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 antitubercular agent presented as an oral dosage form for oral use. It is employed in the treatment of active tuberculosis and in the prophylaxis of latent Mycobacterium tuberculosis infection in adults and children.

GNH India supplies Nicotibine as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to EU quality standards and provides reliable global distribution.

Manufacturer / TM Owner

Bepharbel Manufacturing S.A.

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Indications & Clinical Uses

  • Isoniazid is used in the antitubercular drug class to manage infections caused by Mycobacterium tuberculosis.
  • Tuberculosis: Reduces bacterial load and promotes cure of active pulmonary and extrapulmonary disease.
  • Latent TB infection prophylaxis: Prevents progression from latent infection to active disease in high‑risk individuals.

How It Works

  • Isoniazid penetrates the mycobacterial cell and is activated by the bacterial enzyme KatG. The active metabolite then binds to and inhibits the enoyl‑ACP reductase (InhA), blocking synthesis of mycolic acids, which are essential components of the mycobacterial cell wall, leading to bacterial death in actively replicating organisms.

Side Effects

Isoniazid may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea
  • Vomiting
  • Loss of appetite
  • Peripheral neuropathy
  • Rash
  • Fever

Serious or Rare Side Effects

  • Hepatotoxicity (elevated liver enzymes, hepatitis)
  • Severe allergic reactions (anaphylaxis, angioedema)
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis
  • Drug‑induced lupus erythematosus
  • Seizures
  • Hematologic abnormalities (anemia, leukopenia)

Precautions & Warnings

  • When prescribing Nicotibine, clinicians should consider several safety measures.
  • Liver function monitoring: Perform baseline and periodic liver enzyme tests, especially in patients with pre‑existing hepatic disease.
  • Alcohol consumption: Advise patients to limit alcohol intake to reduce risk of hepatotoxicity.
  • Peripheral neuropathy risk: Supplement with pyridoxine (vitamin B6) to prevent nerve damage.
  • Pregnancy and lactation: Use only if benefits outweigh risks; assess on a case‑by‑case basis.
  • Drug resistance: Ensure adherence to full treatment course to prevent emergence of resistant Mycobacterium strains.
  • Store at ambient temperature: Keep below 25 °C in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Isoniazid interacts with several medicines that may alter its efficacy or increase toxicity.

Major Interactions (Avoid)

  • Rifampicin: Induces hepatic enzymes, markedly lowering isoniazid plasma concentrations.
  • Phenytoin: Increases neurotoxic risk and may reduce isoniazid efficacy.
  • Alcohol: Synergistic hepatotoxic effect, heightening liver injury risk.

Moderate Interactions (Monitor Closely)

  • Carbamazepine: May increase neurotoxicity; monitor neurological status.
  • Pyrazinamide: Combined hepatotoxic potential; check liver function regularly.
  • Acetylcysteine: May alter isoniazid metabolism; adjust monitoring as needed.

Frequently Asked Questions

Nicotibine contains isoniazid, an antitubercular medication prescribed to treat active tuberculosis disease and to prevent the development of active disease in individuals with latent Mycobacterium tuberculosis infection. It is part of standard combination regimens recommended by WHO and national TB programs.

Isoniazid inhibits the synthesis of mycolic acids, which are essential components of the mycobacterial cell wall. By blocking the enzyme InhA (enoyl‑ACP reductase), it prevents cell‑wall formation, leading to bacterial death in actively replicating Mycobacterium tuberculosis organisms.

The dosage of isoniazid is individualized by the prescribing clinician based on patient age, weight, liver function, and treatment regimen. The prescriber determines the appropriate strength, frequency, and duration in accordance with national TB guidelines.

Safety data are limited; isoniazid is classified as a pregnancy‑category D drug in many regions, indicating potential risk. It may be used during pregnancy only when the expected benefit outweighs the risk, and pyridoxine supplementation is recommended. Breastfeeding decisions should be made with a healthcare professional.

To request Nicotibine, 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 and any necessary import documentation.

Isoniazid is one of the core first‑line agents for TB because of its potent bactericidal activity, oral availability, and low cost. Compared with alternatives such as rifampicin or ethambutol, it has a distinct mechanism targeting mycolic‑acid synthesis, but it carries a higher risk of hepatotoxicity and peripheral neuropathy, requiring monitoring and pyridoxine supplementation.

Nicotibine should be stored at ambient temperature, preferably below 25 °C, in its original container to protect from moisture and light. Keep the product out of reach of children and do not use after the expiry date.

Nicotibine is taken orally, usually with food or a glass of water to reduce gastrointestinal irritation. The exact dosing schedule—once daily or as directed—must follow the prescriber’s instructions and be part of a complete anti‑TB regimen.

The most serious adverse reactions include hepatotoxicity, which can progress to severe hepatitis or liver failure, and hypersensitivity reactions such as Stevens‑Johnson syndrome. Neurological toxicity, manifested as peripheral neuropathy or seizures, can also occur, especially in patients with pre‑existing risk factors.

Individuals with known hypersensitivity to isoniazid or any component of the formulation should avoid Nicotibine. Patients with severe liver disease, active hepatitis, or those who cannot safely receive pyridoxine supplementation should be evaluated carefully before use.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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