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

Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory and analgesic effects. The main mechanism of action of indomethacin is the inhibition of 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 of the active substance of the drug indomethacin is determined in the moisture of the anterior chamber of the eye for several hours.

Systemic absorption of indomethacin with local administration of the drug is negligible.

Indications:

- Inhibition of miosis during surgical interventions on the eyeball;

- Prevention of inflammatory complications after surgery for cataract and in the area of the anterior chamber of the eye;

- Reduction of the pain syndrome "in the eye area" in the postoperative period after photorefractive keratectomy in the first day after the operation.

Contraindications:

- Hypersensitivity to the active or auxiliary substances of the drug;

- hypersensitivity to acetylsalicylic acid (or other salicylates) and / or other NSAIDs;

- attacks of bronchial asthma in a history in response to the use of acetylsalicylic acid or other NSAIDs;

- stomach ulcer;

severe hepatic impairment;

- severe renal insufficiency;

- Pregnancy (starting from the 6th month);

- the period of breastfeeding;

- Children under 18 years of age (no data on effectiveness and safety);

- simultaneous application with indirect anticoagulants, other NSAIDs, including derivatives of salicylic acid (in doses of 3 g per day and above adults);

- simultaneous application with diflunizal, heparin, lithium preparations, methotrexate in high doses (from 15 mg / week and more) and ticlopidine.

Carefully:

- Patients who are predisposed to allergic reactions;

- with simultaneous application with: diuretics, angiotensin-converting enzyme (ACE) inhibitors, methotrexate (in doses less than 15 mg / week), pentoxifylline; drugs that affect the mucosa of the gastrointestinal tract (GIT) (salts, oxides and hydroxides of magnesium, aluminum and calcium), zidovudine, beta-adrenoblockers, cyclosporine, desmopressin, thrombolytic agents.

- when implanting intrauterine devices.

Pregnancy and lactation:Indocollir can be used during the first five months of pregnancy only if the intended benefit to the mother exceeds the possible risk to the fetus.

Starting from the 6th month of pregnancy, the use of eye drops of indomethacin is contraindicated in connection with the risk of cardiotoxic effects on the fetus (premature closure of the arterial duct and the development of pulmonary arterial hypertension), as well as a decrease in renal function (up to the development of oligohydroamnion).

The use of indocollir increases the risk of edema in the mother.

The use of Indocollir before delivery can cause prolonged bleeding time in the mother and newborn.

Since NSAIDs, including indomethacin, penetrate into breast milk, breastfeeding should be stopped during treatment with Indocollir or exclude its use during breastfeeding.

Dosing and Administration:

For topical application in ophthalmology.

Looking up, gently pull down the lower eyelid and instill the drug into the conjunctival sac of the affected eye.

To inhibit miosis during surgical interventions on the eyeball - 1 drop 4 times a day on the eve of the operation and 1 drop 4 times for 3 hours immediately before the operation.

For the prevention and treatment of inflammatory complications after surgery for cataracts and in the area of the anterior chamber of the eye - 1 drop 4-6 times a day starting 24 hours before the operation and until the symptoms of inflammation completely disappear after it.

To relieve the pain syndrome (in the eye area) in the postoperative period after photorefractive keratectomy - 1 drop 4 times a day for the first few days.

Side effects:

The incidence of adverse events was assessed as follows according to the WHO classification: very often (> 1/10), often (> 1/100, <1/10); infrequently (> 1/1000, <1/100), rarely (> 1/10000, <1/1000), very rarely (<1/10000).

From the side of the organ of vision:

Rarely - local reactions of hypersensitivity in the form of itching and hyperemia, a feeling of moderate burning and / or temporary loss of vision clearness immediately after instillation of eye drops; increased photosensitivity, surface dot keratitis.

Rarely - corneal ulceration, which can be complicated by corneal perforation, especially in patients with damaged cornea or who received corticosteroids.

Overdose:No cases of overdose have been reported at this time. In case of local overdose of the drug should be washed eyes with warm water. In case of suspicion of oral use of the drug, treatment is symptomatic.

Interaction:

Despite the fact that the systemic absorption of indomethacin in local application in the form of eye drops is insignificant, the risk of drug interaction with other medicinal products can not be completely ruled out.

Indirect anticoagulants, other NSAIDs, diflunizal, heparin.

It is known that the use of indomethacin in other dosage forms simultaneously with indirect anticoagulants, other non-steroidal anti-inflammatory drugs in their daily dose of 3 grams and above (including salicylic acid derivatives, for example, acetylsalicylic acid, etc.), and diflunizalom heparin increases the risk of gastrointestinal tract ulceration and bleeding, and in combination with diflunizalom until fatal.

