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MEDIKINET is a brand name for Methylphenidate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Attention-Deficit/Hyperactivity Disorder (ADHD) Methylphenidate is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when remedial measures alone prove insufficient. Treatment must be initiated under the supervision of…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Treatment must be initiated under the supervision of a specialist in childhood and/or adolescent behavioural disorders.
Pre-treatment screening:
Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient’s cardiovascular status including blood pressure and heart rate. 4). 4). • Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months; • Height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart; • Development of de novo or worsening of pre-existing psychiatric disorders should be monitored at every adjustment of dose and then least every 6 months and at every visit.
Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate. Dose titration Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started at the lowest possible dose.
The effect occurs within an hour after ingestion if the dose is sufficiently high. g. at breakfast and lunch), increasing if necessary by weekly increments of 5-10 mg in the daily dose according to tolerability and degree of efficacy observed.
Doses above 60 mg daily are not recommended. The total daily dose should be administered in divided doses (usually 2-3). For doses not realisable/practicable with this strength, other strengths of this medicinal product and other methylphenidate containing products are available.
In the treatment of hyperkinetic disorders/ADHD, the times at which the doses of Methylphenidate Hydrochloride Tablets are administered should be selected to provide the best effect when it is most needed to combat school and social behavioural difficulties.
The last doses should, in general, not be given within 4 hours before bedtime in order to prevent disturbances in falling asleep. However, if the effect of the medicinal product wears off too early in the evening, disturbed behaviour may recur.
A small evening dose (5 mg) may help to solve this problem. The pros and cons of a small evening dose versus disturbances in falling asleep should be considered. The maximum daily dose of methylphenidate hydrochloride is 60 mg. Long-term (more than 12 months) use in children and adolescents The safety and efficacy of long term use of methylphenidate has not been systematically evaluated in controlled trials.
The list below shows all adverse drug reactions (ADRs) observed during clinical trials and post-market spontaneous reports with Methylphenidate Hydrochloride Tablets and those, which have been reported with other methylphenidate hydrochloride formulations.
If the ADRs with Methylphenidate Hydrochloride Tablets and the methylphenidate formulation frequencies were different, the highest frequency of both databases was used. The list is based on data for children, adolescents and adults.
Frequency estimate: very common (≥ 1/10) common (≥ 1/100 to < 1/10) uncommon (≥ 1/1,000 to <1/100) rare (≥ 1/10,000 to <1/1,000) very rare (<1/10,000) not known (cannot be estimated from the available data). Infections and infestations Common: nasopharyngitis Uncommon: gastroenteritis Blood and lymphatic system disorders Very rare: leukopenia, thrombocytopenia, anaemia, thrombocytopenic purpura Not known: pancytopenia Immune system disorders Uncommon: hypersensitivity reactions such as angioneurotic oedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticaria, pruritus*, rashes and eruptions* Metabolism and nutrition disorders* Very common: decreased appetite** Common: anorexia, moderate reduction in weight and height gain during prolonged use in children* Psychiatric disorders* Very common: insomnia, nervousness Common: abnormal behaviour, aggression*, affect lability, agitation*, anorexia, anxiety*, depression*, irritability, restlessness**, sleep disorder**, libido decrease***, panic attack***, stress***, bruxism∞ Uncommon: hypervigilance, auditory, visual and tactile hallucinations*, anger, suicidal ideation*, mood altered, mood swings, anger, suicidal ideation, tearfulness, psychotic disorders*, tics* or worsening of pre-existing tics of Tourette’s syndrome*, tension*** Rare: mania*, disorientation, libido disorder, obsessive-compulsive disorder (including trichotillomania and dermatillomania) Very rare: suicidal attempt (including completed suicide)*, transient depressed mood*, abnormal thinking, apathy Not known: delusions*, thought disturbances*, confusional state, dependence, logorrhoea Cases of abuse and dependence have been described, more often with immediate- release formulations (frequency not known).
Methylphenidate treatment is not indicated in all children with ADHD and the decision to use the medicinal product must be based on a very thorough assessment of the severity and chronicity of the child’s symptoms in relation to the child’s age (6 – 18 years).
Long-term use (more than 12 months) in children and adolescents The safety and efficacy of long term use of methylphenidate has not been systematically evaluated in controlled trials. Methylphenidate treatment should not and need not, be indefinite.
Methylphenidate treatment is usually discontinued during or after puberty. e. 4 for cardiovascular status, growth, appetite, development of de novo or worsening of pre- existing psychiatric disorders. Psychiatric disorders to monitor for are described below, and 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.
