Posology : מינונים

4.2. Posology and method of administration

Dosage regimen
The dosage of Ritalin should be individualised according to the patient's clinical needs and responses.
In the treatment of ADHD, an attempt should be made to time administration to coincide with the periods of greatest academic, behavioural, or social stress.
Ritalin should be started at a low dose, with increments at weekly intervals. Daily doses above 60 mg are not recommended for the treatment of narcolepsy, or for the treatment of ADHD in children.
Daily doses above 80 mg are not recommended for the treatment of ADHD in adults.
If symptoms do not improve after dose titration over a period of one month, the drug should be discontinued.
If symptoms worsen or other adverse effects occur, the dosage should be reduced or, if necessary, the drug discontinued.
If the effect of the drug wears off too early in the evening, disturbed behaviour and/or inability to go to sleep may recur. A small evening dose of Ritalin may help to solve this problem.

Special populations
Renal impairment
No studies have been performed in renally impaired patients (see section 5.2 Pharmacokinetic properties).
Hepatic impairment
No studies have been performed in hepatically impaired patients (see section 5.2 Pharmacokinetic properties).
Geriatric patients
No studies have been performed in patients over 60 years of age (see section 5.2 Pharmacokinetic properties).

Pre-treatment screening
Before initiating Ritalin treatment, patients should be assessed for pre-existing cardiovascular RIT API 11APR24 V14           Page 3 of 23           reference: New Zealand Data Sheet Jan.2024 and psychiatric disorders and a family history of sudden death, ventricular arrhythmia and psychiatric disorders. Weight and height should also be measured before treatment and documented on a growth chart (see section 4.3 Contraindications and section 4.4 Special warnings and precautions for use).

Periodic assessment of the treatment in ADHD
Drug treatment does not need to be indefinite. Physicians should periodically re-evaluate the treatment with trial periods off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
When used in children with ADHD, treatment can usually be discontinued during or after puberty.

Target population

ADHD
Children (6 years and over) and adolescents
Ritalin Tablets:
Start with 5 mg once or twice daily (e.g. at breakfast and lunch) with weekly increments of 5 to 10 mg. The total daily dosage should be administered in divided doses.


Ritalin LA Capsules:
Ritalin LA (methylphenidate hydrochloride modified-release capsules) is for oral administration once daily in the morning. The recommended starting dose of Ritalin LA is 20 mg. When in the judgement of the clinician a lower initial dose is appropriate, patients may begin treatment with Ritalin LA 10 mg.
A maximum daily dose of 60 mg should not be exceeded.

Adults
Ritalin LA Capsules:
Ritalin LA is administered as a single dose once daily. Ritalin LA provides comparable overall exposure (AUC) of methylphenidate compared to the same total dose of Ritalin tablets administered twice daily.
Patients new to methylphenidate:
(See 5.2 Pharmacokinetic properties) The recommended starting dose of Ritalin LA in patients who are not currently taking methylphenidate is 20 mg once daily.
Patients currently using methylphenidate:
Treatment may be continued with the same daily dose.
A maximum daily dose of 80 mg should not be exceeded.
There is no difference in dosing recommended between male and female adult patients (see 5.1 Pharmacodynamic properties).



RIT API 11APR24 V14           Page 4 of 23           reference: New Zealand Data Sheet Jan.2024 Switching patients from Ritalin tablets to Ritalin LA capsules
The recommended dose of Ritalin LA should be equal to the total daily dose of the immediate release formulation not exceeding a total dose of 60 mg in children and 80 mg in adults.
Examples involving switch from the immediate-release formulation are provided in Table 1.

Table 1 Recommended daily dose when switching patients to Ritalin LA
Previous methylphenidate dose                      Recommended Ritalin LA dose 5mg methylphenidate twice daily                        10 mg once daily 
10 mg methylphenidate twice daily                      20 mg once daily 
15 mg methylphenidate twice daily                      30 mg once daily 
20 mg methylphenidate twice daily                      40 mg once daily

For other methylphenidate regimens, clinical judgement should be used when selecting the starting dose. Ritalin LA dosage may be adjusted at weekly intervals in 10 mg increments for children or in 20 mg increments for adults.

Narcolepsy
Only the Ritalin tablets formulation is approved in the treatment of narcolepsy in adults.

Adults
Ritalin Tablets:
The average daily dose is 20 to 30 mg, given in 2 to 3 divided doses. Some patients may require 40 to 60 mg daily, while for others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
A maximum daily dose of 60 mg should not be exceeded.

Method of administration

General recommendations
Ritalin Tablets:
Ritalin 10 mg tablets can be taken with or without food (see 5.2 Pharmacokinetic properties).

Ritalin LA Capsules:
Ritalin LA capsules and/or their contents should not be crushed, chewed, or divided.
Ritalin LA capsules may be administered with or without food.
They may be swallowed whole or alternatively may be administered by sprinkling the contents over a small amount of food (see the instructions: Administration by sprinkling LA capsule contents on food).
Administration by sprinkling Ritalin LA capsule contents on food
The capsules may be carefully opened and the beads sprinkled over soft food (e.g. apple- sauce). The food should not be warm because this could affect the modified-release properties of this formulation.


RIT API 11APR24 V14                  Page 5 of 23     reference: New Zealand Data Sheet Jan.2024 The mixture of drug and food should be consumed immediately in its entirety. The drug and food mixture should not be stored for future use.