Pirfenidone
Generic Name
Pirfenidone 534 mg tablet
Manufacturer
Multiple manufacturers
Country
Global, including Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| pirfedone 534 mg tablet | ৳ 80.00 | ৳ 480.00 |
Description
Overview of the medicine
Pirfenidone is an antifibrotic agent used for the treatment of idiopathic pulmonary fibrosis (IPF). It helps slow down the progression of the disease by reducing fibrosis and inflammation in the lungs.
Uses & Indications
Dosage
Adults
Initial dose is typically 267 mg three times daily for 7 days, increasing to 534 mg three times daily for the next 7 days, and then to a maintenance dose of 801 mg three times daily. The 534 mg tablet can be used during titration or as part of a maintenance regimen. Total daily dose should not exceed 2403 mg.
Elderly
No specific dose adjustment is required based on age, but caution is advised due to potential for decreased renal or hepatic function.
Renal_impairment
No dose adjustment needed for mild to moderate renal impairment. Not recommended for severe renal impairment (CrCl <30 mL/min).
Hepatic_impairment
Dose adjustment may be required for mild to moderate hepatic impairment. Contraindicated in severe hepatic impairment.
How to Take
Take orally with food to reduce nausea and dizziness. Swallow tablets whole with water. Do not crush, chew, or break.
Mechanism of Action
The exact mechanism of action is not fully understood, but it is believed to exert its antifibrotic and anti-inflammatory effects by inhibiting the synthesis of pro-collagen I, TGF-β, and TNF-α, and by modulating fibroblast proliferation.
Pharmacokinetics
Onset
Not acutely acting; therapeutic effects are observed with long-term treatment, often after several months.
Excretion
Mainly excreted in the urine, with approximately 80% of the dose recovered as metabolites.
Half life
Approximately 2 to 3 hours.
Absorption
Well absorbed after oral administration, with peak plasma concentrations occurring within 0.5 to 4 hours. Food increases the extent of absorption (AUC) by approximately 80% and reduces Cmax.
Metabolism
Primarily metabolized in the liver via CYP1A2 (approximately 48%) and other CYP isoenzymes (25%).
Side Effects
Contraindications
- Hypersensitivity to pirfenidone or any of its excipients.
- History of angioedema with pirfenidone.
- Severe hepatic impairment or end-stage liver disease.
- Severe renal impairment requiring dialysis.
Drug Interactions
Fluvoxamine (strong CYP1A2 inhibitor)
Significantly increases pirfenidone exposure; co-administration is contraindicated.
Ciprofloxacin (moderate CYP1A2 inhibitor)
Increases pirfenidone exposure; use with caution, consider dose reduction of pirfenidone.
CYP1A2 inducers (e.g., Omeprazole, Rifampicin)
May decrease pirfenidone exposure, potentially reducing efficacy; avoid co-administration.
Other CYP1A2 inhibitors (e.g., Amiodarone, Propafenone)
May increase pirfenidone exposure; use with caution.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Limited data on overdose. Symptoms may include severe gastrointestinal side effects (nausea, vomiting, diarrhea) and potentially increased risk of liver enzyme elevation or photosensitivity reactions. Treatment is supportive and symptomatic.
Pregnancy & Lactation
Not recommended during pregnancy unless the potential benefit outweighs the potential risk to the fetus. It is unknown if pirfenidone is excreted in human milk; a decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to pirfenidone or any of its excipients.
- History of angioedema with pirfenidone.
- Severe hepatic impairment or end-stage liver disease.
- Severe renal impairment requiring dialysis.
Drug Interactions
Fluvoxamine (strong CYP1A2 inhibitor)
Significantly increases pirfenidone exposure; co-administration is contraindicated.
Ciprofloxacin (moderate CYP1A2 inhibitor)
Increases pirfenidone exposure; use with caution, consider dose reduction of pirfenidone.
CYP1A2 inducers (e.g., Omeprazole, Rifampicin)
May decrease pirfenidone exposure, potentially reducing efficacy; avoid co-administration.
Other CYP1A2 inhibitors (e.g., Amiodarone, Propafenone)
May increase pirfenidone exposure; use with caution.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Limited data on overdose. Symptoms may include severe gastrointestinal side effects (nausea, vomiting, diarrhea) and potentially increased risk of liver enzyme elevation or photosensitivity reactions. Treatment is supportive and symptomatic.
Pregnancy & Lactation
Not recommended during pregnancy unless the potential benefit outweighs the potential risk to the fetus. It is unknown if pirfenidone is excreted in human milk; a decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture, specific to the manufacturer's guidelines.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by FDA (USA) and DGDA (Bangladesh)
Patent Status
Generic versions available in many countries
Clinical Trials
Extensive clinical trials (e.g., CAPACITY, ASCEND) demonstrated pirfenidone's efficacy in reducing disease progression and mortality in patients with IPF.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) should be performed before initiating treatment, monthly for the first 6 months, and every 3 months thereafter, or as clinically indicated.
- Renal function tests may be considered.
Doctor Notes
- Emphasize adherence to the titration schedule and taking medication with food to improve tolerability.
- Educate patients about the importance of sun protection and reporting any signs of liver injury promptly.
- Regular monitoring of liver function tests is crucial for patient safety.
Patient Guidelines
- Take Pirfenidone with food to minimize gastrointestinal side effects.
- Avoid exposure to sunlight and use sunscreen/protective clothing due to photosensitivity.
- Report any signs of liver problems (e.g., yellow skin/eyes, dark urine, abdominal pain) to your doctor immediately.
- Do not stop taking the medicine suddenly 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 one.
Driving Precautions
Pirfenidone may cause dizziness and fatigue. Patients should be cautious when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Maintain a healthy and balanced diet.
- Stay hydrated by drinking plenty of fluids.
- Protect skin from sun exposure due to increased photosensitivity.
- Avoid smoking, as it can worsen IPF and interact with pirfenidone metabolism.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.