Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Pharma Dynamics (Pty) Ltd, 1<sup>st</sup> Floor, Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa
RADD is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children 6 to 17 years of age and in adults aged 18 to 65 who meet DSM-IV criteria for ADHD.
Dosage should be individualised according to the need and response of each individual patient.
The recommended starting dose of RADD 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.
The recommended dose of RADD for patients who are currently taking methylphenidate three times daily at doses of 15 to 60 mg/day is provided in the table below. Dosing recommendations are based on current dose regimen and clinical judgement.
| Previous Methylphenidate Daily Dose | Recommended RADD Dose |
|---|---|
| 5 mg Methylphenidate hydrochloride twice or three times daily | 18 mg once daily |
| 10 mg Methylphenidate hydrochloride twice or three times daily | 36 mg once daily |
| 15 mg Methylphenidate hydrochloride twice or three times daily | 54 mg once daily |
| 20 mg Methylphenidate hydrochloride twice or three times daily | 72 mg once daily |
Clinical judgement should be used when selecting the dose for patients currently taking methylphenidate (as contained in RADD) in other regimens.
Dosage may be adjusted 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 for adolescents aged between 13–18 years and 108 mg in adults. In general, dosage adjustment may proceed at approximately weekly intervals.
Daily dosage above 54 mg is not recommended in children between 6–12 years. Daily dosage above 72 mg is not recommended in adolescents aged 13–18 years. Daily dosage above 108 mg is not recommended in adults.
The long-term use of RADD has not been systematically evaluated. The medical practitioner who elects to use RADD for extended periods (over 12 months) in patients with ADHD should periodically re-evaluate the long-term use usefulness of RADD for the individual patient with trials off-treatment to assess the patient’s functioning without pharmacotherapy.
If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or, if necessary, RADD should be discontinued.
Use of RADD in patients over 65 years has not been established.
RADD should not be used in children under the age of 6 years
RADD is administered orally, once daily. As the effects has been shown to be present 12 hours after dosing, RADD should be taken in the morning.
RADD must be swallowed whole with adequate liquid and must not be chewed, divided or crushed.
RADD may be administered with or without food.
Signs and symptoms of RADD, in an overdosage, result principally from overstimulation of the CNS and excessive sympathomimetic stimulations. They include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions, coma, grand mal convulsion, euphoria, confusional state, confusion, hallucinations (auditory and/or visual), hyperhidrosis, delirium, flushing, headache, pyrexia, tachycardia, palpitations, heart rate increased, sinus dysrhythmias, hypertension, mydriasis, and dry mouth
Treatment consists of appropriate supportive measures and symptomatic treatment of lifethreatening events e.g. hypertensive crisis, cardiac dysrhythmias, convulsions. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. For the most current guidance for treatment of symptoms of overdose, the practitioner should consult a certified Poison Control Centre or current toxicological publication.
If the patient is conscious, administration of activated charcoal and a laxative is recommended. In the presence of severe intoxication, a carefully titrated dose of benzodiazepine should be given.
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 RADD has not been established.
The prolonged release of methylphenidate from RADD should be considered when treating patients with overdose.
24 months.
Store at or below 25°C.
Keep the container tightly closed.
RADD tablets are packed into white, round HDPE bottles with round, white plastic childresistant screw cap with three break-points, ring and integrated desiccant. Bottles, containing 30 tablets are packed into printed outer cartons.
No special 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.
