Febsan 40/Febsan 80 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 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

Initially 40 mg once daily. Patient who do not achieve a serum uric acid <6 mg/dL after 2 wk w/ 40 mg 80 mg once daily.

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Overdosage

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

Administration

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

Contraindications

Concurrent treatment w/ azathioprine, mercaptopurine & theophylline.

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Special Precautions

Potential for gout flares, elevated liver enzymes & adverse CV events after initiation of therapy. Consider concomitant prophylaxis w/ NSAID or colchicine for gout flares. Monitor for rash, chest pain, shortness of breath or neurologic symptoms suggesting a stroke. Not recommended for the treatment of asymptomatic hyperuricemia; patients in whom the rate of urate formation is greatly increased (eg, malignant disease & its treatment, Lesch-Nyhan syndrome). Severe renal (CrCl <30 mL/min) & hepatic (Child-Pugh class C) impairment. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Liver function abnormalities, nausea, arthralgia & rash. Diarrhea, headache, musculoskeletal stiffness, constipation, GERD, flushing, dizziness & gout flares.

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Drug Interactions

May cause increased plasma conc of drugs metabolized by XO (eg, theophylline, mercaptopurine, azathioprine).

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Storage

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

Description

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

Action

View Febsan 40/Febsan 80 mechanism of action for pharmacodynamics and pharmacokinetics details.

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

Febsan 40 FC tab 40 mg

Packing/Price

10's

Form

Febsan 80 FC tab 80 mg

Packing/Price

10's

Febsan 40/Febsan 80

febuxostat

Manufacturer:

SRS Pharma

Distributor:

Triple Tact

Marketer:

A-Z Med Inc