Radd 18/27/36 and 54 mg Prolonged-release tablet

RADD is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children 6 to 17 years of age and in adults aged 18 to 65 who meet DSM-IV criteria for ADHD.

Posology
Dosage should be individualised according to the need and response of each individual patient.
Patients New to Methylphenidate
The recommended starting dose of RADD for patients who are not currently taking methylphenidate, or for patients who are on stimulants other than methylphenidate, is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults.
Patients Currently Using Methylphenidate
The recommended dose of RADD for patients who are currently taking methylphenidate three times daily at doses of 15 to 60 mg/day is provided in the table below. Dosing recommendations are based on current dose regimen and clinical judgement.
Previous Methylphenidate Daily Dose
Recommended RADD Dose
5 mg Methylphenidate hydrochloride twice or three times daily 18 mg once daily
10 mg Methylphenidate hydrochloride twice or three times daily 36 mg once daily
15 mg Methylphenidate hydrochloride twice or three times daily 54 mg once daily
20 mg Methylphenidate hydrochloride twice or three times daily 72 mg once daily
Clinical judgement should be used when selecting the dose for patients currently taking methylphenidate (as contained in RADD) in other regimens.
Dosage may be adjusted in 18 mg increments to a maximum of 54 mg/day for children aged between 6 u2013 12 years and to a maximum of 72 mg for adolescents aged between 13 u2013 18 years and 108 mg in adults. In general, dosage adjustment may proceed at approximately weekly intervals.
Daily dosage above 54 mg is not recommended in children between 6 u2013 12 years. Daily dosage above 72 mg is not recommended in adolescents aged 13 u2013 18 years. Daily dosage above 108 mg is not recommended in adults.
Maintenance/Extended Treatment
The long-term use of RADD has not been systematically evaluated. The medical practitioner who elects to use RADD for extended periods (over 12 months) in patients with ADHD should periodically re-evaluate the long-term use usefulness of RADD for the individual patient with trials off-treatment to assess the patientu2019s functioning without pharmacotherapy.
Changing from one extended-release methylphenidate medicine to another
The efficacy and tolerability profile of RADD over the dosing period is determined by the specific release profile of the medicine. Other extended-release methylphenidate formulations with different release profiles may have different efficacy and tolerability profiles. It is recommended that changing from one extended-release methylphenidate medicine to another only be carried out under additional medical supervision.
Dose reduction and discontinuation
If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or, if necessary, RADD should be discontinued.
Special populations
Elderly: Use of RADD in patients over 65 years has not been established.
Paediatric population
RADD should not be used in children under the age of 6 years.
Method of administration
RADD is administered orally, once daily. As the effects has been shown to be present 12 hours after dosing, RADD should be taken in the morning. RADD must be swallowed whole with adequate liquid and must not be chewed, divided or crushed. RADD may be administered with or without food (see section 4.5).

• known hypersensitivity to methylphenidate or to any of the excipients in RADD (see section 6.1)
• patients with marked anxiety, tension and agitation, since RADD may aggravate these symptoms (see section 4.4)
• patients with poorly controlled open-angle or angle-closure glaucoma
• patients diagnosed with phaeochromocytoma
• patients undergoing treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing MAOIs, due to the risk of hypertensive crisis (see section 4.5).
• patients with a family history or diagnosis of Touretteu2019s syndrome (see section 4.4)
• patients diagnosed or with a history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder
• patients with hyperthyroidism
• diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that is not well-controlled)
• pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening dysrhythmias and channelopathies (disorders caused by the dysfunction of ion channels) (see section 4.4)
• pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis or stroke (see section 4.4)
• patients with a history of substance or alcohol abuse
• Pregnancy and lactation (see section 4.6).

