Dexamfetamine Sulfate ▼ Abbreviated Prescribing Information

▼This medicinal product is subject to additional monitoring.

Abbreviated Prescribing Information: Dexamfetamine Sulfate 1 mg/ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear colourless solution containing 1 mg/ml of dexamfetamine sulfate. Therapeutic Indications: for treatment of narcolepsy in adults and indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when response to previous methylphenidate treatment is considered clinically inadequate. For Narcolepsy: In adults, the initial dose is 10mg per day in divided doses which may be increased by 10 to 60 mg a day at weekly intervals if necessary. In elderly patients, the initial dose is 5 mg per day with increase by increments of 5 mg a day at weekly intervals. For ADHD: Dexamfetamine should be initiated with careful dose titration, beginning at the lowest possible dose. The recommended starting dose is 5 mg once or twice daily, which may be increased by 5 mg increments each week based on tolerability and efficacy. The usual maximum daily dose in children and adolescents is 20 mg, though doses up to 40 mg may be required in rare cases for optimal titration. Dosing times for dexamfetamine should be chosen to provide best effect when it is most needed to combat school and social behavioural difficulties. Normally the first increasing dose is given in the morning. To avoid sleep disturbance, doses should not be taken too late after lunchtime. The regimen that provides adequate symptom control with the lowest effective daily dose should be used. Treatment should be stopped if symptoms do not improve after one month of appropriate dose adjustment. If paradoxical symptom worsening or serious adverse events occur, the dose should be reduced or discontinued. Dexamfetamine sulfate is not licensed for use in adults and elderly population for ADHD. Dexamfetamine should be used with careful titration and dosing and with caution in patients with renal or hepatic insufficiency. Paediatric population: Dexamfetamine should not be used in children under 6 years. Method of administration: oral. Contra-indications: Hypersensitivity to dexamfetamine or to any of the excipients, hypersensitivity to sympathomimetic amines, glaucoma, phaeochromocytoma, symptomatic cardiovascular disease, structural cardiac abnormalities and/or moderate or 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), advanced arteriosclerosis, concomitant use of monoamine oxidase inhibitors (MAOI) or within 14 days of MAOI treatment, hyperthyroidism or thyrotoxicosis, severe depression, anorexia nervosa/anorexic disorders, suicidal ideation, hyperexcitability, psychotic symptoms, severe and episodic (Type I) Bipolar (affective) Disorder (that is not well-controlled), schizophrenia, psychopathic/borderline personality disorder, Gilles de la Tourette syndrome or similar dystonias, cerebrovascular disorders (cerebral aneurysm, vascular abnormalities including vasculitis or stroke), porphyria and history of drug abuse or alcohol abuse. Special Warnings and Precautions for use: Before prescribing, clinicians should assess cardiovascular status, review relevant medical and family history, and record baseline growth measures. Patients should undergo ongoing monitoring of growth, cardiovascular and psychiatric status—with vital signs, growth measures and psychiatric symptoms reviewed at dose changes and at least every 6 months—and be assessed for any risk of dexamfetamine diversion, misuse or abuse. Dexamfetamine should not be used in patients with known drug or alcohol dependency because of a potential for abuse, misuse, or diversion. Long-term use of dexamfetamine in children and adolescents (over 12 months) has not been systematically studied, and treatment should not be indefinite, usually being discontinued during or after puberty. Patients on extended therapy require careful ongoing monitoring of cardiovascular status, growth, appetite, and psychiatric symptoms, with periodic re-evaluation, including annual trial periods off medication to assess functioning without pharmacotherapy. Cardiovascular monitoring should include blood pressure and pulse, with attention to symptoms such as palpitations, chest pain, syncope, or dyspnea; treatment is contraindicated in patients with serious pre-existing cardiac disorders unless specialist advice is obtained, as stimulants may increase heart rate and blood pressure and have been associated with sudden death, cardiomyopathy, and other cardiovascular events, particularly with misuse. Cerebrovascular risks, including rare cerebral vasculitis, should be considered if new neurological symptoms arise. Psychiatric comorbidities are common, and dexamfetamine may exacerbate pre-existing psychosis, mania, aggression, anxiety, tics, or suicidal ideation; careful monitoring at dose adjustments and at least every six months is required, with discontinuation if severe symptoms develop. Growth retardation and reduced weight gain may occur, so height, weight, and appetite should be tracked, and caution used in patients with anorexia nervosa. Seizure risk is increased in patients with epilepsy or prior EEG abnormalities, and discontinuation is warranted if seizures occur. There is potential for abuse, misuse, and psychological dependence, particularly in patients with substance use risk factors; non-stimulant alternatives should be considered for high-risk individuals. Withdrawal requires careful supervision due to possible unmasking of depression, chronic overactivity, extreme fatigue, or EEG changes. Dexamfetamine should not be used to treat normal fatigue, may induce positive amphetamine drug screens, and should be used with caution in renal or hepatic insufficiency due to possible increased plasma levels. Long-term safety is not fully established; treatment should be discontinued if hematological abnormalities arise. The formulation contains liquid maltitol, contraindicated in fructose intolerance, and benzoic acid, which may increase jaundice in newborns up to four weeks old. Any warning from the MC, CHM CSM or MHRA: No. Black Triangle notice: ▼ This medicinal product is subject to additional monitoring. A list of very common, common, and serious adverse reactions is presented below: Very common: decreased appetite, reduced weight gain, weight loss during prolonged use in children, insomnia, and nervousness. Common: arrhythmia, palpitations, tachycardia, abdominal pain and cramps, nausea, vomiting, dry mouth, changes in blood pressure and heart rate (usually increases), arthralgia, vertigo, dyskinesia, headache, hyperactivity, abnormal behaviour, aggression, excitation, anorexia, anxiety, depression and irritability. Serious: leukopenia, thrombocytopenia, thrombocytopenic purpura, angina pectoris, cardiac arrest, cardiomyopathy, myocardial infarction, Tourette’s syndrome, blurred vision, ischaemic colitis, chest pain, hyperpyrexia, sudden death, hepatic coma, angioedema, anaphylaxis, Growth retardation in children, rhabdomyolysis, convulsions, choreoathetoid movements, intracranial haemorrhage, concentration difficulties, hyperreflexia, stroke, tremor, ataxia, neuroleptic malignant syndrome, hallucinations, psychosis, psychotic reactions, suicidal behaviour (including completed suicide), tics, confusion, dependence, dysphoria, impaired cognitive test performance, night terrors, obsessive-compulsive behaviour, panic states, paranoia, renal damage, erythema multiforme, exfoliative dermatitis, fixed drug eruption, cerebral vasculitis, cerebral occlusion, Raynaud’s phenomenon, toxic hypermetabolic state, hyperpyrexia, acidosis, and death due to cardiovascular collapse. Refer to the SmPC for full details of adverse reactions. Legal Category: Prescription only medicine. Pack Size and NHS Price: 150ml – £183.86. Marketing Authorisation Number: PL 00427/0282. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [Nov-2025]