Home > Isoniazid (75mg) + Rifampicin (150mg) + Ethambutol (275mg) + Pyrazinamide (400mg) > Rifampicin + Isoniazid + Ethambutol + Pyrazinamide (Generic)

Rifampicin + Isoniazid + Ethambutol + Pyrazinamide (Generic)

Isoniazid (75mg) + Rifampicin (150mg) + Ethambutol (275mg) + Pyrazinamide (400mg)
Price: ₹650 - ₹1000 for a 28-tablet blister
Mfr: Various (Sun Pharma, Intas, etc.) | Form: Tablet (Blister Pack)

📋 Clinical Overview

A first-line, fixed-dose combination (FDC) anti-tubercular therapy (ATT) used in the intensive phase of treatment for drug-susceptible pulmonary and extrapulmonary tuberculosis. This specific strength is designed for patients weighing 30-37 kg, aligning with WHO weight-band dosing recommendations. It is a cornerstone of India's Revised National Tuberculosis Control Programme (RNTCP), now NTEP (National Tuberculosis Elimination Programme), to improve adherence and prevent monotherapy.

💊 Dosage & Administration

  • Adult: This specific FDC (75/150/275/400 mg) is for patients weighing 30-37 kg. Standard NTEP weight-band dosing: 25-39 kg: 2 tablets; 40-54 kg: 3 tablets; 55-69 kg: 4 tablets; ≥70 kg: 5 tablets. All doses are once daily.
  • Pediatric: Not typically used as a single FDC in young children. Pediatric dispersible tablets or weight-band syrups are preferred. For older children/adolescents, weight-band dosing as for adults applies.
  • Renal Adjusment: Isoniazid, Rifampicin, Pyrazinamide: No significant adjustment in mild-moderate CKD. Ethambutol: Dose reduction required. GFR 10-50 mL/min: 15-25 mg/kg; GFR <10 mL/min: 15 mg/kg. Avoid in severe renal failure if possible.
  • Hepatic Adjusment: Contraindicated in severe impairment. In mild-moderate impairment, use with extreme caution, frequent LFT monitoring, and consider avoiding Pyrazinamide.
  • Instruction: Take all tablets as a single daily dose, on an empty stomach (at least 1 hour before or 2 hours after food), preferably in the morning. Swallow whole with water. Do not crush or chew. Adhere strictly to DOT (Directly Observed Treatment) under NTEP.

⚠️ Contraindications

  • History of severe hypersensitivity (e.g., hepatitis, DRESS, SJS) to any component.
  • Severe liver impairment or active liver disease at treatment initiation.
  • Acute gout.
  • Optic neuritis (for Ethambutol).

🔬 Mechanism of Action

Combination therapy targeting multiple, distinct pathways in Mycobacterium tuberculosis to achieve rapid bactericidal and sterilizing activity, preventing emergence of resistance.

🤕 Side Effects

  • Orange/red discoloration of urine, sweat, tears (Rifampicin - harmless).
  • Nausea, vomiting, abdominal discomfort.
  • Skin rash, itching.
  • Peripheral neuropathy (Isoniazid) - tingling/numbness in hands/feet.
  • Arthralgia, hyperuricemia (Pyrazinamide).

🤰 Special Populations

Pregnancy: Pregnancy Category C (US FDA). Use only if clearly needed. Isoniazid, Rifampicin, Ethambutol are considered relatively safe. Pyrazinamide is included in WHO guidelines but used with caution in India; often omitted in some regimens. Supplement with Pyridoxine (Vit B6) 25-50 mg/day.
Lactation: All drugs are excreted in breast milk but considered compatible with breastfeeding. Infant should receive pyridoxine supplementation if mother is on high-dose INH. Monitor infant for jaundice/diarrhea.
Alcohol: STRICTLY CONTRAINDICATED. Synergistic hepatotoxicity with Isoniazid, Rifampicin, and Pyrazinamide. Increases risk of hepatitis and treatment failure.
Driving: Caution advised. May cause dizziness, visual disturbances (Ethambutol), or peripheral neuropathy, impairing ability to drive or operate machinery.

🔄 Drug Interactions

🔁 Alternatives to Rifampicin + Isoniazid + Ethambutol + Pyrazinamide (Generic)

Same composition (Isoniazid (75mg) + Rifampicin (150mg) + Ethambutol (275mg) + Pyrazinamide (400mg)), different brands:

AKT-4 R-Cinex Macleods-4 Zukamin-4