Pirfenidone Capsule, 267 mg 267 mg/1
Pirfenidone Capsule, 267 mg · CAPSULE · Macleods Pharmaceuticals Limited
Pirfenidone Capsule, 267 mg is a capsule containing pirfenidone capsule, 267 mg at 267 mg/1, taken oral. Manufactured by Macleods Pharmaceuticals Limited.
Key Facts
- Brand Name
- Pirfenidone Capsule, 267 mg
- Generic Name
- Pirfenidone Capsule, 267 mg
- NDC Code (Product)
33342-461- Manufacturer
- Macleods Pharmaceuticals Limited
- Strength
- 267 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA212748
- Drug Class
- Pyridone [EPC]
- Marketing Start
- 07/20/2020
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 & Administration
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 )]. 2.2 Recommended Dosage The recommended daily maintenance dosage of pirfenidone capsule is 801 mg three times daily for a total of 2403 mg/day. Doses should be taken with food at the same time each day. Upon initiation of treatment, titrate to the full dosage of 2403 mg/day over a 14-day period as follows: Table 1. Dosage Titration for Pirfenidone Capsules in Patients with IPF Treatment days Dosage Days 1…
Contraindications
4 CONTRAINDICATIONS None. None
Drug 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 )] . Use of fluvoxamine or other strong CYP1A2 inhibitors should be discontinued prior to administration of pirfenidone and avoided during pirfenidone treatment. In the event that fluvoxamine or other strong CYP1A2 inhibitors are the only drug of choice, dosage reductions are recommended. Monitor for adverse reactions and consider discontinuation of pirfenidone as needed [see Dosage and Administration ( 2.4 )]…
Adverse Reactions
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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of pirfenido…
Frequently Asked Questions
What is Pirfenidone Capsule, 267 mg used for?
Pirfenidone Capsule, 267 mg contains Pirfenidone Capsule, 267 mg. It is a capsule taken oral. Consult your doctor for specific uses.
Is Pirfenidone Capsule, 267 mg a controlled substance?
Pirfenidone Capsule, 267 mg is not classified as a controlled substance by the DEA.
What is the generic name for Pirfenidone Capsule, 267 mg?
The generic name for Pirfenidone Capsule, 267 mg is Pirfenidone Capsule, 267 mg. There are no other listed brand versions of Pirfenidone Capsule, 267 mg.
What is the NDC code for Pirfenidone Capsule, 267 mg 267 mg/1?
The NDC (National Drug Code) for Pirfenidone Capsule, 267 mg 267 mg/1 is 33342-461, listed by Macleods Pharmaceuticals Limited.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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