Tobrex^® 2X (Drops) Instructions for Use

Marketing Authorization Holder

Novartis Pharma AG (Switzerland)

Manufactured By

Alcon-Cusi, S.A. (Spain)

ATC Code

S01AA12 (Tobramycin)

Active Substance

Tobramycin (Rec.INN registered by WHO)

Dosage Form

Tobrex® 2X

Eye drops 0.3%: 5 ml dropper bottle

Dosage Form, Packaging, and Composition

5 ml – plastic Drop Tainer dropper bottles (1) with a dispenser – cardboard packs.

Clinical-Pharmacological Group

Antibiotic for topical use in ophthalmology

Pharmacotherapeutic Group

Antibiotic-aminoglycoside

Pharmacological Action

A broad-spectrum antibiotic from the aminoglycoside group. In low concentrations, it acts bacteriostatically (blocks the 30S ribosomal subunit and disrupts protein synthesis), and in higher concentrations, it acts bactericidally (disrupts the function of cytoplasmic membranes, causing the death of the microbial cell).

Highly active against Staphylococcus spp. (including Staphylococcus aureus, Staphylococcus epidermidis /coagulase-negative and coagulase-positive/, as well as penicillin-resistant strains); Streptococcus spp. (including α-β-hemolytic species, some non-hemolytic species, Streptococcus pneumoniae); Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis (indole-negative) and indole-positive species of Proteus spp., Haemophilus influenzae, Haemophilus aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus (Herellea vaginicola), some species of Neisseria spp. (including Neisseria gonorrhoeae).

Pharmacokinetics

With topical application, systemic absorption is low.

Indications

Blepharitis; conjunctivitis; keratoconjunctivitis; blepharoconjunctivitis; keratitis; iridocyclitis; prevention of postoperative complications in ophthalmology.

ICD codes

Dosage Regimen

For topical ophthalmic use only. Instill drops into the conjunctival sac.

For mild to moderate infections, instill one to two drops into the affected eye(s) every 4 hours.

For severe infections, instill two drops into the affected eye(s) hourly until improvement, then reduce frequency prior to discontinuation.

For postoperative prophylaxis, use one to two drops in the operated eye four times daily for 3 to 5 days. Follow the surgeon’s specific instructions.

Do not touch the dropper tip to any surface to avoid contamination.

If using other topical ophthalmic products, administer them at least 5 minutes apart.

The usual duration of therapy is 7 to 10 days. Do not exceed the prescribed duration.

Complete the full course of treatment even if symptoms improve.

If no improvement is observed after 3 days of therapy, re-evaluate the patient.

Adverse Reactions

Allergic reactions itching and swelling of the eyelids, conjunctival hyperemia, lacrimation. Burning sensation and a feeling of a foreign body in the eye may occur.

Contraindications

Hypersensitivity to tobramycin, children under 1 year of age, breastfeeding period.

Use in Pregnancy and Lactation

There is insufficient experience with the use of the drug during pregnancy and breastfeeding. Use during pregnancy is not recommended. Use during breastfeeding is contraindicated.

Pediatric Use

Contraindicated for use in children under 1 year of age.

Geriatric Use

Use with caution in elderly patients to avoid the risk of exacerbation of chronic diseases.

Special Precautions

Cross-hypersensitivity to other aminoglycosides may develop, and the possibility should be considered that patients who have developed hypersensitivity to topical tobramycin may also be sensitive to other topical and/or systemic aminoglycosides.

Serious adverse reactions, including neurotoxicity, ototoxicity, and nephrotoxicity, may occur in patients receiving systemic tobramycin therapy. Use caution when combining topical Tobramycin with systemic aminoglycosides.

Use with caution in patients with suspected or confirmed neuromuscular disorders, such as Parkinson’s disease or myasthenia gravis. Aminoglycosides may exacerbate muscle weakness due to a potential effect on neuromuscular conduction.

Long-term use of the antibiotic may lead to excessive growth of non-susceptible microorganisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

Patients who experience temporary blurred vision after using tobramycin are not recommended to engage in activities requiring increased attention and quick reactions until their vision is restored.

Drug Interactions

With simultaneous topical use of tobramycin with systemic aminoglycoside antibiotics, systemic side effects may be enhanced.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.