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What are the uses and side effects of Axepta?

Friday, 06 October 2006
Answered by: Dr. Chandra M. Gulhati
Editor,
MIMS,
New Delhi
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Q. I would like to know about the medicines Axepta or Attentrol, which are given for attention deficit hyperactivity disorder (ADHD). Who is the manufacturer of this medicine and their contact information? What are the side effects of this medicine?

A.  Axepta is the brand name of a medicine called atomoxetine. It is indicated for ADHD (Attention Deficit Hyperactivity Disorder) as just one part of the comprehensive treatment programme in children above 6 years of age. The prescribing details are as follows: Dose:
  • Not recommended in children under 6 years.
  • Over 6 years and under 70kg: Initially 0.5 mg/kg daily for minimum 7 days before increasing to maintenance 1-2mg/kg daily; maximum 1-8mg/kg daily.
  • Over 70kg: Initially 40 mg daily for minimum 7 days before increasing to maintenance 80 mg daily; maximum 100 mg daily. Administer as a single daily dose in the morning or as two evenly divided doses morning and late afternoon or early evening. Not to be used in: Glaucoma. Special Precautions:
  • Hepatic or renal insufficiency
  • suicide tendency, clinical worsening, behavioural change (monitor initially and at dose change)
  • Hypertension, hypotension, tachycardia, cardiovascular or cerebrovascular disease.
  • Monitor pulse and BP periodically.
  • Pre-existing structural cardiac abnormalities.
  • History of hyperthyroidism.
  • Seizure history.
  • Monitor growth development, cognition and sexual maturation during long term treatment. Risk of urinary retention. Side effects: Abdominal pain, decreased appetite, weight loss, anorexia, dry mouth, early waking, somnolence, dizziness, mood swings, irritability, suicidal ideation, Mydriasis, dermatitis, fatigue, gastro-intestinal upset, skin reactions, upper respiratory tract infections , palpitations, hypertension, orthostatic hypotension, urinary disorders, sweating, sexual dysfunction. Discontinue if signs of liver injury.
  • A.  Axepta is the brand name of a medicine called atomoxetine. It is indicated for ADHD (Attention Deficit Hyperactivity Disorder) as just one part of the comprehensive treatment programme in children above 6 years of age. The prescribing details are as follows: Dose:
  • Not recommended in children under 6 years.
  • Over 6 years and under 70kg: Initially 0.5 mg/kg daily for minimum 7 days before increasing to maintenance 1-2mg/kg daily; maximum 1-8mg/kg daily.
  • Over 70kg: Initially 40 mg daily for minimum 7 days before increasing to maintenance 80 mg daily; maximum 100 mg daily. Administer as a single daily dose in the morning or as two evenly divided doses morning and late afternoon or early evening. Not to be used in: Glaucoma. Special Precautions:
  • Hepatic or renal insufficiency
  • suicide tendency, clinical worsening, behavioural change (monitor initially and at dose change)
  • Hypertension, hypotension, tachycardia, cardiovascular or cerebrovascular disease.
  • Monitor pulse and BP periodically.
  • Pre-existing structural cardiac abnormalities.
  • History of hyperthyroidism.
  • Seizure history.
  • Monitor growth development, cognition and sexual maturation during long term treatment. Risk of urinary retention. Side effects: Abdominal pain, decreased appetite, weight loss, anorexia, dry mouth, early waking, somnolence, dizziness, mood swings, irritability, suicidal ideation, Mydriasis, dermatitis, fatigue, gastro-intestinal upset, skin reactions, upper respiratory tract infections , palpitations, hypertension, orthostatic hypotension, urinary disorders, sweating, sexual dysfunction. Discontinue if signs of liver injury.
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