Fibroz
Generic Name
Pirfenidone
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| fibroz 150 mg capsule | ৳ 350.00 | ৳ 3,500.00 |
Description
Overview of the medicine
Fibroz 150 mg Capsule contains Pirfenidone, an antifibrotic agent used to treat Idiopathic Pulmonary Fibrosis (IPF), a chronic, progressive lung disease. It helps slow the progression of the disease and preserves lung function.
Uses & Indications
Dosage
Adults
Initial titration: Day 1-7: 1 capsule (150 mg) three times daily. Day 8-14: 2 capsules (300 mg) three times daily. Day 15 onwards: 3 capsules (450 mg) three times daily. Administer with food.
Elderly
No specific dose adjustment required for elderly patients based on age alone, but caution with renal/hepatic impairment.
Renal_impairment
Mild renal impairment (CrCl 50-80 mL/min): No dose adjustment. Moderate renal impairment (CrCl 30-49 mL/min): Use with caution, dose reduction might be needed. Severe renal impairment (CrCl <30 mL/min) or ESRD: Not recommended.
How to Take
Administer orally with food to reduce nausea and dizziness. Swallow the capsules whole with water. Do not crush, chew, or open the capsules.
Mechanism of Action
Pirfenidone reduces fibroblast proliferation, inhibits the production of pro-fibrotic mediators (e.g., TGF-beta, PDGF), and decreases collagen synthesis. Its precise mechanism is not fully understood, but it is believed to act through antioxidant, anti-inflammatory, and antifibrotic pathways to reduce lung fibrosis.
Pharmacokinetics
Onset
Not immediately observable, effects are seen over several weeks/months with sustained treatment.
Excretion
Approximately 80% of the dose is excreted in urine, mostly as the inactive metabolite. Less than 1% is excreted as unchanged drug.
Half life
Approximately 2 to 3 hours.
Absorption
Well absorbed orally, bioavailability is about 50%. Peak plasma concentrations are reached 0.5 to 4 hours after dosing with food. Food significantly reduces Cmax and AUC but improves tolerability.
Metabolism
Primarily metabolized in the liver by cytochrome P450 enzymes (mainly CYP1A2) to an inactive metabolite.
Side Effects
Contraindications
- •Hypersensitivity to Pirfenidone or any excipients
- •Concomitant use of fluvoxamine
- •Severe hepatic impairment or end-stage liver disease
- •End-stage renal disease requiring dialysis
Drug Interactions
Fluvoxamine
Strong CYP1A2 inhibitor, significantly increases pirfenidone exposure. Concomitant use is contraindicated.
CYP1A2 inducers (e.g., rifampicin, omeprazole, smoking)
May decrease pirfenidone exposure and efficacy. Avoid concomitant use or adjust dose.
Other CYP1A2 inhibitors (e.g., ciprofloxacin, amiodarone)
May increase pirfenidone exposure. Use with caution, dose adjustment may be needed.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. Symptoms may include severe nausea, vomiting, dizziness, and fatigue. Management involves supportive care and monitoring of vital signs. There is no specific antidote.
Pregnancy & Lactation
Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus. Limited human data available. Lactation: Not known if pirfenidone is excreted in human milk. A decision should be made whether to discontinue nursing 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 24-36 months from manufacturing date
Availability
Available in pharmacies and hospitals
Approval Status
Approved by FDA and DGDA (Bangladesh)
Patent Status
Patents expired in some regions, generic versions available
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Global Brand Names
International brand names for this medicine
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