dexamfetamine sulfate: clinical use

Prescribing considerations

• For ADHD, initiation and supervision should be by an appropriate childhood or adolescent behavioural-disorders specialist and form part of a comprehensive treatment programme.
• Document cardiovascular and family history, psychiatric and medical comorbidity, concomitant medicines, height, weight, appetite and risks of misuse or diversion before treatment.
• Use particular caution with renal or hepatic impairment because experience is limited and exposure may be prolonged.
• Review ongoing clinical need and avoid abrupt withdrawal after prolonged treatment unless medically necessary and closely supervised.

Contraindications and cautions

• Hypersensitivity to dexamfetamine, excipients or sympathomimetic amines.
• Glaucoma, phaeochromocytoma, hyperthyroidism or thyrotoxicosis, advanced arteriosclerosis or porphyria.
• Specified serious cardiovascular or cerebrovascular disease, structural heart abnormalities, moderate or severe hypertension or serious arrhythmia.
• Current or recent monoamine oxidase inhibitor treatment.
• Specified severe psychiatric disorders, anorexia nervosa, suicidal ideation, Tourette syndrome or similar dystonias.
• History of drug or alcohol abuse.

Monitoring

• Record blood pressure and pulse during adjustment and at least every six months thereafter.
• For children and adolescents, record height, weight and appetite at least every six months using a growth chart.
• Assess new or worsening psychiatric symptoms, aggression and depression at each review and after treatment changes.
• Monitor for tics, seizures, cardiovascular symptoms, misuse, dependence and diversion.
• Promptly assess chest pain, unexplained syncope, dyspnoea, sustained tachycardia, arrhythmia or neurological symptoms.

Clinical pharmacology

Dexamfetamine is the dextrorotatory amphetamine isomer and a centrally acting sympathomimetic stimulant. It is rapidly absorbed orally, crosses the blood–brain barrier and is eliminated mainly in urine; urinary pH affects elimination.

Formulation and product differences

• The selected tablets are licensed for paediatric ADHD after inadequate methylphenidate response. Their score lines aid swallowing but do not create equal portions, and they contain isomalt.
• The selected oral solution is licensed for the same paediatric ADHD context and for adult narcolepsy. It contains liquid maltitol and benzoic acid, should be stored upright and used within the stated period after opening.
• The oral solution is under additional monitoring.

Oral solution

Route: Oral

Strengths: 1 mg/mL

Tablet

Route: Oral

Strengths: 5 mg, 10 mg, 20 mg