Tobradex St

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

    • Tobradex St Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Tobramycin 0.3%, dexamethasone 0.05%; oph. susp; contains benzalkonium chloride.

    Pharmacological Class

    Aminoglycoside + steroid.

    See Also

    How Supplied

    Susp—2.5mL, 5mL, 10mL; Oint—3.5g

    How Supplied

    Tobradex ST: is supplied as a 2.5mL or 5mL suspension in a 4mL or 8mL natural polyethylene DROPTAINER® bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap.

    Storage

    Tobradex ST: Store at 2°C to 25°C (36°F to 77°F). Protect from light. After opening, Tobradex® ST can be used until the expiration date on the bottle.

    Manufacturer

    Eyevance Pharmaceuticals

    Tobradex St 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 St Dosage and Administration

    Prior to Treatment Evaluations

    • Evaluate IOP prior to the initial prescription and renewal of the medication order.

    • Perform ophthalmic examination with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining, prior to the initial prescription and renewal of the medication order. Reevaluate the patient if signs and symptoms fail to improve after 2 days.

    Adults and Children

    <2yrs: not established. ≥2yrs: 1 drop every 2hrs for 1st 24–48hrs, then every 4–6hrs. Reduce dose as condition improves; max 20mL for initial ℞.

    Tobradex St 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 St Boxed Warnings

    Not Applicable

    Tobradex St 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

    Intraocular Pressure Increase

    • Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision. Monitor IOP if this product is used for more than 10 days.

    Aminoglycoside Sensitivity

    • Sensitivity to topically applied aminoglycosides may occur. 

    Cataracts

    • May result in posterior subcapsular cataract formation.  

    Delayed Healing

    • May delay healing and increase the incidence of bleb formation when steroids are used after cataract surgery.

    • The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. 

    Bacterial Infections

    • Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. May mask infection or enhance existing infection in acute purulent conditions of the eye.

    • Re-evaluate patients if signs and symptoms fail to improve after 2 days. 

    Viral Infections

    • Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Must use great caution in the treatment of patients with a history of herpes simplex. 

    Fungal Infections

    • Consider fungal infections in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.

    Risk of Contamination

    • Do not touch the dropper tip of the bottle to any surface.

    Contact Lens Wear

    • Do not wear contact lenses during the course of therapy.

    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 St Pharmacokinetics

    Elimination

    Renal.

    Tobradex St Interactions

    Not Applicable

    Tobradex St 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 St Clinical Trials

    See Literature

    Tobradex St Note

    Not Applicable

    Tobradex St Patient Counseling

    Patient Counseling

    Storage and Handling

    • Store bottle upright and away from light. Shake well before use.

    Avoid Contamination 

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

    Contact Lens Wear 

    • Do not wear contact lenses while using this product. 

    Ability to Drive and Use Machines 

    • May temporarily blur following dose administration. Use caution when operating machinery or driving a motor vehicle.

     

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