Tobrex 0.3% Ophthalmic Drops5 ml

Tobrex 0.3% Ophthalmic Drops5 ml

Composition:

Each milliliter of solution contains Tobramycin 3 mg (0.3%).
Excipients include benzalkonium chloride, disodium edetate dihydrate, sodium chloride, hypromellose, and water for injections.

Product Description:

• Tobrex is a topical ophthalmic antibacterial agent containing tobramycin, a broad-spectrum aminoglycoside antibiotic.
• It exerts a potent bactericidal effect by disrupting bacterial protein synthesis and increasing cytoplasmic membrane permeability. 
• Tobramycin exhibits high activity against Pseudomonas aeruginosa, Staphylococcus species (including penicillinase-producing strains), Escherichia coli, Proteus species, Klebsiella species, and other Gram-negative and Gram-positive ocular pathogens. 
• It demonstrates limited activity against most Streptococcus species and enterococci.

Indications for Use:

Treatment of external infectious and inflammatory conditions of the eye and its adnexa caused by tobramycin-susceptible pathogens (blepharitis, conjunctivitis, keratoconjunctivitis, blepharoconjunctivitis, keratitis, and iridocyclitis).
Management of severe ocular infections (as part of combination antimicrobial therapy).
Prevention of postoperative infectious complications in ophthalmic surgery.

Method of Administration and Dosage:

• The product is intended exclusively for topical ophthalmic instillation into the conjunctival sac.
• Dosage regimens and treatment duration are determined by the attending physician according to clinical severity:
• Mild-to-moderate infections: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) every 4 hours.
• Severe acute infections: Instill 2 drops into the affected eye(s) every 30 to 60 minutes until clinical improvement is observed, after which instillation frequency should be gradually reduced prior to discontinuation.

Contraindications:

Known hypersensitivity to tobramycin, other aminoglycoside antibiotics, or any of the excipients in the formulation.

Precautions:

• Caution is advised when using the product in patients with pre-existing renal impairment, auditory/vestibular dysfunction, myasthenia gravis, or Parkinson's disease, particularly if significant systemic absorption is anticipated.
• The preservative benzalkonium chloride may be absorbed by soft contact lenses and cause discoloration or ocular irritation. 
• Contact lenses should be removed prior to instillation and reinserted no earlier than 15 minutes after application. 
• Prolonged use of topical antibiotics may result in overgrowth of non-susceptible microorganisms, including fungi. 
• To prevent contamination, avoid touching the dropper tip to the eyelids, surrounding skin, or any other surfaces.

Adverse Reactions / Side Effects:

• Local Ocular Effects: common — ocular pruritus, eyelid edema, conjunctival hyperemia, localized discomfort, burning, tearing; uncommon — dry eye, punctate keratitis.
• Systemic Adverse Effects (in cases of significant systemic absorption or prolonged use):
• Nervous System Disorders: headache, fatigue, disorientation, neuromuscular blockade, ototoxicity (hearing loss, tinnitus).
• Gastrointestinal Disorders: nausea, vomiting, transient elevations of liver enzymes and serum bilirubin.
• Hematologic Disorders: anemia, granulocytopenia, thrombocytopenia.
• Metabolic Disorders: electrolyte imbalances (hypocalcemia, hyponatremia, hypokalemia, hypomagnesemia).
• Other: allergic reactions, potential nephrotoxicity.

Pregnancy and Lactation:

Tobrex should be used during pregnancy and breastfeeding only if the anticipated therapeutic benefit to the mother outweighs the potential risk to the fetus or infant.
Breastfeeding should be temporarily suspended if treatment becomes necessary during the lactation period.

Storage Conditions:

Store at a temperature not exceeding 25 °C. Keep out of reach of children.
After opening, the contents of the bottle must be used within 28 days.

Packaging:

The cardboard box contains a 5 mL plastic Drop-Tainer dropper bottle and a medical instruction insert.