Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Shire Pharmaceuticals Ireland Limited, Block 2 & 3, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland
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 under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10 and should be based on a complete history or evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptom.
The specific aetiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and specialised psychological, educational, and social resources.
A comprehensive treatment programme typically includes psychological, educational and social measures as well as pharmacotherapy and is aimed at stabilising children with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal EEG. Learning may or may not be impaired.
Methylphenidate treatment is not indicated in all children with this syndrome and the decision to use the drug 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.
Appropriate educational placement is essential, and psychosocial intervention is generally necessary. Where remedial measures alone prove insufficient, the decision to prescribe a stimulant must be based on rigorous assessment of the severity of the child’s symptoms. The use of methylphenidate should always be used in this way according to the licensed indication and according to prescribing/diagnostic guidelines.
Equasym XL consists of an immediate release component (30% of the dose) and a modified release component (70% of the dose). Hence Equasym XL 10 mg yields an immediate-release dose of 3 mg and an extended release dose of 7 mg methylphenidate hydrochloride. The extended-release portion of each dose is designed to maintain a treatment response through the afternoon without the need for a midday dose. It is designed to deliver therapeutic plasma levels for a period of approximately 8 hours, which is consistent with the school day rather than the whole day (see section 5.2 “Pharmacokinetic properties”). For example, 20 mg of Equasym XL is intended to take the place of 10 mg at breakfast and 10 mg at lunchtime of immediate release methylphenidate hydrochloride.
Treatment must be initiated under the supervision of a specialist in childhood and/or adolescent behavioural disorders.
Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient’s cardiovascular status including blood pressure and heart rate. A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death and accurate recording of pre-treatment height and weight on a growth chart (see sections 4.3 and 4.4)
Growth, psychiatric and cardiovascular status should be continuously monitored (see also Section 4.4).
Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate.
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. The recommended starting daily dose is 5 mg once daily or twice daily (e.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. Equasym 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.
The maximum daily dose of methylphenidate hydrochloride is 60 mg.
For doses not realisable/practicable with this strength, other strengths of this medicinal product and other methylphenidate containing products are available.
Patients Currently Using Methylphenidate: Patients established on an immediate release methylphenidate hydrochloride formulation may be switched to the milligram equivalent daily dose of Equasym XL.
Equasym XL should not be taken too late in the morning as it may cause disturbances in sleep. If the effect of the medicinal product wears off too early in the late afternoon or evening, disturbed behaviour and/or inability to go to sleep may recur. A small dose 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 Equasym 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.
Equasym XL should be given in the morning before breakfast.
The capsules may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened, and the capsule contents sprinkled onto a small amount (tablespoon) of apple sauce and given immediately, and not stored for future use. Drinking some fluids, e.g. water, should follow the intake of the sprinkles with apple sauce. The capsules and the capsule contents must not be crushed or chewed.
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. 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 drug 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 drug is either temporarily or permanently discontinued.
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.
Methylphenidate is not licensed for use in adults in ADHD. Safety and efficacy have not been established in this age group.
Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group.
Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.
When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from formulations with extended durations of action.
Acute overdose, mainly due to overstimulation of the central and sympathetic nervous systems, may result in vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, psychosis, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis and dryness of mucous membranes.
There is no specific antidote to methylphenidate overdosage.
Treatment consists of appropriate supportive measures.
The patient must be protected against self injury and against external stimuli that would aggravate overstimulation already present. If the signs and symptoms are not too severe and the patient is conscious, gastric contents may be evacuated by induction of vomiting or gastric lavage. 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. In the presence of severe intoxication, a carefully titrated dose of a benzodiazepine should be given before performing gastric lavage.
Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Efficacy of peritoneal dialysis or extracorporeal haemodialysis for overdose of methylphenidate has not been established.
3 years.
Store below 25°C.
Clear or opaque PVC/Aclar blister with aluminum foil backing and vinyl seal coating.
Pack sizes:
10 modified-release capsules, hard.
28 modified-release capsules, hard.
30 modified-release capsules, hard.
60 modified-release capsules, hard.
100 modified-release capsules, hard (10 mg and 20 mg capsules only).
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
