Properties
What is it?
International Nonproprietary Name: TOBRAMYCIN Active Substance: Tobramycin Clinical-Pharmacological Group: Antibacterial drug of the aminoglycoside group for topical ophthalmic use. Composition and Dosage Form: Ophthalmic Ointment 0.3%: in a 3.5 g tube 1 g of tobramycin contains 3 mg. As a preservative, it contains 0.5% chlorobutanol, mineral oil, petrolatum base. Pharmacological Properties: Tobramycin is a water-soluble aminoglycoside antibiotic that acts on a broad spectrum of Gram-positive and Gram-negative microorganisms causing ophthalmic diseases. In vitro studies have shown that tobramycin is effective against susceptible strains of the following microorganisms: Staphilococci, including Staphilococcus aureus and St. Epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Studies have shown that microorganisms resistant to gentamicin in some cases retain sensitivity to tobramycin, however, an increase in bacterial resistance cannot be ruled out with prolonged use of the drug. Indications: Ocular infections caused by bacteria susceptible to TOBREX. The use of TOBREX should be accompanied by appropriate monitoring of bacterial sensitivity. Clinical studies have confirmed that the use of tobramycin in children is safe and effective. Dosage and Administration: For mild and moderate diseases, the ointment should be applied to the affected eye (both eyes) 2-3 times a day; in case of severe infectious disease, apply to the affected eye (both eyes) every 3-4 hours until the condition improves. The dose of the drug should be gradually reduced until its complete discontinuation. The use of TOBREX ointment and drops is possible together. Side Effects: The most common adverse reactions are local ocular hypersensitivity, manifested by eyelid hyperemia and edema, as well as conjunctival erythema. Similar reactions develop with the use of other aminoglycoside antibiotics. Other side effects are not observed with the use of TOBREX. In addition to topical use of TOBREX, systemic administration of other aminoglycosides requires monitoring of their content in blood plasma. Based on clinical studies, it has been established that TOBREX ophthalmic ointment causes side effects in a significantly smaller number of patients (3.7%) than gentamicin ophthalmic ointment (10.6%). Contraindications: * Hypersensitivity to any component of the preparation. Pregnancy and Lactation: Animal studies have not confirmed the teratogenic effect of the drug. Tobrex is prescribed to pregnant women only when absolutely necessary. Special Instructions: It is not used for intraocular injection. In case of hypersensitivity reaction with topical use of aminoglycosides, the use of TOBREX should be discontinued. Safety Measures: Prolonged use of antibiotics may contribute to the increased growth of resistant microorganisms, including fungi. In case of superinfection, appropriate treatment is necessary. Ophthalmic ointments can cause delayed wound healing. Overdose: Symptoms of overdose coincide with side effects (punctate keratitis, erythema, increased tearing, eyelid edema and hyperemia). Storage Conditions: Store the preparation at a temperature of 8-30 C, in a place protected from children. Shelf Life: 1 year; 1 month after opening the vial or tube. Manufacturer: ALCON, Belgium
