Requip IR

Requip IR 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, the manufacturer's guidance on discontinuation should be followed before initiating REQUIP.
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.
Parkinson's Disease: Adults: REQUIP should be taken three times a day and may be taken with or without food (see Pharmacology: Pharmacokinetics under Actions).
Treatment initiation: The initial dose should be 0.25 mg t.i.d (three times a day). A guide for the titration regimen for the first four weeks of treatment is given in the table as follows: (see Table 2.)

Click on icon to see table/diagram/image

Therapeutic regimen: After the initial titration, weekly increments of up to 3 mg/day may be given. REQUIP is usually given in divided doses three times per day.
A therapeutic response may be seen between 3 mg and 9 mg/day, although adjunct therapy patients may require higher doses. If sufficient symptomatic control is not achieved or maintained after the initial titration period, as described previously, the dose of REQUIP may be increased until an acceptable therapeutic response is established.
The safety and efficacy of doses above 24 mg/day have not been established and this dose should not be exceeded.
When REQUIP is given as 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 20% in patients receiving ropinirole concurrently. In patients with advanced Parkinson's disease receiving REQUIP in combination with L-dopa, dyskinesias can occur during the initial titration of REQUIP. 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 should be discontinued gradually by reducing the number of daily doses over the period of one week.
If treatment is interrupted for one day or more, re-initiation by dose titration should be considered (see previously mentioned).
Restless Legs Syndrome: REQUIP should be taken once-daily before bedtime, however the dose can be taken up to 3 hours before retiring. REQUIP may be taken with or without food (see Pharmacology: Pharmacokinetics under Actions).
Treatment Initiation (Week 1): The recommended initial dose is 0.25 mg once daily for 2 days. If this dose is well tolerated the dose may be increased to 0.5 mg once daily for the remainder of Week 1.
Therapeutic Regimen (Week 2 onwards): Following treatment initiation, the daily dose can be increased according to the regimen as follows until optimal therapeutic response is achieved. (See Table 3.)

Click on icon to see table/diagram/image

First signs of a response can be anticipated after one week of treatment in some patients, although further titration to achieve optimal effect is likely to be required. The mean daily dose in clinical trials was 2 mg/day.
Doses above 4 mg/day have not been investigated in patients with Restless Legs Syndrome.
As with other dopamine agonists, it is necessary to discontinue ropinirole treatment gradually by reducing the daily dose (see Precautions).
If treatment is interrupted for one day or more, re-initiation by dose titration should be considered (see previously mentioned).
Elderly: The clearance of ropinirole is decreased in patients aged 65 years or above, but the dose of REQUIP for elderly patients can be titrated in the normal manner.
Children and Adolescents: The safety and efficacy of ropinirole have not been established in patients under 18 years of age therefore, REQUIP 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.
The use of ropinirole in patients with severe renal impairment (creatinine clearance less than 30 mL/min) without regular dialysis has not been studied.
Parkinson's Disease: 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 REQUIP 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 dialysis. Supplemental doses after dialysis are not required.
Restless Legs Syndrome: 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 is 0.25 mg once daily. Further dose escalations should be based on tolerability and efficacy. The recommended maximum dose is 3 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required.
Hepatic impairment: The use of ropinirole in patients with hepatic impairment has not been studied. Administration of REQUIP to such patients is not recommended.
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