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ATOMOXETINE is a brand name for Atomoxetine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Atomoxetine Macleods is indicated for the treatment of Attention- Deficit/Hyperactivity Disorder (ADHD) in children of 6 years and older, in adolescents and in adults as part of a comprehensive treatment programme. Treatment must be initiated by a specialist in the treatment of ADHD, such as a paediatrician,…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Atomoxetine Macleods can be administered as a single daily dose in the morning. g. nausea or somnolence] or efficacy) when taking Atomoxetine Macleods 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.
5 mg/kg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. 2 mg/kg/day (depending on the patient’s weight and available dosage strengths of atomoxetine).
2 mg/kg/day. 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:
Atomoxetine Macleods should be initiated at a total daily dose of 40mg. 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 80mg. 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:
Atomoxetine Macleods 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 80 mg to 100 mg.
The maximum recommended total daily dose is 100 mg. The safety of single doses over 120mg and total daily doses above 150 mg have not been systematically evaluated. 4).
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.
0% for decreased appetite). Abdominal pain and decreased appetite are usually transient. Associated with decreased appetite, some patients experienced growth retardation early in therapy in terms of both weight and height gain. On average, after an initial decrease in weight and height gain, patients treated with atomoxetine recovered to mean weight and height as predicted by group baseline data over the long-term treatment.
Nausea, vomiting and somnolence2 can occur in about 10% to 11% of patients particularly during the first month of therapy. 5%). 4). 8%) have been reported in patients taking atomoxetine. Atomoxetine should be used with caution in any condition that may predispose patients to hypotension.
The following table of undesirable effects is based on adverse event reporting and laboratory investigations from clinical trials and post marketing spontaneous reports in children and adolescents: Tabulated list of adverse reactions Frequency estimate: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
System Organ Class Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Not known Metabolism and nutrition Appetite decreased Anorexia (loss of appetite) disorders Psychiatric disorders Irritability, mood swings, insomnia3, agitation*, anxiety, depression and depressed mood *, tics * Suicide-related events, aggression, hostility, emotional lability * Psychosis (including hallucinations) * Bruxism Nervous system disorders Headache, somnolence2 Dizziness Syncope, tremor, migraine, paraesthesia*, hypoaesthesia*, Seizure** Eye disorders Mydriasis Vision blurred Cardiac disorders Palpitations, sinus tachycardia.
4) Asthenia Investigations Blood pressure increased4, heart rate increased4 Weight decreased 1Also includes abdominal pain upper, stomach discomfort, abdominal discomfort and epigastric discomfort. 6% of EMs). 1% of EMs). 1kg in PM).
4 Special Warnings and Special Precautions for Use – Cardiovascular Effects). Severe cardiovascular disorders may include severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels).
Severe cerebrovascular disorders may include cerebral aneurysm or stroke. 4 Special Warnings and Special Precautions for Use – Cardiovascular Effects). 4 Special warnings and precautions for use Suicide-related behaviour Suicide related behaviour (suicide attempts and suicidal ideation) has been reported in patients treated with atomoxetine.
In double blind clinical trials, suicide related behaviours were uncommon but more frequently observed among children and adolescents treated with atomoxetine compared to those treated with placebo, where there were no events. In adult double-blind clinical trials there was no difference in the frequency of suicide related behaviour between atomoxetine and placebo.
Patients who are being treated for ADHD should be carefully monitored for the appearance or worsening of suicide related behaviour. Sudden death and pre-existing cardiac abnormalities Sudden death has been reported in patients with structural cardiac abnormalities who were taking atomoxetine at usual doses.
Although some serious structural cardiac abnormalities alone carry an increased risk of sudden death, atomoxetine should only be used with caution in patients with known serious structural cardiac abnormalities and in consultation with a cardiac specialist.
Cardiovascular effects Atomoxetine can affect heart rate and blood pressure. 8). However, combined data from controlled and uncontrolled ADHD clinical trials show that approximately 8-12% of children and adolescents, and 6-10% adults experience more pronounced changes in heart rate (20 beats per minute or greater) and blood pressure (15-20 mmHg or greater).