General: Methylphenidate treatment is not indicated in all children with ADHD, the decision to use RADD must be based on a very thorough assessment of the severity and chronicity of the childu2019s symptoms in relation to the childu2019s age and not simply on the presence of one or more abnormal behavioural characteristics.
RADD should not be used for the treatment of attention deficit or hyperactivity secondary to amenable causes, including acute stress reactions.
Use in adults: Safety and efficacy have not been established for the initiation of treatment in adults or the routine continuation of treatment beyond 18 years of age. If treatment withdrawal has not been successful when an adolescent has reached 18 years of age continued treatment into adulthood may be necessary. The need for further treatment of these adults should be reviewed regularly and undertaken annually.
Weight decrease has been reported with methylphenidate treatment in adults. In adults, weight should be regularly monitored.
Use in the elderly: Methylphenidate should not be used in the elderly (over 65) as safety and efficacy have not been established.
Use in children under 6 years of age: RADD should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.
Long-term use (more than 12 months) in children and adolescents: Controlled studies regarding the safety and efficacy of long-term use of methylphenidate have not been undertaken. RADD treatment should not and need not, be indefinite, with treatment generally being discontinued during or after puberty. Careful monitoring for cardiovascular status, growth, appetite, development of de novo or worsening of pre-existing psychiatric disorders is essential in this patient group. Psychiatric disorders to be monitored 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. In the event extended use (more than 12 months) is required in children and adolescents with ADHD, periodic re-evaluation of the benefits should be undertaken by stopping therapy and assessing the patient's functioning without pharmacotherapy. It is recommended that RADD is de-challenged 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 considered for treatment should have a careful history (including assessment for a family history of sudden cardiac or unexplained death or malignant dysrhythmia) and physical exam to assess for the presence of cardiac disease. Should cardiac disease be suspected, further specialist cardiac evaluation is to be undertaken. The development of symptoms suggestive of cardiac disease (e.g. palpitations, exertional chest pain, unexplained syncope, dyspnoea) during RADD treatment require immediate specialist cardiac evaluation.
RADD is contraindicated in patients with hypertension (see section 4.3). ADHD patients whose underlying medical conditions might be compromised by increases in heart rate and/or blood pressure, e.g. heart failure and hypertension, should be closely monitored as methylphenidate increases heart-rate, systolic and diastolic blood pressure. Whilst taking RADD, patient blood pressure should be monitored at appropriate intervals in all patients, especially in those with hypertension (see section 4.3). Patients who develop symptoms suggestive of cardiac disease during RADD treatment should undergo prompt cardiac evaluation.
Sudden death and pre-existing structural cardiac abnormalities or other serious cardiac disorders: Cases of sudden death have been reported in ADHD patients with structural cardiac abnormalities and other serious cardiac disorders, treated with methylphenidate used at usual doses. Although some serious heart problems alone may carry an increased risk of sudden death, RADD is not recommended in patients with structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of RADD (see section 4.3). Before initiating RADD treatment, patients should be assessed for pre-existing cardiovascular disorders such as congenital long QT syndrome, or a family history of sudden death and ventricular dysrhythmia.
Misuse and cardiovascular events: Misuse of stimulants of the central nervous system, such as RADD, may be associated with sudden death and other serious cardiovascular adverse events.
Cerebrovascular disorders: Patients with pre-existing central nervous system (CNS) abnormalities, e.g. cerebral aneurysm and/or other vascular abnormalities such as vasculitis or pre-existing stroke should not be treated with RADD. Patients with additional risk factors (such as a history of cardiovascular disease, concomitant medicines that elevate blood pressure) should be assessed at every visit for neurological signs and symptoms after initiating treatment with RADD. Cerebral vasculitis appears to be a very rare idiosyncratic reaction to methylphenidate exposure (as contained in RADD). There is little evidence to suggest that patients at higher risk can be identified and the initial onset of symptoms may be the first indication of an underlying clinical problem. Early diagnosis, based on a high index of suspicion, may allow the prompt withdrawal of RADD and early treatment. The diagnosis should therefore be considered in any patient who develops new neurological symptoms that are consistent with cerebral ischemia during RADD therapy. These symptoms could include severe headache, numbness, weakness, paralysis, and impairment of coordination, vision, speech, language or memory.
Treatment with RADD is not contraindicated in patients with hemiplegic cerebral palsy.
Tics: RADD is associated with the onset or exacerbation of motor and verbal tics. Worsening of Touretteu2019s syndrome has also been reported. Family history and clinical evaluation for tics or Touretteu2019s syndrome should therefore be established prior RADD treatment. Regular monitoring for the emergence or worsening of tics during treatment with RADD is required.
Growth retardation: Long-term treatment with RADD may retard normal growth and weight in children. Careful monitoring is required, patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
Depression/Fatigue: RADD should not be used to treat depression and/or for the prevention or treatment of normal fatigue states.
Psychiatric disorders: Co-morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing RADD. Prior to initiating treatment with RADD, patients should be assessed for pre-existing psychiatric disorders and a family history of psychiatric disorders. Treatment of ADHD with RADD should not be initiated in patients with acute psychosis, acute mania or acute suicidality. These acute conditions should be treated and controlled before ADHD treatment is considered. In the case of emergent psychiatric symptoms or exacerbation of pre-existing psychiatric disorders, RADD should not be prescribed (see section 4.3). Development or worsening of psychiatric disorders should be monitored at every adjustment of dose, then at least every 6 months, and at every visit; discontinuation of treatment may be appropriate.
Emergence of new psychotic or manic symptoms: Treatment-emergent psychotic symptoms (visual/tactile/auditory hallucinations and delusions) or mania in patients without prior history of psychotic illness or mania can be caused by RADD at normal doses. In the event manic or psychotic symptoms occur, consideration should be given to a possible causal role for RADD, and discontinuation of treatment may be appropriate.
