Indomethacin

Pharmacological properties

ophthalmic drug belongs to the group of NSAIDs. when applied topically, it has analgesic and anti-inflammatory effects; inhibits the activity of prostaglandinsynthetase. active substance - indomethacin, belongs to the indole group of NSAIDs.

Pharmacokinetics There is no data.

Indications

• Elimination of myosis during cataract surgery; prevention of inflammatory processes after cataract surgery or after surgery on the anterior chamber of the eye; elimination of pain in the eyes after photorefractive keratectomy during the first few days after surgery.

Application

For topical use in adults in ophthalmology, the dose, frequency and duration are determined individually.

Elimination of miosis during surgery: 1 drop 4 times a day the day before surgery and 1 drop (4 times) 3 hours before surgery.

For the prevention of inflammatory processes after surgery for cataracts or after surgery on the anterior chamber of the eye: 1 drop 4-6 times a day until the symptoms disappear completely; instillation should be started 24 hours before surgery.

To eliminate eye pain after photorefractive keratectomy: 1 drop 4 times a day for the first few days after surgery.

Directions for use. For instillation of the drug, the lower eyelid should be slightly pulled back and 1 drop of the solution should be instilled into the conjunctival sac of the eye, while looking up.

Contraindications

Iii trimester of pregnancy; a detected allergy to indomethacin or drugs with a similar effect, for example, other NSAIDs or acetylsalicylic acid; patients with a history of asthma attacks caused by acetylsalicylic acid or other NSAIDs; active peptic ulcer; severe hepatocellular damage; severe renal failure.

As a rule, this drug should not be used in combination (see INTERACTIONS) with oral anticoagulants; other NSAIDs (including high doses of salicylates (3 g / day for adults); diflunisal; heparin; lithium; high doses of methotrexate; ticlopidine.

Side effects

The reactions that are sometimes noted are a slight, transient sensation of burning or acute pain and / or visual impairment after instillation.

Reactions that are rarely detected are hypersensitivity reactions, accompanied by itching and redness; there is evidence of a possible manifestation of acute asthma-like symptoms of respiratory tract damage: difficulty breathing, suffocation; photosensitivity is possible; spot keratitis.

In isolated cases, NSAIDs can cause a negative effect on the cornea, such as keratitis and corneal ulcers, which may be complicated by its perforation, especially if the drug is used in patients with a weakened cornea.

special instructions

This drug contains an organomercury compound that can cause an allergic reaction,

Cautions regarding use. In case of development of symptoms of hypersensitivity, drug treatment should be discontinued.

If there is a risk of developing an eye infection, appropriate treatment is prescribed.

NSAIDs can slow corneal healing.

NSAIDs can increase bleeding in the tissues of the eye during surgery, especially in patients with a tendency to bleed or in patients taking other drugs that can prolong bleeding.

It is not recommended to wear contact lenses during treatment with the drug.

If other drops for the eyes are used at the same time during Indocollyre treatment, the interval between instillations should be at least 15 minutes.

When instilling, do not touch the eye or eyelids with the tip of the dropper bottle.

During pregnancy and breastfeeding. The effect of the drug on the occurrence of developmental deficiencies in humans has not been reported. However, additional epidemiological studies are needed that confirm the absence of any risk.

The use of prostaglandin synthesis inhibitors in the III trimester of pregnancy can have such consequences for the fetus:

• cardiopulmonary toxicity (pulmonary hypertension with premature closure of the ductus arteriosus);
• impaired renal function, leading to renal failure, which is accompanied by oligohydramnios;
• at the end of pregnancy, an increase in bleeding time is possible in mothers and children.

Therefore, indomethacin can be prescribed in the first 5 months of pregnancy only if absolutely necessary. Starting from the 6th month of pregnancy, the use of indomethacin is contraindicated.

The period of breastfeeding. It is known that NSAIDs pass into breast milk, so their use during lactation should be avoided.

