Requip Xl

2.1 General Dosing Considerations REQUIP XL Extended-Release Tablets are taken once daily, with or without food. Taking REQUIP XL with food may reduce the occurrence of nausea; this has not been established in controlled clinical trials [see Clinical Pharmacology (12.3)]. Tablets must be swallowed whole and must not be chewed, crushed, or divided. If a significant interruption in therapy with REQUIP XL has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s Disease

The starting dose is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals as appropriate, depending on therapeutic response and tolerability, up to a maximally recommended dose of 24 mg/day.

In clinical trials, dosage was initiated at 2 mg/day and gradually titrated based on individual therapeutic response and tolerability. Doses greater than 24 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 1 week or longer after each dose increment. Caution should be exercised during dose titration because too rapid a rate of titration may lead to dose selection that may not provide additional benefit, but that may increase the risk of adverse reactions [see Clinical Studies (14.2)]. Due to the flexible dosing design used in clinical studies, specific dose response information could not be determined.

When REQUIP XL is administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be decreased gradually as tolerated. In the placebo-controlled advanced Parkinson’s disease study, the L-dopa dose was reduced once patients reached a dose of REQUIP XL of 8 mg/day. Overall, L-dopa dose reduction was sustained in 93% of patients treated with REQUIP XL and in 72% of patients on placebo. On average the L-dopa dose was reduced by 34% in patients treated with REQUIP XL [see Clinical Studies (14)].

REQUIP XL should be discontinued gradually over a 7-day period.

2.3 Switching From Immediate-Release Ropinirole Tablets to REQUIP XL

Patients may be switched directly from immediate-release ropinirole to REQUIP XL Tablets. The initial dose of REQUIP XL should most closely match the total daily dose of the immediate-release formulation of REQUIP, as shown in Table 1.

Table 1. Conversion from Immediate-Release REQUIP to REQUIP XL

Immediate-Release Ropinirole Tablets

Total Daily Dose (mg)

REQUIP XL Tablets

Total Daily Dose (mg)

0.75 to 2.25

2

3 to 4.5

4

6

6

7.5 to 9

8

12

12

15 to 18

16

21

20

24

24

Following conversion to REQUIP XL, the dose may be adjusted depending on therapeutic response and tolerability[see Dosage and Administration (2.2)].

2.1 General Dosing Recommendations • REQUIP XL extended-release tablets are taken once daily, with or without food [see Clinical Pharmacology (12.3)]. • Tablets must be swallowed whole and must not be chewed, crushed, or divided. • If a significant interruption in therapy with REQUIP XL has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s Disease

The starting dose is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals as appropriate, based on therapeutic response and tolerability. The maximum recommended dose of REQUIP XL is 24 mg/day.

In clinical trials, dosage was initiated at 2 mg/day and gradually titrated based on individual patient therapeutic response and tolerability. Doses greater than 24 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 1 week or longer after each dose increment. Monitor patients during dose titration because too rapid a rate of titration may lead to dose selection that may not provide additional benefit, but that may increase the risk of adverse reactions [see Clinical Studies (14.2)]. Due to the flexible dosing design used in clinical trials, specific dose-response information could not be determined.

REQUIP XL should be discontinued gradually over a 7-day period.

Renal Impairment

No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The recommended initial dose of REQUIP XL for patients with end-stage renal disease on hemodialysis is 2 mg once daily. Further dose escalations should be based on tolerability and need for efficacy. The recommended maximum total daily dose is 18 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of REQUIP XL in patients with severe renal impairment without regular dialysis has not been studied.

2.3 Switching from Immediate-release Ropinirole Tablets to REQUIP XL

Patients may be switched directly from immediate-release ropinirole to REQUIP XL tablets. The initial dose of REQUIP XL should most closely match the total daily dose of the immediate-release formulation of REQUIP®, as shown in Table 1.

Table 1. Conversion from Immediate-release REQUIP to REQUIP XL

Immediate-release Ropinirole Tablets

Total Daily Dose (mg)

REQUIP XL Tablets

Total Daily Dose (mg)

0.75 to 2.25

2

3 to 4.5

4

6

6

7.5 to 9

8

12

12

15

16

18

18

21

20

24

24

Following conversion to REQUIP XL, the dose may be adjusted depending on therapeutic response and tolerability[see Dosage and Administration (2.2)].

2.4 Effect of Gastrointestinal Transit Time on Medication Release

REQUIP XL is designed to release medication over a 24-hour period. If rapid gastrointestinal transit occurs, there may be risk of incomplete release of medication and medication residue being passed in the stool.