Aggressive or hostile behaviour: Patients beginning treatment with RADD should be monitored for the appearance or worsening of aggressive behaviour or hostility. Aggression is frequently associated with ADHD, however, emergence or worsening of aggression has been reported during treatment with RADD. Patients should be monitored at treatment initiation, at every dose adjustment and then at least every 6 months or every visit. Medical practitioners should evaluate the need for adjustment of the treatment regimen in patients experiencing behavioural changes, bearing in mind that upwards or downwards titration may be appropriate. Treatment interruption can be considered.
RADD should be given with caution in the following conditions:
Exacerbation of pre-existing psychotic or manic symptoms: Administration of RADD may exacerbate symptoms of behaviour disturbances and thought disorder in psychotic patients.
Abuse, misuse and dependence: RADD should be given cautiously to patients with a history of narcotic dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. Frank psychotic episodes can occur, especially with parenteral abuse. Patient age, the presence of risk factors for substance use disorder (such as comorbid oppositional-defiant or conduct disorder and bipolar disorder), and previous or current substance abuse should be taken into account when deciding on a course of treatment for ADHD. Caution is called for in emotionally unstable patients, such as those with a history of drug or alcohol dependence, because such patients may increase the dosage on their own initiative. For some high-risk substance abuse patients, RADD may not be suitable.
Seizures: RADD should be used with caution in patients with epilepsy. Evidence indicates lowering of the convulsive threshold in patients with prior history of seizures, prior EEG abnormalities in absence of seizures, and in patients without a history of convulsions and no EEG abnormalities. If seizure frequency increases or new-onset seizures occur, treatment should be discontinued.
Suicidal tendency: Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be evaluated immediately by their doctor. Consideration should be given to the exacerbation of an underlying psychiatric condition and to a possible causal role of RADD treatment. Treatment of an underlying psychiatric condition may be necessary, and consideration should be given to a possible discontinuation of RADD.
Anxiety, agitation or tension: Worsening of pre-existing anxiety, agitation or tension is associated with RADD treatment. Clinical evaluation for anxiety, agitation or tension prior RADD treatment should be undertaken with regular monitoring. RADD is contraindicated in patients suffering from these conditions (see section 4.3).
Forms of bipolar disorder: Particular care should be taken in the treatment of ADHD in patients with comorbid bipolar disorder (including untreated Type I Bipolar Disorder or other forms of bipolar disorder) due to the risk of possible precipitation of a mixed/manic episode in such patients. Prior to initiating treatment with RADD, 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. Close ongoing monitoring is essential in these patients. (see section 4.2). Patients should be monitored for symptoms at every adjustment of dose, then at least every 6 months and at every visit.
Visual adverse reactions: Symptoms of visual disturbances have been reported. Difficulties with accommodation and blurring of vision have been reported.
Increased intraocular pressure and glaucoma: Cases of transient elevation of intraocular pressure (IOP) associated with methylphenidate treatment have been reported. RADD should only be prescribed to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Patients with a history of abnormally increased IOP or open-angle glaucoma, and patients at risk for acute angle-closure glaucoma (e.g. patients with significant hyperopia) must be closely monitored. RADD is not recommended in patients with acute angle glaucoma. RADD is contraindicated in all patients with poorly controlled glaucoma (see section 4.3).
Haematological effects: The long-term safety of treatment with methylphenidate, as in RADD is not fully known. Patients requiring long-term therapy should therefore be carefully monitored and complete and differential blood counts and a platelet count performed periodically. In the event of leukopenia, thrombocytopenia, anaemia or other alterations, including those indicative of serious renal or hepatic disorders, discontinuation of treatment should be considered.
Potential for gastrointestinal obstruction: RADD must be swallowed whole with the aid of liquids. Tablets should not be chewed, divided or crushed. RADD is contained within a non-absorbable shell designed to release the medicine at a prolonged rate. The tablet shell together with insoluble core components are eliminated from the body. Patients should not be concerned if they occasionally notice something that resembles a tablet in their stools. As RADD is non-deformable and does not appreciably change shape in the GI tract, RADD should not be administered to patients with pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic) or in patients with dysphagia or significant difficulty in swallowing tablets. There have been reports of obstructive symptoms in patients with known strictures. Due to the prolonged release design of the tablet, RADD should only be administered to patients who are able to swallow the tablet whole.
Use with serotonergic medicinal products: Serotonin syndrome has been reported following co-administration of methylphenidate with serotonergic medicines such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). The concomitant use of RADD and serotonergic medicines is not recommended as this may lead to the development of serotonin syndrome. If concomitant use of RADD with a serotonergic medicine is warranted, prompt recognition of the symptoms of serotonin syndrome is important. These symptoms may include mental-status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular abnormalities (e.g. tremor, myoclonus, hyperreflexia, incoordination, rigidity), seizures and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). RADD must be discontinued as soon as possible if serotonin syndrome is suspected and appropriate treatment instituted.
Withdrawal: Careful supervision is required during RADD withdrawal, as withdrawal may unmask depression as well as chronic over-activity. Some patients may require long-term follow up.
Careful supervision is required during withdrawal from abusive use since severe depression may occur.
Drug screening: Methylphenidate may induce a false positive laboratory test for amphetamines, particularly with immunoassay screen test.
Renal or hepatic insufficiency: There is no experience with the use of RADD in patients with renal or hepatic insufficiency.
Priapism: Prolonged and painful erections requiring immediate medical attention (in some cases including surgical intervention) have been reported in association with methylphenidate, in both paediatric and adult patients. Although mainly in association with a change in the treatment regimen, priapism can also develop after some time on methylphenidate, or during periods of withdrawal (holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
Lactose: RADD contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take RADD.

