Instructions Indocollir 0.1% eye drops 1 mg/ml dropper bottle 5 ml
Composition
active ingredient: indomethacin;
1 ml of solution contains 1 mg of indomethacin;
excipients: thiomersal, arginine, hydroxypropyl-beta-cyclodextrin, diluted hydrochloric acid, purified water.
Dosage form
Eye drops.
Main physicochemical properties: clear solution.
Pharmacotherapeutic group
Drugs used in ophthalmology. Nonsteroidal anti-inflammatory drugs.
ATX code S01B S01.
Pharmacological properties
Pharmacodynamics
The drug belongs to the group of nonsteroidal anti-inflammatory analgesics for topical use.
Indomethacin inhibits prostaglandin synthetase and belongs to the indole group of drugs.
Pharmacokinetics
No data.
Indication
– Inhibition of miosis during surgery.
– Prevention of inflammatory processes after cataract surgery or after surgery on the anterior chamber of the eye.
– Elimination of eye pain after photorefractive keratectomy during the first few days after surgery.
Contraindication
– Last trimester of pregnancy (see section “Use during pregnancy or breastfeeding”);
– a known allergy to indomethacin or drugs with a similar effect, such as other non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin;
- history of asthma attacks caused by aspirin or other NSAIDs;
– active peptic ulcer of the stomach and duodenum;
– severe hepatocellular disorders;
– severe renal failure.
Interaction with other medicinal products and other types of interactions
To avoid mixing and interaction of active ingredients, the interval between instilling different drops into the eyes should be 15 minutes.
If necessary, indomethacin eye drops can be combined with eye drops containing corticosteroids.
Although only a small amount of indomethacin enters the systemic circulation after instillation of eye drops, drug interactions do occur. Therefore, it is advisable to consider the interactions observed with systemic use of NSAIDs.
Combinations that are not recommended
Oral anticoagulants: increased risk of bleeding caused by the use of oral anticoagulants (suppression of platelet function and damage to the gastric mucosa by NSAIDs).
If such a combination is necessary, close clinical and laboratory monitoring should be performed.
Other NSAIDs (including salicylates at doses greater than 3 g/day in adults): increased risk of gastrointestinal ulcers and bleeding (synergism).
Diflunisal: fatal gastrointestinal bleeding accompanied by increased plasma concentrations of indomethacin (competitive interaction with glucuronide-binding enzymes).
Heparins: increased risk of bleeding (suppression of platelet function and damage to the gastric mucosa of NSAIDs).
If such a combination is unavoidable, close clinical monitoring (and
laboratory control of unfractionated heparins).
Lithium: as described for indomethacin, diclofenac, ketoprofen, metindole, phenylbutazone, piroxicam.
Lithium levels in the blood may rise to toxic levels (decreased excretion
lithium by the kidneys).
If such a combination is necessary, careful monitoring of lithium blood levels and dose adjustments should be made during combination treatment and then after discontinuation of the nonsteroidal anti-inflammatory drug.
Methotrexate at doses of 15 mg per week or more: toxic effects of methotrexate on
blood system is enhanced because its renal clearance is influenced by
anti-inflammatory drugs is reduced.
Ticlopidine: increased risk of bleeding (synergism of antiplatelet activity).
If such a combination is necessary, careful monitoring of clinical and
laboratory parameters, including bleeding time.
Combinations requiring caution
Diuretics, angiotensin-converting enzyme (ACE) inhibitors. Acute renal failure in patients with dehydration (decreased
glomerular filtration by inhibiting vasodilator prostaglandins
nonsteroidal anti-inflammatory drugs). In addition, the antihypertensive effect is weakened.
Patients should be hydrated and renal function monitored at the beginning of treatment.
Methotrexate in doses less than 15 mg per week. The toxic effect of methotrexate on the blood system is increased, since its renal clearance is reduced by anti-inflammatory drugs. During the first few weeks of combined treatment, a complete blood count should be performed weekly. Even with minor changes in renal function, close monitoring of the patient's condition is necessary, as well as the condition of elderly patients.
Pentoxifylline: Increased risk of bleeding. Increased clinical monitoring and more frequent monitoring of bleeding time.
Zidovudine: Increased risk of erythrocyte toxicity (effect on reticulocytes), accompanied by severe anemia, 8 days after starting NSAIDs.
Complete blood cell and reticulocyte counts should be performed 8 and 15 days after starting NSAID treatment.
