Strattera ® (atomoxetine)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Strattera Summary of Product Characteristics (SmPC)

Strattera® (atomoxetine): Posology and method of administration

Strattera can be administered as a single daily dose in the morning but some patients might benefit from taking it twice daily

Posology

STRATTERA can be administered as a single daily dose in the morning. Patients who do not achieve a satisfactory clinical response (tolerability [e.g., nausea or somnolence] or efficacy) when taking STRATTERA as a single daily dose might benefit from taking it as twice daily evenly divided doses in the morning and late afternoon or early evening.

Paediatric population:

Dosing of paediatric population up to 70 kg Body Weight:

STRATTERA should be initiated at a total daily dose of approximately 0.5mg/kg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance dose is approximately 1.2mg/kg/day (depending on the patient’s weight and available dosage strengths of atomoxetine). No additional benefit has been demonstrated for doses higher than 1.2mg/kg/day. The safety of single doses over 1.8mg/kg/day and total daily doses above 1.8 mg/kg have not been systematically evaluated. In some cases it might be appropriate to continue treatment into adulthood.

Dosing of paediatric population over 70 kg Body Weight:

STRATTERA should be initiated at a total daily dose of 40 mg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance dose is 80mg. No additional benefit has been demonstrated for doses higher than 80 mg. The maximum recommended total daily dose is 100 mg. The safety of single doses over 120mg and total daily doses above 150mg have not been systematically evaluated.

Adults:

STRATTERA should be initiated at a total daily dose of 40 mg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance daily dose is 80mg to 100mg. The maximum recommended total daily dose is 100 mg. The safety of single doses over 120mg and total daily doses above 150mg have not been systematically evaluated.

Additional information for the safe use of this product:

Pre-treatment screening:

Prior to prescribing it is necessary to take an appropriate medical history and conduct a baseline evaluation of a patient’s cardiovascular status, including blood pressure and heart rate.

Ongoing monitoring:

Cardiovascular status should be regularly monitored with blood pressure and pulse recorded after each adjustment of dose and then at least every 6 months. For paediatric patients the use of a centile chart is recommended. For adults, current reference guidelines for hypertension should be followed.

Withdrawal of Treatment:

In the study programme no distinct withdrawal symptoms have been described. In cases of significant adverse effects, atomoxetine may be stopped abruptly; otherwise the drug may be tapered off over a suitable time period.

Treatment with STRATTERA need not be indefinite. Re-evaluation of the need for continued therapy beyond 1 year should be performed, particularly when the patient has reached a stable and satisfactory response.

Special Populations

Hepatic insufficiency:

For patients with moderate hepatic insufficiency (Child-Pugh Class B), initial and target doses should be reduced to 50% of the usual dose. For patients with severe hepatic insufficiency (Child-Pugh Class C), initial dose and target doses should be reduced to 25% of usual dose.

Renal insufficiency:

Subjects with end-stage renal disease had higher systemic exposure to atomoxetine than healthy subjects (about a 65% increase), but there was no difference when exposure was corrected for mg/kg dose. STRATTERA can therefore be administered to ADHD patients with end-stage renal disease or lesser degrees of renal insufficiency using the usual dosing regimen. Atomoxetine may exacerbate hypertension in patients with end-stage renal disease.

Approximately 7% of Caucasians have a genotype corresponding to a non-functional CYP2D6 enzyme (called CYP2D6 poor metabolisers). Patients with this genotype have a several-fold higher exposure to atomoxetine when compared to patients with a functional enzyme. Poor metabolisers are therefore at higher risk of adverse events. For patients with a known poor metaboliser genotype, a lower starting dose and slower up titration of the dose may be considered.

Elderly population:

The use of atomoxetine in patients over 65 years of age has not been systematically evaluated.

Paediatric population under six years of age:

The safety and efficacy of STRATTERA in children under 6 years of age have not been established. Therefore, STRATTERA should not be used in children under 6 years of age.

Method of administration

For oral use. Strattera can be administered with or without food.

REFERENCE

Strattera Summary of Product Characteristics

Date of Last Review: November 02, 2018

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