Atomoxetine Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Attention Deficit Disorder

40 mg once a day the morning. Alternatively, the dose may be administered as 20 mg orally twice a day, in the morning and late afternoon/early evening.

The dose may be increased after a minimum of three days to a target total daily dose of approximately 80 mg administered as either a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening.

After two to four weeks, the dose may be increased to a maximum of 100 mg in patients who have not received optimal response.

There are no data to support increased effectiveness at higher doses.

Usual Pediatric Dose for Attention Deficit Disorder

Less than 6 years: The safety and efficacy of atomoxetine in patients less than 6 years of age have not been established.

Greater than or equal to 6 years of age and up to 70 kg body weight:
0.5 mg/kg once a day in the morning. Alternatively, the dose may be administered as 0.25 mg/kg orally twice a day, in the morning and late afternoon/early evening.

The dose may then be increased after a minimum of three days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening.

No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day.

Greater than or equal to 6 years of age and over 70 kg body weight:
40 mg once a day the morning. Alternatively, the dose may be administered as 20 mg orally twice a day, in the morning and late afternoon/early evening.

The dose may be increased after a minimum of three days to a target total daily dose of approximately 80 mg administered as either a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening.

After two to four weeks, the dose may be increased to a maximum of 100 mg in patients who have not received optimal response.

There are no data to support increased effectiveness at higher doses.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

For patients with moderate HI (Child-Pugh class B), the initial target dose is 50% of the normal target dose.

For patients with severe HI (Child-Pugh class C), the initial target dose is 25% of the normal target dose.

Atomoxetine should be discontinued in patients who develop jaundice or laboratory evidence of liver injury.

Dose Adjustments

In children and adolescents up to 70 kg body weight undergoing concomitant therapy with a strong CYP450 2D6 inhibitor, the recommend initial dose is 0.5 mg/kg/day. This initial dosage may be increased to the usual target dose of 1.2 mg/kg/day only if symptoms have failed to improve after 4 weeks of treatment and the initial dosage is well tolerated.

In children and adolescents over 70 kg body weight and adults undergoing concomitant therapy with a strong CYP450 2D6 inhibitor or in patients known to be poor metabolizers of CYP450 2D6, the recommend initial dose is 40 mg/day. This initial dosage may be increased to the usual target dose of 80 mg/day only if symptoms have failed to improve after 4 weeks of treatment and the initial dosage is well tolerated.

The results of a double-blind, placebo-controlled study suggest that in children and adolescents (6 to 16 years of age) with ADHD who respond well to initial treatment with atomoxetine may retain their response during long-term treatment at a lower dose (0.5 mg/kg/day) than was required to achieve the acute response (1.2 to 1.8 mg/kg/day). However, additional studies are required to confirm these findings.

Precautions

Short-term clinical trial report an increased risk of suicidal thinking in children and adolescents treated with atomoxetine. Pediatric patients should be closely observed for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the first few months following initiation of treatment and dosage adjustments. It is recommended to monitor patients with face-to-face contact weekly for the first 4 weeks, then every other week for the next 4 weeks, then at 12 weeks, and as clinically indicated thereafter. It is recommended to consider contact by telephone between face-to-face visits, if appropriate. Family members and caregivers should be instructed to monitor the patient on a daily basis for new or increased thoughts of suicide or changes in mood or behavior including irritability or anxiety.

The concomitant administration of atomoxetine and monoamine oxidase inhibitors (MAOI) is contraindicated. Atomoxetine should not be taken within 2 weeks of discontinuing an MAOI and treatment with an MAOI should not be started within 2 weeks of discontinuing atomoxetine.

Atomoxetine is not recommended for use in patients with narrow angle glaucoma or serious cardiac abnormalities and used with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease.

Orthostatic hypotension and syncope have been reported in clinical trials. Therefore, atomoxetine should be used with caution in patients with conditions that may predispose them to hypotension.

There are reports of treatment emergent psychotic or manic symptoms (such as hallucinations, delusional thinking, or mania) developing in pediatric patients without a previous history of psychotic illness or mania. If such symptoms occur, clinicians should consider atomoxetine as having a possible causative role and subsequently consider discontinuation of treatment.

Growth of children and adolescents should be monitored during atomoxetine treatment. Open-label studies have reported a lag in the weight and height gain of pediatric and adolescent patients receiving atomoxetine therapy which lags behind that predicted by normative population data for about the first 9 to 12 months of therapy. However, weight and height appear to rebound and stabilize with long-term treatment.

Treatment emergent hostility-related effects have been reported in short-term clinical trials. Patients beginning therapy should be monitored for the appearance or worsening of aggression or hostility.

Prior to prescribing atomoxetine in a child or adolescent, the clinician is advised to weigh the potential risks with the benefit and clinical need.

Dialysis

Data not available

Other Comments

Atomoxetine may be taken with or without food. Atomoxetine capsules should be taken whole, they are not intended to be opened.

Physicians who use atomoxetine for extended periods of time should periodically reevaluate the long-term usefulness of the drug for the individual patient. The results of a meta-analysis have demonstrated that atomoxetine (mean dose 1.41 mg/kg/day) was well tolerated and maintained efficacy in adolescents with ADHD without evidence of tolerance for up to 2 years. It should be noted that the majority of symptom improvement occurred within the first 3 months of treatment.

Pulse and blood pressure should be measured at baseline, following dose increases, and periodically while on atomoxetine therapy.

Patients should be monitored for symptoms of urinary retention and/or hesitancy.

Atomoxetine may be discontinued without being tapered.

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