Product image of Granupas (Aminosalicylic Acid) supplied by GNH India

Granupas

Active Ingredient:
Aminosalicylic Acid
Origin:
EU

Granupas (Aminosalicylic Acid)

Granupas is a prescription oral medication that contains the active ingredient aminosalicylic acid. It is supplied in an unspecified strength and dosage form, and is marketed in the European Union. Aminosalicylic acid belongs to the antitubercular drug class and works by inhibiting folate synthesis in Mycobacterium tuberculosis, thereby interfering with bacterial growth. Granupas is used under medical supervision for the treatment of tuberculosis in patients.

Manufacturer / TM Owner

Eurocept International Bv

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Indications & Clinical Uses

Granupas is indicated for the management of active tuberculosis caused by Mycobacterium tuberculosis.

  • First‑line therapy in combination with other antitubercular agents
  • Treatment of pulmonary TB
  • Treatment of extrapulmonary TB
  • Use in patients with drug‑sensitive TB strains
  • Part of multi‑drug regimens to prevent resistance
  • Adjunct therapy for patients who cannot tolerate isoniazid
  • Used in retreatment regimens where resistance to first‑line drugs is identified

Side Effects

Aminosalicylic acid may cause a range of adverse effects, most of which are mild and reversible.

Common

  • Nausea or vomiting
  • Abdominal discomfort or diarrhea
  • Rash or mild skin irritation
  • Elevated liver enzymes (asymptomatic)
  • Loss of appetite
  • Headache
  • Metallic taste
  • Dizziness
  • Fatigue
  • Mouth ulcers

Serious

  • Severe hepatic injury or hepatitis
  • Agranulocytosis or severe neutropenia
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis
  • Interstitial nephritis
  • Severe hypersensitivity reactions
  • Blood dyscrasias
  • Seizures
  • Severe anemia
  • Cardiac arrhythmias
  • Renal failure

Most patients experience only mild symptoms, but clinicians monitor for signs of serious toxicity during therapy. Patients are advised to report any persistent gastrointestinal upset or skin changes promptly.

Precautions & Warnings

When prescribing Granupas, clinicians consider several precautionary measures to ensure safe use and to minimize risk of adverse outcomes.

  • Assess liver function before initiating therapy and monitor periodically.
  • Evaluate complete blood count, especially neutrophil levels, during treatment.
  • Use caution in patients with pre‑existing renal impairment.
  • Avoid use in individuals with known hypersensitivity to aminosalicylic acid or related salicylates.
  • Consider potential interactions with other antitubercular drugs that affect hepatic metabolism.
  • Pregnant or breastfeeding women should be evaluated by a specialist before use.
  • Discontinue if signs of severe hepatic or hematologic toxicity appear.

Avoid Interactions

Aminosalicylic acid can interact with several medications, affecting its efficacy or increasing the risk of toxicity.

Avoid

  • Concurrent use with high-dose aspirin or other salicylates, which may increase the risk of gastrointestinal bleeding.
  • Co‑administration with hepatotoxic drugs such as isoniazid, rifampicin, or pyrazinamide, which can exacerbate liver injury.
  • Combining with drugs that cause bone marrow suppression, such as linezolid, may potentiate hematologic toxicity.

Use with caution

  • Use with other antitubercular agents that are metabolized by the liver; dose adjustments may be needed.
  • Caution when taken with anticoagulants (e.g., warfarin) as salicylates can affect clotting parameters.
  • Monitor renal function when combined with nephrotoxic agents like aminoglycosides.
  • Consider potential interaction with antiretroviral therapy in HIV‑co‑infected patients.

Frequently Asked Questions

Aminosalicylic acid inhibits folate synthesis in Mycobacterium tuberculosis, which interferes with bacterial DNA replication and growth.

Granupas is prescribed as part of a multi‑drug regimen for active tuberculosis, typically combined with other antitubercular agents to improve efficacy and reduce resistance.

Common adverse effects include nausea, vomiting, abdominal discomfort, diarrhea, rash, mild liver enzyme elevations, loss of appetite, headache, metallic taste, dizziness, fatigue, and mouth ulcers.

Treatment should be discontinued if the patient develops signs of severe hepatic injury, hematologic toxicity, or any serious hypersensitivity reaction, and the prescriber should be consulted.

Yes, Granupas is intended to be used in combination with other antitubercular medications, but clinicians should monitor for potential liver toxicity and adjust doses as needed.

The safety of Granupas in pregnancy has not been fully established; a specialist should evaluate the risks and benefits before prescribing to pregnant or breastfeeding women.

Baseline liver function tests and a complete blood count are recommended to assess hepatic and hematologic status before initiating therapy.

Granupas may cause mild elevations in liver enzymes; in rare cases it can lead to severe hepatitis, so periodic monitoring of liver function is advised.

No specific dietary restrictions are required, but patients should avoid excessive alcohol consumption, which can increase the risk of liver injury.

A rash may be a sign of an allergic reaction; patients should contact their healthcare provider promptly for evaluation and possible discontinuation of the drug.

Yes, salicylate components can affect clotting; patients on warfarin or other anticoagulants should be monitored closely for changes in coagulation parameters.

Granupas should be used with caution in patients with renal dysfunction, and renal function should be monitored during treatment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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