Diclofenac - instructions for use, dose, side effects, contraindications

Excipients: propylene glycol 17.0 mg, disodium edetate dihydrate (disodium ethylenediaminetate-raucetic acid, trilon B) 0.1 mg, sodium chloride 0.5 mg, sodium dihydrogen phosphate hydrate (sodium phosphate monosubstituted 2-hydroxy) -2 , 5 mg, sodium hydrogen phosphate dodecahydrate (sodium dibasic di-substituted 12-water) -5.06 mg, sodium hydroxide solution 1 M - to pH 6.5-7.5, macrogol glycerylricinoleate (polyoxyl 35 castor oil) 20.0 mg , water for injection - up to 1 ml.

Description:Transparent colorless or light yellow solution.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

The non-steroidal anti-inflammatory agent, a derivative of phenylacetic acid, has anti-inflammatory and analgesic effects and a moderate antipyretic effect. By indiscriminately inhibiting cyclooxygen-zu 1 (COX1) and cyclooxygenase 2 (COX2), it breaks the metabolism of arachidonic acid, reduces the amount of prostaglandins (Pg) in the inflammatory focus.

With topical application reduces edema and pain in inflammatory processes of non-infectious etiology, blocks the development of miosis. Besides, diclofenac inhibits platelet aggregation. With long-term use has a desensitizing effect.

Pharmacokinetics:

The drug penetrates well into various tissues of the eye, with the exception of the lens.

The maximum therapeutic concentration (TC_m_Oh) in the moisture of the anterior chamber is achieved 30 minutes after installation. In the systemic circulation in therapeutically significant concentrations does not penetrate.

Indications:

- inhibition of miosis during surgery for cataract;

- treatment and prevention of inflammatory processes after surgical interventions on the eyeball;

- prevention of cystic edema of the macula after operations for cataracts;

- treatment of non-infectious conjunctivitis;

- treatment and prevention of post-traumatic inflammatory process (as an addition to local antibiotic therapy).

Contraindications:

- hypersensitivity to drug components

- hematopoiesis of unclear origin

- erosive-ulcerative processes in the gastrointestinal tract at the stage of exacerbation

Carefully:

Bronchial asthma caused by the use of acetylsalicylic acid; epithelial herpetic keratitis (including in the anamnesis); diseases that cause blood clotting disorders (including hemophilia, prolonged bleeding time, a tendency to bleed); elderly age.

Children under 18 years of age should be used only if the expected curative effect exceeds the risk of possible side effects.

Pregnancy and lactation:It is possible to use the drug to treat pregnant and lactating mothers as prescribed by the doctor if the expected therapeutic effect exceeds the risk of possible side effects.

Dosing and Administration:

Locally. To inhibit intraoperative miosis, the drug is instilled in the conjunctival sac for 2 hours at intervals of 30 minutes (4 times) before surgery.

For the prophylaxis of cystic edema of the macula, the drug is instilled 1 drop 3 times a day for 2-3 weeks in the field of surgery.

With a therapeutic purpose, assign 1 drop 3-4 times a day, depending on the severity of the condition. The course of treatment can last from 1 to 2 weeks.

Side effects:Burning in the eye, blurred vision (immediately after instillation);corneal opacity (throat), iritis; allergic reactions: itching in the eyes, hyperemia, angioedema, fever, chills, photosensitivity, skin rash (mainly erythematous, urticaria), multiforme exudative erythema; nausea, vomiting.

Interaction:If necessary, can be used simultaneously with other eye drops, including those containing glucocorticosteroids. In this case, the break between the installations should be at least 5 minutes to prevent the leaching of the active substances with subsequent doses.

Special instructions:Contact lenses are removed prior to the installation of the drug and set again no earlier than 30 minutes after instillation.

Effect on the ability to drive transp. cf. and fur:If there is a fuzziness of visual perception after installation, it is necessary to refrain from driving vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions, before its restoration.

Form release / dosage:

Eye drops 0.1%.

Packaging:

To 5 ml in bottles with a nozzle-dispenser and a cap screwed from plastic or in bottles of polymer withplugs-droppers and caps screwed (bottles-dropper polymer).

Each vial with instructions for use is placed in a pack of cardboard.

50 bottles with an equal number of instructions but the application is placed in boxes of cardboard for delivery to hospitals.

Storage conditions:

In the dark place at a temperature of 15 to 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years. After opening the vial, use within 1 month.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001146

Date of registration:01.11.2010

The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp15.02.2016

Illustrated instructions

Instructions

Diclofenac (Diclofenac)