Diklo-F - instructions for use, doses, side effects, contraindications

Composition:Each ml of the drug contains: 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 up to pH 7.7, water for injection up to 1 ml.

Description:

Transparent solution from colorless to light yellow color.

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

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Diclofenac has an anti-inflammatory, analgesic and antipyretic effect. The mechanism of action is due to indiscriminate inhibition of cyclooxygenase 1 and 2, which leads to suppression of the synthesis of prostaglandins in the inflammatory focus.

When used as a 0.1% solution of eye drops diclofenac reduces inflammation of the eye, resulting from infection, trauma or surgery; reduces miosis during surgical operations, reduces the synthesis of prostaglandins in the moisture of the anterior chamber.

Pharmacokinetics:

The drug penetrates well into various tissues of the eye except for the lens.

C max occurs within 30 minutes, the highest concentration is observed in the moisture of the anterior chamber. Systemic absorption is observed. However, the drug concentration achieved in the blood is well below the detection limit and is not clinically relevant.

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 with penetrating and non-penetrating injuries of the eyeball (as an addition to local antibiotic therapy).

Contraindications:

- hypersensitivity to the active substance of the drug or to any of the auxiliary ingredients that form part of this dosage form of the drug;

- hypersensitivity to acetylsalicylic acid or other NSAIDs;

- violation of hematopoiesis of unknown origin;

- erosive and ulcerative processes in the gastrointestinal tract in the acute stage.

Carefully:Epithelial herpetic keratitis (including in the anamnesis); diseases that cause blood clotting disorders (including hemophilia, prolonged bleeding time, a tendency to bleed); elderly age. There is no data on the use of the drug in children, so use the drug only if the expected benefit exceeds the potential risk.

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:

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.

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

Other indications: 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:In rare cases, during the application of the drug, the following undesirable side effects were noted: burning eyes, blurred vision (immediately after instillation); opacity of the cornea (thorns), iritis. Allergic reactions: itchy eyes, redness, angioneurotic edema of the face, fever, chills, photosensitivity, cutaneous rash (primarily erythematous, urticaria), erythema multiforme; nausea, vomiting.

Overdose:There is no evidence of an overdose of the drug.

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 in conjunction with lithium preparations, 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:

Patients using contact lenses should use Diklo-F® only with the lenses removed and can wear them 15 minutes after instillation.

After removal of contact lenses, instillation is performed after 5 minutes.

The bottle must be closed after each use. Do not do it

touch the tip of the pipette to the eye.

During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:Eye drops 0.1%.

Packaging:To 5 ml in a plastic bottle-dropper with a screw cap. Each vial-dropper along with the instruction for use is placed in a cardboard box.

Storage conditions:At a temperature of no higher than 30 ° C in a dark place. Do not freeze. Keep out of the reach of children.

Shelf life:2 years. Drops should be used within a month after opening the vial. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014523 / 01

Date of registration:20.03.2008

The owner of the registration certificate:Sentiss Pharma Pvt. Ltd.Sentiss Pharma Pvt. Ltd. India

Manufacturer: & nbsp

SENTISS PHARMA Pvt. Ltd India

Representation: & nbspSENTISS RUSS LLCSENTISS RUSS LLCRussia

Information update date: & nbsp07.03.2016

Illustrated instructions

Instructions

Diklo-F (Diclo-F)