Posology : מינונים

4.2.           Posology and method of administration

Oral use.
Individual dose titration against efficacy and tolerability is recommended.

Ropinirole prolonged-release tablets should be taken once a day and at a similar time each day. The tablets must be swallowed whole and must not be chewed, crushed or divided.

The tablets may be taken with or without food. A high fat meal may double the AUC and Cmax in some individuals (See 5.2 Pharmacokinetics).

Adults

Initial titration
The starting dose of ropinirole prolonged-release tablets is 2 mg once daily for the first week; this should be increased to 4 mg once daily from the second week of treatment. A therapeutic response may be seen at a dose of 4 mg once daily of ropinirole prolonged-release tablets.

Therapeutic regimen
Patients should be maintained on the lowest dose of ropinirole prolonged-release tablets that achieves symptomatic control.


If sufficient symptomatic control is not achieved or maintained at a dose of 4 mg once daily of ropinirole prolonged-release tablets, the daily dose may be increased by 2 mg at weekly or longer intervals up to a dose of 8 mg once daily of prolonged-release tablets.


If sufficient symptomatic control is still not achieved or maintained at a dose of 8 mg once daily of ropinirole prolonged-release tablets, the daily dose may be increased by 2 mg to 4 mg at two weekly or longer intervals.
The maximum daily dose of ropinirole prolonged-release tablets is 24 mg.

It is recommended that patients are prescribed the minimum number of ropinirole prolonged-release tablets that are necessary to achieve the required dose by utilising the highest available strengths of ropinirole prolonged-release tablets.

When ropinirole prolonged-release tablets are administered as adjunct therapy to levodopa, it may be possible to gradually reduce the levodopa dose, depending on the clinical response. In clinical trials, the levodopa dose was reduced gradually by approximately 30% in patients receiving ropinirole prolonged-release tablets concurrently. In patients with advanced Parkinson’s disease receiving ropinirole prolonged-release tablets in combination with L-dopa, dyskinesias can occur during the initial titration of ropinirole prolonged release tablets. In clinical trials it was shown that a reduction of the L-dopa dose may ameliorate dyskinesia (see also 4.8 Undesirable effects).

When switching treatment from another dopamine agonist to ropinirole, the marketing authorisation holder’s guidance on discontinuation should be followed before initiating ropinirole.

As with other dopamine agonists, it is necessary to discontinue ropinirole treatment gradually by reducing the daily dose over the period of one week (see section 4.4).


Dose interruption or discontinuation
If it is necessary to discontinue ropinirole treatment, this should be done gradually by reducing the daily dose over the period of one week.


Renal impairment

In parkinsonian patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/min) no change in the clearance of ropinirole was observed, indicating that no dosage adjustment is necessary in this population.

A study into the use of ropinirole in patients with end stage renal disease (patients on haemodialysis) has shown that a dose adjustment in these patients is required as follows: 
The recommended initial dose of ropinirole PR is 2 mg once daily. Further dose escalations should be based on tolerability and efficacy. The recommended maximum dose is 18 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required.

The use of ropinirole in patients with severe renal impairment (creatinine clearance less than 30 ml/min) without regular haemodialysis has not been studied.

Hepatic impairment

The use of ropinirole in patients with hepatic impairment has not been studied.
Elderly

The clearance of ropinirole is decreased by approximately 15% in patients aged 65 years or above. Although a dose adjustment is not required, ropinirole dose should be individually titrated, with careful monitoring of tolerability, to the optimal clinical response. In patients aged 75 years and above, slower titration during treatment initiation may be considered.

Children and adolescents

Ropinirole prolonged-release tablets are not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.