Fexoxan

Fexoxan

febuxostat

Manufacturer:

Gracure Pharmaceuticals

Distributor:

Mc Graw Pharma
Concise Prescribing Info
Contents
Febuxostat
Indications/Uses
Chronic management of hyperuricemia in patients w/ gout.
Dosage/Direction for Use
Initially 40 mg once daily. Hyperuricemia in patient w/ gout 40 or 80 mg once daily. Patient who did not achieve the serum acid (sUA) <6 mg/dL after 2 wk w/ 40 mg 80 mg is recommended. Severe renal impairment Limit to 40 mg once daily.
Administration
May be taken with or without food: May be taken w/o regard to antacid use.
Contraindications
Patients treated w/ azathioprine or mercaptopurine.
Special Precautions
Concurrent prophylactic treatment w/ NSAID or colchicine is recommended to prevent gout flares during initiation of treatment. Higher rate of CV thromboembolic events (CV deaths, non-fatal MI, & non-fatal strokes); monitor for signs & symptoms of MI & stroke. Obtain a liver test panel (serum ALT, AST, alkaline phosphatase, & total bilirubin) as a baseline before initiating treatment. Interrupt treatment if the patient is found to have abnormal liver tests (ALT >3x the upper limit of the reference range); do not restart in patients w/o another explanation for the liver test abnormalities. Risk for severe drug induced liver injury w/ elevations of serum ALT (>3x) or bilirubin (>2x). Secondary hyperuricemia (including organ transplant recipients). Not recommended for use in patients w/ increased rate of urate formation (eg, malignant disease & its treatment, Lesch-Nyhan syndrome). Severe hepatic impairment (Child Pugh class C). Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Drug Interactions
Altered metabolism of theophylline. May increase plasma conc of drugs metabolized by XO (eg, mercaptopurine & azathioprine).
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
Fexoxan FC tab 40 mg
Packing/Price
30's (P18/film-coated tab)
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