Pirfenidone
Generic Name
Pirfenidone 801 mg Tablet
Manufacturer
Various manufacturers (generic)
Country
Global
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| pirfedone 801 mg tablet | ৳ 125.00 | ৳ 750.00 |
Description
Overview of the medicine
Pirfenidone is an oral medication used to treat idiopathic pulmonary fibrosis (IPF), a chronic, progressive, and usually fatal lung disease. It helps to slow the progression of the disease and preserve lung function.
Uses & Indications
Dosage
Adults
Initial titration: Typically starts with 267 mg three times daily for 7 days, then increased to 534 mg three times daily for another 7 days, then to the full maintenance dose of 801 mg three times daily (total 2403 mg/day).
Elderly
No specific dose adjustment required, but monitor for adverse effects.
Renal_impairment
Mild to moderate renal impairment: No dose adjustment. Severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring dialysis: Contraindicated.
How to Take
Take orally with food to reduce nausea and dizziness. Swallow tablets whole with water, do not crush or chew.
Mechanism of Action
Pirfenidone reduces fibroblast proliferation, production of profibrotic proteins and cytokines (e.g., TGF-β, PDGF, TNF-α), and collagen synthesis. It also exhibits anti-inflammatory and antioxidant properties.
Pharmacokinetics
Onset
Not immediate; chronic treatment required for clinical benefits.
Excretion
Mainly through urine (approximately 80% as metabolites).
Half life
Approximately 2 to 3 hours.
Absorption
Oral, bioavailability is approximately 50%. Food increases Tmax but reduces Cmax slightly, leading to better tolerability.
Metabolism
Primarily hepatic via CYP1A2; minor contributions from other CYP enzymes.
Side Effects
Contraindications
- Hypersensitivity to pirfenidone or any excipients.
- History of angioedema with pirfenidone.
- Severe hepatic impairment or end-stage liver disease.
- Severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring dialysis.
- Concomitant use of fluvoxamine.
Drug Interactions
Smoking (CYP1A2 inducer)
Decreases pirfenidone exposure; advise patients to stop smoking.
Omeprazole (CYP1A2 inducer)
May decrease pirfenidone exposure; monitor effectiveness.
Fluvoxamine (strong CYP1A2 inhibitor)
Significantly increases pirfenidone exposure; concomitant use is contraindicated.
Ciprofloxacin (moderate CYP1A2 inhibitor)
Increases pirfenidone exposure; reduce pirfenidone dose to 801 mg/day.
Amiodarone, Propafenone (CYP1A2 inhibitors)
May increase pirfenidone levels; use with caution.
Storage
Store below 30°C (86°F), protect from moisture and light. Keep out of reach of children.
Overdose
Limited experience with overdose. Management should be symptomatic and supportive.
Pregnancy & Lactation
Not recommended during pregnancy unless clearly necessary, as there is limited data and potential risk to the fetus. Avoid during breastfeeding, as pirfenidone is excreted in milk.
Side Effects
Contraindications
- Hypersensitivity to pirfenidone or any excipients.
- History of angioedema with pirfenidone.
- Severe hepatic impairment or end-stage liver disease.
- Severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring dialysis.
- Concomitant use of fluvoxamine.
Drug Interactions
Smoking (CYP1A2 inducer)
Decreases pirfenidone exposure; advise patients to stop smoking.
Omeprazole (CYP1A2 inducer)
May decrease pirfenidone exposure; monitor effectiveness.
Fluvoxamine (strong CYP1A2 inhibitor)
Significantly increases pirfenidone exposure; concomitant use is contraindicated.
Ciprofloxacin (moderate CYP1A2 inhibitor)
Increases pirfenidone exposure; reduce pirfenidone dose to 801 mg/day.
Amiodarone, Propafenone (CYP1A2 inhibitors)
May increase pirfenidone levels; use with caution.
Storage
Store below 30°C (86°F), protect from moisture and light. Keep out of reach of children.
Overdose
Limited experience with overdose. Management should be symptomatic and supportive.
Pregnancy & Lactation
Not recommended during pregnancy unless clearly necessary, as there is limited data and potential risk to the fetus. Avoid during breastfeeding, as pirfenidone is excreted in milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved in many countries including US, EU, and Bangladesh
Patent Status
Generic versions available, patents may have expired in some regions
Clinical Trials
Pirfenidone's efficacy and safety in IPF have been established through multiple pivotal clinical trials, including CAPACITY and ASCEND studies, demonstrating reduction in lung function decline and progression-free survival.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) at baseline, monthly for the first 6 months, then every 3 months thereafter.
- Monitor for signs and symptoms of photosensitivity.
Doctor Notes
- Emphasize the importance of liver function monitoring and patient education on photosensitivity and GI adverse events.
- Advise patients on proper administration with food and avoidance of CYP1A2 inhibitors.
- Confirm patient understands the titration schedule.
Patient Guidelines
- Take the medicine with food to minimize stomach upset.
- Protect your skin from sun exposure; use sunscreen and protective clothing.
- Report any signs of liver problems (e.g., yellowing skin/eyes, dark urine, severe nausea) to your doctor immediately.
- Do not stop taking the medicine without consulting your doctor.
Missed Dose Advice
If a dose is missed, take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.
Driving Precautions
May cause dizziness or fatigue. Patients should be cautious when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Avoid excessive sun exposure and tanning beds.
- Stay hydrated.
- Maintain a balanced diet.
- Avoid smoking.
- Limit alcohol consumption, especially if you have liver issues.
Alternative Medicines in Bangladesh
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.