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General: Treatment with methylphenidate is not indicated in all cases of ADHD and should be considered only after detailed history taking and evaluation of the patient. The decision to prescribe methylphenidate should depend on the physician's assessment of the chronicity and severity of the symptoms and in paediatric patients, the appropriateness to the child's age. Prescription should not depend solely on the presence of isolated behavioural characteristics. When the symptoms are associated with acute stress reactions, treatment with methylphenidate is usually not indicated.
Sudden death and pre-existing structural cardiac abnormalities or other serious heart problems: It is essential that patients with pre-existing structural cardiac abnormalities or other serious heart problems being considered for treatment are assessed by a cardiologist before initiating treatment. On-going cardiological supervision should be maintained throughout treatment in these patients.
Children and Adolescents: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.
Stimulant products, including methylphenidate, generally should not be used in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may increase the risk of sudden death due to the 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).
Adults: Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs.
Cardiovascular Conditions: Ritalin is contraindicated in patients with severe hypertension. Ritalin 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).
Methylphenidate should be used cautiously in patients with hypertension. 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.
Children, adolescents, or adults who are being considered for treatment with stimulant medicine should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease. Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant 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: 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 Ritalin. Patients with additional risk factors (history of cardiovascular disease, concomitant medicine that elevates blood pressure) should be assessed regularly for neurological/psychiatric signs and symptoms after initiating treatment with Ritalin (see Cardiovascular Conditions as previously mentioned, and Interactions).
Psychiatric Conditions: Ritalin should not be used to treat severe depression or for the prevention or treatment of normal fatigue states. In psychotic patients, administration of methylphenidate may exacerbate symptoms of behaviour disturbance and thought disorder. 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 Ritalin 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. Methylphenidate should not be used as treatment for severe depression of either exogenous or endogenous origin.
In the case of emergent psychiatric symptoms or exacerbation of pre-existing psychiatric symptoms, Ritalin 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 Ritalin (see Adverse Reactions). Physicians should consider treatment discontinuation if psychotic symptoms occur.
Bipolar Illness: 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.
Aggressive behaviour: Ritalin has been causally associated with aggression. Emergent aggressive behaviour or an exacerbation of baseline aggressive behaviour has been reported during stimulant therapy, including Ritalin. 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 and caregivers of patients should be alerted about the need to monitor for clinical worsening, suicidal behaviour or thoughts or unusual changes in behaviour and to seek medical advice immediately if these symptoms appear. The physician should initiate appropriate treatment of the underlying psychiatric condition and consider a possible change in the ADHD treatment regimen.
Motor and verbal tics: CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette's syndrome has also been reported (see Adverse Reactions). Therefore, clinical evaluation for tics in patients should precede use of stimulant medicine. Family history should be assessed and clinical evaluation for tics or Tourette's syndrome in patients should precede use of methylphenidate for ADHD treatment. Ritalin 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.
Serotonin syndrome: Serotonin syndrome has been reported following co-administration of methylphenidate with serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). The concomitant use of methylphenidate and serotonergic drugs is not recommended as this may lead to the development of serotonin syndrome. The symptoms of serotonin syndrome may include mental status changes (e.g. agitation, hallucinations, delirium, and coma), autonomic instability (e.g. tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g. tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Prompt recognition of these symptoms is important so that treatment with methylphenidate and serotonergic drugs can be immediately discontinued and appropriate treatment instituted (see Interactions).
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.
Careful follow up of weight and height in children aged 7 to 10 years who were randomised to either methylphenidate or non-medicine treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medicine treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e. treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.
Published data are inadequate to determine whether chronic use of amphetamines may cause similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
The retardation of growth referred to under Adverse Reactions is usually followed by catch-up growth when the medicine is discontinued. In order to minimise such complications, drug-free periods over weekends, school holidays and long vacations are advocated by some specialists.
Fatigue: Methylphenidate should not be employed for the prevention or treatment of normal fatigue states.
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.
Priapism: Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both paediatric 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 discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
Peripheral Vasculopathy, including Raynaud's Phenomenon: Stimulants, including Ritalin and Ritalin LA, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, have been observed in postmarketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g. rheumatology referral) may be appropriate for certain patients.
Drug abuse and dependence: Caution is called for in emotionally unstable patients, such as those with a history of drug or alcohol dependence, because they may increase the dosage on their own initiative. Chronic abuse can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. Frank psychotic episodes may occur, especially in response to parenteral abuse.
Clinical data indicate that children given Ritalin are not more likely to abuse drugs as adolescents or adults. Methylphenidate abuse or dependence does not appear to be a problem in adolescents or adults who were treated with methylphenidate for ADHD as children.
Use with alcohol: Alcohol may exacerbate the CNS adverse reactions of psychoactive drugs, including methylphenidate. Therefore, it is advisable for patients to abstain from alcohol during treatment.
Withdrawal: Careful supervision is required during drug withdrawal, since this may unmask depression as well as the effects of chronic over-activity. Some patients may require long-term follow-up.
Haematological effects: Data on safety and efficacy of long-term use of methylphenidate are not complete. Patients requiring long-term therapy should be carefully monitored and periodic complete blood counts, differential and platelet counts are advisable during prolonged therapy. In the event of haematological disorders appropriate medical intervention should be considered (see Adverse Reactions).
Effects on laboratory tests: Methylphenidate may induce false positive laboratory tests for amphetamines, particularly with immunoassays screen test.
Effects on Ability to Drive or Operate Machinery: Ritalin 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: Methylphenidate should not be used in children under 6 years of age, since safety and efficacy in this age group have not been established. Medicines should be kept out of the reach of children.
