MRP Under Process
Official PMBI MRP is being updated for catalog code 1761.
Locate Jan Aushadhi KendraClinical Overview
Pirfenidone Tablets (200mg, 400mg) is an oral synthetic pyridone antifibrotic and anti-inflammatory agent on the WHO Model List framework. It suppresses the synthesis of transforming growth factor-beta (TGF-beta), basic fibroblast growth factor (bFGF), and platelet-derived growth factor (PDGF), inhibiting fibroblast proliferation and extracellular matrix (collagen) deposition in pulmonary parenchyma. It also scavenges reactive oxygen species and inhibits TNF-alpha and IL-1beta. Clinically proven to reduce the rate of forced vital capacity (FVC) decline and disease progression. Indicated for the treatment of mild-to-moderate Idiopathic Pulmonary Fibrosis (IPF).
Active Pharmaceutical Ingredients
Verified Clinical References
Usage Guidelines
Take orally WITH FOOD (during or immediately after meals) with a full glass of water. Titrate upward over 3 weeks: Week 1: 200 mg three times daily (600 mg/day); Week 2: 400 mg three times daily (1200 mg/day); Week 3 and maintenance: 600-800 mg three times daily (up to 1800-2403 mg/day). Taking with food significantly reduces nausea and dizziness.
General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.
Possible Side Effects
Common: Photosensitivity rash (severe sunburn reaction upon sun exposure in >30%), nausea, diarrhea, dyspepsia, anorexia, fatigue, weight loss, dizziness, elevated transaminases. Rare/Severe: Drug-induced liver injury / jaundice, and severe angioedema.
*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.
Precautions & Warnings
Black Box Warning: Photosensitivity and rash; patients MUST apply broad-spectrum sunscreen (SPF >= 50), wear sun-protective clothing, and strictly avoid direct sunlight or tanning beds. Black Box Warning: Hepatotoxicity; monitor liver function tests (ALT, AST, bilirubin) prior to initiation, monthly for the first 6 months, and every 3 months thereafter. Avoid cigarette smoking (smoking induces CYP1A2, reducing pirfenidone plasma levels by 50%).
Medical Disclaimer: Statutory Clinical Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice, pulmonological diagnosis, or respiratory management recommendations. Inhalation therapies and allergy medications should be used strictly under the guidance of a qualified pulmonologist or registered medical practitioner.