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Rivex 80

Rivex 80

febuxostat

Manufacturer:

Unison

Distributor:

Unison

Marketer:

B.Grimm Pharma
Concise Prescribing Info
Contents
Febuxostat
Indications/Uses
Chronic hyperuricemia in conditions where urate deposition has already occurred (including history, or presence of, tophus &/or gouty arthritis). Prevention & treatment of hyperuricaemia in adults receiving chemotherapy for haematologic malignancies at intermediate to high risk tumor lysis syndrome (TLS).
Dosage/Direction for Use
Gout Initially 80 mg once daily. Serum uric acid >6 mg/dL (357 μmol/L) after 2-4 wk of initial dose May increase dose to 120 mg once daily. TLS 120 mg once daily. Start 2 days before start of cytotoxic therapy & continue for 7-9 days according to chemotherapy duration. Mild hepatic impairment 80 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concurrent use w/ azathioprine or mercaptopurine.
Special Precautions
Discontinue use if serious skin & hypersensitivity reactions including SJS, DRESS, & TEN are suspected. Permanently discontinue use if no other explanation for abnormalities is elucidated & in patients who develop ALT >3x ULN & serum total bilirubin >2x ULN. Not recommended in patients w/ ischemic or congestive heart disease; conditions which greatly increase urate formation rate (eg, malignant disease & treatment, Lesch-Nyhan syndrome). CV thromboembolic events (CV deaths, non-fatal MI & strokes). Monitor patients for signs & symptoms of CV events. Fatal & non-fatal hepatic failure. Increased gout flares may occur after initiating treatment. Gout patients w/ established CV disease. Patients w/ previous similar skin reactions to allopurinol. Evaluate LFTs at baseline & periodically thereafter & in patients experiencing signs & symptoms of hepatic injury (eg, fatigue, LFTs (eg, ALT >3x ULN). Consider prophylactic low-dose aspirin in patients w/ history of CV disease. Administer NSAID or colchicine (up to 6 mth) to prevent gout flare. Moderate to severe (Child-Pugh class C) hepatic impairment. Severe renal impairment (CrCl <30 mL/min). Not to be used during pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Rash; diarrhea, nausea; arthralgia. CV death, MI; DRESS, SJS, TEN; abnormal liver function, raised ALT/SGPT & serum AST level; acute gout, myositis, rhabdomyolysis; CVA.
Drug Interactions
Risk of azathioprine or mercaptopurine toxicity. Elevated levels of l-methylxanthine w/ theophylline.
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
Rivex 80 FC tab 80 mg
Packing/Price
3 × 10's
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