Isoniazid (300mg)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

Isoniazid (INH) is a first-line, bactericidal antitubercular agent, considered a cornerstone of tuberculosis (TB) treatment and prevention in India. It is a prodrug activated by the bacterial catalase-peroxidase enzyme (KatG), leading to inhibition of mycolic acid synthesis, essential for the mycobacterial cell wall. It is highly effective against actively dividing Mycobacterium tuberculosis organisms and is a key component of the Directly Observed Treatment, Short-course (DOTS) strategy.

OnsetDurationBioavailability
Peak plasma concentration is reached within 1-2 hours post oral administration.Its bactericidal effect is concentration-dependent and persists due to its mechanism of action on cell wall synthesis. Dosing is typically once daily.Approximately 90% following oral administration; absorption is reduced by food.

2. Mechanism of Action

Isoniazid is a prodrug activated by the mycobacterial catalase-peroxidase enzyme (KatG). The activated form forms a covalent adduct with NAD+ and NADP+, which then potently inhibits the enoyl-acyl carrier protein reductase (InhA) enzyme. This inhibition disrupts the synthesis of mycolic acids, which are long-chain fatty acids critical for the formation and integrity of the mycobacterial cell wall.

3. Indications & Uses

  • Active Pulmonary Tuberculosis (as part of combination therapy)
  • Active Extrapulmonary Tuberculosis (e.g., meningeal, miliary, skeletal)
  • Latent Tuberculosis Infection (LTBI) treatment and prevention

4. Dosage & Administration

Adult Dosage: Active TB: 5 mg/kg (usually 300 mg) once daily or 15 mg/kg (max 900 mg) 2-3 times per week under DOTS. LTBI: 5 mg/kg (max 300 mg) once daily for 6-9 months, or 900 mg twice weekly for 3 months.

Administration: Take on an empty stomach, at least 1 hour before or 2 hours after meals, with a full glass of water to maximize absorption. If GI upset occurs, may be taken with food, acknowledging reduced absorption. Pyridoxine (10-25 mg daily) should be co-administered. For LTBI, adherence is critical; use pill boxes or reminders.

5. Side Effects

Common side effects may include:

  • Peripheral neuropathy (numbness, tingling in hands/feet)
  • Asymptomatic elevation of liver transaminases (up to 20% of patients)
  • Nausea, vomiting, epigastric discomfort
  • Rash
  • Pyridoxine deficiency

6. Drug Interactions

DrugEffectSeverity
RifampicinIncreases risk of hepatotoxicity. Also induces INH metabolism, potentially lowering levels.Major
PyrazinamideSynergistic hepatotoxicity risk.Major
Phenytoin / CarbamazepineINH inhibits their metabolism, leading to increased levels and toxicity (ataxia, nystagmus).Major
WarfarinINH may potentiate anticoagulant effect; monitor INR closely.Moderate
Ketoconazole / ItraconazoleINH may decrease their plasma levels via CYP induction.Moderate
Antacids (Aluminum-containing)May decrease INH absorption. Separate administration by at least 2 hours.Moderate
Acetaminophen (Paracetamol)Increased risk of hepatotoxicity, especially in overdose settings.Moderate
DisulfiramIncreased risk of neuropsychiatric reactions.Moderate
Diazepam, TriazolamINH may inhibit their metabolism, increasing sedation.Moderate

7. Patient Counselling

  • DO take the medicine exactly as prescribed, at the same time each day.
  • DO take pyridoxine (Vitamin B6) daily as advised by your doctor.
  • DO take on an empty stomach for best effect.
  • DO report any yellowing of eyes/skin, dark urine, loss of appetite, unexplained nausea/vomiting, or abdominal pain IMMEDIATELY.
  • DO complete the full course of treatment, even if you feel better.
  • DONT consume ANY alcohol during treatment and for some time after.
  • DONT stop the medicine without consulting your doctor.
  • DONT take with antacids without a 2-hour gap.

8. Toxicology & Storage

Overdose: Occurs within 30 min to 3 hours. Symptoms include: nausea, vomiting, slurred speech, dizziness, blurred vision, visual hallucinations, seizures (often refractory), metabolic acidosis (elevated anion gap), hyperglycemia, coma, and respiratory distress. Acute hepatic necrosis may follow within 24-48 hours.

Storage: Store below 30°C, in a cool, dry place, protected from light and moisture. Keep the container tightly closed. Keep out of reach of children. Do not use after the expiry date printed on the pack.