TOBROPT

Active material: Tobramycin
When ATH: S01AA12
CCF: Antibiotics for topical use in ophthalmology
ICD-10 codes (testimony): H00, H01.0, H04.3, H04.4, H10.2, H10.4, H10.5, H16, H16.2, H44, Z29.2
At KFU: 06.05.04
Manufacturer: S.C. ROMPHARM Company S.R.L. (Romania)

Pharmaceutical form, composition and packaging

Eye drops 0.3% as a clear, colorless or slightly yellowish solution.

Excipients: boric acid, sodium chloride, Sodium sulfate anhydrous, tyloxapol, benzalkonium chloride, sodium hydroxide solution 1 m or 0.5 M solution of sulfuric acid, Purified water.

5 ml – flakonah- polymer (1) – packs cardboard.

Pharmacological action

Broad-spectrum antibiotic of the aminoglycoside group for local application in ophthalmology. Bacteriostatic, blocking 30S subjedinitsu ribosom and disrupts protein synthesis.

Vsokoakteven against koagulaza-negative, koagulaza-positive staphylococci and penicillinoustojčivyh strains (incl. Staphylococcus epidermidis, Staphylococcus aureus), some species of streptococci (incl. Beta-hemolytic strains of group a, some non-hemolytic strains, Streptococcus pneumoniae), Pseudomonas aeruginosa, indole-positive and indole-negative Proteus spp. (incl. Proteus is wonderful, Proteus vulgaris), Escherichia coli, Klebsiella pneumoniae, Haemophilias influenzae, Haemophilus aegyptius, Enterobacter aerogenes, Moraxella lacunata, Morganella morganii, Acinetobacter calcoaceticus, Neisseria spp. (incl. Neisseria gonorrhoeae).

Some gentamicin-resistant strains retain high sensitivity to tobramicinu.

Not effective against Most strains of Streptococcus Group D.

Pharmacokinetics

Tobramycin well permeates through GEB. Systemic absorption when instillation in kongungualny bag small.

In zacapawanyi in kongungualny bag aminoglikozida found in therapeutic concentrations in corneal stroma, moisture front camera, vitreous body during 6 no. Aminoglycosides not metabolised, kidneys are allocated.

Testimony

- .Aloe;

- Conjunctivitis;

- Keratokonъyunktyvyt;

— blefarokongunguit;

- Keratit;

— endophthalmitis;

- Dakriocistit;

— mejbomit (barley);

-Prevention of postoperative infectious complications in ophthalmology.

Dosage regimen

The drug should be used locally 1 every drop 4 no.

At acute infections You can repeat the burrow every 30 min or 1 no.

At netâželom infectious process drug instill 1-2 drops in kongungualny bag the affected eye (or eyes) every 4 no.

At acute severe infection process (endophthalmitis) the drug buried in the bag kongungualny every 30-60 m, reduce inflammation decreases frequency of instillation.

Side effect

Allergic reactions: in 15% cases – burning, paresthesia, itching of the conjunctiva; in 1-5% cases – hyperemia mucous membranes of the eyes, foreign body sensation in the eye, lacrimation; <1% cases – .Aloe, keratit, swelling of the eyelids, eye pain, xemoz, the deposition of crystals, Corneal ulceration.

Contraindications

- Childhood and adolescence up 18 years;

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug.

Pregnancy and lactation

Use of the drug during pregnancy and lactation (breast-feeding) contraindicated.

Cautions

Tobropt is intended only for local use.

The bottle must be closed after each use. In order to preserve sterility solution does not follow the tip of the dropper touch the eye.

Prolonged use of the drug can lead to increased growth of resistant microorganisms (incl. mushrooms). Recommended sowing after treatment, If clinical result unsatisfactory.

Patients, using rigid contact lenses, must apply eye drops only after removing contact lenses. Lenses can be worn through 15 minutes after instillation of drug. During the period of treatment can not wear soft contact lenses.

With the development of allergic reactions should discontinue use of the drug.

Before use, shake the bottle.

Effects on ability to drive vehicles and management mechanisms

The drug does not cause fatigue and visual impairment and, respectively, It does not affect the ability to drive vehicles and management mechanisms. Patients, which after application temporarily lost the clarity of vision, It is not recommended to drive a car or work with complex equipment immediately after instillation, drug.

Overdose

Symptoms: punctate keratitis, эritema, increased lacrimation, itching and swelling of the century.

Treatment: symptomatic therapy.

Drug Interactions

If you are applying to Tobropta with systemic antibiotics of the aminoglycoside may increase systemic side effects (incl. nephrotoxic, ototoksicski, mineral metabolism and violations gemopoaiza).

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in closed original container out of reach of children, dry, dark place at a temperature of 15 ° to 25 ° C. Shelf life – 3 year.

After opening bottle the drug should be stored no more than 4 weeks.