It is not known how methylphenidate may affect plasma concentrations of concomitantly administered medicines. Therefore, caution is recommended when combining methylphenidate with other medicines, especially those with a narrow therapeutic window (see section 4.4).
Pharmacokinetic interactions
Methylphenidate is not metabolised by cytochrome P450 to a clinically relevant extent. Inducers or inhibitors of cytochrome P450 are not expected to have any relevant impact on methylphenidate pharmacokinetics. Conversely, the d- and l- enantiomers of methylphenidate do not relevantly inhibit cytochrome P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A. However, studies indicate that methylphenidate (as contained in RADD) may inhibit the metabolism of warfarin, anticonvulsants (e.g. phenobarbitone, phenytoin, primidone), and some antidepressants (tricyclic and selective serotonin reuptake inhibitors). It may be necessary to adjust the dosage of these medicines that are already being taken and monitor plasma medicines concentrations (or, in the case of warfarin, coagulation times), when initiating or discontinuing concomitant use of RADD. RADD co-administration did not increase plasma concentrations of the CYP2D6 substrate desipramine. The stimulant effects of RADD are inhibited by chlorpromazine, haloperidol and lithium. Disulfiram may inhibit the metabolism and excretion of RADD.

Pregnancy
RADD should not be used during pregnancy as safety has not been established (see section 4.3). Cases of neonatal cardiorespiratory toxicity, specifically foetal tachycardia and respiratory distress have been reported. Teratogenicity has been shown in laboratory animals.
Breastfeeding
Methylphenidate is excreted in human milk, RADD should not be used during breastfeeding (see section 4.3).
Fertility
No relevant effects observed in non-clinical studies.

RADD may have a moderate influence on the ability to drive and use machines. RADD may cause changes to vision (including blurring, altered visual depth perception), sedation and dizziness, patients should be advised to avoid driving or operating heavy machinery until they know how RADD affects them.

