Diclofenac eye drops 0.1%, 5ml – MPEZ

Composition

Composition 1 ml of the drug: Active ingredient: diclofenac sodium – 1.0 mg. Auxiliary substances:  benzalkonium chloride, disodium edetate, boric acid, trometamine, polyoxyl 35, castor oil, water for injection.

Pharmacological action

of NSAIDs, a derivative of phenylacetic acid. It has a pronounced anti-inflammatory, analgesic and moderate antipyretic effect. The mechanism of action is associated with inhibition of the activity of COX, the main enzyme of arachidonic acid metabolism, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. The analgesic effect is caused by two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous systems). Inhibits the synthesis of proteoglycan in cartilage. In rheumatic diseases, it reduces joint pain at rest and during movement, as well as morning stiffness and swelling of the joints, and helps to increase the volume of movement. Reduces post-traumatic and post-operative pain, as well as inflammatory edema. Inhibits platelet aggregation. With prolonged use, it has a desensitizing effect. When applied topically in ophthalmology, it reduces swelling and pain in inflammatory processes of non-infectious etiology. Pharmacokineticsafter oral use, it is absorbed from the gastrointestinal tract. Food intake slows down the rate of absorption, but the degree of absorption does not change. About 50% of the Active ingredient is metabolized during the” first pass ” through the liver. With rectal use, absorption is slower. The time to reach Cmax in plasma after oral use is 2-4 hours, depending on the dosage form used, after rectal use – 1 hour, intravenous use-20 minutes. The concentration of the Active ingredient in plasma is linearly dependent on the amount of the applied dose. It doesn’t accumulate. Binding to plasma proteins is 99.7% (mainly with albumin). Penetrates the synovial fluid, Cmax is reached 2-4 hours later than in plasma. It is largely metabolized with the formation of several metabolites, among which two are pharmacologically active, but to a lesser extent than diclofenac. The systemic clearance of the Active ingredient is approximately 263 ml / min. T1/2 from plasma is 1-2 hours, from synovial fluid – 3-6 hours. Approximately 60% of the dose is excreted as metabolites by the kidneys, less than 1% is excreted unchanged in the urine, and the remainder is excreted as metabolites in the bile.

Indications

For topical application: inhibition of miosis during cataract surgery, prevention of cystoid macular edema associated with lens removal and implantation, non-infectious eye inflammation, post-traumatic inflammatory process in penetrating and non-penetrating eyeball wounds.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, “aspirin triad”, hematopoietic disorders of unknown etiology, hypersensitivity to diclofenac and components of the dosage form used, or other NSAIDs.

How to take, course of use and dosage

Locally. To inhibit intraoperative miosis, the drug is instilled into the conjunctival sac for 2 hours with an interval of 30 minutes (4 times) before surgery.

To prevent cystic edema of the macula, the drug is instilled 1 drop 3-4 times a day for 2 weeks after surgery.

Other indications:  take 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.

Special instructions

With extreme caution, it is used for diseases of the liver, kidneys, gastrointestinal tract in the anamnesis, dyspeptic phenomena, bronchial asthma, arterial hypertension, heart failure, immediately after serious surgical interventions, as well as in elderly patients. If a history of allergic reactions to NSAIDs and sulfites is indicated, diclofenac is used only in urgent cases. In the course of treatment, systematic monitoring of liver and kidney function, peripheral blood picture is necessary. Rectal use is not recommended in patients with a history of anorectal diseases or anorectal bleeding. Externally, it should be applied only on undamaged areas of the skin. Avoid contact with diclofenac in the eyes (with the exception of eye drops) or on the mucous membranes. Patients using contact lenses should apply eye drops no earlier than 5 minutes after removing the lenses. It is not recommended for use in children under 6 years of age. During the period of treatment with dosage forms for systemic use, alcohol consumption is not recommended. Influence on the ability to drive vehicles and mechanisms During treatment, it is possible to reduce the speed of psychomotor reactions. If visual clarity is impaired after applying eye drops, do not drive a car or engage in other potentially dangerous activities.

Form of production

Eye drops

Active ingredient

Diclofenac

Conditions of release from pharmacies

By prescription

Description

For adults and children as prescribed by a doctor

Indications

Corneal Injuries, Conjunctivitis