Expiration date: 05/2025

The composition and form of issue:

Eye drops, 1 ml active substance:

tobramycin 3 mg

auxiliary substances: boric acid sodium chloride sodium sulfate anhydrous tyloxapol benzalkonium chloride 1 M solution of sodium hydroxide or 0. 5 M solution of sulfuric acid purified water 

in bottles-droppers of polymeric, white color, closed with polymer caps with safety rings, 5 ml in a pack of cardboard 1 vial-dropper.

Description of dosage form:

The solution is transparent, colorless or slightly yellowish.

Pharmacokinetics:

It permeates through gematoentsefalichesky barrier. Systemic absorption during instillation in the conjunctival SAC is insignificant. With instillation into the conjunctival SAC is found in therapeutic concentrations in the stroma of the cornea, the anterior chamber, the vitreous humor for 6 h. the Aminoglycosides are not metabolized, excreted by the kidneys.

Description of the pharmacological action:

Broad-spectrum antibiotic from the group of aminoglycosides. Acts bacteriostatic (inhibits 30S subunit of ribosomes and disrupts protein synthesis).

Is highly active against coagulationfeatures, coagulasepositive staphylococci and penitsillinoustoychivyh strains (including Staphylococcus epidermidis, Staphylococcus aureus), streptococci (including & beta-hemolytic strains of group A, some phenolicresin strains of Streptococcus pneumoniae), Pseudomonas aeruginosa, indolpologitiona and indolotricationah Proteus species (including Proteus mirabilis, Proteus vulgaris), Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Haemophilus aegyptius, Enterobacter aerogenes, Moraxella lacunata, Morganella morganii, Acinetobacter calcoaceticus, Neisseria spp. (including Neisseria gonorrhoeae). Some gentamicin-resistant strains retain high sensitivity to tobramycin.

Ineffective against most strains of Streptococcus group D.

Indications:

Infection of the eye and its appendages:

• blepharitis
  
• conjunctivitis
  
• keratoconjunctivitis
  
• blepharoconjunctivitis
  
• keratitis
  
• endophthalmitis
  
• dacryocystitis
  
• mabait (barley)
  
• postoperative infectious complications in ophthalmology (prevention).
  

Contraindications:

• hypersensitivity to the components of the drug
  
• the age of 18
  
• pregnancy, lactation.
  

Side effect:

In applying the drug may be a manifestation of allergic reactions in 15% of cases — burning sensation, paresthesia, itching of the conjunctiva in 1-5% — hyperemia of the mucous membrane of the eye, foreign body sensation in eye, lacrimation less than 1% — blepharitis, keratitis, eyelid edema, eye pain, chemosis, deposition of crystals, ulceration of the cornea.

Drug interaction:

In the case of co-administration of the drug Cobopt with systemic antibiotics of the aminoglycoside may increase systemic side effects (nephrotoxic, ototoxic actions, violations of mineral metabolism and hematopoiesis).

Method of application and doses:

Locally.

1 drop every 4 hours for acute infections, you can repeat the instillation after every 30 min or 1 h.

When mild infectious process, the drug is instilled 1-2 drops into the conjunctival SAC of the affected eye (or eyes) every 4 h. In the case of severe acute infectious process (endophthalmitis) the drug is instilled every 30 to 60 min, decreasing inflammation reduce the frequency of instillation of the drug.

Overdose:

Symptoms: point keratitis, erythema, increased lacrimation, itching and swelling of the eyelid.

Treatment: symptomatic therapy.

Precautionary measures:

Tobropt is intended only for local use.

The bottle must be closed after each use. Do not touch the tip of the pipette to the eye to preserve the sterility of the solution.

Prolonged use of the drug Tobropt, as in the case of use of other antibiotics, can lead to increased growth of unreceptive microorganisms (including fungi). It is recommended to sow after treatment, if the clinical result is unsatisfactory.

Patients using hard contact lenses should use eye drops only after removing contact lenses. The lenses can be worn after 15 minutes after instillation of the drug.

During treatment, you can not wear soft contact lenses.

With the development of allergic reactions, the use of the drug should be stopped.

Before use, shake the contents of the bottle.

Influence on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. The use of the drug Tobropt does not cause fatigue and visual impairment, therefore, does not affect the ability of driving vehicles and management mechanisms. Patients who have temporarily lost visual clarity after the application, it is not recommended to drive a car or work with complex equipment immediately after instillation of the drug.

Shelf life:

After opening the bottle to 4 weeks.