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AMBINET XL 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) Ambinet XL is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children aged and over 6 years of age and adults when remedial measures alone prove insufficient. Treatment must be initiated and supervised by a…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Treatment must be initiated and supervised by a doctor specialised in the treatment of ADHD such as an expert paediatrician, a child and adolescent psychiatrist or an adult psychiatrist. Pre-treatment screening If required by national practice, in adults new to Ambinet XL, a cardiologist advice is needed prior to treatment initiation in order to check the absence of cardiovascular contraindications.
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 in children should be recorded at least 6 monthly with maintenance of a growth chart; - weight should be recorded for adults regularly; - development of de novo or worsening of pre-existing psychiatric disorders should be monitored at every adjustment of dose and then at least every 6 months and at every visit.
Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate. Dose titration General aspects - The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.
The effect occurs within an hour after ingestion if the dose is sufficiently high. - Children should not take Ambinet XL too late in the morning as it may cause disturbances in sleep. - For doses not realisable/practicable with this strength, other strengths of this medicinal product and other methylphenidate-containing products are available.
Children Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started at the lowest possible dose. This is normally achieved using an immediate-release formulation taken in divided doses.
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. Ambinet XL 10 mg once daily may be used in place of immediate-release methylphenidate hydrochloride 5 mg twice daily from the beginning of treatment where the treating physician considers that twice daily dosing is appropriate from the outset and twice daily treatment administration is impracticable.
Ambinet XL consists of an immediate-release component (50% of the dose) and a modified-release component (50% of the dose). Hence Ambinet XL 10 mg yields an immediate-release dose of 5 mg and an extended-release dose of 5 mg methylphenidate hydrochloride.
The table below shows all adverse drug reactions (ADRs) observed during clinical trials and post-market spontaneous reports with Ambinet XL and those, which have been reported with other methylphenidate hydrochloride formulations. If the ADRs with Ambinet XL and the methylphenidate formulation frequencies were different, the highest frequency of both databases was used.
The table 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 Affect lability, aggression*, agitation*, anorexia, anxiety*, depression*, irritability, abnormal behaviour, restlessness**, sleep disorder**, libido decrease***, bruxism***, panic attack***, stress*** Uncommon Hypervigilance, auditory, visual and tactile hallucinations*, anger, suicidal ideation*, mood changes, mood swings, 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.
Methylphenidate treatment is not indicated in all patients 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 patient's symptoms. When treatment of children is considered, assessment of the severity and chronicity of the child's symptoms should be related to the child's age (6 - 18 years).
Long-term use (more than 12 months) The safety and efficacy of long-term use of methylphenidate has not been systematically evaluated in controlled trials. Methylphenidate treatment should not and need note, be indefinite. e. 4 for cardiovascular status, growth (children), weight, 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) 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 patient’s condition (for children preferably during times of school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued.
Use in the elderly Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in patients older than 60 years of age. 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.
1. 5, in therapy with H2-receptor blockers, proton pump inhibitors or in antacid therapy
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The extended-release portion of each dose is designed to maintain a treatment response through the afternoon without the need for a midday dose. 2). For example, 20 mg of Ambinet XL is intended to take the place of 10 mg at breakfast and 10 mg at lunchtime of immediate-release methylphenidate hydrochloride.
Patients currently established on an immediate-release methylphenidate hydrochloride formulation may be switched to the milligram equivalent daily dose of Ambinet XL. If the effect of the medicinal product wears off too early in the evening, disturbed behaviour may recur.
A small dose (5 mg) of an immediate-release methylphenidate hydrochloride tablet late in the day may help to solve this problem. In that case, it could be considered that adequate symptom control might be achieved with a twice daily immediate-release methylphenidate regimen.
The pros and cons of a small evening dose of immediate-release methylphenidate versus disturbances in falling asleep should be considered. Treatment should not continue with Ambinet XL if an additional late dose of immediate-release methylphenidate is required, unless it is known that the same extra dose was also required for a conventional immediate-release regimen at equivalent breakfast/lunchtime dose.
The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed. The maximum daily dose of methylphenidate hydrochloride in children is 60 mg. Adults Continuation of methylphenidate therapy Adult patients who have shown clear benefit from treatment with Ambinet XL in childhood and/or adolescence may continue treatment with Ambinet XL into adulthood, initially at the same daily dose (mg/day).
Whether or not a dose adjustment depending on efficacy and tolerability is necessary or possible must be reviewed regularly. Adults new to Ambinet XL Any treatment with methylphenidate requires individual dose titration against efficacy and tolerability because individual response may vary substantially.
Initiation of treatment in adults who are new to Ambinet XL therefore requires careful dose titration. Dose titration should be started at the lowest possible dose. The recommended starting dose is 10 mg daily, which may be increased if necessary by weekly increments of 10 mg in the daily dose according to tolerability and degree of efficacy observed.
The total daily dose should be given in two divided doses in the morning and at midday. The aim of individual titration should be to find the lowest daily dose that achieves satisfactory symptom control. Compared to children and adolescents, adult patients may require a higher daily dose, based on the patient's body weight.
The maximum daily dose is based on the patient's body weight and must not […]
4. ** ADRs from clinical trials in adult patients that were reported with 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) $ Frequency derived from adult clinical trials and not on data from trials in children and adolescents; may also be relevant for children and adolescents Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows […]
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.
Changes in diastolic and systolic blood pressure values were also observed in clinical trial data from adult ADHD patients. 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. Methylphenidate should be discontinued in patients under treatment with repeated measures of tachycardia, arrhythmia or increased systolic blood pressure (> 95th percentile) and referral to a cardiologist should be considered.
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 patients 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.
Adults Sudden deaths, 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 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. 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 […]