Tobrin 0.3% Eye Ointment 5 g

Tobrin 0.3% Eye Ointment 5 g

Composition:

Each gram of ointment contains Tobramycin 3 mg (0.3%).
Excipients include chlorobutanol anhydrous, liquid paraffin (mineral oil), and white soft paraffin (petrolatum).

Product Description:

• Tobrin is a topical ophthalmic antibacterial preparation containing tobramycin, a broad-spectrum aminoglycoside antibiotic.
• It exerts a potent bactericidal effect by inhibiting bacterial protein synthesis and disrupting cytoplasmic membrane permeability.
• Tobramycin displays 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 has limited activity against most Streptococcus species and enterococci.

Indications for Use:

Treatment of external infectious and inflammatory diseases of the eye and its adnexa caused by tobramycin-susceptible microorganisms (blepharitis, conjunctivitis, keratoconjunctivitis, blepharoconjunctivitis, keratitis, and iridocyclitis).
Prevention of postoperative infectious complications in ophthalmic surgery.

Method of Administration and Dosage:

• The product is intended exclusively for topical ophthalmic application into the conjunctival sac.
• For mild-to-moderate infections:
  Apply a 1 to 1.5 cm ribbon of ointment into the conjunctival sac of the affected eye(s) 2 to 3 times daily, or at bedtime as an adjunct to eye drops.
  As inflammation improves, reduce application frequency gradually prior to discontinuation.
• For severe or acute infections:
  Apply a 1.5 cm ribbon into the conjunctival sac every 3 to 4 hours until clinical improvement is achieved, then taper dosage gradually.
• Duration of treatment: Typically ranges from 7 to 10 days.

Contraindications:

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

Precautions:

• Caution is advised when administering the product to patients with pre-existing renal impairment, auditory/vestibular dysfunction, myasthenia gravis, or Parkinson's disease, particularly if significant systemic absorption is anticipated.
• Prolonged use of topical antibiotics may result in the overgrowth of non-susceptible organisms, including fungi. 
• Contact lens wear is generally not recommended during the treatment of active ocular infections. 
• To prevent contamination, avoid touching the tube tip to the eyelids, surrounding skin, or any other surfaces.

Adverse Reactions / Side Effects:

• Local Ocular Effects: common — ocular pruritus, eyelid edema, conjunctival hyperemia, ocular discomfort, tearing; uncommon — dry eye, localized irritation.
• 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:

Tobrin 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 between 15 °C and 30 °C.
Keep out of reach of children.

Packaging:

The cardboard box contains an aluminum tube containing 5 g of ointment and a medical instruction insert.