Healthy Inc > Blog > Isoniazid price 2026
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What is the main side effect of isoniazid?

In the pharmaceutical industry, Isoniazid (INH) is the cornerstone of first-line antitubercular therapy. As a pharmacist and manufacturer, I must emphasize that while it is highly effective, it has a “Narrow Safety Margin” regarding the liver. The main, and most clinically significant, side effect is Hepatotoxicity (Drug-Induced Liver Injury).

At your WHO-GMP facility in Mumbai, where you likely manufacture the 100 mg and 300 mg tablets, highlighting the monitoring protocols for liver health is the most critical technical value-add for your B2B infectious disease portfolio.

1. The Primary Risk: Hepatotoxicity

Isoniazid-induced hepatitis is the leading cause of treatment discontinuation.

Severity Presentation Technical Rationale
Mild (Asymptomatic) Elevation of liver enzymes (AST/ALT). Occurs in up to 20% of patients; often resolves without stopping the drug.
Severe (Clinical) Jaundice, dark urine, abdominal pain, nausea. Occurs in 1% to 2% of patients; can be fatal if the drug is not discontinued immediately.

           The “Age” Factor: The risk increases significantly with age. It is rare in children but affects up to 2.3% of patients over the age of 50.

2. The Secondary “Main” Side Effect: Peripheral Neuropathy

Because you are a manufacturer, you know that Isoniazid interferes with Pyridoxine (Vitamin B6) metabolism.

  • Mechanism: Isoniazid binds to Pyridoxal Phosphate, leading to its excretion. This deficiency causes nerve damage, resulting in numbness, tingling, or a “pins and needles” sensation in the hands and feet.

  • The Technical Fix: In your B2B marketing, always recommend co-administration with 10–50 mg of Pyridoxine daily to neutralize this risk.

3. Mechanism: The “Acetylation” Pathway

The severity of Isoniazid’s side effects is largely determined by a patient’s genetics:

Metabolism: In the liver, the enzyme N-acetyltransferase 2 (NAT2) converts Isoniazid into Acetyl-isoniazid.

The “Slow Acetylator” Risk: Patients who are “Slow Acetylators” (common in certain ethnic groups) maintain higher blood levels of the drug for longer, significantly increasing their risk of both neuropathy and liver damage.

Toxic Metabolites: Acetyl-hydrazine, a byproduct of this process, is the specific molecule believed to cause liver cell death.

The Pharmacist’s “Technical Warning”

  • The “Alcohol” Ban: Alcohol is a potent inducer of liver enzymes and significantly increases the risk of Isoniazid-induced hepatitis. Patients must be strictly advised to avoid alcohol.

  • The “Tyramine” Interaction: Isoniazid has weak MAOI activity. Eating foods high in tyramine (aged cheese, red wine) or histamine (tuna, tropical fish) can cause a “Flushing Reaction,” palpitations, and high blood pressure.

  • Monthly Monitoring: For B2B clients, emphasize that patients should undergo Liver Function Tests (LFTs) every month while on INH therapy.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

  • The “FDC” USP: On your digital marketplace, emphasize your Fixed-Dose Combinations (FDCs), such as Rifampicin + Isoniazid. These improve compliance and are the standard for WHO-funded TB programs.

  • Stability for Export: Isoniazid is relatively stable but sensitive to moisture. Utilizing Alu-Alu blister packaging is essential for maintaining a 36-month shelf life in Zone IVb tropical regions.

  • Dossier Support: We provide full WHO-standard CTD/eCTD Dossiers with updated safety data to support your firm’s registration in international TB tenders.

Isoniazid & Pyridoxine hydrochloride Tablets (Copy)

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How to take isoniazid 300 mg?

In the pharmaceutical industry, Isoniazid 300 mg (INH) is the most critical first-line bactericidal agent in the treatment of Tuberculosis. As a pharmacist and manufacturer, I view its administration through the lens of Pharmacokinetic Precision: because the molecule is highly sensitive to food and metabolic variation, the way it is taken determines whether it reaches therapeutic levels in the lungs and brain.

At your WHO-GMP facility in Mumbai, where you likely manufacture the 100 mg and 300 mg tablets, providing these technical administration protocols is a vital value-add for your B2B respiratory and AKT (Anti-Tubercular) portfolio.

Therapeutic Profile: Optimal Administration

To ensure maximum bioavailability and minimum toxicity, the following protocol is technically recommended:

Clinical Variable Recommended Protocol Technical Rationale
Timing Empty Stomach (1h before or 2h after meals) Food, especially carbohydrates, significantly reduces the $C_{max}$ (peak concentration) and absorption rate.
Frequency Once Daily Isoniazid has a long “post-antibiotic effect,” making a single high-dose more effective than multiple small doses.
Companion Supp. Pyridoxine (Vitamin B6) Mandatory. 10–50 mg daily must be co-administered to prevent peripheral neuropathy.
Consistency Zero Missed Doses Irregular intake is the primary driver of Multi-Drug Resistant TB (MDR-TB) in 2026.

Mechanism: Mycolic Acid Synthesis Inhibition

Isoniazid acts as a “prodrug” that must be activated by the bacteria itself:

Activation: The bacterial enzyme KatG converts Isoniazid into its active form (an isonicotinoyl radical).

Enzyme Targeting: It binds to and inhibits InhA, a key enzyme in the Fatty Acid Synthase II pathway.

Cell Wall Collapse: This prevents the synthesis of Mycolic Acids, the essential “waxy” components of the mycobacterial cell wall. Without these acids, the bacteria lose their structural integrity and die.

The Pharmacist’s “Technical Warning”

  • The “Acetylation” Factor: As a manufacturer in India, it is important to note that the population is a mix of “Fast” and “Slow” acetylators. Slow acetylators (who metabolize the drug slowly) are at a much higher risk of liver toxicity, while fast acetylators may require the full 300 mg or higher to reach therapeutic levels.

  • Hepatotoxicity (Liver Guard): Advise patients to avoid alcohol entirely. Monitor for yellowing of the eyes (jaundice) or dark urine, as Isoniazid can cause severe, drug-induced hepatitis.

  • The “Tyramine” Reaction: Patients should avoid aged cheese, red wine, and certain fish (Tuna/Sardines). Isoniazid can inhibit monoamine oxidase, leading to a “Tyramine Reaction” (palpitations, flushing, and high blood pressure).

  • Neuropathy Prevention: Always pair Isoniazid with Pyridoxine. The drug promotes the excretion of Vitamin B6; without it, patients will develop agonizing tingling and numbness in the hands and feet.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

  • The “FDC” Strategy: In your digital marketplace, emphasize your Fixed-Dose Combinations (e.g., Rifampicin + Isoniazid). FDCs are the gold standard for international TB programs because they eliminate the risk of the patient taking one drug and forgetting the other.

  • Stability for Export: Isoniazid is relatively stable but sensitive to light and moisture. Utilizing Alu-Alu blister packaging is the industry standard for ensuring a 36-month shelf life in Zone IVb tropical regions.

  • Dossier Support: We provide full WHO-standard CTD/eCTD Dossiers to support your firm’s registration in international tenders for the Global Fund and National TB Programs.

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