T-MYCIN

Tobramycin 0.3%

Sterile Eye Drops & Ointment

Description:

T-Mycin is a Sterile Eye Drops & Ointment containing Tobramycin, which is effective against bacterial infections.

Composition:

T-Mycin Sterile Eye Drops: Each ml contains Tobramycin USP 3 mg.

T-Mycin Sterile Eye Ointment: Each gram contains Tobramycin USP 3 mg.

Pharmacology:

Tobramycin is a member of aminoglycosides, which shows bactericidal activity by inhibiting normal protein synthesis of bacteria. Indications: For 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 its use.

Dosage & Administration:

For Eye Drops: In mild to moderate disease, 1 or 2 drops into the affected eye(s) every 4 hours. In severe infections, 2 drops into the affected eye(s) hourly until improvement, following which dosage should be reduced prior to discontinuation.

For Eye Ointment: In mild to moderate disease it should be applied thinly and evenly into the conjunctival sac of the affected eyes 2 to 3 times per day. For severe cases it should be applied thinly and evenly into the conjunctival sac of the affected eyes 3 to 4 times per day. Following improvement, treatment should be reduced prior to discontinuation.

Contraindications:

Patients with known hypersensitivity to any of its components.

Pregnancy:

This drug 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.

Children:

Clinical studies have shown Tobramycin to be safe and effective for use in children.

Precautions:

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If super-infection or drug resistance occurs, or irritation or sensitization to any of the components of this preparation develops, treatment should be discontinued and appropriate therapy should be initiated. The patient should be advised to consult a physician if improvement fails to occur, or if signs of super-infection occur.

Side effects:

The most frequent side effects of Tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling and conjunctival erythema.

Storage:

Store at 8o- 27o C. Keep out of the reach of children.

Packing:

T-Mycin Sterile Eye Drops: Plastic dropper bottle containing 5ml eye drops.

T-Mycin Sterile Eye Ointment: Tube containing 3g eye ointment.