Tobradex Oph Oint

— THERAPEUTIC CATEGORIES —
  • Ocular allergy/inflammation
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Tobradex Oph Oint Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Tobramycin 0.3%, dexamethasone 0.1%; contains chlorobutanol.

    Pharmacological Class

    Aminoglycoside + steroid.

    See Also

    How Supplied

    Susp—2.5mL, 5mL, 10mL; Oint—3.5g

    How Supplied

    Tobradex Ointment: is supplied in a 3.5g aluminum tube with a white polyethylene tip and white polyethylene cap.

    Storage

    Tobradex Ointment: Store at 2°C to 25°C (36°F to 77°F). After opening, Tobradex® (tobramycin and dexamethasone ophthalmic ointment) can be used until the expiration date on the tube.

    Manufacturer

    Novartis Pharmaceuticals Corp

    Tobradex Oph Oint Indications

    Indications

    Ocular inflammation associated with infection or risk thereof.

    Indications

    Ocular inflammation associated with infection or risk thereof.

    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. 

    Tobradex Oph Oint Dosage and Administration

    Adults and Children

    <2yrs: not established. ≥2yrs: apply small amount (½ inch) in conjunctival sac up to 3–4 times daily; max 8g for initial ℞.

    Tobradex Oph Oint Contraindications

    Contraindications

    Viral, fungal, or mycobacterial infections of the eye.

    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.

    Tobradex Oph Oint Boxed Warnings

    Not Applicable

    Tobradex Oph Oint Warnings/Precautions

    Warnings/Precautions

    Corneal or scleral thinning. Glaucoma. Monitor for secondary infections, intraocular pressure and cataracts in prolonged use. Monitor blood levels in combined aminoglycoside therapy. Discontinue if hypersensitivity reactions occur. Do not wear contact lenses. Avoid abrupt cessation. Pregnancy. Nursing mothers.

    Warnings/Precautions

    • For topical ophthalmic use. Not for injection into the eye.

    • Cross-sensitivity to other aminoglycoside antibiotics may occur. Discontinue use and institute appropriate therapy if hypersensitivity reaction develops.

    • Prolonged use may suppress the host response and increase the risk of secondary ocular infections. Steroids may mask infection or enhance existing infection in acute purulent conditions and parasitic infections of the eye.

    • Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Routinely monitor intraocular pressure (IOP) even though it may be difficult in pediatric patients and uncooperative patients.

    • In those diseases that cause thinning of the cornea or sclera, perforations may occur with the use of steroids.

    • Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Initiate appropriate therapy if superinfection occurs. 

    • Do not wear contact lenses during use or if signs/symptoms of bacterial infection are present.

    Pregnancy Considerations

    • No adequate and well-controlled studies in pregnant women. Increased risk of intra-uterine growth retardation with prolonged or repeated use during pregnancy.

    • Use during pregnancy only if potential benefit justifies the potential risk to the fetus.

    • Monitor infants born to mothers who received substantial doses of corticosteroids during pregnancy for signs of hypoadrenalism.

    Nursing Mother Considerations

    • Use caution when administered to a nursing woman.

    • It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. 

    Pediatric Considerations

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

    Geriatric Considerations

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

    Tobradex Oph Oint Pharmacokinetics

    Elimination

    Renal.

    Tobradex Oph Oint Interactions

    Not Applicable

    Tobradex Oph Oint Adverse Reactions

    Adverse Reactions

    Local effects (eg, eye pain, eyelids pruritus, eyelid edema, conjunctival hyperemia or erythema), increased intraocular pressure, glaucoma, cataracts, corneal perforations, optic nerve damage, delayed wound healing, secondary infection, blurred vision.

    Tobradex Oph Oint Clinical Trials

    See Literature

    Tobradex Oph Oint Note

    Not Applicable

    Tobradex Oph Oint Patient Counseling

    Patient Counseling

    • 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. 

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