Pirfenidone Capsule, 267 Mg
Generic Name: pirfenidone capsule, 267 mg
Brand Names:
Pirfenidone Capsule, 267 Mg
11 DESCRIPTION Pirfenidone belongs to the chemical class of pyridone. Pirfenidone capsules USP are available as a white to off-white hard gelatin capsule containing 267 mg of pirfenidone for oral administration. Pirfenidone has a molecular formula of C 12 H 11 NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone.
Overview
11 DESCRIPTION Pirfenidone belongs to the chemical class of pyridone. Pirfenidone capsules USP are available as a white to off-white hard gelatin capsule containing 267 mg of pirfenidone for oral administration. Pirfenidone has a molecular formula of C 12 H 11 NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone.
Uses
1 INDICATIONS AND USAGE Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone capsules are a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Take with food. Recommended dosage: 801 mg three times daily (2403 mg/day). ( 2 ) Upon initiation of treatment, titrate to the full dosage of 2403 mg/day over a 14-day period as follows: Treatment days Dosage Days 1 through 7 267 mg three times daily (801 mg/day) Days 8 through 14 534 mg three times daily (1602 mg/day) Days 15 onward 801 mg three times daily (2403 mg/day) Consider temporary dosage reduction, treatment interruption, or discontinuation for management of adverse reactions. ( 2.3 , 5.1 , 5.2 , 5.3 , 5.4 ) Prior to treatment, conduct liver function tests. ( 2.1 ) 2.1 Testing Prior to Pirfenidone Capsules Administration Conduct liver function tests prior to initiating treatment with pirfenidone capsules [ see Warnings and Precautions ( 5.1 )].
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Liver Enzyme Elevations and Drug-Induced Liver Injury [see Warnings and Precautions ( 5.1 )] • Photosensitivity Reaction or Rash [see Warnings and Precautions ( 5.2 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.3 )] • Gastrointestinal Disorders [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, decreased appetite, gastro-esophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia.
Interactions
7 DRUG INTERACTIONS Moderate (e.g., ciprofloxacin) and strong inhibitors of CYP1A2 (e.g., fluvoxamine) increase 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. ( 7.1 ) 7.1 CYP1A2 Inhibitors Pirfenidone is metabolized primarily (70 to 80%) via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6 and 2E1. Strong CYP1A2 Inhibitors The concomitant administration of pirfenidone and fluvoxamine or other strong CYP1A2 inhibitors (e.g., enoxacin) is not recommended because it significantly increases exposure to pirfenidone [see Clinical Pharmacology ( 12.3 )] .
Warnings
5 WARNINGS AND PRECAUTIONS Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with pirfenidone including cases of drug-induced liver injury. In the postmarketing setting, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcomes, have been reported. Monitor ALT, AST, and bilirubin before and during treatment. Temporary dosage reductions or discontinuations may be required. ( 2.1 , 5.1 ) Photosensitivity and rash: Photosensitivity and rash have been noted with pirfenidone. Avoid exposure to sunlight and sunlamps. Wear sunscreen and protective clothing daily. Temporary dosage reductions or discontinuations may be required. 4 CONTRAINDICATIONS None. None
Pregnancy
8.1 Pregnancy Risk Summary The data with pirfenidone use in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage. In animal reproduction studies, pirfenidone was not teratogenic in rats and rabbits at oral doses up to 3 and 2 times, respectively, the maximum recommended daily dose (MRDD) in adults [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Pirfenidone capsules USP are available as follows: White opaque cap and white opaque body size ‘1’ hard gelatin capsule containing white to pale yellow powder with ‘F70’ imprinted on cap with brown ink. The capsule is supplied either in a bottle, a 14-day titration blister pack or a 4-week maintenance blister pack.
Frequently Asked Questions
What is Pirfenidone Capsule, 267 Mg used for?▼
1 INDICATIONS AND USAGE Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone capsules are a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ( 1 )
What are the side effects of Pirfenidone Capsule, 267 Mg?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Liver Enzyme Elevations and Drug-Induced Liver Injury [see Warnings and Precautions ( 5.1 )] • Photosensitivity Reaction or Rash [see Warnings and Precautions ( 5.2 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.3 )] • Gastrointestinal Disorders [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, decreased appetite, gastro-esophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia.
Can I take Pirfenidone Capsule, 267 Mg during pregnancy?▼
8.1 Pregnancy Risk Summary The data with pirfenidone use in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage. In animal reproduction studies, pirfenidone was not teratogenic in rats and rabbits at oral doses up to 3 and 2 times, respectively, the maximum recommended daily dose (MRDD) in adults [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
What are the important warnings for Pirfenidone Capsule, 267 Mg?▼
5 WARNINGS AND PRECAUTIONS Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with pirfenidone including cases of drug-induced liver injury. In the postmarketing setting, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcomes, have been reported. Monitor ALT, AST, and bilirubin before and during treatment. Temporary dosage reductions or discontinuations may be required. ( 2.1 , 5.1 ) Photosensitivity and rash: Photosensitivity and rash have been noted with pirfenidone. Avoid exposure to sunlight and sunlamps. Wear sunscreen and protective clothing daily. Temporary dosage reductions or discontinuations may be required. 4 CONTRAINDICATIONS None. None
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.