Composition:
Each 1ml solution contains 3mg Tobramycin (0.3%)
Mechanism of action:
Tobramycin is active against susceptible strains of the following microorganisms:
- Staphylococci, including S. aureus and S. epidermidis, 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.
Indications:
Tob-Ophtal is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria.
Contraindications:
Tobramycin 0.3% ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.
Dosage and administrations:
- 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.
Pediatric Use: Clinical studies have shown tobramycin to be safe and effective for use in children, but 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 younger patients.
Warnings and Precautions:
- 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 occurs, discontinue use.
As with other antibiotic preparations, prolonged use may result in overgrowth of no susceptible 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 ocular infection.
Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the solution.
Adverse Reactions:
The most frequent adverse reactions to are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema.
Pregnancy and Lactation:
Pregnancy: Reproduction studies has 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.
Tobramycin should be used during pregnancy only if clearly needed.
Lactation: Because of the potential for adverse reactions in nursing infants from Tobramycin, 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.
Over dosage:
Clinically apparent signs and symptoms of an over dosage of Tobramycin 0.3% ophthalmic solution: Punctate keratitis, erythema, increased lacrimation, edema and lid itching.
May be similar to adverse reaction effects seen in some patients.