Xigduo XR 10/1000mg Tab

Manufacturer
AstraZeneca Pharmaceuticals

Registraction Number     
MAL20091652AZ

 

Content

• Active Ingredients:
  • Dapagliflozin propanediol monohydrate: 10 mg
  • Metformin hydrochloride (extended-release): 1000 mg
• Formulation: Extended-release tablet

Indications

• Adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus
• Dapagliflozin component:
  • Reduces the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression.
  • Reduces the risk of hospitalization for heart failure in patients with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors.
• Metformin component:
  • Improves glycemic control in patients with type 2 diabetes mellitus.

Instructions for Use

• Dosage:
  • Adults and pediatric patients aged 10 years and older:
    • Dapagliflozin: Starting dose of 5 mg once daily, may increase to 10 mg once daily.
    • Metformin extended-release: Starting dose of 500 mg once daily, may increase to 2000 mg once daily.
  • Maximum daily dose: Dapagliflozin 10 mg and Metformin extended-release 2000 mg.
• Administration:
  • Take once daily with food to reduce gastrointestinal side effects.
  • Swallow the tablet whole; do not crush, chew, or split.
• Renal Function Monitoring:
  • Assess renal function prior to initiating treatment and periodically thereafter.
  • Not recommended for use in patients with eGFR persistently below 45 mL/min/1.73 m².
• Temporary Discontinuation:
  • Discontinue prior to iodinated contrast imaging procedures in patients with eGFR below 60 mL/min/1.73 m².
  •  Withhold for at least 3 days prior to surgery or procedures associated with prolonged fasting.