The physician who elects to use methylphenidate for extended periods (over 12 months) in children and adolescents with ADHD should periodically re-evaluate the long term usefulness of the medicinal product for the individual patient with trial periods off medication to assess the patient’s functioning without pharmacotherapy.
It is recommended that methylphenidate 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.
Use in adults Methylphenidate is not licensed for use in adults with ADHD. Safety and efficacy have not been established in this age group. Use in the elderly Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group.
Use in children under 6 years of age Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established. Cardiovascular status Patients who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden cardiac or unexplained death or malignant arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further specialist cardiac evaluation if initial findings suggest such history or disease.
5) • 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 channels) • pre-existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities including vasculitis or stroke
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Methylphenidate treatment should not and need not, be indefinite. Methylphenidate treatment is usually discontinued during or after puberty. The physician who elects to use methylphenidate for extended periods (over 12 months) in children and adolescents with ADHD should periodically re-evaluate the long term usefulness of the medicinal product for the individual patient with trial periods off medication to assess the patient’s functioning without pharmacotherapy.
It is recommended that methylphenidate is de-challenged at least once yearly to assess the child’s condition (preferable during times of school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued.
Dose reduction and discontinuation Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a one-month period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or discontinued.
Adults Methylphenidate is not licensed for use in adults with ADHD. Safety and efficacy have not been established in this age group. Elderly Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group.
Children under 6 years of age Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established. Hepatic impairment Methylphenidate has not been studied in patients with hepatic impairment.
Caution should be exercised in these patients. Renal impairment Methylphenidate has not been studied in patients with renal impairment. Caution should be exercised in these patients. Method of administration Oral use. The tablets should be swallowed whole or divided into halves with the aid of liquids, either with meals or after meals.
The effect of food on the absorption of methylphenidate from Methylphenidate Hydrochloride Tablets has not been studied; therefore, a possible effect of food on absorption cannot be excluded. e. that doses should be given at same times, relative to the time of meals, on each day, preferably with or immediately after meals.
Nervous system disorders Very common: headache Common: tremor**, somnolence, dizziness, dyskinesia, psychomotor hyperactivity, Uncommon: sedation, akathisia*** Very rare: convulsions, choreo-athetoid movements, reversible ischaemic neurological deficit.
4 **ADRs from clinical trials in adult patients that were reported at a higher frequency than in children and adolescents ***Based on the frequency calculated in adult ADHD studies (no cases were reported in the paediatric studies) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard
Patients who develop symptoms such as palpitations, exceptional chest pain, unexplained syncope, dyspnoea or other symptoms suggestive of cardiac disease during methylphenidate treatment should undergo a prompt specialist cardiac evaluation.
Analyses of data from clinical trials of methylphenidate in children and adolescents with ADHD showed that patients using methylphenidate may commonly experience changes in diastolic and systolic blood pressure of over 10 mmHg relative to controls.
The short- and long-term clinical consequences of these cardiovascular effects in children and adolescents are not known, but the possibility of clinical complications cannot be excluded as a result of the effects observed in the clinical trial data.
Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate. 3 for conditions in which methylphenidate treatment is contraindicated. Cardiovascular status should be carefully monitored.
Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months. 3). Sudden death and pre-existing cardiac structural abnormalities or other serious cardiac disorders Sudden death has been reported in association with the use of stimulants of the central nervous system at usual doses in children, some of whom had cardiac structural abnormalities or other serious heart problems.
Although some serious heart problems alone may carry an increased risk of sudden death, stimulant products are not recommended in children or adolescents with known cardiac structural abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medicine.
Misuse and cardiovascular events Misuse of stimulants of the central nervous system may be associated with sudden death and other serious cardiovascular adverse events. 3 for cerebrovascular conditions in which methylphenidate treatment is contraindicated.
Patients with additional risk factors (such as a history of cardiovascular disease, concomitant medications that elevate blood pressure) should be assessed at every visit for neurological signs and symptoms after initiating treatment with methylphenidate.
Cerebral vasculitis appears to be a very rare idiosyncratic reaction to methylphenidate exposure. 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 methylphenidate and early treatment. The diagnosis should therefore be considered in any patient who develops new neurological symptoms that are consistent with cerebral ischemia during methylphenidate therapy.
These symptoms could include severe headache, numbness, weakness, paralysis, and impairment of coordination, vision, speech, language or memory. Treatment with methylphenidate is not contraindicated in patients with hemiplegic cerebral palsy.
Priapism Prolonged and […]