APO-ATOMOXETINE

What it is

APO-ATOMOXETINE is available as capsules containing 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg of atomoxetine (as hydrochloride). Atomoxetine hydrochloride is available as capsules for oral administration. Atomoxetine is a relatively potent inhibitor of the presynaptic noradrenaline transporter, a moderate inhibitor of serotonin uptake and a weak inhibitor of dopamine uptake.

Approved indications

— Treatment of Attention Deficit Hyperactivity Disorder (ADHD) as defined by DSM-IV criteria in children 6 years of age and older, adolescents and adults.

Dosing overview

APO-ATOMOXETINE may be taken with or without food. Atomoxetine may be discontinued without tapering the dose.

Key safety warnings

Short-term placebo controlled studies in over 2200 children and adolescents with ADHD found a positive signal for suicidal thoughts (5 patients) and behaviours (1 patient) in children 12 years of age and younger on atomoxetine compared to placebo. All children being treated with atomoxetine should be monitored closely for suicidality, clinical worsening, and unusual changes of behaviour, especially during the first few months of treatment or at times of dose change. Families and caregivers of children and adolescents being treated with APO-ATOMOXETINE should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behaviour, and the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Atomoxetine can affect heart rate and blood pressure. It is recommended that heart rate and blood pressure should be measured at baseline, following atomoxetine dose adjustment, and periodically while on therapy to detect possible clinically important increases, particularly during the first few months of therapy. Additional data from ADHD clinical trials has shown that approximately 39% of paediatric patients experienced clinically relevant changes (≥ 20 beats per minute) in heart rate during the study, and 33% experienced clinically relevant changes (≥ 15 mm Hg) in diastolic blood pressure and 23% in systolic blood pressure (≥ 20 mm Hg) during the study. Serotonin syndrome has been reported following concomitant use of atomoxetine with other serotonergic medicinal products including serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, triptans, opioids, and tricyclic and tetracyclic antidepressants. Post-marketing reports indicate that atomoxetine can cause severe liver injury in rare cases, including acute liver failure, with spontaneous reports of liver injury manifested by elevated hepatic enzymes and bilirubin with jaundice. Sudden death has been reported in association with atomoxetine treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems, and atomoxetine generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems.

Contraindications

APO-ATOMOXETINE is contraindicated in patients with: known hypersensitivity to atomoxetine or any excipients in this product; symptomatic cardiovascular disease including moderate to severe hypertension, atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, or ventricular flutter, advanced arteriosclerosis; uncontrolled hyperthyroidism; phaeochromocytoma or a history of phaeochromocytoma; and concurrent use with monoamine oxidase inhibitors or within 2 weeks after discontinuing a monoamine oxidase inhibitor. In clinical studies, use of atomoxetine was associated with an increased risk of mydriasis and therefore its use is not recommended in patients with narrow angle glaucoma.

PBS listing

APO-ATOMOXETINE is listed on the PBS in seven strengths: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg capsules. All strengths except 100 mg are listed with an ex-manufacturer price of A$28.68, the 80 mg capsule is priced at A$37.29, and the 100 mg capsule is priced at A$45.85. All PBS items have a streamlined restriction and latest schedule effective 2026-05-01.

Regulatory history

APO-ATOMOXETINE was registered on the ARTG on 2017-09-29 across seven strengths (10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg capsules) in licence category RE. In March 2016, the PBAC recommended APO-ATOMOXETINE for treatment of Attention-deficit hyperactivity disorder, noting that the restriction should be updated to include lisdexamfetamine as an appropriate first line treatment, in addition to dexamphetamine and methylphenidate.