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General: Treatment with methylphenidate is not indicated in all cases of attention-deficit/hyperactivity disorder, and should be considered only after detailed history-taking and evaluation. The decision to prescribe methylphenidate should depend on an assessment of the severity of symptoms and, in pediatric patients, their appropriateness to the child's age, and not simply on the presence of one or more abnormal behavioural characteristics. Where these symptoms are associated with acute stress reactions, treatment with methylphenidate is usually not indicated.
Cardiovascular: Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems: Sudden death has been reported in association with the use of stimulants of the central nervous system at usual doses in patients with structural cardiac abnormalities or other serious problems. A causal relationship with stimulant products has not been established since some of these conditions alone may carry an increased risk of sudden death. Stimulant products, including methylphenidate, generally should not be used in patients with known structural cardiac abnormalities or other serious cardiac disorders that may increase the risk of sudden death due to sympathomimetic effects of a stimulant drug. Before initiating methylphenidate treatment, patients should be assessed for pre-existing cardiovascular disorders and a family history of sudden death and ventricular arrhythmia (see Dosage & Administration).
Cardiovascular Conditions: Methylphenidate is contraindicated in patients with severe hypertension. Methylphenidate increases heart rate and systolic and diastolic blood pressure. Therefore, caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g. those with pre-existing hypertension, severe cardiovascular disorders are contraindicated (see Contraindications).
Blood pressure should be monitored at appropriate intervals in all patients taking methylphenidate, especially in those with hypertension. Patients who develop symptoms suggestive of cardiac disease during methylphenidate treatment should undergo a prompt cardiac evaluation.
Misuse and Cardiovascular Events: Misuse of stimulants of the central nervous system, including methylphenidate, may be associated with sudden death and other serious cardiovascular adverse events.
Cerebrovascular Conditions: 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 methylphenidate. Patients with additional risk factors (history of cardiovascular disease, concomitant medications that elevate blood pressure) should be assessed regularly for neurological/psychiatric signs and symptoms after initiating treatment with methylphenidate (see previously mentioned paragraph on Cardiovascular Conditions and Interactions).
Psychiatric: Co-morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing stimulant products. Prior to initiating treatment with methylphenidate, patients should be assessed for pre-existing psychiatric disorders and a family history of psychiatric disorders (see Dosage & Administration). Treatment of ADHD with stimulant products including methylphenidate 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 symptoms, methylphenidate should not be given to patients unless the benefit outweighs the potential risk.
Psychotic Symptoms: Psychotic symptoms, including visual and tactile hallucinations or mania have been reported in patients administered usual prescribed doses of stimulant products, including methylphenidate (see Adverse Reactions). Physicians should consider treatment discontinuation.
Depression or Psychosis: Methylphenidate should not be used as treatment for severe depression of either exogenous or endogenous origin. In psychotic patients, administration of methylphenidate may exacerbate symptoms of behavioural disturbance and thought 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.
Treatment emergent psychotic or manic symptoms, e.g. hallucinations, delusional thinking, or mania in children and 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.
Aggressive Behavior: Emergent aggressive behaviour or an exacerbation of baseline aggressive behaviour has been reported during stimulant therapy, including methylphenidate. However, patients with ADHD may experience aggression as part of their medical condition. Therefore causal association with treatment is difficult to assess. Physicians should evaluate the need for adjustment of treatment regimen in patients experiencing these behavioural changes, bearing in mind that upwards or downwards titration may be appropriate. Treatment interruption can be considered.
Suicidal Tendency: Patients with emergent suicidal ideation and behaviour during treatment for ADHD should be evaluated immediately by their physician. The physician should initiate appropriate treatment of the underlying psychiatric condition and consider a possible change in the ADHD treatment regimen.
Tics: Methylphenidate is associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette's syndrome has also been reported (see Adverse Reactions). Family history should be assessed and clinical evaluation for tics or Tourette's syndrome in children should precede use of methylphenidate for ADHD treatment. Methylphenidate is contraindicated in case of diagnosis or family history of Tourette's syndrome (see Contraindications). Patients should be regularly monitored for the emergence or worsening of tics during treatment with methylphenidate.
Growth Retardation: Moderately reduced weight gain and slight growth retardation have been reported with the long-term use of stimulants, including methylphenidate, in children (see Adverse Reactions). Growth should be monitored as clinically necessary during treatment with methylphenidate, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
Seizures: There is some clinical evidence that methylphenidate may lower the convulsion threshold in patients with a history of seizures, with prior EEG abnormalities in the absence of seizures and, rarely, in the absence of a history of seizures and no prior EEG evidence of seizures. Safe concomitant use of anticonvulsants and methylphenidate has not been established. In the presence of seizures, the drug should be discontinued.
Methylphenidate should be used with caution in patients with epilepsy as clinical experience has shown that it can cause an increase in seizure frequency in a small number of such patients. If seizure frequency increases, methylphenidate should be discontinued.
Priapism: Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
Drug Abuse and Dependence: Chronic abuse of methylphenidate can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. Frank psychotic episodes may occur, especially with parenteral abuse. Clinical data indicate that children given methylphenidate are not more likely to abuse drugs as adolescents or adults. Caution is called for in emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because they may increase the dosage on their own initiative.
Withdrawal: Careful supervision is required during drug withdrawal, since this may unmask depression as well as the effects of chronic overactivity. Some patients may require long-term follow-up.
Hematological Effects: The long-term safety and efficacy profiles of methylphenidate are 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 haematological disorders appropriate medical intervention should be considered (see Adverse Reactions).
Other Drug Dependence: As with other stimulants, the possibility of habituation or abuse must be considered, particularly in emotionally unstable patients and those with a history of drug dependence or alcoholism, because such patients may increase the dose on their own initiative. Alcohol may exacerbate the CNS adverse reactions of psychoactive drugs, including methylphenidate. Therefore, it is advisable for patients to abstain from alcohol during treatment.
Chronic abuse of methylphenidate can lead to marked tolerance and psychic dependence with varying degrees of abnormal behaviour. Frank psychotic episodes may occur, especially in response to parenteral abuse. Methylphenidate abuse of dependence does not appear to be a problem in adolescents or adults who were treated with methylphenidate for ADHD as children.
Careful supervision is required during drug withdrawal, since this may unmask depression as well as the effects of chronic overactivity. Some patients may require long-term follow-up.
Excipients: Sucrose Intolerance: This medicinal product contains sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose isomaltose insufficiency should not take this medicine.
Effects on ability to drive and use machines: Methylphenidate can cause dizziness, drowsiness, and visual disturbances including difficulties with accommodation, diplopia, and blurred vision. It may have a moderate influence on the ability to drive and use machines. Patients should be warned of these possible effects and advised that if affected, they should avoid potentially hazardous activities such as driving or operating machinery.
Driving and Using Machines: Methylphenidate may cause dizziness, drowsiness, blurred vision, hallucinations or other CNS side effects (see Adverse Reactions). Patients experiencing such side effects should refrain from driving, operating machinery, or engaging in other potentially hazardous activities.
Use in Children: Pediatric Patients under 6 years of age: Methylphenidate should not be used in children under 6 years of age, since safety and efficacy in this age group have not been established.
