Дифталь®

General characteristics. Structure:

Active ingredient: diclofenac;

1 ml of drug contains 1 mg of diclofenac of sodium in terms of 100% substance;

excipients: a benzalkoniya chloride, boric acid, sodium pyroborate, polysorbate 80, water for injections.

Pharmacological properties:

Pharmacodynamics. Diftal treats ophthalmologic drugs, nonsteroid antiflogistika. Active ingredient – sodium diclofenac – is derivative phenylacetic acid and belongs to group of non-steroidal anti-inflammatory drugs. The mechanism of effect of diclofenac of sodium is connected with the expressed inhibition of synthesis of prostaglandins.

Diclofenac inhibits a miosis during operation for a cataract and reduces inflammatory process and the eye pain caused by damage of an epithelium of a cornea after some types of surgical intervention.

Data on influence of diclofenac on a wound repair is absent.

Pharmacokinetics. Preclinical data showed that peak concentration of 14C-mechenny diclofenac were revealed in a cornea and a conjunctiva in 30 minutes after an instillation of eyes. In 6 hours drug is removed almost completely. Penetration of diclofenac into an anterior chamber of an eye was confirmed at people. Diclofenac levels in plasma which do not give in to measurement could not be revealed.

Pharmaceutical characteristics:

 

main physical and chemical properties: transparent colourless or slightly yellowish liquid.

Indications to use:

Postoperative inflammatory process after removal of a cataract and other surgical interventions.

Pain relief at photophobia.

Posttraumatic inflammatory process at not getting eyeglobe wounds.

Miosis inhibition during operation for a cataract.

Prevention of tsistoidny macular hypostasis after removal of a cataract and implantation of a crystalline lens.

Route of administration and doses:

Just before use it is necessary to take a bottle in a palm to warm up it to body temperature. To remove a lid and, to press slightly on the bottle case, to dig solution in eyes (a conjunctival cavity). In order to avoid a spontaneous effluence of solution at storage, after an instillation of drug it is necessary to close a lid densely. Store drug in vertical position according to the recommendations specified in the section "Storage conditions".

Operations in the eyes and their complications.

Before operation appoint on 1 drop of 5 times for 3 hours.

After operation appoint on 1 drop 3 times in day of operation, then – on 1 drop of 3-5 times a day, duration is defined individually.

Pain relief and photophobia; posttraumatic inflammatory process.

On 1 drop each 4-6 hours.

If pain is caused by the surgical procedure (for example, operation for sight correction), dig in 1-2 drops for an hour before operation, on 1-2 drops within the first 15 minutes after surgical intervention and on 1 drop each 4-6 hours during the next 3 days.

Patients of advanced age. There are no indications which demand dose adjustment from patients of advanced age.

The doser remains sterile before opening of primary packaging. The patient has to be informed that it is necessary to avoid possible contact of a top of the doser with an eye or adjacent fabrics as it can contaminate solution.

If it is necessary to dig in in an eye and other drugs, the interval between an instillation of different medicines has to make at least 5 minutes.

Features of use:

Eye drops are not intended for injections. They cannot be entered subkonjyunktivalno.

Antiinflammatory effect of ophthalmologic non-steroidal anti-inflammatory drugs can mask the beginning and/or progressing of eye infections. In the presence of an infection or if there is a risk of development of an infection, along with Diftal the corresponding therapy has to be appointed.

Though messages on side effects are absent, there is a theoretical opportunity that at patients who use other medicines prolonging a bleeding time or at patients with the known disturbances of a svorachivayemost of blood at Diftal's use the exacerbation of a disease can be observed.

This medicine the benzalkoniya contains in quality of preservative chloride. Therefore drug should not be used during carrying soft contact lenses. Before use of drops of a lens it is necessary to remove, dress them again it is possible not earlier than in 15 minutes after a drug instillation.

Ability to influence speed of response at control of motor transport or work with other mechanisms. Patients at whom the sight illegibility is observed should refrain from control of vehicles and work with mechanisms.

Side effects:

Often – a burning sensation in eyes (from weak to moderate severity) which passes independently.

Seldom – an itch, reddening of eyes and an illegibility of sight right after an instillation of eye drops.

After a frequent instillation of eyes the dot keratitis and damage of an epithelium of a cornea was usually observed.

Patients with risk factor have emergence of a helcoma and its thinning, such as, during use of corticosteroids or at associated diseases, such as infectious diseases or a pseudorheumatism, diclofenac use was connected in some cases with emergence of a helcoma or its thinning. Most of patients were treated a long time.

In isolated cases it was reported about cases диспноэ and exacerbations of bronchial asthma.

Interaction with other medicines:

About Diftal's interaction with other medicines still it was not reported.

It is possible to appoint drug in combination with simultaneous topical administration of corticosteroids, and also antibiotics and beta-blockers. It is recommended to sustain a five-minute interval between Diftal's use and other eye drug.

Contraindications:

Hypersensitivity to active ingredient or any of excipients.

As well as other non-steroidal anti-inflammatory drugs, Diftal is contraindicated to patients with the attacks of bronchial asthma, urticaria, acute rhinitis connected using acetylsalicylic acid or other drugs which inhibit synthesis of prostaglandins. There is a possibility of cross sensitivity to acetylsalicylic acid, derivatives of fenilotstovy acid and other non-steroidal anti-inflammatory drugs. Therefore it is necessary to be careful at treatment of patients with sensitivity to these drugs.

Overdose:

About cases of overdose by Diftal it was not reported. However accidental use of drug inside practically does not represent risk of emergence of side effects as the bottle contains only 5 mg or 10 mg of diclofenac of sodium that makes about 3-6% of the recommended maximum peroral daily dose for adults. The recommended peroral dose for children makes 2 mg/kg of body weight.

Use during pregnancy or feeding by a breast.

It is necessary to avoid use of drug during pregnancy.

During feeding by a breast use is possible. After oral administration of 50 mg of diclofenac in the form of tablets, coated (the maintenance of 5-10 bottles), the amount of active agent revealed in breast milk was so scanty that did not cause any by-effects in the child.

Children.

Drug is not used for treatment of children due to the lack of data on safety.

Storage conditions:

Period of validity. 2 years. A period of validity after opening of a bottle – 28 days. Not to use drug after the termination of the period of validity specified on packaging. To store in protected from light and the place, unavailable to children, at a temperature not over 25 ˚С.

Issue conditions:

According to the recipe

Packaging:

On 5 ml or 10 ml in the bottle enclosed in a pack.