Indocollyre (Indomethacin) 0.1% 5ml eye drops

Release form and composition: 

Eye drops 0.1% in a transparent, almost colourless sterile solution.

1 ml contains:

indomethacin 1 mg

Excipients: thiomersal, arginine, hydroxypropylmethacrylate, hydrochloric acid, purified water.

5 ml – vial-dropper plastic (1) – boxes: cardboard.

Pharmacological action:

NSAIDs for topical application in ophthalmology. Has anti-inflammatory and analgesic effect.

The main mechanism of drug action is the inhibition of the synthesis of prostaglandins, which play an important role in the pathogenesis of inflammation and pain.

Pharmacokinetics:

There is documented evidence that the drug enters the anterior chamber of the eye. After a single instillation of the active ingredient of the drug is determined in the anterior chamber for several hours.

The local application Indokarya low systemic absorption.

Indications:

• inhibition of miosis during surgery for cataract
• treatment and prevention of inflammatory processes after surgical interventions on the eyeball
• prophylaxis of cystic edema of macula after surgery for cataract
• treatment of non-infectious conjunctivitis
• treatment and prevention of post-traumatic inflammatory process in penetrating and nonpenetrating wounds of the eyeball (as addition to local antimicrobial therapy).

Dosing regimen:

For the inhibition of intraoperative miosis the drug instilled 1 drop into the conjunctival SAC during 2 hours with an interval of 30 min (4 times) before the operation.

For prophylaxis of cystic edema of the macula the drug is instilled to 1 drop 3-4 times/day for 1 month after surgery.

For other indications appoint 1 drop 3-4 times/day depending on the severity of the condition. The course of treatment can last from 1 to 4 weeks.

Side effects:

From the body of the vision: rarely – slight or moderate pain and/or temporary loss of blurred vision immediately after instillation of eye drops prolonged use Indokarya – clouding of the cornea, conjunctivitis.

Allergic reactions: rarely – itching and redness of the skin.

Long-term use Indokarya may develop systemic side effects of indomethacin.

Contraindications:

• hypersensitivity to the preparation components
• hypersensitivity to acetylsalicylic acid or other NSAIDs, manifested by attacks of asthma, the occurrence of urticaria, acute rhinitis.

Use caution when Intecolor:

• epithelial herpetic keratitis (including in anamnesis)
• diseases that cause violation of blood coagulation (including hemophilia, prolonged bleeding time, bleeding tendency).

Pregnancy and lactation:

Adequate and well-controlled clinical studies on the safety of Indokarya during pregnancy and lactation (breastfeeding) has not been conducted. However, the drug can be used in the first 5 months of pregnancy if the expected benefit of therapy for the mother outweighs the potential risk to the fetus. Starting from the 6th month of pregnancy to prescribe the drug should not be, because it can lead to dysfunction of the vascular system and kidney in the fetus.

Indomethacin is excreted in breast milk, so if you need the use of the drug during lactation should decide the issue of termination of breastfeeding or to avoid its use during breast-feeding.

Special instructions:

Before the instillation of the drug should remove contact lenses you can install them in 15 minutes after instillation.

The bottle must be closed after each use of the drug. Do not touch the tip of the pipette to the eye.

Effects on ability to drive vehicles and management mechanisms

Patients after application of the drug is temporarily lost the clarity of vision, it is not recommended to drive or operate complex equipment, machines or any other complex equipment that requires clarity of vision immediately after instillation of the drug.

Overdose:

Accidental ingestion poses the risk of side effects.

Drug interactions:

Indicalor may potentiate the effects of anticoagulants, lithium preparations.

Not recommended simultaneous application of the drug with diflunizalom (may develop bleeding from the gastrointestinal tract) and other NSAIDs, including acetylsalicylic acid in high doses (3 g/day or more).

Concurrent use of indomethacin with beta-blockers and saluretikami may attenuate the effects of the latter.

If necessary, you can use simultaneously with other eye drops, including that containing corticosteroids. The interval between applications should be at least 5 minutes to prevent washout of active substances and subsequent doses.

Terms and conditions of storage:

List B. the Drug should be stored out of reach of children at temperature not exceeding 25°C. shelf Life – 2 years.

After opening the bottle the drug should be used within 6 weeks.