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Okubraks (Ocubrax)

General characteristic:

main physical and chemical properties: sterile solution from colourless till poorly yellow color;

Structure. 1 ml of solution includes sodium of diclofenac 1 mg and Tobramycinum of 3 mg;

other components: dinatrium edetat, sodium chloride, borax, polyoxyfishing castor oil, sulphuric acid and/or sodium hydroxide (for definition rn), the water purified. As preservative is added tiomersat.

Form of release of medicine. Drops are eye.

Farmakoterapevtichesky group. The combined drug which includes antimicrobic and anti-inflammatory drugs for use in ophthalmology. Code of automatic telephone exchange S01CC.

Pharmacological properties.

Pharmacodynamics. Okubraks includes two active components: sodium diclofenac and Tobramycinum.

Sodium diclofenac is the non-steroidal anti-inflammatory drug derivative of phenylacetic acid, with antiinflammatory and analgetic action. Sodium diclofenac strong inhibitor of cyclooxygenase, enzyme that transforms arachidonic acid to prostaglandins which are active mediators of inflammatory reactions and developing of pain. It was shown that diclofenac suppresses synthesis of prostaglandins in a conjunctiva and tsiliarny a body. Unlike steroid anti-inflammatory drugs, ophthalmologic use of diclofenac of sodium does not lead to increase of intraocular pressure (HERE) or to the others the effects characteristic of steroids.

Tobramycinum – an antibiotic of group of aminoglycosides with antimicrobic action concerning a wide range of gram-positive and gram-negative ophthalmologic pathogenic microorganisms. In vitro Tobramycinum active against sensitive strains of such microorganisms:

Staphylococcus, including S.aureus and S.epidermidis (koagulyazo positive and koagulyazo-negative), and also strains resistant to penicillin.

Staphylococcus, including some beta and hemolitic types of group A, some not hemolitic types and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, the most part of strains of Proteus vulgaris, Haemophilus influenzae and H.aegyptium, Moraxella lacunata, Acinetobacter calcoaceticus and some types of Neisseria.

Researches of sensitivity of bacteria showed that in certain cases microorganisms resistant to gentamycin, remain sensitive to Tobramycinum. The considerable part of microflora does not show resistance to Tobramycinum; however it can develop in the period of long use.

Researches antiinflammatory and antimicrobic effect of the combined drug showed that efficiency of drug of Okubraks corresponds to efficiency at use of each of ingredients separately.

The therapeutic effectiveness of drug of Okubraks was estimated in comparative clinical research at introduction of a fiksovany dose of the combined drug that contained two antibiotics and a strong corticosteroid (dexamethasone). Though the statistical difference between 14 and 21 days of treatment was revealed at the general of calculation of cells with Tyndall's effect (opalescence and precipitated calcium superphosphates) in favor of the combined comparative drug, both drugs were clinically equivalent.

Preclinical data the concerning safety. Researches of toxicity of the combined drug on animals within 13 weeks did not reveal any serious changes after local an instillation in an eye. Drug showed good eye tolerance in rabbits after frequent introductions to a short span and after introduction of repeated doses at prolonged use.

As both active components have the low level of absorption after their local use in an eye, any undesirable system effects are not expected.

Pharmacokinetics. After introduction to an eye diclofenac of sodium is absorbed in intraocular liquid and gets into an average chamber of the eye. Tobramycinum is absorbed in a cornea; the maximum concentration is reached in 20 minutes.

After local use in an eye of drug of Okubraks, system absorption of both active ingredients is almost equal to zero.

Indications for use. Preventions and treatments the inflammation of a front segment of an eye after surgical intervention concerning a cataract when it is necessary uses of non-steroidal anti-inflammatory drug and exists the accompanying bacterial infection of an eye or the risk of development of such infection can be high.

Way of use and dose. As a rule dig in 2 drops in the affected eye 4 times a day respectively to such scheme of use:

- - a day before operation implementation: 2 drops 4 times a day;

- - in day of implementation of operation: 2 drops before operation;

- - during the postoperative period: 2 drops 4 times a day.

- At the controlled clinical trials of implementation of operation for a cataract this combination came to light effective within 21 days.

The doctor can change the number of daily introductions and duration of treatment.

Way of use: to incline the head back, delay a lower eyelid, look upward and dig drops in a conjunctival sac. Carefully close eyes and you hold them closed within several seconds.

Side effect. Though this drug as a rule it is good to be transferred, there can sometimes be irritations, burning, dacryagogue, feeling of a third-party body. All these side effects insignificant also disappear after a treatment suspension.

Contraindications. Use of drug is contraindicated to patients with hypersensitivity to any of drug components.

As well as in case of use of other non-steroidal anti-inflammatory drugs, drug of Okubraks is contraindicated to patients that suffer on a virus keratoconjunctivitis with an active helcoma, and to those patients who have uses of acetylsalicylic acid or other inhibitors of prostaglandins can bring to asthmatic crisis, the small tortoiseshell or acute rhinitis.

Overdose. Thanks to characteristics of drug at topical administration or in case of its accidental proglatyvaniye of any toxic effects it is not expected.

Features of use. As Okubraks is a sterile drug, it is necessary to adhere to such instructions:

- drug has to be used only by one patient;

- the instillation of drug has to be carried out in the most hygienic conditions: it is necessary to wash up hands and not to allow that the tip of a bottle concerned any surface (including an eye);

after everyone an instillation it is necessary to close a bottle densely;

after completion of treatment it is necessary to throw out all rest of drug.

Pregnancy and lactation

There are no specific data concerning safety and efficiency use of drug during pregnancy and a lactation; therefore it should be applied only when the advantage of treatment justifies possible risk.

These concerning uses of drug in pediatrics are limited therefore drug should be used at children only under control of the doctor.

Influence on ability to steer the car or other mechanical means. Treatment by drug of Okubraks does not influence ability to manage motor transport and mechanisms.

Interaction with other medicines. Interaction with other medicines. it is not described.

Before use of other ophthalmologic drugs it is necessary to wait not less than five minutes. It is necessary to consider a possibility of cross sensitivity to the others of aminoglikozidny antibiotics, acetylsalicylic acid, phenylacetic acid and other non-steroidal anti-inflammatory drugs.

Terms and storage conditions. To store at a temperature below 25 °C in densely closed bottle. A drug period of validity 2 years from the date of production. A period of validity after opening of a bottle - 1 month.

"Oksolin-darnitsa   Okulokheel"