Xanthistop- Febuxostat film coated tablets

Xanthistop (febuxostat) is used to treat gout in adults who were not treated successfully with or who are not able to take allopurinol. Gout is a type of arthritis in which uric acid, a naturally occurring substance in the body, builds up in the joints and causes sudden attacks of redness, swelling, pain, and heat in one or more joints. Xanthistop is in a class of medications called xanthine oxidase inhibitors. It works by decreasing the amount of uric acid that is made in the body. Xanthistop is used to prevent gout attacks but not to treat them once they occur.

Therapeutic Indications

Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history or presence of tophus and/or gouty arthritis). Xanthistop is indicated in adults.

Posology and method of administration

  • The recommended oral dose of Xanthistop  is 80 mg once daily without regard to food.
  • If serum uric acid is > 6 mg/dl (357 μmol/L) after 2-4 weeks, Xanthistop 120 mg once daily may be considered.
  • Xanthistop works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks.
  • The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L).
  • Gout flare prophylaxis of at leat 6 months is recommended.
  • Elderly dosage : No dose adjustment is require. in the elderly.
  • Renal impairment :  The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance < 30 ml/min). No dose adjustment is necessary In patients with mild or moderate renal impairment.
  • Hepatic impairment :  The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment. The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment.
  • Paediatric population : The safety and the efficacy of febuxostat in children aged below the age of 18 years have not been established. No data are available.
M04AA03  febuxostat ANTIGOUT PREPARATIONS Preparations inhibiting uric acid production IPC pharma Inspire Pharmaceutical Company 

Xanthistop – Information Leaflet

AR- Patient_Information_Leaflet
Xanthistop – AR- Patient_Information_Leaflet
ENG-Patient-Information-Leaflet
Xanthistop – ENG-Patient-Information-Leaflet

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