Pulmova 267 mg (Tablet)

Indications

• Treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF) in adults

Pharmacology

• Agent with anti-inflammatory properties
• Agent with antioxidant properties
• Agent with anti-fibrotic properties
• Improves lung function
• Reduces acute exacerbations in patients with IPF
• Suppresses TGF-β1 (transforming growth factor-β1)
• Downregulates expression of pro-inflammatory cytokines

Dosage & Administration

• Route of administration: Oral with food
• Recommended daily dose for IPF patients: 2403 mg/day
• Titration regimen for initiating treatment
• Dose adjustments for gastrointestinal events
• Dose adjustments for photosensitivity reaction or rash
• Dose adjustments for hepatic function

Interaction

• Moderate and strong inhibitors of CYP1A2 affect systemic exposure
• Dosage adjustments with concomitant use of specific medications
• Reduced incidence of adverse reactions observed in fed group

Contraindications

• Hypersensitivity to active substance or excipients
• Concomitant use of fluvoxamine
• Severe hepatic impairment or end stage liver disease
• Severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis

Side Effects

• Common side effects
• Rare side effects

Pregnancy & Lactation

• Precautionary measures for avoiding use during pregnancy
• Unknown excretion of pirfenidone or its metabolites in human milk
• Effects on fertility and reproductive performance in rats

Precautions & Warnings

• Elevated liver enzymes monitoring and temporary dosage adjustments
• Photosensitivity and rash precautions
• Gastrointestinal disorders monitoring and temporary dosage adjustments

Use in Special Populations

• Safety and effectiveness in children & adolescents unknown
• Monitoring and dosage modification in hepatic impairment
• Monitoring and dosage modification in renal impairment

Overdose Effects

• Limited clinical experience with overdose
• Mild, transient adverse reactions

Therapeutic Class

• Immunosuppressant

Storage Conditions

• Cool & dry storage
• Protection from light & moisture
• Keep out of reach of children

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