Details

---

Manufacturer
Aspen SA Operations (Pty) Ltd

Registraction Number
MAL19990042AZ



Content

• Active Ingredient: Azathioprine 50 mg per tablet
• Excipients: Each tablet contains pregelatinized maize starch
• Formulation: Yellow, round, biconvex, film-coated tablets, scored, branded "IM 5"
• Packaging: 100 tablets per bottle

Indication
Imuran 50mg Tablets are indicated for:

• Organ Transplants: Prevention of rejection in kidney, liver, or heart transplants
• Autoimmune Diseases: Treatment of conditions such as severe rheumatoid arthritis, systemic lupus erythematosus, chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune hemolytic anemia, and chronic refractory idiopathic thrombocytopenic purpura

Instructions

• Dosage:
  • Organ Transplants:
    • Loading dose: 5 mg/kg body weight per day
    • Maintenance dose: 1–4 mg/kg body weight per day
  • Autoimmune Diseases:
    • Initial dose: 1–3 mg/kg body weight per day
• Administration: Take tablets orally, preferably 1 hour before or 3 hours after meals to enhance absorption
• Monitoring:
  • Regular blood tests to monitor blood cell counts and liver function
  • Adjustments may be necessary based on laboratory results
• Contraindications:
  • Hypersensitivity to azathioprine or any component of the tablet
  • Pregnancy and breastfeeding
  • Active infections
• Cautions:
  • Increased risk of infections and certain cancers due to immunosuppression
  • Use with caution in patients with liver or kidney impairment
  • Avoid live vaccines during treatment
• Pregnancy Category: D (Risk to fetus exists; use only if potential benefit justifies the risk)
• Breastfeeding: Not recommended due to potential excretion in breast milk