Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2022 Publisher: Janssen-Cilag (New Zealand) Ltd, Auckland, NEW ZEALAND
CONCERTA is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactiveimpulsive or inattentive symptoms that caused impairment and were present before age 7 years.
Need for comprehensive treatment programme: CONCERTA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational and social) for patients with this syndrome. Stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.
Long term use: The effectiveness of CONCERTA for long-term use has not been systematically evaluated in controlled trials. Therefore the physician who elects to use CONCERTA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
CONCERTA is administered orally once daily and should be taken in the morning.
CONCERTA must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed.
CONCERTA may be administered with or without food.
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 section 4.3 Contraindications and section 4.4 Special warnings and precautions for use).
Growth, psychiatric and cardiovascular status should be continuously monitored (see also section 4.4 Special warnings and precautions for use).
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.
Dosage may be adjusted in 9 mg increments between 18 mg and 36mg and consecutively in 18 mg increments to a maximum of 54 mg/day for children aged between 6-12 years and to a maximum of 72 mg/day for adolescents aged between 13-18 years. In general, dosage adjustment may proceed at approximately weekly intervals.
Dosage can be adjusted from an initial dose of 18 or 36 mg/day in 18mg increments to a maximum of 72mg/day taken once daily in the morning. In general, dosage adjustment may proceed at approximately weekly intervals.
Patients respond at different dose levels and CONCERTA must be titrated to effect on an individual patient needs and response basis. A maximum dose of 108 mg/day have been included in clinical trials (see Clinical Trials).
Patients New to Methylphenidate: The recommended starting dose of CONCERTA for patients who are not currently taking methylphenidate, or for patients who are on 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 CONCERTA for patients who are currently taking methylphenidate two or three times daily at doses of 10-60 mg per day is provided in Table 1.
Table 1. Recommended dose conversions from methylphenidate regimens to CONCERTA:
| Previous methylphenidate daily dose | Recommended CONCERTA starting dose |
|---|---|
| 5 mg methylphenidate three times daily | 18 mg every morning |
| 10 mg methylphenidate three times daily | 36 mg every morning |
| 15 mg methylphenidate three times daily | 54 mg every morning |
| 20 mg methylphenidate three times daily | 72 mg every morning |
Clinical judgement should be used when selecting the dose for patients currently taking methylphenidate in other regimens. Daily dosage above 54 mg is not recommended for children aged between 6-12 years. Daily dosage above 72 mg is not recommended for adolescents aged between 13-18 years.
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 onemonth period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or discontinued.
Use of CONCERTA in patients under six years of age has not been studied in controlled trials. CONCERTA should not be used in patients under six years old.
Use of CONCERTA in patients over 65 years of age has not been studied in controlled trials.
CONCERTA must be swallowed whole with the aid of liquids. Tablets should not be chewed, divided or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
The prolonged release of methylphenidate from CONCERTA should be considered when treating patients with overdose.
Signs and symptoms of CONCERTA 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, hallucination (auditory and/or visual), hyperhidrosis, headache, pyrexia, tachycardia, palpitations, heart rate increased, sinus arrhythmia, hypertension, mydriasis, and dry mouth.
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 pyrexia.
Efficacy of peritoneal dialysis or extracorporeal haemodialysis for CONCERTA overdosage has not been established.
18 mg, 36 mg, 54 mg: 3 years.
27 mg: 2 years.
Store below 25°C. Keep container tightly closed.
CONCERTA tablets are supplied in HDPE bottles containing silica gel desiccant.
Pack sizes: 28, 30, 56, 60 and 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
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