Ritalin LA

Ritalin LA Special Precautions





Full Prescribing Info
Special Precautions
General: Treatment with Ritalin 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 Ritalin 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 behavioral characteristics. Where these symptoms are associated with acute stress reactions, treatment with Ritalin 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 Ritalin, 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 Ritalin 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: 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).
Blood pressure should be monitored at appropriate intervals in all patients taking Ritalin, especially those with hypertension. Patients who develop symptoms suggestive of cardiac disease during Ritalin treatment should undergo a prompt cardiac evaluation.
Misuse and Cardiovascular Events: Misuse of stimulants of the central nervous system, including Ritalin, 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 medications that elevate blood pressure) should be assessed regularly for neurological/psychiatric signs and symptoms after initiating treatment with Ritalin (see previously mentioned 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 Ritalin, 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.
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.
Aggressive behavior: Emergent aggressive behavior or an exacerbation of baseline aggressive behavior has been reported during stimulant therapy, including Ritalin. Physicians should evaluate the need for adjustment of treatment regimen in patients experiencing these behavioral 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 behavior or thoughts or unusual changes in behavior and to seek medical advice immediately if these symptoms appear. The physician should initiate appropriate treatment of any underlying psychiatric condition and consider a possible discontinuation or change in the ADHD treatment.
Tics: Ritalin 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 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 Ritalin.
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, diarrhea). 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).
Priapism: Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism generally developed after some time on the drug, often subsequent to an increase in dose. Priapism has also been reported 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.
Growth retardation: Moderately reduced weight gain and slight growth retardation have been reported with the long-term use of stimulants, including Ritalin, in children (see ADVERSE REACTIONS). Growth should be monitored as clinically necessary during treatment with Ritalin, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
Seizures: Ritalin 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, Ritalin should be discontinued.
Drug abuse and dependence: Chronic abuse of Ritalin can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes may occur, especially with parenteral abuse. Clinical data indicate that children given Ritalin 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 Ritalin 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 hematological disorders appropriate medical intervention should be considered (see ADVERSE REACTIONS).
Driving and using machines: 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: Pediatric patients under 6 years of age: Ritalin should not be used in children under 6 years of age, since safety and efficacy in this age group have not been established.
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