Product image of Isoniazida Labesfal (Isoniazid) supplied by GNH India

Isoniazida Labesfal

Active Ingredient:
Isoniazid
Origin:
EU

Isoniazida Labesfal (Isoniazid)

Isoniazid, the active ingredient in Isoniazida Labesfal, is an antitubercular presented as an injectable for intramuscular use. It treats active and latent tuberculosis in adults and children.

GNH India supplies Isoniazida Labesfal as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Labesfal Laboratorios Almiro, S.A.

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Indications & Clinical Uses

Isoniazid is an antitubercular drug used within the Mycobacterium tuberculosis treatment pathway.

  • Active tuberculosis: forms part of combination therapy to eradicate Mycobacterium tuberculosis.
  • Latent tuberculosis infection: used alone or with rifampicin to prevent progression to active disease.
  • Pediatric tuberculosis: administered under medical supervision to treat TB in children.

How It Works

  • Isoniazid inhibits the synthesis of mycolic acids, essential components of the mycobacterial cell wall, by targeting the enzyme InhA after conversion to its active form by bacterial catalase‑peroxidase. This disruption compromises cell wall integrity, leading to bacterial death, particularly in actively replicating Mycobacterium tuberculosis.

Side Effects

Isoniazid may cause a range of adverse reactions, from mild to severe.

Common Side Effects

  • Peripheral neuropathy: tingling or numbness, especially in the extremities.
  • Hepatotoxicity: elevated liver enzymes, mild jaundice.
  • Nausea or vomiting.
  • Rash or mild skin eruption.
  • Fever or flu‑like symptoms.
  • Loss of appetite.

Serious or Rare Side Effects

  • Severe hepatitis: jaundice, dark urine, abdominal pain.
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Drug‑induced lupus erythematosus.
  • Seizures, especially in overdose.
  • Anaphylactic reaction.
  • Agranulocytosis or severe neutropenia.

Precautions & Warnings

Before initiating therapy, clinicians should assess liver function and consider patient‑specific risk factors.

  • Liver monitoring: obtain baseline hepatic enzymes and repeat periodically.
  • Alcohol use: avoid or limit alcohol consumption to reduce hepatotoxic risk.
  • Pyridoxine supplementation: give vitamin B6 to prevent peripheral neuropathy, especially in high‑risk patients.
  • Pregnancy: category B; use only if benefits outweigh potential risks.
  • Renal impairment: adjust monitoring as needed for patients with severe kidney disease.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Isoniazid interacts with several medicines that can alter its safety or efficacy.

Major Interactions (Avoid)

  • Rifampicin: increased hepatotoxicity when used together.
  • Pyrazinamide: additive liver toxicity in combination regimens.
  • Alcohol: synergistic risk of liver injury.
  • Carbamazepine, Phenytoin, Phenobarbital: enzyme induction reduces isoniazid levels.
  • HIV protease inhibitors: may increase isoniazid concentrations.

Moderate Interactions (Monitor Closely)

  • Acetylation status: slow acetylators have higher plasma levels.
  • Vitamin B6 (pyridoxine): high doses may reduce isoniazid efficacy.
  • Warfarin: monitor INR as isoniazid can affect anticoagulation.
  • Antacids containing aluminum or magnesium: may decrease absorption if oral formulation used.
  • Antiretroviral drugs (e.g., efavirenz): monitor for neuropsychiatric effects.

Frequently Asked Questions

Isoniazida Labesfal contains isoniazid, an antitubercular agent used to treat active tuberculosis and to prevent disease progression in individuals with latent Mycobacterium tuberculosis infection. It is administered as part of a multidrug regimen under medical supervision.

Isoniazid is converted by the bacterial enzyme catalase‑peroxidase into an active metabolite that blocks the synthesis of mycolic acids, essential lipids in the mycobacterial cell wall. This inhibition weakens the wall, leading to bacterial death, especially in rapidly dividing Mycobacterium tuberculosis cells.

The dosage of Isoniazida Labesfal is determined by the prescribing clinician based on the patient’s age, weight, disease severity, and treatment protocol. Healthcare professionals follow national or WHO guidelines to select the appropriate dose and duration.

Isoniazida Labesfal is classified as Pregnancy Category B, indicating that animal studies have not shown risk and there are no adequate human studies. It may be used during pregnancy when the benefits outweigh potential risks, and it is generally considered compatible with breastfeeding under medical advice.

To place an order, 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 cold‑chain if needed), and import documentation.

Isoniazida Labesfal (isoniazid) is a first‑line agent with high early bactericidal activity, often used in combination with rifampicin, pyrazinamide, and ethambutol. Compared with newer agents, it is inexpensive and well‑studied, but it carries a higher risk of hepatotoxicity and peripheral neuropathy, requiring monitoring and pyridoxine supplementation.

Isoniazida Labesfal should be stored at 2‑8 °C, protected from light, and kept in its original packaging to maintain stability. Do not freeze or shake the vial. If temperature excursions occur, discard the product according to local regulations.

The product is supplied as an injectable solution for intramuscular injection. Administration is performed by a qualified healthcare professional using aseptic technique, typically into the gluteal or deltoid muscle, following the dose prescribed by the treating physician.

The most serious risks include severe hepatitis, which may present with jaundice, dark urine, and abdominal pain, and rare hypersensitivity reactions such as Stevens‑Johnson syndrome or toxic epidermal necrolysis. Neurological toxicity, such as seizures, can also occur, especially in overdose or in patients with pre‑existing conditions.

Isoniazida Labesfal is contraindicated in patients with known hypersensitivity to isoniazid or any component of the formulation. It should also be avoided in individuals with acute liver failure or severe hepatic impairment until a specialist determines that benefits outweigh risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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