In turn, diflunizal can increase the concentration of indomethacin in the blood plasma.

Lithium preparations. Indomethacin can increase the concentration of lithium in the blood to toxic values, due to a decrease in the excretion of lithium by the kidneys.

Methotrexate (at a dose of 15 mg per week or more). Due to a decrease in excretion of methotrexate by the kidneys while taking indomethacin and / or other anti-inflammatory drugs, its hematotoxic effect is increased. Carefully indomethacin apply with methotrexate (in a dose less than 15 mg / week) - weekly blood test in the first weeks combined administration, as well as monitoring of renal dysfunction, especially in the elderly.

Ticlopidine. Indomethacin increases the antiplatelet action of ticlopidine and increases the risk of bleeding.

Indomethacin when combined with beta-blockers can weaken their effect.

Indomethacin may increase nephrotoxicity cyclosporine, especially in elderly patients.

NSAIDs can lead to an increased antidiuretic effect desmopressin.

Use caution when using indomethacin with diuretics and with ACE inhibitors, since patients with dehydration have a risk of acute renal failure (due to a decrease in glomerular filtration by inhibiting vasodilating prostaglandins after NSAID administration) and a decrease in antihypertensive effect.

In such situations, it is necessary to provide the patient with water and monitor the kidney function at the beginning of the treatment.

Combined use with pentoxifylline - increased risk of bleeding from the digestive tract (application under medical supervision and monitoring the duration of bleeding).

Drugs that affect the gastrointestinal mucosa (salts, oxides and hydroxides of magnesium, aluminum and calcium) reduce absorption of indomethacin from the gastrointestinal tract; recommend a separate reception with antacids (if possible, an interval of more than 2 hours).

NSAIDs, including indomethacin, can lead to an increase in the toxic effect zidovudine on reticulocytes with transition to acute anemia in 8 days after initiation of therapy with NSAIDs.

Combined use with thrombolytics - an increased risk of bleeding.

There is a suggestion that with the use of indomethacin, a risk of rupture of the implantable intrauterine device is possible.

With the simultaneous use of Indocollir with other eye drops, including those containing corticosteroids, to exclude the effect of "washing out" (reducing the concentration), the drugs should be injected with an interval of at least 15 minutes.

Special instructions:

The drug indocollir contains thiomersal, which can cause allergic reactions. When there are signs of individual intolerance, the drug should be discarded.

Like other NSAIDs, Indocollir can slow the healing of the cornea.

If there is an infection or a threat of its development, an adequate antibiotic therapy is prescribed at the same time.

When combined NSAIDs with lithium preparations are 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 can prolong bleeding time during surgery on the eyeball, especially in patients with blood clotting disorders or receiving anticoagulants. The combined use of indocollir with indirect indications for anticoagulants, heparin and ticlopidine should be carried out under close supervision of the physician and control of laboratory parameters, including bleeding time.

When combining Indocollir with methotrexate in a dose of less than 15 mg / week during the first weeks of joint use, the number of blood cells should be monitored, as well as close monitoring of patients with symptoms of renal failure and elderly patients.

The time between taking Indocollir and any antacid should be at least 2 hours.

When combined with diuretics and ACE inhibitors, it is necessary to monitor kidney function and prevent dehydration of the patient's body.

Before using the drug, contact lenses should be removed and placed back no earlier than 15 minutes after the drug is used.

An interval of 15 minutes should be observed while using Indocollir with other eye drops.

Do not touch the tip of the vial with any surface to avoid contamination of the vial and its contents.

The bottle must be closed after each use.

Effect on the ability to drive transp. cf. and fur:In some patients, the use of Indocollir preparation may be accompanied by a temporary loss of clarity of visual perception (immediately after instillation of eye drops); therefore, care must be taken when carrying out potentially dangerous activities requiring increased concentration and speed of psychomotor reactions (vehicle management, work with moving mechanisms) .

Form release / dosage:

Eye drops 0.1%.

Packaging:

Primary packaging: 5 ml each in a plastic vial with a stopper and a screw cap.

Secondary packaging: one bottle with instructions for use is enclosed in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

1,5 years.

Do not use after the expiry date printed on the package.

Shelf life after opening the bottle is 15 days.

Terms of leave from pharmacies:On prescription

Registration number:П N015363 / 01

Date of registration:16.06.2009 / 24.10.2016

The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia

Manufacturer: & nbsp

Laboratoire CHAUVIN, S.A. France

Representation: & nbspVALEANT LLC VALEANT LLC Russia

Information update date: & nbsp11.02.2018

Illustrated instructions

Instructions

Indocollar (Indocollyre)