Tobrex eye dr 0.3% 5ml

International Name

Tobramycin

Product Name

Tobrex

Clinical and Pharmacological Group

Ophthalmology → Antibacterial agents for topical use → Antibiotics

An antibacterial medicine from the aminoglycoside group for topical use in ophthalmology.

Composition and Dosage Form

Eye drops 0.3%: 5 ml bottle.

Each 1 ml contains:

• Tobramycin — 3 mg;
• Benzalkonium chloride — 0.01%;
• Neutral substance and distilled water.

Eye ointment 0.3%: 3.5 g tube.

Each 1 g contains:

• Tobramycin — 3 mg;
• Excipients: 0.5% chlorobutanol, mineral oil, petrolatum base.

Indications

Eye diseases caused by bacteria sensitive to the medicine.

The use of the medicine should be accompanied by appropriate monitoring of bacterial susceptibility.

Clinical studies have demonstrated that the use of tobramycin is safe and effective in children.

Method of Administration and Dosage

Solution

For mild to moderate disease — 1–2 drops into the affected eye (or both eyes) every four hours.

For acute infectious diseases — 2 drops every hour until the condition improves, after which the dose should be gradually reduced until complete discontinuation.

Ointment

For mild to moderate disease, the ointment should be applied to the affected eye (or both eyes) 2–3 times daily.

For severe infectious disease — apply to the affected eye (or both eyes) every 3–4 hours until the condition improves, after which the dose should be gradually reduced until complete discontinuation.

The ointment and eye drops may be used together.

Adverse Effects

The most common adverse reaction is local ocular hypersensitivity, manifested by hyperemia and swelling of the eyelids, as well as conjunctival erythema. Similar reactions may occur with the use of other aminoglycoside antibiotics.

No other adverse effects have been observed with the use of Tobrex.

When other aminoglycosides are administered systemically alongside topical use, their plasma concentrations should be monitored.

Clinical studies demonstrated that Tobrex ophthalmic ointment causes adverse effects in a significantly lower percentage of patients (3.7%) than gentamicin ophthalmic ointment (10.6%).

Contraindications

Hypersensitivity to any component of the medicine.

Pregnancy and Lactation

Animal studies did not demonstrate teratogenic effects of the medicine. In pregnant women, it should be prescribed only when absolutely necessary.