Tobramycin with Hydroxypropylmethyl Cellulose 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections

Trade Name :
Tobracin

Composition:
Each ml contains:
Tobramycin Sulfate USP eq. to Tobramycin 0.3% w/v + Hydroxypropylmethyl Cellulose IP 0.25% w/v + Benzalkonium Chloride Solution 0.2% v/v, Sterile Aqueous Base q.s.

Dosage Form :
Eye Drops

Dosage and Method of Administration :
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.

Indications :
Tobramycin is indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin.
Clinical studies have shown tobramycin to be safe and effective for use in children.

Pharmacological Properties :
Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.
In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. Aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillinresistant 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 mirabillis, Morganellamorganii, most Proteus vulgaris strains, Haemophilus influenzea and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin

Warnings :
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 to tobramycin ophthalmic solution 0.3% occurs, discontinue use.

Precautions :
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 conjunctivitis.

Contraindications :
It is contraindicated in patients with known hypersensitivity to any of its components.

Use in Special Population :
Pregnancy :
Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the foetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers :
Because of the potential for adverse reactions in nursing infants from TOBREX®, 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.
Paediatric Use :
Safety and effectiveness in paediatric patients below the age of two months has not been established.
Geriatric Use :
No overall clinical differences in safety or effectiveness have been observed between elderly and younger patients.

Shelf-Life :
15 Months

Packaging Information :
Product is packed in a 5 ml plastic bottle with a plastic nozzle pre sterilized and plastic cap.

Storage and Handling Instructions :
Store at room temperature. Protect from light.