Summary of the safety profile
Tabulated list of adverse effects
System Organ Class
Frequency
Side effects
Infections and Infestations
Frequent
Nasopharyngitis, upper respiratory tract infection, sinusitis
Blood and lymphatic system disorders
Less frequent
Frequency unknown
Anaemia leukopenia, thrombocytopenia, thrombocytopenic purpura
Pancytopenia, epistaxis*
Immune system disorders
Less frequent
Hypersensitivity reactions, angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritus NEC, rashes, eruptions, exanthemas NEC
Metabolism and nutrition disorders
Frequent
Anorexia, decreased appetite, moderately reduced weight and height gain during prolonged use in children
Psychiatric disorders
Frequent
Less frequent
Frequency unknown
Insomnia, nervousness, anorexia, affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, mood swings, tics, depressed mood, libido decreased, tension, bruxism, panic attack
Psychotic disorders, auditory, visual and tactile hallucination, anger, suicidal ideation, mood altered, restlessness, tearfulness, worsening of pre-existing tics of Tourette's syndrome, logorrhoea, hypervigilance, sleep disorder, mania, disorientation, libido disorder, confusional state, suicidal attempt (including completed suicide, transient depressed mood, abnormal thinking, apathy, repetitive behaviours, over-focussing
Delusions, thought disturbances, dependence, cases of abuse and dependence
Nervous system disorders
Frequent
Less frequent
Frequency unknown
Headache, dizziness, psychomotor hyperactivity, somnolence, paraesthesia, tension headache
Sedation, tremor, lethargy, convulsion, choreoathetoid movements, reversible ischaemic neurological deficit, neuroleptic malignant syndrome
Cerebrovascular disorders (including vasculitis, cerebral haemorrhages, cerebrovascular accidents, cerebral arteritis, cerebral occlusion), grand mal convulsion, migraine, dyskinesia
Eye disorders
Frequent
Less frequent
Frequency unknown
Accommodation disorder
Blurred vision, dry eye, difficulties in visual accommodation, visual impairment, diplopia
Mydriasis
Ear and labyrinth disorders
Frequent
Vertigo
Cardiac disorders
Frequent
Less frequent
Frequency unknown
Arrhythmia, tachycardia, palpitations
Chest pain, angina pectoris, cardiac arrest, cardiac dysrhythmias myocardial infarction
Supraventricular tachycardia, bradycardia, ventricular extrasystoles, extrasystoles
Vascular disorders
Frequent
Less frequent
Frequency unknown
Hypertension
Hot flush, cerebral arteritis and/or occlusion, peripheral coldness, Raynaud's phenomenon
Respiratory, thoracic and mediastinal disorders
Frequent
Less frequent
Cough, oropharyngeal pain, nasal congestion
Dyspnoea, nasopharyngitis
Gastrointestinal disorders
Frequent
Less frequent
Abdominal pain upper, diarrhoea, nausea, abdominal discomfort, vomiting, dry mouth, dyspepsia
Constipation
Hepatobiliary disorders
Less frequent
Frequency unknown
Hepatic enzyme elevations, abnormal liver function, including hepatic coma
Hepatocellular injury, acute* hepatic failure*
Skin and subcutaneous tissue disorders
Frequent
Less frequent
Alopecia, pruritus, rash, urticaria
Angioedema, bullous conditions, exfoliative conditions, hyperhidrosis, macular rash, erythema, erythema multiforme, exfoliative dermatitis, fixed drug eruption
Musculoskeletal, connective tissue and bone disorders
Frequent
Less frequent
Arthralgia, muscle tightness, muscle spasms
Myalgia, muscle twitching, muscle cramps
Renal and urinary disorders
Less frequent
Frequency unknown
Haematuria, pollakiuria
Incontinence
Reproductive system and breast disorders
Frequent
Less frequent
Frequency unknown
Erectile dysfunction
Gynaecomastia
Priapism, erection increased and prolonged erection
General disorders and administrative site conditions
Frequent
Less frequent
Frequency unknown
Pyrexia, growth retardation during prolonged use in children, fatigue, irritability, feeling jittery, asthenia, thirst
Chest pain, sudden cardiac death, decreased medicine effect
Chest discomfort, hyperpyrexia, decreased therapeutic response*
Investigations
Frequent
Less frequent
Changes in blood pressure and heart rate (usually an increase), decreased weight, increased alanine amino-transferase
Increased hepatic enzyme, increased blood alkaline phosphatase, increased blood bilirubin, decreased platelet count, abnormal white blood cell-count, cardiac murmur
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. An email can be sent directly to the company, [email protected], to ensure safety of the product.

Signs and symptoms: Signs and symptoms of RADD, in an overdosage, result principally from overstimulation of the CNS and excessive sympathomimetic stimulations. They include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions, coma, grand mal convulsion, euphoria, confusional state, confusion, hallucinations (auditory and/or visual), hyperhidrosis, delirium, flushing, headache, pyrexia, tachycardia, palpitations, heart rate increased, sinus dysrhythmias, hypertension, mydriasis, and dry mouth.
Management of overdose: There is no specific antidote to methylphenidate overdosage. Treatment consists of appropriate supportive measures and symptomatic treatment of life-threatening events e.g. hypertensive crisis, cardiac dysrhythmias, convulsions. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. For the most current guidance for treatment of symptoms of overdose, the practitioner should consult a certified Poison Control Centre or current toxicological publication. If the patient is conscious, administration of activated charcoal and a laxative is recommended. In the presence of severe intoxication, a carefully titrated dose of benzodiazepine should be given. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia. Efficacy of peritoneal dialysis or extracorporeal haemodialysis for overdose of RADD has not been established. The prolonged release of methylphenidate from RADD should be considered when treating patients with overdose.