Combinations to consider
Beta-blockers. Decreased antihypertensive effect (NSAIDs inhibit the action of vasodilator prostaglandins).
Cyclosporine: Risk of increased nephrotoxicity, particularly in elderly patients.
Desmopressin. Potentiation of antidiuretic activity.
Intrauterine contraceptives. Risk of reduced effectiveness of IUDs (relationship not proven).
Thrombolytics: Increased risk of bleeding.
Application features
Warning
This product contains an organomercury compound, which may cause an allergic reaction.
Precautions for use
− If symptoms of hypersensitivity develop, treatment with the drug should be discontinued.
− If there is a risk of developing eye infection, appropriate treatment should be prescribed.
− NSAIDs may slow corneal healing.
− NSAIDs may increase bleeding in the tissues of the eye during surgery, especially in patients with a tendency to bleed or in patients receiving other drugs that can prolong bleeding.
− It is not recommended to wear contact lenses during treatment with the drug.
− If other eye drops are used simultaneously during treatment with Indocollir®, the interval between instillations should be at least 15 minutes.
−When instilling the drug, do not touch the eye with the tip of the bottle.
Use during pregnancy or breastfeeding
Pregnancy
The drug has not been reported to cause malformations in humans. However, additional epidemiological studies are needed to confirm the absence of any risk.
In the third trimester of pregnancy, the use of prostaglandin synthesis inhibitors may have
the following consequences for the fetus:
− toxic effect on the cardiopulmonary system (pulmonary hypertension with premature closure of the ductus arteriosus);
− impaired renal function, which can lead to renal failure, accompanied by oligohydramnios.
At the end of pregnancy, bleeding time may increase in both mother and baby.
Therefore, indomethacin can be used in the first 5 months of pregnancy only if the expected benefit to the mother outweighs the risk to the fetus.
Starting from the 6th month of pregnancy, the use of indomethacin is contraindicated.
Breastfeeding period.
NSAIDs are known to pass into breast milk, so their use in breastfeeding women should be avoided.
Ability to influence reaction speed when driving vehicles or other mechanisms
Patients who experience loss of vision immediately after instillation should temporarily refrain from driving or operating other machinery.
Method of administration and doses
The drug is intended for topical use in ophthalmology by adults. The dose, frequency and duration of use are determined individually by the doctor.
Inhibition of miosis during surgery:
Apply 1 drop 4 times a day the day before surgery and 1 drop 4 times 3 hours before surgery.
Prevention of inflammation after cataract surgery or after surgery on the anterior chamber of the eye:
1 drop 4-6 times a day until the symptoms of the disease disappear completely, starting instillation 24 hours before surgery.
Elimination of eye pain after photorefractive keratectomy:
1 drop 4 times a day for the first few days after surgery.
Instructions for use
To instill the solution, slightly pull back the lower eyelid and instill 1 drop of the solution into the conjunctival sac, while the patient should look up.
Children
No specific studies involving children have been conducted, so the drug is not recommended for use in pediatric practice.
Overdose
In case of overdose, side effects may be exacerbated.
Treatment is symptomatic therapy.
Adverse reactions
Lacrimation, corneal abscess, corneal and conjunctival edema, allergic reactions including urticaria, angioedema.
Reactions that occur sometimes
Minor transient burning sensation, sharp pain and/or blurred vision after instillation.
Rare reactions
– Hypersensitivity reactions: accompanied by itching and redness; there is data on the possible manifestation of acute asthma-like symptoms of respiratory tract damage: difficulty breathing, suffocation;
– possible photosensitivity;
– punctate keratitis.
In rare cases, NSAIDs can cause adverse effects on the cornea, such as keratitis and corneal ulceration, which may be complicated by corneal perforation, especially when used in patients with weakened corneas.
Expiration date
18 months.
After first opening, the contents of the bottle should be used within 15 days.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
5 ml dropper bottle in a cardboard box.
Vacation category
According to the recipe.
Manufacturers
Chauvin Laboratory/Laboratoire Chauvin.
Dr. Gerhard Mann, Chem.-Pharm. Factory GmbH/Dr. Gerhard Mann, Chem.-pharm. Fabric GmbH.
Location of manufacturers and their business address
Industrial Zone Ripotier Haut 07200 Aubenas, France/Zone Industrielle Ripotier Haut 07200 Aubenas, France.
Brunsbutteler Damm 165-173, 13581 Berlin, Germany.
