Products | Tobrawin

Tobrawin

5ML

Tobrawin

Tobramycin Ophthalmic Solution USP

Tobramycin Ophthalmic Solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria.

Composition:

Tobramycin Sulfate USP
equivalent to Tobramycin 0.3% w/v
Stabilized Oxychloro Complex 0.005% w/v
(As preservative)
Sterile Aqueous Base q.s.

Indications:

Tobramycin Ophthalmic Solution is a topical antibiotic 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 Ophthalmic Solution. Clinical studies have shown Tobramycin to be safe and effective for use in pediatric patients.

Dosage and 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.

Contraindications:

Tobramycin Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.

Storage:

Store below 30°C. Protect from light & moisture. Do not freeze.

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 occurs, discontinue the use.
  • If irritation persists or increases, discontinue the use and consult the ophthalmologist.
  • Do not touch the nozzle tip or other dispensing tip to any surface since this may contaminate the solution.
  • Use the solution within one month after opening the container.
  • If the solution becomes dark brown, it should be discarded.
  • Patients should be advised to avoid contamination of the dispensing tip.
  • Keep out of reach of children.
  • NOT FOR INJECTION. FOR EXTERNAL USE ONLY.
Pharmacokinetics:

Tobramycin is poorly absorbed across the cornea and conjunctiva and minimal amounts are absorbed into the eye after topical administration of Tobramycin.

Drug Interactions:

No interaction studies have been performed.
Topical corticosteroids, when used in combination with Tobramycin 3mg/ml, may mask the clinical signs of bacterial, fungal or viral infections and may suppress hypersensitivity reactions.
If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye Ointments should be administered last.

Pregnancy:

Pregnancy Category B: 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 fetus due to Tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

Nursing Mothers:

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.

Pediatric Use:

Safety and effectiveness in pediatric 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 the elderly and other adult patients.

Symptoms And Treatment Of Overdosage:

Clinically apparent signs and symptoms of an overdose of Tobramycin Ophthalmic Solution (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

Special Instructions:

Patients should be advised to avoid contamination of the dispensing tip.

Presentation:

Tobrawin Eye Drops are available in 5 ml sterile plastic bottle.