impairment of fertility was noted in studies of subcutaneous tobramycin in rats at doses of 50 and 100 mg/kg/day.

    Pregnancy

    Category C

    Corticosteroids have been found to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy. Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well controlled studies in pregnant women. Tobramycin and Dexamethasone Ophthalmic Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Close
  • Nursing Mothers

    Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tobramycin and Dexamethasone Ophthalmic Suspension is administered to a nursing woman.

    Close
  • Pediatric Use

    Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

    Close
  • Geriatric Use

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

    Close
  • ADVERSE REACTIONS

    Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available. The most frequent adverse reactions to topical ocular tobramycin [TOBREX®* (tobramycin ophthalmic solution)] are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration. The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

    Secondary Infection

    The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

    Close
  • OVERDOSAGE

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

    Close
  • DOSAGE AND ADMINISTRATION

    One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

    Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

    Close
  • HOW SUPPLIED

    Sterile ophthalmic suspension in 2.5 mL (NDC 61314-647-25), 5 mL (NDC 61314-647-05) and 10 mL (NDC 61314-647-10) DROP-TAINER®* dispensers.

    STORAGE

    Store at 8° to 25°C (46° to 77°F).

    Store suspension upright and shake well before using.

    Rx Only

    *TOBREX and DROP-TAINER are registered trademarks of Alcon Research, Ltd.

    Revised: October/2015

    9012413-1015                

    SANDOZ
    a Novartis company

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

    Printed in USA

    Close
  • PRINCIPAL DISPLAY PANEL

    NDC 61314-647-05

    Tobramycin and Dexamethasone Ophthalmic Suspension

    Rx only

    STERILE

    5 mL

    FOR TOPICAL OPHTHALMIC USE ONLY

    SANDOZ
    a Novartis company

    Each mL contains: Active: tobramycin 0.3% (3 mg), dexamethasone 0.1% (1 mg). Preservative: benzalkonium chloride 0.01%. Inactive: tyloxapol, edetate disodium, sodium chloride, hydroxyethyl cellulose, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH), purified water.

    PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the suspension.

    STORAGE: Store upright at 8º- 25ºC (46º- 77ºF).

    SHAKE WELL BEFORE USING.

    READ ENCLOSED INSERT.

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

    Printed in USA
    Rev. 10/2015

    9012418-1015

    LOT:

    EXP.:

    carton

    NDC 61314-647-05

    Tobramycin and Dexamethasone Ophthalmic Suspension

    FOR TOPICAL OPHTHALMIC USE ONLY

    Rx only

    STERILE 5 mL

    SANDOZ

    Each mL contains: Active: tobramycin 0.3% (3 mg), dexamethasone 0.1% (1 mg). Preservative: benzalkonium chloride 0.01%. Inactive: tyloxapol, edetate disodium, sodium chloride, hydroxyethyl cellulose, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH), purified water. Read enclosed insert.

    STORAGE: Store upright at 8º- 25ºC (46º- 77ºF).

    SHAKE WELL BEFORE USING.

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

    Printed in USA
    Rev. 10/2015

    LOT:

    EXP.:

    H14080-1015

    label
    Close
  • INGREDIENTS AND APPEARANCE
    TOBRAMYCIN AND DEXAMETHASONE  
    tobramycin and dexamethasone suspension/ drops
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61314-647
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOBRAMYCIN (UNII: VZ8RRZ51VK) (TOBRAMYCIN - UNII:VZ8RRZ51VK) TOBRAMYCIN 3 mg  in 1 mL
    DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    TYLOXAPOL (UNII: Y27PUL9H56)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    SULFURIC ACID (UNII: O40UQP6WCF)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61314-647-25 2.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/02/2009
    2 NDC:61314-647-05 5 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/02/2015
    3 NDC:61314-647-10 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/02/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA authorized generic NDA050592 01/02/2009
    Labeler - Sandoz Inc. (005387188)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    Name Address ID/FEI Business Operations
    Alcon Research Ltd 007672236 MANUFACTURE(61314-647)
    Close