Urostat 80

• Gout: Indicated for chronic management of hyperuricemia in patients with gout; not recommended for asymptomatic hyperuricemia.

Febuxostat is a non-purine, selective xanthine oxidase (XO) inhibitor. It decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine to xanthine and thus to uric acid.

Adult Dose (Oral):

• Chronic Gout: Initial: 40 mg/day; maintenance: 40-80 mg/day; increase if serum uric acid >6 mg/dL after 2 weeks.
• Tumor Lysis Syndrome: 120 mg once daily (start 2 days before cytotoxic therapy, minimum 7 days).

Mild-Moderate Hepatic Impairment (Child-Pugh A/B): No dosage adjustment needed.

Mild-Moderate Renal Impairment (CrCl 30-89): No dosage adjustment needed.

Common Side Effects:

• Diarrhea
• Headache
• Increased liver enzymes
• Nausea
• Skin rash
• Gout flares
• Edema

Use in Pregnancy: Category C; febuxostat may be unsafe; animal studies have shown harmful effects on the developing baby.

Precautions:

• Febuxostat may cause dizziness, sleepiness, blurred vision which may affect driving ability.
• Prescribed to reduce episodes of gout attack.
• Take at the same time every day.
• Take plenty of fluids (2-3 litres) daily.
• When first starting, you might have more gout attacks; do not stop on having an acute attack.
• Avoid alcohol (may cause gout flare).
• Stop and inform doctor if symptoms like rash, itchiness, breathing difficulties, fever or swelling occur.
• Flare prophylaxis with NSAID or colchicine for up to 6 months recommended.
• Monitor for signs and symptoms of MI and stroke.
• Monitor liver function tests periodically.

Overdose: Studied in healthy subjects at doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.

Storage: Keep below 30 degree C, away from light and moisture. Keep out of reach of children.