Atomoxetine

Generic name
Atomoxetine
Brand name
ATC Code
N06BA09
Compare …

Atomoxetine

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Atomoxetine is primarily metabolized by CYP2D6, followed by glucuronidation.

The following clinical parameters have been found [SmPC]: 

  Extensive metabolizers Poor metabolizers
Tmax 1-2 hours 1-2 hours
t½ 3.6-5.2 hours 21-21.6 hours
Vd 0.84 l/kg 0.85 l/kg
Cl 0.35 l/kg/hour 0.03 l/kg/hour
F 63% 94%

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

ADHD
  • Oral
    • 6 years up to 18 years and < 70 kg
      • Initial dose: 0.5 mg/kg/day in 1 dose For 7 days..
      • Maintenance dose: the initial dose can be raised depending on the clinical response and the tolerance weekly by 0.3-0.4 mg/kg/day to 0.8 - 1.2 mg/kg/day in 1 dose. Max: 1.8 mg/kg/day.
      • Directions for administration:

        In an unsatisfactory clinical response or when side effects occur, the dosage can be given in 2 doses.

      • No added value can be expected from dosages above 1.8 mg/kg/day or 120 mg/day.
        Atomoxetine should be prescribed by a child and youth psychiatry specialist.

    • 6 years up to 18 years and ≥ 70 kg
      • Initial dose: 40 mg/day in 1 dose For 7 days.
      • Maintenance dose: The initial dose can be raised depending on the clinical response and the tolerance weekly by 20 mg to  80 mg/day in 1 dose. Max: 100 mg/day.
      • Directions for administration:

        In an unsatisfactory clinical response or when side effects occur, the dosage can be given in 2 doses

      • No added value can be expected from dosages above 120 mg/kg/day or 120 mg/day. Atomoxetine should be prescribed by a child and youth psychiatry specialist.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Very common (> 10%): headaches, sleepiness, decreased appetite, abdominal pain, nausea, vomiting, elevated blood pressure, elevated pulse rate.

Common (1-10%): anorexia, irritation, mood changes, sleeplessness, agitation, anxiety, depression and depressed mood, tics. Dizziness, mydriasis, obstipation, dyspepsia, dermatitis, rash, itching, fatigue, restlessness, weight loss.

Uncommon (0.1-1%): suicidal behaviour, aggression, hostility, emotional lability, psychosis (including hallucinations), syncope, tremor, migraine, paraesthesia, hypoesthesia, seizures, palpitations, sinus tachycardia, extended QT interval, increased bilirubin values in the blood, hyperhidrosis, allergic reactions, weakness.

Rare (0.01–0.1%): Raynaud's disease, hepatotoxicity (abnormal liver function values, jaundice, hepatitis, liver damage, acute liver failure), delayed urination, urinary retention, genital pain in men, priapism.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

According to the manufacturer, atomoxetine must never be given in combination with – or within two weeks after stopping – an MAO inhibitor. An MAO inhibitor may not be started within two weeks after stopping atomoxetine.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Atomoxetine must be gradually increased and the effect can only be assessed properly after 4-6 weeks.
A small number of cases of hepatotoxicity have been described. Patients should be instructed to contact you in the event of jaundice, dark urine, malaise or upper abdominal complaints.
A slightly increased risk of suicidal behaviour has been described in clinical studies; this information is also included in the patient information leaflet.
Clinical studies show that there is an apparent link between the use of atomoxetine and an elevated risk of mydriasis. That is why using atomoxetine is not recommended in narrow-angle glaucoma.
|In addition, atomoxetine should be avoided in cases of hypersensitivity.

If severe side effects occur of if there is no effect, it is possible that the metabolization of the drug may be different. CYP2D6 can determine the variation in response. Genotyping can be considered.

Monitor growth and development during treatment. In case of growth retardation or insufficient weight gain, dose reduction or treatment-free intervals may be considered.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Centrally acting sympathomimetics
N06BA02
N06BA12
Xanthine derivatives
N06BC01

References

  1. CBO, ADHD- Richtlijn voor de diagnostiek en behandeling van ADHD bij kinderen en jeugdigen, www.cbo.nl, 2005
  2. Michelson D, et al., Atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, dose-response study., Pediatrics, 2001, 108(5), E83
  3. Kratochvil CJ, et al, Atomoxetine and methylphenidate treatment in children with ADHD: a prospective, randomized, open-label trial, J Am Acad Child Adolesc Psychiatry, 2002, 41(7), 776-784
  4. Michelson D, et al., Once-daily atomoxetine treatment for children and adolescents with attention deficit hyperactivity disorder: a randomized, placebo-controlled study., Am J Psychiatry, 2002, 159(11), 1896-1901
  5. Eli Lilly Nederland BV, SmPC Strattera (RVG 31494) 01-01-2016, www.geneesmiddeleninformatiebank.nl
  6. Lilly USA, Prescribing Information Strattera 06-04-2015, www.lilly.com
  7. National Collaborating Centre for Mental Health., Attention Deficit Hyperactivity Disorder: Diagnosis and Management of ADHD in Children, Young People and Adults, Leicester (UK): British Psychological Society (UK);, 2009
  8. Lilly, SmPC Strattera 10mg/18mg/25mg/40mg/60mg/80mg/100mg Hartkapseln (60775.01.00.05.00/70522.00.00/70523.00.00), 05/2015
  9. Lilly, SmPC Strattera 4mg/ml Lösung zum Einnehmen (91691.00.00), 05/2015

Changes

Therapeutic Drug Monitoring


Overdose