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Pirfenidone Tablets
  • Professionals
  • FDA PI

Pirfenidone Tablets

Dosage form: tablet, film coated
Drug class:Miscellaneous uncategorized agents

Medically reviewed by Drugs.com. Last updated on Jun 1, 2022.

Indications and Usage for Pirfenidone Tablets

Pirfenidone Tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Pirfenidone Tablets Dosage and Administration

Testing Prior to Pirfenidone Tablets Administration

Conduct liver function tests prior to initiating treatment with Pirfenidone Tablets [see Warnings and Precautions (5.1)].

Recommended Dosage

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 Tablets in Patients with IPF
Treatment daysDosage
Days 1 through 7267 mg three times daily (801 mg/day)
Days 8 through 14534 mg three times daily (1602 mg/day)
Days 15 onward801 mg three times daily (2403 mg/day)

Dosages above 2403 mg/day are not recommended for any patient. Patients should not take 2 doses at the same time to make up for a missed dose. Patients should not take more than 3 doses per day.

Dosage Modifications due to Adverse Reactions

Patients who miss 14 or more days of pirfenidone should re-ini...