Febunol-40/Febunol-80

Febunol-40/Febunol-80

febuxostat

Manufacturer:

Stallion Labs

Distributor:

Ambica
Concise Prescribing Info
Contents
Febuxostat
Indications/Uses
Chronic hyperuricaemia in conditions where urate deposition has already occurred including a history, or presence of tophus &/or gouty arthritis.
Dosage/Direction for Use
40 mg or 80 mg once daily. Starting dose: 40 mg once daily. 80 mg once daily may be considered if serum uric acid is >6 mg/dL after 2-4 wk. Mild hepatic impairment 80 mg.
Administration
May be taken with or without food.
Special Precautions
Not recommended in patients w/ ischaemic heart disease or CHF; patients in whom the rate of urate formation is greatly increased (eg, malignant disease & its treatment, Lesch-Nyhan syndrome); organ transplant recipients. Stop treatment immediately if serious allergic/hypersensitivity reactions including Stevens-Johnson syndrome & acute anaphylactic reaction/shock occur. Do not start treatment until an acute attack of gout has completely subsided; flare prophylaxis for at least 6 mth w/ an NSAID or colchicine is recommended. Concomitant treatment w/ mercaptopurine/azathioprine. Liver function test is recommended prior to the initiation of therapy & periodically thereafter. Patients w/ alteration of thyroid function. Contains lactose; rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Severe renal impairment (CrCl <30 mL/min). Moderate to severe hepatic impairment. Not to be used during pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Gout flares; headache; diarrhoea, nausea; liver function abnormalities; rash; oedema.
Drug Interactions
Increased plasma conc of mercaptopurine & azathioprine. Increased metabolism & decreased efficacy w/ potent inducers of UGT enzymes.
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.
Presentation/Packing
Form
Febunol-40 FC tab 40 mg
Packing/Price
100's;30's
Form
Febunol-80 FC tab 80 mg
Packing/Price
30's
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