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Noric 40

Noric 40

febuxostat

Manufacturer:

Stallion Labs

Distributor:

JustRight Healthcare
Concise Prescribing Info
Contents
Febuxostat
Indications/Uses
Chronic hyperuricaemia in conditions where urate deposition has already occurred including history, or presence of tophus &/or gouty arthritis.
Dosage/Direction for Use
Initially 40 mg once daily, may consider 80 mg once daily if serum uric acid is >6 mg/dL (357 micromol/L) after 2-4 wk. Gout flare prophylaxis of at least 6 mth is recommended. Patient w/ mild hepatic impairment 80 mg.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue use if serious allergic/hypersensitivity reactions including SJS occur. Not recommended in patients w/ ischaemic heart disease or CHF; patients in whom rate of urate formation is greatly increased eg, malignant disease & its treatment, Lesch-Nyhan syndrome; organ transplant recipients; rare hereditary problems of galactose intolerance. Not to be started until an acute attack of gout has completely subsided. Flare prophylaxis w/ NSAID or colchicine at treatment initiation for at least 6 mth is recommended. Patients w/ alteration of thyroid function. LFT is recommended prior to initiation of therapy & periodically thereafter. Not recommended in concomitant use w/ mercaptopurine/azathioprine. Exercise caution before driving, using machinery or participating in dangerous activities. Efficacy & safety have not been fully evaluated in patients w/ severe renal impairment (CrCl <30 mL/min) & not been studied in patients w/ severe hepatic impairment (Child-Pugh class C). Limited information in patients w/ moderate hepatic impairment. Not to be used during pregnancy & lactation. Safety & efficacy have not been established in childn <18 yr.
Adverse Reactions
Gout flares; headache; diarrhoea, nausea; liver function abnormalities; rash; oedema.
Drug Interactions
May increase plasma conc of mercaptopurine/azathioprine leading to toxicity. Increased exposure (Cmax, AUC & t1/2) w/ naproxen. May possibly lead to increased metabolism & decreased efficacy w/ potent UGT enzyme inducers. Delayed absorption & decreased Cmax w/ Mg & Al hydroxide-containing antacid.
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
Noric 40 FC tab 40 mg
Packing/Price
30's
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