Diclo-F® eye drops

Benzalkonium chloride 0.1 mg, disodium edetate 1.0 mg, boric acid 15.0 mg, tromethamine 6.0 mg, polyoxyl 35 castor oil 20.0 mg, povidone 15.0 mg, sodium hydroxide or hydrochloric acid to pH 7 7, water for injection to 1 ml.

Trade Name:

Diclo- F eye drops

Composition:

Active ingredient:
Diclofenac sodium 1.0 mg

Excipients:

Benzalkonium chloride 0.1 mg, disodium edetate 1.0 mg, boric acid 15.0 mg, tromethamine 6.0 mg, polyoxyl 35 castor oil 20.0 mg, povidone 15.0 mg, sodium hydroxide or hydrochloric acid to pH 7 7, water for injection to 1 ml.

Pharmacotherapeutic Group:

Nonsteroidal antiinflammatory drug (NSAID)

Indications:

  • Inhibition of myosis during the cataract operations;
  • Treatment and prophylaxis of inflammatory processes after surgical interventions in the eyeball;
  • Prophylaxis of cystic edema of macula after cataract operations;
  • Treatment of noninfectious conjunctivitis;
  • Treatment and prophylaxis of post-traumatic inflammatory processes in penetrating and nonpenetrating wounds of the eyeball (as addition to the local antibacterial therapy).

Dosage and administration:

For topical application: To inhibit the intra-operational myosis, the eye drops are instilled into the conjunctival sac during 2 hours with the interval of 30 minutes (4 times) before initiation of the surgery.

For prophylaxis of cystic edema of macula the preparation is instilled postoperatively for 3 – 4 times a day of 1 drop during 2 weeks.

Other indications: 1 drop 3 – 4 times a day depending on gravity of state. The course of treatment can take from 1 to 2 weeks.

Contraindications:

  • Hypersensitivity to the active substance of the preparation or to any auxiliary component of this preparation;
  • Hypersensitivity to the acetylsalicylic acid or another nonsteroidal antiinflammatory drugs
  • Hemodyscrasia unexplained;
  • Erosive-ulcerative processes in the gastrointestinal tract in the acute stage.

Warning and precautions:

Epithelial herpetic keratitis (including in anamnesis); diseases causing disturbances in blood coagulation (including hemophilia, prolonged time of hemorrhage, tendency toward the hemorrhages); elderly age. No data on the use of the drug in children, so the drug should be used only if the expected benefit outweighs the potential risk

Use in pregnancy, lactation and children

There are no data on the use of the preparation in pregnancy and lactation. When using NSAIDs in the III trimester of pregnancy may increase the risk of circulatory disorders of the fetus.

Therefore, it should be used in these categories of patients only when the expected benefit exceeds potential risk.

Adverse effects:

During the use of the preparation the following undesirable side effects rarely have been observed: burning of eyes, blurring of visual perception (immediately after instillation); corneal opacity (leucoma), iritis.

Allergic reactions: eyes itch, hyperemia, angioneurotic edema of face, fever, chill, photosensitization, skin rash (predominantly erythematous, hives), multiform exudative erythema; nausea, vomiting.

Drug Interaction:

It is not recommended the simultaneous use of this preparation with diflunisal (for a possible hemorrhage in the gastrointestinal tract) and another NSAIDs, including acetylsalicylic acid in large doses (3 g and more a day), sulfonylurea drugs, methotrexate. Use in conjunction with lithium drugs, digitoxin, indirect anticoagulants leads to enhancement of their effect. If necessary, the preparation can be used simultaneously with other eye drops, including glucocorticosteroids. In this case, the time interval between the instillations must be not less than 5 minutes for preventing the active ingredients from washing out by the subsequent doses.

Over-dosage:

There are no data on the overdose of the preparation.

Other related information:

  • The patients with contact lenses must remove them when using Diclo-F® and replace the lenses only 15 minutes after the instillation of the drops. Instill preparation in 5 min after removing contact lenses.
  • The vial must be close after each use. Do not touch the tip of the dropper to the eye.
  • In the course of treatment, it is necessary to avoid the potentially dangerous forms of activity, which require the increased concentration of attention and fast psycho-motor reactions.

Packaging:

Eye drops 0,1%.

  • 5 ml into plastic vial dropper with a screw-cap. Each vial-dropper, together with instructions for use is placed in a carton unit.
  • 5 ml into vial of dark glass, closed with a rubber stopper, crimped with aluminum cap with a protective plastic cap. One glass vial with a sterile dropper, packed in a plastic bag, placed in a carton unit with instructions for use.

Storage Conditions:

Store at the temperature below 30 °C in a place protected from light. Do not freeze. Keep away from children

Shelf-life:

  • 2 years
  • After opening the vial, the preparation should be used within 1 month
  • Do not use after the expiration date indicated on the packing