Indocollir, eye drops 0.1% 5 ml

It is intended for local application in ophthalmology. It has analgesic and anti-inflammatory effect.

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

Pharmacokinetics

There is confirmed evidence that the drug penetrates into the anterior chamber of the eye. With a single instillation the active ingredient of the drug is determined in the moisture of the anterior chamber for several hours.

In local administration of Indocollir systemic absorption is low.

Indications

Inhibition of miosis during surgical interventions on the eyeball; prevention of inflammatory complications after surgery for cataracts and in the anterior chamber of the eye; reduction of pain in the eye area in the postoperative period after photorefractive keratectomy on the 1st day after surgery.

Pharmacological effect

Intended for local use in ophthalmology. Has analgesic and anti-inflammatory effects.

The main effect of the drug is to inhibit the synthesis of prostaglandins, which play an important role in the pathogenesis of inflammation and pain.

Pharmacokinetics

There is confirmed evidence that the drug penetrates the anterior chamber of the eye. With a single instillation, the active substance of the drug is determined in the moisture of the anterior chamber for several hours.

When Indocollir is applied topically, systemic absorption is low.

Special instructions

Indocollir contains thiomersal, which can cause allergic reactions. If signs of individual intolerance appear, the drug should be discontinued.
Like other NSAIDs, Indocollir may slow corneal healing.
If an infection is present or there is a threat of its development, adequate antibacterial therapy is simultaneously prescribed.
When using NSAIDs together with lithium preparations as prescribed by a doctor, it is necessary to adjust the dose of the latter before, during and after treatment with NSAIDs, depending on the concentration of lithium in the blood.
NSAIDs may prolong bleeding time during ocular surgery, especially in patients with bleeding disorders or those receiving anticoagulants. For medical reasons, the combined use of the drug Indocollir with indirect anticoagulants, heparin and ticlopidine should be carried out under close medical supervision and monitoring of laboratory parameters, including bleeding time.
When Indocollir is combined with methotrexate at a dose of less than 15 mg/week, blood cell counts should be monitored during the first weeks of co-administration, and patients with symptoms of renal failure and the elderly should be closely monitored.
The time between taking Indocollir and any antacid should be at least 2 hours.
When used together with diuretics and ACE inhibitors, it is necessary to monitor renal function and prevent dehydration of the patient.
Before using the drug, contact lenses should be removed and put back no earlier than 15 minutes after using the drug.
An interval of 15 minutes should be maintained when using Indocollir with other eye drops.
Do not touch the tip of the bottle to any surface to avoid contamination of the bottle and its contents.
The bottle must be closed after each use.

Active ingredient

Indomethacin

Composition

Eye drops 0.1% in the form of a transparent solution of pale yellow color.

1 mlindomethacin 1 mg.

Excipients:

Thiomersal,

arginine,

hydroxypropyl betacyclodextrin,

hydrochloric acid,

purified water.

Pregnancy

Indomethacin in ophthalmology can be used during the first 5 months of pregnancy only if the expected benefit to the mother outweighs the possible risk to the fetus. Starting from the 6th month of pregnancy, the use of indomethacin eye drops is contraindicated due to the risk of cardiotoxic effects on the fetus (premature closure of the ductus arteriosus and the development of pulmonary arterial hypertension), as well as decreased renal function (up to the development of oligohydramnios).
The use of indomethacin eye drops during pregnancy increases the risk of maternal edema; use before delivery may prolong bleeding time in the mother and newborn.
Because NSAIDs, including indomethacin, pass into breast milk, breastfeeding should be discontinued during treatment with indomethacin eye drops or its use should be avoided during breastfeeding

Contraindications

Hypersensitivity to indomethacin; hypersensitivity to acetylsalicylic acid (or other salicylates) and/or other NSAIDs; a history of bronchial asthma attacks in response to the use of acetylsalicylic acid or other NSAIDs; stomach ulcer; severe liver failure; severe renal failure; pregnancy (starting from the 6th month); breastfeeding period; age under 18 years; simultaneous use with indirect anticoagulants, other NSAIDs, incl. salicylic acid derivatives; simultaneous use with diflunisal, heparin, lithium preparations, methotrexate in high doses and ticlopidine.
With caution: patients prone to allergic reactions; when used simultaneously with diuretics, ACE inhibitors, methotrexate (in doses less than 15 mg/week), pentoxifylline, drugs that affect the gastrointestinal mucosa (salts, oxides and hydroxides of magnesium, aluminum and calcium), zidovudine, beta-blockers, cyclosporine, desmopressin, thrombolytics; during implantation of intrauterine devices.

