Ibustrin (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmacia & Upjohn, S.p.A. (Italy)

ATC Code

B01AC10 (Indobufen)

Active Substance

Indobufen (Rec.INN registered by WHO)

Dosage Form

Ibustrin

Tablets 200 mg: 30 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (3) – cardboard packs.

Clinical-Pharmacological Group

Antiplatelet agent

Pharmacotherapeutic Group

NSAID

Pharmacological Action

Antiplatelet agent. It suppresses platelet activity and prevents thrombus formation upon contact with foreign surfaces or during pathological vascular changes.

It does not affect blood clotting factors and slightly increases bleeding time. It inhibits COX enzymes and thromboxane synthase.

Indications

Prevention of thrombus formation in ischemic cerebrovascular and cardiovascular diseases, atherosclerotic lesions of peripheral vessels, venous thrombosis, diabetes, lipid metabolism disorders, and during hemodialysis.

ICD codes

Dosage Regimen

Administer orally with a full glass of water.

Take twice daily, typically every 12 hours.

The standard adult dose is 200 mg (one tablet) per administration.

For specific conditions, adjust as follows: in severe renal impairment (creatinine clearance less than 30 mL/min), reduce the dose to 100 mg twice daily.

For patients undergoing hemodialysis, administer a single 200 mg dose immediately before the session.

Adjust the dose for elderly patients over 65 years of age based on renal function and clinical response.

Do not crush or chew the tablets; swallow them whole.

Take with or immediately after meals to minimize potential gastrointestinal discomfort.

Adhere strictly to the prescribed dosing schedule to maintain consistent antiplatelet activity.

Adverse Reactions

Possible: dyspeptic symptoms, allergic reactions, gum bleeding, nosebleeds, gastrointestinal bleeding, hematuria.

Contraindications

Hypersensitivity to indobufen; hemorrhagic disorders, erosive and ulcerative lesions of the gastrointestinal tract in the acute phase; pregnancy.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

If use during lactation is necessary, the issue of discontinuing breastfeeding should be considered.

Use in Renal Impairment

Before a hemodialysis session, the dose of indobufen is selected individually, depending on the creatinine clearance.

Geriatric Use

Dose adjustment is required for elderly patients (over 65 years of age).

Special Precautions

Use with caution in patients with a history of gastrointestinal diseases, diabetes mellitus (more frequent blood glucose monitoring is necessary), and during treatment with other antiplatelet agents or NSAIDs.

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.