Febulas 40/Febulas 80 Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Febuxostat

Indications/Uses

Chronic management of hyperuricemia in patients w/ gout.

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Dosage/Direction for Use

40 mg or 80 mg once daily. Starting dose: 40 mg once daily. Patient who does not achieve serum uric acid <6 mg/dL after 2 wk w/ 40 mg 80 mg once daily. Severe renal impairment Limit dose to 40 mg once daily.

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Overdosage

View Febulas 40/Febulas 80 overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food: May be administered w/o regard to food or antacid use.

Contraindications

Patients treated w/ azathioprine or mercaptopurine.

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Special Precautions

Not recommended for asymptomatic hyperuricemia. Increased gout flares during initiation of treatment. Prophylactic therapy (ie, NSAID or colchicine upon initiation of treatment) may be beneficial for up to 6 mth in case of gout flares. Monitor for signs & symptoms of MI & stroke. Limited available data w/ use during pregnancy. No data on presence in human milk. Safety & effectiveness have not been established in ped patients.

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Use In Pregnancy & Lactation

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Adverse Reactions

Liver problems, nausea, gout flares, joint pain, rash.

Drug Interactions

May increase plasma conc of xanthine oxidase substrate drugs, azathioprine or mercaptopurine resulting in severe toxicity.

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Storage

View Febulas 40/Febulas 80 storage conditions for details to ensure optimal shelf-life.

Description

View Febulas 40/Febulas 80 description for details of the chemical structure and excipients (inactive components).

MIMS Class

Hyperuricemia & Gout Preparations

ATC Classification

M04AA03 - febuxostat ; Belongs to the class of preparations inhibiting uric acid production. Used in the treatment of gout.

Regulatory Classification

Presentation/Packing

Form

Febulas 40 FC tab 40 mg

Packing/Price

30's

Form

Febulas 80 FC tab 80 mg

Packing/Price

30's

Febulas 40/Febulas 80

febuxostat

Manufacturer:

Delta Pharma

Distributor:

Biomed