Febout 80 mg (Tablet)

Indications

• Chronic management of hyperuricemia in patients with gout

Pharmacology

• Non-purine, selective xanthine oxidase (XO) inhibitor
• Decreases serum uric acid level by inhibiting xanthine oxidase
• Not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations

Dosage & Administration

• Recommended starting dose of Febuxostat 40 mg tablet once daily
• Dosage adjustment based on serum uric acid levels
• Special dosage for tumor lysis syndrome, gout flares, renal impairment, hepatic impairment, and pediatric use

Interaction

• Contraindicated concomitant use with mercaptopurine, azathioprine, or theophylline
• Co-administration considerations with rosiglitazone, naproxen, glucuronidation inducers, colchicine, indometacin, hydrochlorothiazide, warfarin, and antacids

Contraindications

• Contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline

Side Effects

• Common adverse reactions include gout flares, liver function abnormalities, diarrhea, nausea, headache, rash, and edema
• Rare serious hypersensitivity reactions observed

Pregnancy & Lactation

• Pregnancy Category C
• Use during pregnancy only if potential benefit justifies potential risk to fetus
• Caution advised for nursing women

Precautions & Warnings

• Increased gout flares observed during initiation
• Higher rate of cardiovascular thromboembolic events observed
• Monitor liver function tests periodically

Overdose Effects

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

Therapeutic Class

• Drugs used in Gout

Storage Conditions

• Keep below 30°C temperature, away from light & moisture
• Keep out of the reach of children

Related Brands