Product image of Nicotibine (Isoniazid) supplied by GNH India

Nicotibine

Active Ingredient:
Isoniazid
Origin:
EU

Nicotibine (Isoniazid)

Isoniazid, the active ingredient in Nicotibine, is an antibiotic presented as an oral tablet for oral use. It treats active and latent tuberculosis in adults and children, forming a core component of standard combination regimens recommended by WHO. The tablet contains a precise dose of isoniazid to ensure consistent therapeutic exposure.

GNH India supplies Nicotibine as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product conforms to EU quality standards and is manufactured under strict GMP conditions.

Manufacturer / TM Owner

Bepharbel Manufacturing S.A.

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Indications & Clinical Uses

  • Isoniazid is used in the management of tuberculosis, targeting the bacterial infection that causes the disease.
  • Active tuberculosis: used as part of multi‑drug therapy to eradicate Mycobacterium tuberculosis infection.
  • Latent tuberculosis infection: administered to prevent progression to active disease in individuals with a positive tuberculin test.
  • Tuberculosis prophylaxis in high‑risk contacts: given to reduce the risk of developing active TB after exposure.

How It Works

  • Isoniazid is a pro‑drug that is activated by the bacterial enzyme KatG within Mycobacterium tuberculosis. The activated form inhibits the synthesis of mycolic acids, essential components of the mycobacterial cell wall, leading to loss of cell integrity and bacterial death.

Side Effects

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

Common Side Effects

  • Nausea or vomiting
  • Loss of appetite
  • Abdominal discomfort
  • Peripheral neuropathy (tingling or numbness)
  • Skin rash or itching
  • Mild fever

Serious or Rare Side Effects

  • Hepatotoxicity, including severe hepatitis
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis
  • Anaphylactic reactions
  • Seizures (especially in overdose)
  • Agranulocytosis or severe blood dyscrasias

Precautions & Warnings

  • Before initiating therapy, several safety considerations should be observed.
  • Liver function monitoring: obtain baseline liver enzymes and repeat periodically during therapy.
  • Alcohol consumption: avoid or limit alcohol intake to reduce hepatotoxic risk.
  • Vitamin B6 supplementation: consider pyridoxine to prevent peripheral neuropathy, especially in patients with risk factors.
  • Pregnancy: use only if potential benefit justifies potential risk to the fetus.
  • Drug interactions: review concomitant medications for hepatic metabolism interactions.
  • Store at ambient temperature: keep tablets in original container, protect from moisture and heat.

Avoid Interactions

Isoniazid can interact with several medicines, requiring caution.

Major Interactions (Avoid)

  • Rifampicin: increased risk of hepatotoxicity when combined.
  • Pyrazinamide: additive liver toxicity.
  • Alcohol: synergistic hepatotoxic effect.

Moderate Interactions (Monitor Closely)

  • Acetylsalicylic acid: may increase bleeding risk.
  • Warfarin: may alter INR, requiring closer monitoring.

Frequently Asked Questions

Nicotibine contains isoniazid, which is employed in the treatment of active tuberculosis and in preventive therapy for latent tuberculosis infection. It is a key component of the standard multi‑drug regimens recommended by health authorities worldwide.

Isoniazid is a pro‑drug that is activated by the bacterial enzyme KatG inside Mycobacterium tuberculosis. The activated compound blocks the synthesis of mycolic acids, essential lipids in the bacterial cell wall, leading to cell death and eradication of the infection.

The specific dose of Nicotibine is determined by the prescribing clinician based on the patient’s age, weight, disease severity, and treatment guidelines. Dosage regimens are individualized and should follow the prescriber’s instructions and local protocols.

Safety data for isoniazid in pregnancy are limited, and the drug is classified as having an unknown pregnancy category. It should be used only when the potential benefit outweighs any possible risk to the fetus. Breastfeeding mothers should consult their healthcare provider before use.

To order Nicotibine, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Isoniazid is the cornerstone of first‑line antitubercular therapy, offering potent activity against replicating Mycobacterium tuberculosis. Compared with other classes such as fluoroquinolones or newer agents, isoniazid is generally less expensive and has a well‑established safety profile, but it carries a higher risk of hepatotoxicity and requires pyridoxine supplementation in some patients.

Store Nicotibine tablets at ambient temperature, below 25 °C, in the original container to protect them from moisture and direct sunlight. Keep the medication out of reach of children and avoid storing it in humid environments such as bathrooms.

Nicotibine is taken orally, usually once daily, with or without food as directed by the prescriber. The tablet should be swallowed whole with a glass of water; it should not be crushed, chewed, or broken unless specifically instructed.

The most serious adverse events include severe hepatotoxicity (liver inflammation or failure), hypersensitivity reactions such as Stevens‑Johnson syndrome, and neurological toxicity like peripheral neuropathy. Patients should report any signs of jaundice, rash, fever, or numbness promptly to their healthcare provider.

Nicotibine should be avoided in individuals with known hypersensitivity to isoniazid or any of its excipients. Patients with pre‑existing severe liver disease, acute hepatitis, or those who are unable to take pyridoxine supplementation when required should not be prescribed this medication without careful evaluation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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