It is indicated in adults for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF). Therapeutic Class
Pirfenidone is a novel agent with anti-inflammatory, antioxidant, and anti-fibrotic properties. It may improve lung function and reduce the number of acute exacerbations in patients with idiopathic pulmonary fibrosis (IPF). The precise mechanism of action of pirfenidone and its specific molecular targets have yet to be elucidated. One vital anti-fibrotic mechanism involves the suppression of TGF-β1 (transforming growth factor-β1), a key cytokine involved in fibrogenesis and extracellular matrix production. There is also evidence to suggest that pirfenidone has the ability to downregulate the expression of potent pro-inflammatory cytokines including TNF-α, interleukin-1, and interferon-gamma. In animal models, pirfenidone can inhibit both the influx of inflammatory cells and the increased pulmonary vascular permeability induced by bleomycin.
Recommended dosage: 801 mg (three capsules) three times daily taken with food. ? Upon initiation of treatment, the daily dosage should be titrated to the full dosage of nine capsules per day over a 14-day period as follows: Treatment days Dosage Days 1 through 7 1 capsule three times a day with meals Days 8 through 14 2 capsules three times a day with meals Days 15 onward 3 capsules three times a day with meals ? Consider temporary dosage reduction, treatment interruption, or discontinuation for management of adverse reactions. ? Prior to treatment, conduct liver function tests.
With medicine: Moderate (e.g., ciprofloxacin) and strong inhibitors of CYP1A2 (e.g., fluvoxamine) increase the systemic exposure of Pirfenidone and may alter the adverse reaction profile of Pirfenidone. Discontinue fluvoxamine prior to administration of Pirfenidone or reduce to 267 mg three times a day. Consider dosage reduction with use of ciprofloxacin.
With food and others: None. A reduced incidence of adverse reactions was observed in the fed group when compared to the fasted group.
The most common side efffects are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, gastro-esophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia
There are no data from the use of Pirfenidone in pregnant women.Lactation: It is unknown whether pirfenidone or its metabolites are excreted in human milk. Available pharmacokinetic data in animals have shown excretion of pirfenidone and/or its metabolites in milk with the potential for accumulation of pirfenidone and/or its metabolites in milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue from Pirfenidone therapy
There is limited clinical experience with overdose. Multiple doses of pirfenidone up to a dose of 4806 mg/day were administered as six 267 mg tablets three times daily to healthy adult volunteers over a 12-day dose escalation period. Adverse reactions were mild, transient, and consistent with the most frequently reported adverse reactions for pirfenidone.
Store in a cool & dry place. Protect from light & moisture. Keep all medicine out of reach of children.
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