Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Delmosart 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 and 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.
Delmosart 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.
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.
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.
Dose titration
Careful dose titration is necessary at the start of treatment with Delmosart. Dose titration should be started at the lowest possible dose. A 27 mg dosage strength is available for those who wish to prescribe between the 18 mg and 36 mg dosages.
For doses not realisable/practicable with this medicinal product, other strengths and medicinal products are available.
Dosage may be adjusted in 18 mg increments In general, dosage adjustment may proceed at approximately weekly intervals.
The maximum daily dosage of Delmosart is 54 mg.
Patients New to Methylphenidate: Clinical experience with Delmosart is limited in these patients (see section 5.1). Delmosart may not be indicated in all children with ADHD syndrome. Lower doses of short-acting methylphenidate formulations may be considered sufficient to treat patients new to methylphenidate. Careful dose titration by the physician in charge is required in order to avoid unnecessarily high doses of methylphenidate. The recommended starting dose of Delmosart for patients who are not currently taking methylphenidate, or for patients who are on stimulants other than methylphenidate, is 18 mg once daily.
Patients Currently Using Methylphenidate: The recommended dose of Delmosart for patients who are currently taking methylphenidate three times daily at doses of 15 to 45 mg/day is provided in Table 1. Dosing recommendations are based on current dose regimen and clinical judgement.
TABLE 1. Recommended Dose Conversion from Other Methylphenidate Hydrochloride Regimens, where available, to Delmosart:
| Previous Methylphenidate Hydrochloride Daily Dose | Recommended Dose |
|---|---|
| 5 mg Methylphenidate three times daily | 18 mg once daily |
| 10 mg Methylphenidate three times daily | 36 mg once daily |
| 15 mg Methylphenidate three times daily | 54 mg once daily |
If improvement is not observed after appropriate dosage adjustment over a one-month period, the medicinal product should be discontinued.
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 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.
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.
In adolescents whose symptoms persist into adulthood and who have shown clear benefit from treatment, it may be appropriate to continue treatment into adulthood. However, start of treatment with Delmosart in adults is not appropriate (see sections 4.4 and 5.1).
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.
Oral use.
Delmosart must be swallowed whole with the aid of liquids, and must not be chewed, broken divided, or crushed (see section 4.4).
Delmosart may be administered with or without food (see section 5.2).
Delmosart is taken once daily in the morning.
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, 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. The efficacy of activated charcoal has not been established.
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.
24 months.
Shelf life after first opening the bottle: 3 months.
This medicinal product does not require any special storage conditions.
HDPE bottle with a child-resistant PP closure with silica gel desiccant integrated into the closure.
18 mg tablets: 28, 30 or 90 prolonged-release tablets.
Not all pack sizes may be marketed.
No special requirements.
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