Children. Special studies involving children have not been conducted, so the drug is not recommended for use in pediatric practice.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Patients whose visual acuity decreases immediately after instillation should temporarily refrain from driving vehicles or working with other mechanisms.

Interactions

To avoid mixing and interaction of active substances, the interval between instillation of different drops should be 15 minutes

If necessary, indomethacin in the form of eye drops can be combined with eye drops that contain corticosteroids.

Although after instillation of eye drops only a small amount of indomethacin enters the systemic circulation, the interaction between the drugs does occur. Therefore, it is desirable to take into account the interaction that is observed with the use of NSAIDs.

The following combinations are not recommended.

• Oral anticoagulants: increased risk of bleeding caused by the use of oral anticoagulants (inhibition of platelet function and damage to the gastric mucosa of NSAIDs).

If such a combination is necessary, then in this case, clinical and laboratory observation is required.

• Other NSAIDs (including salicylates at a dose of 3 g / day for adults): increased risk of peptic ulcers and bleeding in the digestive tract (synergism).
• Diflunisal: lethal bleeding in the digestive tract, accompanied by an increased concentration of indomethacin in the blood plasma (competitive interaction with glucuronide-binding enzymes).
• Heparins: increased risk of bleeding (inhibition of platelet function and damage to the gastric mucosa of NSAIDs).

If such a combination is necessary, then clinical observation and laboratory monitoring of unfractionated heparins are required.

• Lithium: as for diclofenac, ketoprofen, methindole, phenylbutazone, piroxicam. Blood lithium levels can increase to toxic levels (by decreasing kidney excretion of lithium).

If such a combination is necessary, then control of the level of lithium in the blood and dose adjustment are required during the combined treatment and after the withdrawal of NSAIDs.

• Methotrexate used at a dose of ≥15 mg / week: the toxic effect of methotrexate on the blood system increases, since its renal clearance decreases under the influence of anti-inflammatory drugs.
• Ticlopidine: increased risk of bleeding (synergy of antiplatelet activity).

If such a combination is necessary, careful monitoring of clinical and laboratory parameters, including bleeding time, is required.

Precautions

• Diuretics, ACE inhibitors.ARF in patients with fixed dehydration (lowering glomerular filtration by inhibiting vasodilating prostaglandins NSAIDs), weakening the antihypertensive effect.

Hydration of patients and monitoring of renal function at the beginning of treatment are required.

• Methotrexate, used at a dose of 15 mg / week: the toxic effect of methotrexate on the blood system increases, since its renal clearance decreases under the influence of anti-inflammatory drugs.

During the first weeks of combination treatment, a weekly complete blood count is required. Even with minor changes in renal function, careful monitoring of the condition of patients, especially the elderly, is necessary.

• Pentoxifylline: increased risk of bleeding.

Strengthen clinical monitoring and frequently check bleeding times.

• Gastrointestinal agents of local action (salts, oxides, hydroxides of magnesium, aluminum and calcium). Decreased gastrointestinal absorption of indomethacin.

Any antacids should be used separately from indomethacin (if possible, then with an interval of ≥2 h).

• Zidovudine. Increased risk of red blood cell toxicity (action on reticulocytes), which is accompanied by severe anemia, 8 days after the start of NSAIDs. It is necessary to count blood cells and reticulocytes 8 and 15 days after the start of NSAID treatment.

Combinations to consider

• Beta-adrenoreceptor blockers: by extrapolation from indomethacin.

Reducing the antihypertensive effect (NSAIDs suppress vasodilator prostaglandins).

• Cyclosporine: risk of increased nephrotoxicity, especially in the elderly.
• Desmopressin: potentiation of antidiuretic activity.
• Intrauterine contraceptives: there is a risk of a decrease in their effectiveness (although the issue is controversial).
• Thrombolytics: increased risk of bleeding.

Overdose

Perhaps an increase in the manifestations of side effects. symptomatic treatment.

Storage conditions

At temperatures up to 25 ° C.