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Lesurix 40/Lesurix 80

Lesurix 40/Lesurix 80

febuxostat

Manufacturer:

Stallion Labs

Distributor:

Ambicare

Marketer:

Sandoz
Concise Prescribing Info
Contents
Febuxostat
Indications/Uses
Chronic hyperuricaemia in conditions where urate deposition occurred (including history, or presence of, tophus &/or gouty arthritis).
Dosage/Direction for Use
40 or 80 mg once daily. Recommended starting dose: 40 mg once daily, may increase to 80 mg once daily if serum uric acid is >6 mg/dL (357 micromol/L) after 2-4 wk. Retest serum uric acid after 2 wk. Gout flare prophylaxis At least 6 mth treatment duration. Patient w/ mild hepatic impairment 80 mg.
Administration
May be taken with or without food.
Special Precautions
Rare reports of serious allergic/hypersensitivity reactions including SJS, TEN & acute anaphylactic reaction/shock. Closely monitor patients for symptoms of allergic/hypersensitivity reaction; immediately discontinue treatment if serious reactions occur. Not recommended in patients w/ ischaemic heart disease or CHF; in whom rate of urate formation is greatly increased (eg, malignant disease & its treatment, Lesch-Nyhan syndrome); & in organ transplant patients. Do not start treatment until acute attack of gout has completely subsided. Gout flares during initiation of treatment may occur; flare prophylaxis is recommended for at least 6 mth w/ NSAID or colchicine at treatment initiation. Perform LFT prior to initiation of therapy & periodically thereafter based on clinical judgment. Reports of increased TSH values (>5.5 IU/mL) in patients on long-term treatment; caution in patients w/ altered thyroid function. Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended w/ concomitant mercaptopurine/azathioprine. May adversely affect ability to drive & use machines. Efficacy & safety have not been fully evaluated in patients w/ severe renal (CrCl <30 mL/min). Safety & efficacy has not been studied in patients w/ moderate & severe (Child Pugh class C) hepatic impairment; & in childn <18 yr. Not to be used during pregnancy & lactation.
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 UGT inducers.
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
Lesurix 40 FC tab 40 mg
Packing/Price
30's
Form
Lesurix 80 FC tab 80 mg
Packing/Price
30's
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