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

auxiliary substances: macrogol glycerylricinoleate (castor oil polyethoxylated), trometamol, disodium edetate dihydrate, mannitol, benzalkonium chloride, hydrochloric acid 1 M solution, purified water.

Description:

Transparent or almost transparent solution, from colorless to light yellow color.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug for topical application.

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:Diclofenac - Non-steroidal anti-inflammatory drug (NSAID), a derivative of phenylacetic acid, has anti-inflammatory and analgesic effect. Indiscriminately inhibiting cyclooxygenase type 1 and 2, disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins in the inflammatory focus. With topical application reduces swelling and pain in inflammatory processes of non-infectious etiology.

Pharmacokinetics:The time to reach the maximum concentration (C max) in the cornea and conjunctiva -30 min after installation, penetrates into the anterior chamber of the eye. In the systemic circulation in therapeutically significant concentrations does not penetrate.

Indications:

- inhibition of miosis during operations for cataract;

- inflammatory process after surgery;

- prevention and treatment of cystic macular edema after surgical removal of cataracts;

- inflammatory processes of non-infectious nature: conjunctivitis, keratoconjunctivitis, corneal erosion, post-traumatic inflammation of the conjunctiva and cornea;

- photophobia after keratotomy.

Contraindications:Hypersensitivity to any component of the drug.

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, propensity to bleed); pregnancy (I, II trimester), children and the elderly.

Pregnancy and lactation:There are no data on the use of the drug during pregnancy and lactation. With the use of NSAIDs in the III trimester of pregnancy, an increased risk of fetal circulatory disorders may occur. Use in pregnant and lactating mothers is possible only for the purpose of the doctor in charge, if the expected therapeutic effect exceeds the risk of developing possible side effects.

Dosing and Administration:

Buried in the conjunctival sac before the operation 1 drop 5 times for 3 hours, immediately after the operation - 1 cap 3 times, then - 1 drop 3-5 times a day for the time needed for treatment; other indications - 1 drop 4-5 times a day. The duration of treatment with the drug is no more than 28 days.

With more prolonged treatment, a detailed ophthalmological examination and precise diagnosis are necessary. Typically, the application is extended from one to several weeks.

Side effects:

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

Overdose:Overdose is unlikely with occasional use inside.

Interaction:

Not recommended simultaneous application of the drug to diflunizalom (since it may develop bleeding from the gastrointestinal tract) and other NSAIDs, including aspirin at high doses (DIG more per day), sulfonylureas, methotrexate.

Application together with drugs Lithium, digitoxin, indirect anticoagulants leads to an increase in their effect.

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

Special instructions:

Shake before use.

After removal of contact lenses, instillation is performed after 5 minutes. The interval between the use of various drops is 5 minutes.

If there is an infection or a threat of its development, local antibacterial treatment is prescribed at the same time.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities.requiring increased concentration of attention and speed of psychomotor reactions. Care should be taken when using the drug:

- during ophthalmic surgical interventions - may increase the time of bleeding, therefore it is recommended to be careful in patients with hemorrhagic diathesis or receiving anticoagulants;

- the anti-inflammatory effect of the drug may mask the symptoms of infections;

- in patients with bronchial asthma in combination with rhinitis or chronic sinusitis, the risk of an allergic reaction with the use of acetylsalicylic acid or non-steroidal anti-inflammatory drugs is increased. The use of the drug in these patients can cause bronchospasm.

The drug is intended only for topical application and is not administered subconjunctivally or into the anterior chamber of the eye;

Form release / dosage:

Eye drops 0.1%.

Packaging:

To 5 ml of solution in a white polymer bottle-dropper closed with a polymer lid with a safety ring. One bottle-dropper along with instructions for use in a cardboard pack.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C. Inaccessible to children!

Shelf life:

3 years. After opening the vial, store it for no more than 4 weeks. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002124/08

Date of registration:27.03.2008

The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania

Manufacturer: & nbsp

S.C. ROMPHARM Company, S.R.L. Romania

Representation: & nbspРомфарма ОООРомфарма ООО

Information update date: & nbsp05.03.2016

Illustrated instructions

Instructions

Diclofenac (Diclofenac)