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Atomoxetine Hydrochloride

ATOMOXETINE HYDROCHLORIDE

Manufacturer: A-S Medication Solutions

Score: 144.0

Quick Summary

Atomoxetine Hydrochloride is a selective norepinephrine reuptake inhibitor used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). It is available in various strengths and should be administered orally, with or without food. The initial dose for children and adolescents up to 70 kg is 0.5 mg/kg, increased to 1.2 mg/kg after a minimum of 3 days, while for those over 70 kg and adults, the initial dose is 40 mg, increased to 80 mg after a minimum of 3 days. Important safety information includes the risk of suicidal ideation in children and adolescents, and contraindications such as hypersensitivity to the drug, use within 2 weeks after discontinuing MAOI, narrow angle glaucoma, pheochromocytoma, and severe cardiovascular disorders. Special considerations are needed for pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
  • Selective norepinephrine reuptake inhibitor
  • Available in various strengths
  • Oral administration, with or without food

Important Safety Information

Warning

Increased risk of suicidal ideation in children and adolescents

Contraindications

  • Hypersensitivity to the drug
  • Use within 2 weeks after discontinuing MAOI
  • Narrow angle glaucoma
  • Pheochromocytoma
  • Severe cardiovascular disorders

Adverse Reactions

  • Nausea
  • Vomiting
  • Fatigue
  • Decreased appetite
  • Abdominal pain
  • Somnolence

Dosing Recommendations

General Guidance

Dose adjustments may be needed for patients with hepatic impairment, strong CYP2D6 inhibitors, or known CYP2D6 poor metabolizers

ADHD

Adult Dose

40 mg, increased to 80 mg after a minimum of 3 days

Pediatric Dose

0.5 mg/kg, increased to 1.2 mg/kg after a minimum of 3 days

Special Population Considerations

Pregnancy

  • Pregnancy Category C
  • No adequate and well-controlled studies in pregnant women

Nursing Mothers

  • Caution should be exercised when administering to a nursing woman

Pediatric Use

  • Safety, efficacy, and pharmacokinetics have been evaluated in pediatric patients
  • Anyone considering the use of atomoxetine in a child or adolescent must balance the potential risks with the clinical need

Geriatric Use

  • The safety, efficacy, and pharmacokinetics of atomoxetine in geriatric patients have not been evaluated

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