Esbriet Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Pirfenidone

Indications/Uses

Idiopathic pulmonary fibrosis (IPF).

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Dosage/Direction for Use

Adult Initially 1 cap tds on days 1-7 then 2 cap tds on days 8-14 then 3 cap tds on day 15 onwards. IPF 3 cap tds.

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Overdosage

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Administration

Should be taken with food: Take w/ food to reduce the possibility of nausea & dizziness. Swallow whole w/ water.

Contraindications

Hypersensitivity. History of angioedema. Concomitant use w/ fluvoxamine. Severe hepatic & renal impairment or end-stage hepatic & renal disease.

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Special Precautions

Discontinue use if angioedema occurs. Not to be used in patients w/ history of angioedema. Dizziness; fatigue; wt loss; hyponatraemia. Photosensitivity reaction & rash. Avoid or minimize exposure to direct sunlight. Perform LFTs prior to initiation, subsequently at mthly intervals for 1st 6 mth & every 3 mth thereafter. Discontinue use if aminotransferase elevation to ≥5 x ULN or if aminotransferase elevation >3 to <5 x ULN accompanied by hyperbilirubinaemia or clinical signs or symptoms indicative of liver injury. Monitor closely if aminotransferase elevation >3 to <5 x ULN w/o bilirubin elevation & w/o symptoms or signs of drug-induced liver injury. Concomitant use w/ CYP1A2 inhibitors. May affect ability to drive & use machines. Not to be used in severe hepatic & renal impairment or end-stage hepatic & renal disease. Mild to moderate hepatic & moderate renal impairment. Avoid use during pregnancy. Lactation. Childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

URTI; decreased wt & appetite; insomnia; headache, dizziness; dyspnoea, cough; dyspepsia, nausea, diarrhoea, GERD, vomiting, constipation; rash; arthralgia; fatigue. UTI; somnolence, dysgeusia, lethargy; hot flush; productive cough; abdominal distension, discomfort & pain, upper abdominal pain, stomach discomfort, gastritis, flatulence; increased ALT, AST & γ-glutamyl transferase; photosensitivity reaction, pruritus, erythema, dry skin, erythematous, macular & pruritic rash; myalgia; asthenia, non-cardiac chest pain; sunburn.

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Drug Interactions

Inhibition of CYP1A2 w/ grapefruit juice. Increased exposure w/ fluvoxamine & other strong & selective CYP1A2 inhibitors, enoxacin, ciprofloxacin, amiodarone, propafenone. Potential to induce hepatic enzyme production by smoking & decreased exposure. Lowered plasma levels w/ omeprazole, rifampicin.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Esbriet detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Immunosuppressants

ATC Classification

L04AX05 - pirfenidone ; Belongs to the class of other immunosuppressants.

Regulatory Classification

Presentation/Packing

Form

Esbriet hard cap 267 mg

Packing/Price

270's

Esbriet

pirfenidone

Manufacturer:

Roche

Distributor:

Zuellig Pharma