Indoftalmik (Drops) Instructions for Use

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

ATC Code

S01BC01 (Indometacin)

Active Substance

Indometacin (Rec.INN registered by WHO)

Dosage Form

Indoftalmik

Eye drops 1 mg/ml: bottle 5 ml 1 pc.

Dosage Form, Packaging, and Composition

Eye drops transparent, greenish-yellow in color.

Excipients: arginine, hydroxypropylbetadex, thiomersal, hydrochloric acid 1 M solution, purified water.

5 ml – low-density polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for topical use in ophthalmology

Pharmacotherapeutic Group

Agents used in ophthalmology; anti-inflammatory agents; nonsteroidal anti-inflammatory agents

Pharmacological Action

NSAID, possesses anti-inflammatory and analgesic action.

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

Pharmacokinetics

There is confirmed data that Indometacin penetrates into the anterior chamber of the eye. After a single instillation, it is detected in the aqueous humor of the anterior chamber for several hours.

Systemic absorption of indometacin with topical application is low.

Indications

Inhibition of miosis during surgical interventions on the eyeball; prevention of inflammatory complications after cataract surgery and in the area of 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.

ICD codes

Dosage Regimen

Instill one drop into the conjunctival sac of the affected eye.

For postoperative inflammation prevention and pain reduction after photorefractive keratectomy, apply four times daily.

For inhibition of miosis during cataract surgery, administer preoperatively as directed by the surgeon.

During surgical interventions and for treating established postoperative inflammatory complications, the frequency and duration of application are determined individually by the physician.

When using multiple topical ophthalmic products, administer Indoftalmik last and maintain an interval of at least 15 minutes between instillations.

Remove contact lenses before application; reinsert them no earlier than 15 minutes after instillation.

Do not allow the dropper tip to contact the eye, eyelids, or any other surface to avoid contamination of the solution.

Immediately after instillation, temporary blurring of vision or a mild burning sensation may occur; exercise caution when driving or operating machinery.

If symptoms persist or worsen, discontinue use and consult a physician.

Strictly adhere to the prescribed regimen and do not exceed the recommended dosage.

Adverse Reactions

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

Contraindications

Hypersensitivity to indometacin; hypersensitivity to acetylsalicylic acid (or other salicylates) and/or other NSAIDs; history of bronchial asthma attacks in response to the use of acetylsalicylic acid or other NSAIDs; gastric ulcer disease; severe hepatic insufficiency; severe renal insufficiency; pregnancy (starting from the 6th month); breastfeeding period; age under 18 years; simultaneous use with indirect anticoagulants, other NSAIDs, including salicylic acid derivatives; simultaneous use with diflunisal, heparin, lithium preparations, methotrexate in high doses and ticlopidine.

With caution in patients predisposed to allergic reactions; with simultaneous use 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; with implantation of intrauterine devices.

Use in Pregnancy and Lactation

Indometacin in ophthalmology can be used during the first 5 months of pregnancy only if the intended benefit to the mother outweighs the possible risk to the fetus. Starting from the 6th month of pregnancy, the use of Indometacin eye drops is contraindicated due to the risk of cardiotoxic effects on the fetus (premature closure of the arterial duct and development of pulmonary arterial hypertension), as well as decreased renal function (up to the development of oligohydramnios).

The use of Indometacin eye drops during pregnancy increases the risk of edema in the mother; use before delivery may cause prolonged bleeding time in the mother and newborn.

Since NSAIDs, including Indometacin, pass into breast milk, breastfeeding should be discontinued during treatment with indometacin in the form of eye drops or its use should be avoided during the breastfeeding period.

Use in Hepatic Impairment

Use of the drug is contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

Use of the drug is contraindicated in severe renal insufficiency.

Pediatric Use

Use of the drug is contraindicated under the age of 18 years (data on efficacy and safety are lacking).

Special Precautions

Like other NSAIDs, Indometacin may slow corneal healing. In the presence of an infection or threat of its development, adequate antibacterial therapy is prescribed simultaneously.

When using NSAIDs concomitantly with lithium preparations (as prescribed by a doctor), the dose of the latter must be adjusted before, during, and after NSAID treatment depending on the blood lithium concentration.

NSAIDs may prolong bleeding time during surgical intervention on the eyeball, especially in patients with bleeding disorders or those receiving anticoagulants. Concomitant use of indometacin with indirect anticoagulants, heparin and ticlopidine for medical reasons should be carried out under close medical supervision and monitoring of laboratory parameters, including bleeding time.

When combining Indometacin eye drops with methotrexate in a dose of less than 15 mg/week, during the first weeks of concomitant use, the blood cell count should be monitored, and close observation should be maintained for patients with symptoms of renal insufficiency and elderly patients.

An interval of at least 2 hours should be observed between the application of indometacin and any antacid.

When used concomitantly with diuretics and ACE inhibitors, renal function should be monitored and patient dehydration should be avoided.

Before using the drug, contact lenses should be removed and reinserted no earlier than 15 minutes after application of the drug.

An interval of 15 minutes should be observed when used concomitantly with other eye drops.

Effect on the ability to drive vehicles and operate machinery

In some patients, the use of Indometacin eye drops may be accompanied by a temporary loss of visual clarity (immediately after instillation), therefore caution must be exercised when performing potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms).

Drug Interactions

Although the systemic absorption of indometacin with topical application in the form of eye drops is insignificant, the risk of drug interaction with other drugs cannot be completely excluded.

It is known that the use of indometacin in other dosage forms simultaneously with indirect anticoagulants, other NSAIDs in 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 up to fatal. In turn, diflunisal may increase the plasma concentration of indometacin.

Indometacin may increase the blood concentration of lithium to toxic levels due to decreased renal excretion of lithium.

When methotrexate (in a dose of 15 mg/week and more) is used concomitantly with indometacin and/or other anti-inflammatory drugs, the excretion of methotrexate decreases and its hematotoxic effect increases. Indometacin is used with caution with methotrexate (in 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 of renal function disorders, especially in elderly individuals.

Combined use with thrombolytics or antiplatelet agents (such as ticlopidine) increases the risk of bleeding.

Indometacin, when used concomitantly with beta-blockers, may weaken their effect.

Indometacin may enhance the nephrotoxic effect of cyclosporine, especially in elderly patients.

NSAIDs may lead to an enhancement of the antidiuretic effect of desmopressin.

Caution should be exercised when using indometacin concomitantly with diuretics and ACE inhibitors, since in dehydrated patients there is a risk of acute renal failure (due to a decrease in glomerular filtration by inhibiting 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 gastrointestinal bleeding (use under medical supervision and control of bleeding time).

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

NSAIDs, including Indometacin, may lead to an enhancement of the toxic effect of zidovudine on reticulocytes with transition to acute anemia 8 days after the start of NSAID therapy.

There is a suggestion that when using indometacin, there may be a risk of rupture of the implanted intrauterine device.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.