1. Atomoxetine should not be used in combination with monoamine oxidase inhibitors (MAOI). Atomoxetine should not be used within a minimum of 2 weeks after discontinuing therapy with MAOI. Treatment with MAOI should not be initiated within 2 weeks after discontinuing atomoxetine.
Atomoxetine should not be used in patients with narrow angle glaucoma, as in clinical trials the use of atomoxetine was associated with an increased incidence of mydriasis. Atomoxetine should not be used in patients with severe cardiovascular or cerebrovascular disorders (see section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Treatment with Atomoxetine Macleods 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. 2) 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.
Atomoxetine Macleods 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.
2) 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.
2). 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 Atomoxetine Macleods in children under 6 years of age have not been established. Therefore Atomoxetine Macleods should not be used in children under 6 years of age.
4) Method of administration For oral use. Atomoxetine Macleods can be administered with or without food.
Adults:
Summary of the safety profile In adult ADHD clinical trials, the following system organ classes had the highest frequency of adverse events during treatment with atomoxetine: gastrointestinal, nervous system and psychiatric disorders.
7%). The majority of these events were mild or moderate in severity and the events most frequently reported as severe were nausea, insomnia, fatigue and headache. A complaint of urinary retention or urinary hesitancy in adults should be considered potentially related to atomoxetine.
The following table of undesirable effects is based on adverse event reporting and laboratory investigations from clinical trials and post marketing spontaneous reports in adults.
Tabulated list of adverse reactions Frequency estimate:
Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), […]
Analysis of these clinical trial data showed that approximately 15-26% of children and adolescents, and 27-32% of adults experiencing such changes in blood pressure and heart rate during atomoxetine treatment had sustained or progressive increases.
Longterm sustained changes in blood pressure may potentially contribute to clinical consequences such as myocardial hypertrophy. As a result of these findings, patients who are being considered for treatment with atomoxetine should have a careful history and physical exam to assess for the presence of cardiac disease, and should receive further specialist cardiac evaluation if initial findings suggest such history or disease.
It is recommended that heart rate and blood pressure be measured and recorded before treatment is started and, during treatment, after each adjustment of dose and then at least every 6 months to detect possible clinically important increases.
For paediatric patients the use of a centile chart is recommended. For adults, current reference guidelines for hypertension should be followed. 3 Contraindications – Severe Cardiovascular and Cerebrovascular Disorders). Atomoxetine should be used with caution in patients whose underlying medical conditions could be worsened by increases in blood pressure and heart rate, such as patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease.
Patients who develop symptoms such as palpitations, exertional chest pain, unexplained syncope, dyspnoea or other symptoms suggestive of cardiac disease during atomoxetine treatment should undergo a prompt specialist cardiac evaluation.
8). As orthostatic hypotension has also been reported, atomoxetine should be used with caution in any condition that may predispose patients to hypotension or conditions associated with abrupt heart rate or blood pressure changes. Cerebrovascular effects Patients with additional risk factors for cerebrovascular conditions (such as a history of cardiovascular disease, concomitant medications that elevate blood pressure) should be assessed at every visit for neurological signs and symptoms after initiating treatment with atomoxetine.
Hepatic effects Very rarely, spontaneous reports of liver injury, manifested by elevated hepatic enzymes and bilirubin with jaundice, have been reported. Also very rarely, severe liver injury, including acute liver failure, have been reported.
Atomoxetine Macleods should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted. , hallucinations, delusional thinking, mania or agitation in patients without a prior history of psychotic illness or mania can be caused by atomoxetine at usual doses.
If such symptoms occur, consideration should be given to a possible causal role of atomoxetine, and discontinuation of treatment should be considered. The possibility that Atomoxetine Macleods will cause the exacerbation of pre-existing psychotic or manic symptoms cannot be excluded.
Aggressive behaviour, hostility or emotional lability Hostility (predominantly aggression, oppositional behaviour and anger) was more frequently observed in clinical trials among children, adolescents and adults treated with Atomoxetine compared to those treated with placebo.
Emotional lability was more frequently […]