Precautions to be taken before handling or administering the medicinal product
Pre-treatment screening:
Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient's cardiovascular status including blood pressure and heart rate. A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death and accurate recording of pretreatment height and weight on a growth chart (see sections 4.3 and 4.4)
Ongoing monitoring
Growth, psychiatric and cardiovascular status should be continuously monitored (see also Section 4.4).
• Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months;
• Height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart;
• Development of de novo or worsening of pre-existing psychiatric disorders, including depression and aggressive behaviour, should be monitored at every adjustment of dose and then at least every 6 months and at every visit.
Patients should be monitored for the risk of diversion, misuse, and abuse of dexamfetamine
Long-term use (more than 12 months) in children and adolescents
Cardiomyopathy has been reported with chronic amfetamine use. The safety and efficacy of long-term use of dexamfetamine has not been systematically evaluated in controlled trials. Dexamfetamine treatment should not be and does not need to be indefinite. Dexamfetamine treatment is usually discontinued during or after puberty. Patients on long-term therapy (i.e. over 12 months) must have careful ongoing monitoring according to the guidance in sections 4.2 and 4.4 for cardiovascular status, growth, appetite, and development of de novo or worsening of pre-existing psychiatric disorders. Psychiatric disorders to monitor for are described below, and include (but are not limited to) motor or vocal tics, aggressive or hostile behaviour, agitation, anxiety, depression, psychosis, mania, delusions, irritability, lack of spontaneity, withdrawal, and excessive perseveration.
The physician who elects to use dexamfetamine for extended periods (over 12 months) in children and adolescents with ADHD should periodically reevaluate the long-term usefulness of the medicinal product for the individual patient with trial periods off medication to assess the patient's functioning without pharmacotherapy. It is recommended that dexamfetamine is dechallenged at least once yearly to assess the child's condition (preferably during times of school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued.
Cardiovascular status
Patients who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden cardiac or unexplained death or malignant arrhythmia) 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. Patients who develop symptoms such as palpitations, exceptional chest pain, unexplained syncope, dyspnoea, or other symptoms suggestive of cardiac disease during dexamfetamine treatment should undergo a prompt specialist cardiac evaluation.
Cardiovascular status should be carefully monitored. Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months.
Treatment with stimulants in general may lead to a minor increase in blood pressure (approx. 2-4 mm Hg) as well as an increase in heart rate (approx. 3-6 beats/minute).
In few patients, these values may be higher.
The short- and long-term clinical consequences of these cardiovascular effects in children and adolescents are not known, but the possibility of clinical complications cannot be excluded as a result of the effects observed in the clinical trial data. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate. See section 4.3 for conditions in which dexamfetamine treatment in contraindicated.
The use of dexamfetamine is contraindicated in certain pre-existing cardiovascular disorders unless specialist paediatric cardiac advice has been obtained (see section 4.3).
Sudden death and pre-existing cardiac structural abnormalities or other serious cardiac disorders.
Sudden death has been reported in association with the use of stimulants of the central nervous system at usual doses in children, some of whom had cardiac structural abnormalities or other serious heart problems. Although some serious heart problems alone may carry an increased risk of sudden death, stimulant products are not recommended in children or adolescents with known cardiac structural abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the onset of sympathomimetic effects of a stimulant medicine (see section 4.3).
Use with caution in patients on guanethidine and patients with mild hypertension or a family history of dystonias. If tics develop, discontinue treatment with dexamfetamine Sulfate. Dexamfetamine is likely to reduce the convulsant threshold therefore caution is advised in patients with epilepsy. Height and weight should be carefully monitored in children as growth retardation may occur. Children who are not gaining weight as expected should have their treatment interrupted temporarily.
Caution should be used when administering dexamfetamine to patients with impaired kidney function or unstable personality.
Drug dependence, with consumption of increasing doses to levels many times those recommended, may occur as tolerance develops. At such levels, a psychosis which may be clinically indistinguishable from schizophrenia can occur.
Treatment should be stopped gradually since abrupt cessation may produce extreme fatigue and mental depression.
Cardiomyopathy has been reported with chronic amfetamine use.
Due to the potential decreased appetite associated with dexamfetamine use, caution is advised in the presence of anorexia nervosa.
Pre-existing structural cardiac abnormalities:
Sudden death has been reported in association with the use of stimulants of the central nervous system at usual doses in children with structural cardiac abnormalities. Although some structural cardiac abnormalities alone may carry an increased risk of sudden death, stimulant products are not recommended in children, adolescents, or adults with known structural cardiac abnormalities (see 4.3, Contraindications).
Blood pressure should be monitored at appropriate intervals in all patients taking dexamfetamine, especially those with hypertension.
Psychiatric adverse events:
• Administration of stimulants may exacerbate symptoms of behaviour disturbance and thought disorders in patients with a pre-existing psychotic disorder.
• Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder and depression.
• Treatment emergent psychotic or manic symptoms, e.g. hallucinations, delusional thinking or mania in children or adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant and discontinuation of treatment may be appropriate.
• Patients beginning treatment with stimulants for ADHD should be monitored for the appearance, or worsening of, aggressive behaviour or hostility.
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