Tobradex Oph Oint Generic Name & Formulations
Tobradex Ointment: is supplied in a 3.5g aluminum tube with a white polyethylene tip and white polyethylene cap.
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.
Tobradex Oph Oint 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
Tobradex Oph Oint 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
Tobradex Oph Oint 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.
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.
Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Tobradex Oph Oint Pharmacokinetics
Tobradex Oph Oint Interactions
Tobradex Oph Oint Adverse Reactions
Tobradex Oph Oint Clinical Trials
Tobradex Oph Oint Note
Tobradex Oph Oint 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.