Requip PD 24 Hour

Requip PD 24 Hour Dosage/Direction for Use

ropinirole

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
When switching treatment from another dopamine agonist to REQUIP PD 24 HOUR, the manufacturer's guidance on discontinuation should be followed before initiating REQUIP PD 24 HOUR.
Individual dose titration against efficacy and tolerability is recommended.
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.
Adults: REQUIP PD 24 HOUR should be taken as a single daily dose and should be taken at a similar time each day.
Treatment Initiation: The dose should be titrated according to the individual clinical response.
Recommended initial dose is 2 mg once daily for one week. A guide for titration regimen for the first four weeks of treatment is given in Table 2. (See Table 2.)

Click on icon to see table/diagram/image

Therapeutic Regimen: If sufficient symptomatic control is not achieved or maintained after the initial titration period as described previously, the daily dose may then be increased by increments of up to 4 mg once every one to two weeks, as necessary. The dose may be adjusted depending on the therapeutic response. The dose may be increased up to a maximum of 24 mg once daily.
The safety and efficacy of doses above 24 mg/day have not been established.
When REQUIP PD 24 HOUR is given as an adjunct therapy to L-dopa, it may be possible to reduce gradually the L-dopa dose, depending on the clinical response. In clinical trials, the L-dopa dose was reduced gradually by approximately 30% in patients receiving REQUIP PD 24 HOUR concurrently. In patients with advanced Parkinson's disease receiving REQUIP PD 24 HOUR in combination with L-dopa, dyskinesias can occur during the initial titration of REQUIP PD 24 HOUR. In clinical trials, it was shown that a reduction of the L-dopa dose may ameliorate dyskinesia (see Adverse Reactions).
As with other dopamine agonists, REQUIP PD 24 HOUR should be discontinued gradually by reducing the daily dose over the period of one week.
If treatment is interrupted for one day or more, re-initiation by dose titration should be considered (see previous text).
Switching from ropinirole immediate release tablets to ropinirole prolonged release tablets: Patients may be switched overnight from REQUIP immediate release (IR) tablets to REQUIP PD 24 HOUR PR tablets. The dose of REQUIP PD 24 HOUR PR tablets should be based on the total daily dose of REQUIP IR tablets that the patient was taking.
Table 3 shows the recommended dose of REQUIP PD 24 HOUR PR tablets for patients switching from REQUIP IR tablets. (See Table 3.)

Click on icon to see table/diagram/image

After switching to REQUIP PD 24 HOUR PR tablets, the dose may be adjusted depending on the therapeutic response (see Treatment Initiation and Therapeutic Regimen previously mentioned).
Children and Adolescents: The safety and efficacy of ropinirole have not been established in patients under 18 years of age; therefore, REQUIP PD 24 HOUR is not recommended for use in patients within this age group.
Elderly: The clearance of ropinirole is decreased in patients aged 65 years or above, but the dose of REQUIP PD 24 HOUR for elderly patients can be titrated in the normal manner.
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 recommended initial dose of REQUIP PD 24 HOUR 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 dialysis has not been studied.
Hepatic Impairment: The use of ropinirole in patients with hepatic impairment has not been studied. Administration of REQUIP PD 24 HOUR to such patients is not recommended.
Administration: REQUIP PD 24 HOUR must be swallowed whole and must not be chewed, crushed or divided. It may be taken with or without food (see Pharmacology: Pharmacokinetics under Actions).
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