Presentation and Status in Health Basket
30 X 18 mg
30 X 27 mg
30 X 36 mg
30 X 54 mg
Patients New to Methylphenidate: The recommended starting dose of this product for patients who are not currently taking methylphenidate or 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 this product for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 to 60 mg/day is provided in prescribing information. Dosing recommendations are based on current dose regimen and clinical judgment. Conversion dosage above 72 mg daily is not recomended.
For full details see prescribing information.
Treatment of attention deficit hyperactivity disorder (ADHD).
Hypersensitivity to Methylphenidate Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with this product. Therefore, it is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product.
Agitation: This product is contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms.
Glaucoma: This product is contraindicated in patients with glaucoma.
Tics: This product is contraindicated in patients with motor tics or with a family history ordiagnosis of Tourette’s syndrome
Monoamine Oxidase Inhibitors: This product is contraindicated during treatment with monoamine oxidase (MAO) inhibitors, and also within a minimum of 14 days following discontinuation of a MAO inhibitor (hypertensive crises may result).
Phaeochromocytoma Hyperthyroidism or Thyrotoxicosis: Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder 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, arrhythmias and channelopathies (disorders caused by the dysfunction of ion chan Pre-existing cerebrovascular disorders cerebral aneurysm, vascular nels).
abnormalities: including vasculitis or stroke.
For full details see prescribing information.
Should not be used in patients under six years old. CNS stimulants have been associated with the onset or exacerbation of motor and verbal tics. May cause suppression of growth, therefore patients requiring long-term therapy should be carefully monitored. Patients who are not growing or gaining weight as expected should have their treatment interrupted. Must be swallowed whole with the aid of liquids. Preexisting severe gastrointestinal narrowing, dysphagia or significant difficulty in swallowing tablets. Should not be used to treat severe depression and/or for the prevention or treatment of normal fatigue states. Psychotic patients. Patients whose underlying medicdbal conditions might be compromised by increases in blood pressure or heart rate. History of drug dependence or alcoholism. Periodic hematologic monitoring is advised during prolonged therapy.
Pregnancy and lactation: Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised if administered to a nursing woman. It is advisable to exercise caution when driving, operating machinery or engaging other potentially hazardous activities.
The following are discussed in more detail in other sections of the labeling: Drug Dependence. Hypersensitivity to Methylphenidate. Agitation. Glaucoma. Tics. Monoamine Oxidase Inhibitors. Serious Cardiovascular Events. Psychiatric Adverse Events. Seizures. Long-Term Suppression of Growth. Visual Disturbance. Potential for Gastrointestinal Obstruction. Hematologic Monitoring. The most common adverse reaction in double-blind clinical trials (>5%) in pediatric patients (children and adolescents) was abdominal pain upper. The most common adverse reactions in double-blind clinical trials (>5%) in adult patients were decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, and hyperhidrosis. The most common adverse reactions associated with discontinuation (≥1%) from either pediatric or adult clinical trials were anxiety, irritability, insomnia, and blood pressure increased. The development program for this product included exposures in a total of 3906 participants in clinical trials. Children, adolescents, and adults with ADHD were evaluated in 6 controlled clinical studies and 11 open-label clinical studies. Safety was assessed by collecting adverse events, vital signs, weights, and ECGs, and by performing physical examinations and laboratory analyses.
For full details see prescribing information.
MAO Inhibitors: This product should not be used in patients being treated (currently or within the preceding 2 weeks) with MAO inhibitors
Vasopressor Agents: Because of possible increases in blood pressure, this product should be used cautiously with vasopressor agents.
Coumarin Anticoagulants, Antidepressants, and Selective Serotonin Reuptake Inhibitors: Human pharmacologic studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), and some antidepressants (tricyclics and selective serotonin reuptake inhibitors). Downward dose adjustment of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing concomitant methylphenidate.
Use with alcohol: Alcohol may exacerbate the adverse CNS effect of psychoactive drugs, including methylphenidate. It is therefore advisable for patients to abstain from alcohol during treatment.
Use with halogenated anaesthetics: There is a risk of sudden blood pressure increase during surgery. If surgery is planned methylphenidate treatment should not be used on the day of surgery.
Use with centrally acting alpha-2 agonists (e.g. clonidine): Serious adverse events, including sudden death, have been reported in concomitant use with clonidine. The safety of using methylphenidate in combination with clonidine or other centrally acting alpha-2 agonists has not been systematically evaluated.
Use with domapinergic drugs: Caution is recommended when administering methylphenidate with dopaminergic drugs, including antipsychotics. Because a predominant action of methylphenidate is to increase extracelluar dopamine levels, methylphenidate may be associated with pharmacodynamic interactions when co-administered with direct and indirect dopamine agonists (including DOPA and tricyclic antidepressants) or with dopamine antagonists including antipsychotics.
Pregnancy and Lactation
Pregnancy: Pregnancy Category C, Methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m² basis, respectively. A reproduction study in rats revealed no evidence of harm to the fetus at oral doses up to 30 mg/kg/day, approximately 15-fold and 3-fold the maximum recommended human dose on a mg/kg and mg/m² basis, respectively. The approximate plasma exposure to methylphenidate plus its main metabolite PPAA in pregnant rats was 1-2 times that seen in trials in volunteers and patients with the maximum recommended dose based on the AUC. The safety of methylphenidate for use during human pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women. this product should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery: The effect of this product on labor and delivery in humans is unknown.
Nursing Mothers: It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if this product is administered to a nursing woman. In lactating female rats treated with a single oral dose of 5 mg/kg radiolabeled methylphenidate, radioactivity (representing methylphenidate and/or its metabolites) was observed in milk and levels were generally similar to those in plasma.
Pediatric Use: This product should not be used in children under six years, since safety and efficacy in this age group have not been established. Long-term effects of methylphenidate in children have not been well established.
Signs and Symptoms: Signs and symptoms of this product overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: vomiting, agitation, muscle twitching, convulsion, grand mal convulsion, confusional state, hallucinations (auditory and/or visual), hyperhidrosis, headache, pyrexia, tachycardia, palpitations, heart rate increased, sinus arrhythmia, hypertension, mydriasis, and dry mouth.
Recommended Treatment: Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage as indicated. Before performing gastric lavage, control agitation and seizures if present and protect the airway. Other measures to detoxify the gut include administration of activated charcoal and a cathartic. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for pyrexia. Efficacy of peritoneal dialysis or extracorporeal hemodialysis for this product overdosage has not been established. The prolonged release of methylphenidate from this product should be considered when treating patients with overdose.
Poison Control Center: As with the management of all overdose, the possibility of multiple-drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of overdose with methylphenidate.