Product image of Ibustrin (Indobufen) supplied by GNH India

Ibustrin

Active Ingredient:
Indobufen
Origin:
EU

Ibustrin (Indobufen)

Indobufen, the active ingredient in Ibustrin, is a platelet aggregation inhibitor presented as an oral tablet for oral use. It is employed to reduce the risk of arterial clot formation in patients with cardiovascular disease, including those who have experienced myocardial infarction or stroke, and is indicated for secondary prevention after myocardial infarction.

GNH India supplies Ibustrin as a licensed, GDP‑compliant supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to international quality standards and provides regulatory documentation for export.

Manufacturer / TM Owner

Laboratórios Pfizer Lda.

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Indications & Clinical Uses

Indobufen is used to inhibit platelet‑mediated clot formation in arterial vascular conditions.

  • Arterial thrombosis: reduces incidence of clot formation in arteries.
  • Myocardial infarction (secondary prevention): lowers risk of recurrent heart attacks.
  • Stroke prevention: decreases likelihood of ischemic stroke in at‑risk patients.
  • Peripheral arterial disease: improves blood flow by preventing arterial occlusion.

How It Works

  • Indobufen reversibly inhibits platelet cyclooxygenase‑1 (COX‑1), which blocks the conversion of arachidonic acid to thromboxane A₂. By reducing thromboxane A₂ synthesis, the drug diminishes platelet activation and aggregation, thereby preventing the formation of arterial thrombi without permanently altering platelet function. The inhibition is dose‑dependent and reversible, allowing normal platelet function to resume after the drug is cleared. Indobufen’s selectivity for COX‑1 over COX‑2 contributes to a lower risk of gastrointestinal side effects compared with non‑selective NSAIDs.

Side Effects

Indobufen may be associated with a range of adverse reactions, which are categorised by frequency and severity.

Common Side Effects

  • Dyspepsia: upper abdominal discomfort or pain.
  • Nausea: feeling of sickness.
  • Headache: mild to moderate head pain.
  • Dizziness: sensation of light‑headedness.
  • Rash: mild skin irritation.

Serious or Rare Side Effects

  • Severe bleeding: gastrointestinal or intracranial hemorrhage.
  • Thrombocytopenia: marked reduction in platelet count.
  • Hepatic dysfunction: elevated liver enzymes or hepatitis.
  • Anaphylaxis: life‑threatening allergic reaction.
  • Neutropenia: low neutrophil count increasing infection risk.

Precautions & Warnings

When prescribing Indobufen, clinicians should consider several precautionary measures to minimise risk.

  • Assess bleeding risk: evaluate history of ulcers or hemorrhage before initiating therapy.
  • Monitor liver function: perform baseline and periodic liver enzyme tests.
  • Use caution in renal impairment: adjust dose or monitor renal parameters in patients with reduced kidney function.
  • Avoid in known hypersensitivity: discontinue if allergic reactions occur.
  • Limit concomitant antiplatelet use: combine with other agents only under specialist guidance.
  • Store at room temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Indobufen can interact with other medicines, affecting its antiplatelet activity or bleeding risk.

Major Interactions (Avoid)

  • Aspirin: additive antiplatelet effect may increase bleeding.
  • Other antiplatelet agents (e.g., clopidogrel, ticagrelor): heightened risk of severe hemorrhage.
  • Anticoagulants (warfarin, direct oral anticoagulants): synergistic anticoagulation leading to major bleeding.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): combined effect on platelet function and gastrointestinal mucosa.
  • Selective serotonin reuptake inhibitors (SSRIs): may impair platelet aggregation and raise bleeding risk.

Moderate Interactions (Monitor Closely)

  • CYP2C9 inhibitors (e.g., fluconazole, amiodarone): may increase indobufen plasma levels.
  • CYP2C9 inducers (e.g., rifampicin, carbamazepine): may reduce therapeutic effect.
  • ACE inhibitors: potential for additive hypotensive effect.
  • Diuretics: monitor electrolytes and renal function when used together.
  • Oral contraceptives: may slightly increase thrombotic risk; monitor closely.

Frequently Asked Questions

Ibustrin contains indobufen, a platelet aggregation inhibitor that is prescribed to reduce the risk of arterial clot formation. It is indicated for preventing arterial thrombosis, for secondary prevention after myocardial infarction, for stroke prevention, and for managing peripheral arterial disease.

Indobufen reversibly blocks platelet cyclooxygenase‑1, which stops the conversion of arachidonic acid into thromboxane A₂. Lower thromboxane A₂ levels reduce platelet activation and aggregation, thereby decreasing the likelihood of arterial thrombus formation while allowing normal platelet function to return after the drug is cleared.

The dosage of Ibustrin is determined by the prescribing clinician based on the patient’s medical condition, age, renal and hepatic function, and concomitant therapies. Healthcare professionals set the appropriate dose and schedule; patients should follow the prescriber’s instructions exactly.

Safety data for indobufen in pregnancy and lactation are limited. The product should only be used if the potential benefit justifies any possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives and risks with their healthcare provider.

To request Ibustrin, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.

Both indobufen and aspirin inhibit platelet cyclooxygenase‑1, but indobufen is a reversible inhibitor and may have a lower incidence of gastrointestinal irritation compared with aspirin’s irreversible action. Clinical choice depends on individual patient risk factors, tolerability, and physician judgment.

Ibustrin should be stored at room temperature, below 25 °C, in its original packaging. Keep the product away from moisture, direct sunlight and heat sources. Do not use if the packaging is damaged or if the tablet shows signs of discoloration.

Ibustrin is taken orally, usually with a glass of water. It may be taken with or without food, but patients should follow the specific instructions given by their prescriber to optimise absorption and reduce gastrointestinal discomfort.

The most serious risks include severe or uncontrolled bleeding, such as gastrointestinal or intracranial hemorrhage, and rare hematologic disorders like thrombocytopenia or neutropenia. Patients should be monitored for signs of bleeding and any sudden changes in blood counts.

Ibustrin is contraindicated in individuals with known hypersensitivity to indobufen or other platelet aggregation inhibitors, in patients with active major bleeding, and in those with severe liver disease. Caution is also advised for patients on multiple antithrombotic agents or with uncontrolled hypertension.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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