Uxoric

Uxoric

febuxostat

Manufacturer:

Sriprasit Pharma

Distributor:

SPS Medical

Marketer:

SPS Medical
Concise Prescribing Info
Contents
Febuxostat
Indications/Uses
Adults w/ chronic hyperuricaemia in conditions where urate deposition has already occurred (including history, or presence of, tophus &/or gouty arthritis). Prevention & treatment of hyperuricaemia in adults undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumour lysis syndrome (TLS).
Dosage/Direction for Use
Gout 80 mg once daily, serum uric acid >6 mg/dL after 2-4 wk Consider to increase dose to 120 mg once daily. TLS 120 mg once daily. Start treatment 2 days before beginning of cytotoxic therapy & continued for 7-9 days according to chemotherapy duration as per clinical judgment. Severe renal impairment (CrCl 15-29 mL/min) Max recommended dose: 40 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ azathioprine or mercaptopurine.
Special Precautions
Discontinue treatment if serious dermatologic reactions (eg, rash; skin peeling or blistering; lips, eyes or mouth swelling or blistering) are suspected. Interrupt treatment if ALT >3x ULN occurs. Not recommended in patients w/ ischaemic heart disease or CHF. Monitor for signs & symptoms of MI & stroke. Increased frequency of acute gout attacks after initiation of treatment. Increased TSH conc (>5.5 µIU/mL). Consider cardiac monitoring in patients receiving chemotherapy for haematologic malignancies at intermediate to high risk of TLS. Perform LFT (serum ALT, AST, alkaline phosphatase, & total bilirubin conc) prior to initiation of therapy & repeatedly promptly in patients w/ manifestations suggestive of liver damage, eg, fatigue, anorexia, upper right abdominal discomfort, dark-colored urine, or jaundice. Severe hepatic impairment (Child-Pugh class C). Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Liver function abnormalities, hepatitis, gallstones; diarrhoea, nausea; headache; rashes. SJS, erythema multiforme, TEN & DRESS.
Drug Interactions
Increased plasma conc of drugs metabolized by xanthine oxidase; azathioprine & mercaptopurine.
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
Uxoric FC tab 80 mg
Packing/Price
10 × 10's
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