foremost Esbriet Dosage Generic name: PIRFENIDONE 267mg Dosage form: capsule Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Drug Images Support Group Q & A Compare Alternatives Pricing & Coupons The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist. Testing Prior to ESBRIET Administration Conduct liver function tests prior to initiating treatment with ESBRIET [see Warnings and Precautions (5.1) ]. Recommended Dosage The recommended daily maintenance dosage of ESBRIET 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 ESBRIET in Patients with IPF 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) 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 ESBRIET should re-initiate treatment by undergoing the initial 2-week titration regimen up to the full maintenance dosage [see Dosage and Administration (2.2) ] . For treatment interruption of less than 14 days, the dosage prior to the interruption can be resumed. If patients experience significant adverse reactions (i.e., gastrointestinal, photosensitivity reaction or rash), consider temporary dosage reductions or interruptions of ESBRIET to allow for resolution of symptoms [see Warnings and Precautions (5.1 , 5.2 , 5.3) ] . Dosage Modification due to Elevated Liver Enzymes Dosage modifications or interruptions may also be necessary when liver enzyme and bilirubin elevations are exhibited. For liver enzyme elevations, modify the dosage as follows: If a patient exhibits >3 but 5 the upper limit of normal (ULN) ALT and/or AST without symptoms or hyperbilirubinemia after starting ESBRIET therapy: Discontinue confounding medications, exclude other causes, and monitor the patient closely. Repeat liver chemistry tests as clinically indicated. The full daily dosage may be maintained, if clinically appropriate, or reduced or interrupted (e.g., until liver chemistry tests are within normal limits) with subsequent re-titration to the full dosage as tolerated. If a patient exhibits >3 but 5 ULN ALT and/or AST accompanied by symptoms or hyperbilirubinemia: Permanently discontinue ESBRIET. Do not rechallenge patient with ESBRIET. If a patient exhibits >5 ULN ALT and/or AST: Permanently discontinue ESBRIET. Do not rechallenge patient with ESBRIET. Dosage Modification due to Drug Interactions Strong CYP1A2 Inhibitors (e.g., fluvoxamine, enoxacin) Reduce ESBRIET to 267 mg three times a day (801 mg/day). Moderate CYP1A2 Inhibitors (e.g., ciprofloxacin) With use of ciprofloxacin at a dosage of 750 mg twice daily, reduce ESBRIET to 534 mg three times a day (1602 mg/day). Next Professional Print this page Add to My Med List More about Esbriet (pirfenidone) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: miscellaneous uncategorized agents Consumer resources Esbriet Esbriet (Advanced Reading) Professional resources Esbriet (AHFS Monograph) Esbriet (FDA) Related treatment guides Idiopathic Pulmonary Fibrosis Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Genentech, Inc. Drug Class Miscellaneous uncategorized agents Related Drugs Idiopathic Pulmonary Fibrosis Ofev , nintedanib , pirfenidone , Actimmune , interferon gamma-1b , More... Esbriet Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Esbriet Images Esbriet 267 mg (InterMune 267 mg ) View all images considering
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