Posology : מינונים

4.2 Posology and method of administration


When switching treatment from another dopamine agonist to ropinirole, the manufacturer's guidance on discontinuation should be followed before initiating ropinirole.
Patients should be down-titrated if they experience disabling somnolence at any dose level. For other adverse events, down-titration followed by more gradual up-titration has been shown to be beneficial.

Populations:

Adults
Individual dose titration against efficacy and tolerability is recommended.
Ropinirole should be taken three times a day, preferably with meals to improve gastrointestinal tolerance.
Treatment initiation:

The initial dose should be 0.25 mg three times daily for 1 week. Thereafter, the dose of ropinirole can be increased in 0.25 mg three times daily increments, according to the following regimen:

Week
1                 2                  3                  4
Unit dose (mg) of ropinirole                      0.25              0.5                0.75               1.0 Total daily dose (mg) of ropinirole               0.75              1.5                2.25               3.0 
Therapeutic regimen:

After the initial titration, weekly increments of 0.5 to 1 mg three times daily (1.5 to 3 mg/day) of ropinirole may be given.
A therapeutic response may be seen between 3 and 9 mg/day of ropinirole. If sufficient symptomatic control is not achieved, or maintained after the initial titration as described above, the dose of ropinirole may be increased up to 24 mg/day.

Doses of ropinirole above 24 mg/day have not been studied.

If treatment is interrupted for one day or more re-initiation by dose titration should be considered (see above).
When ropinirole is administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be reduced gradually according to the symptomatic response. In clinical trials, the levodopa dose was reduced gradually by around 20% in patients treated with ropinirole as adjunct therapy. In patients with advanced Parkinson's disease receiving ropinirole in combination with L-dopa, dyskinesias can occur during the initial titration of ropinirole. In clinical trials it was shown that a reduction of the L-dopa dose may ameliorate dyskinesia (see also section 4.8).


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


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
The safety and efficacy of ropinirole have not been established in patients under 18 years of age; therefore ropinirole is not recommended for use in patients within this age group.

Renal impairment

In patients with mild to moderate renal impairment (creatinine clearance 30-50 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 initial dose of ROPINIROLE TEVA should be 0.25 mg three times a day. Further dose escalations should be based on tolerability and efficacy. The recommended maximum dose is 18 mg/day in patients receiving regular haemodialysis.
Supplemental doses after haemodialysis 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. Administration of ropinirole to such patients is not recommended.
Hepatic impairment
The use of ropinirole in patients with hepatic impairment has not been studied. Administration of ropinirole to such patients is not recommended.