Side Effects

On the part of the organ of vision: rarely – local hypersensitivity reactions in the form of itching and hyperemia, a moderate burning sensation and/or temporary loss of clarity of vision immediately after instillation of eye drops, increased photosensitivity, superficial punctate keratitis; very rarely – corneal ulceration, which may be complicated by corneal perforation, especially in patients with damaged corneas or those receiving corticosteroids.

Interaction

Although the systemic absorption of indomethacin when applied topically as eye drops is negligible, the risk of drug interactions with other drugs cannot be completely excluded.
It is known that the use of indomethacin in other dosage forms simultaneously with indirect anticoagulants, other NSAIDs at a dose of 3 g/day and higher (including salicylic acid derivatives, for example, acetylsalicylic acid), diflunisal and heparin increases the risk of ulcers and bleeding in the gastrointestinal tract, and in combination with diflunisal, even fatal. In turn, diflunisal can increase the concentration of indomethacin in the blood plasma.
Indomethacin may increase the concentration of lithium in the blood to toxic levels due to a decrease in lithium excretion by the kidneys.
With simultaneous use of methotrexate (at a dose of 15 mg/week or more) with indomethacin and/or other anti-inflammatory drugs, the elimination of methotrexate decreases and its hematotoxic effect increases. Indomethacin is used with caution with methotrexate (at a dose of less than 15 mg/week) – weekly monitoring of blood counts is necessary in the first weeks of combined use, as well as monitoring for renal dysfunction, especially in the elderly.
Combined use with thrombolytics or antiplatelet agents (such as ticlopidine) increases the risk of bleeding.
Indomethacin, when used together with beta-blockers, may weaken their effect.
Indomethacin may enhance the nephrotoxic effect of cyclosporine, especially in elderly patients.
NSAIDs may enhance the antidiuretic effect of desmopressin.
Caution should be exercised when using indomethacin concomitantly with diuretics and ACE inhibitors, since in patients with dehydration there is a risk of acute renal failure (due to a decrease in glomerular filtration by inhibition of vasodilatory prostaglandins after taking NSAIDs) and a decrease in the hypotensive effect. In such situations, it is necessary to provide the patient with water and monitor renal function at the beginning of treatment.
Combined use with pentoxifylline increases the risk of bleeding from the gastrointestinal tract (use under medical supervision and control the duration of bleeding).
Drugs that affect the gastrointestinal mucosa (salts, oxides and hydroxides of magnesium, aluminum and calcium) reduce the absorption of indomethacin from the gastrointestinal tract; Separate administration with antacids is recommended (if possible, an interval of more than 2 hours).
NSAIDs, incl. indomethacin, can lead to an increase in the toxic effect of zidovudine on reticulocytes with the transition to acute anemia 8 days after the start of NSAID therapy.
There is an assumption that when using indomethacin there is a possible risk of rupture of the implantable intrauterine device.
When using the drug Indocollir simultaneously with other eye drops, including those containing corticosteroids, to avoid the effect of “washing out” (decrease in concentration), the drugs should be administered at intervals of at least 15 minutes.

Overdose

Currently, no cases of overdose have been reported. In case of local overdose of the drug, rinse the eyes with warm water. In case of suspected oral use of the drug, treatment is symptomatic

Recommendations for use

The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the dosage form of a particular drug with the indications for use and dosage regimen.
Apply topically, instill 1 drop into the conjunctival sac of the affected eye 4 times a day. During surgical interventions on the eyeball and for the treatment of inflammatory complications after surgery, the frequency and duration of use is determined by the doctor.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C.

Shelf life

1.5 years.
Do not use after the expiration date indicated on the package.
Shelf life after opening the bottle is 15 days

Manufacturer

Chauvin Laboratory, France