May 27, 2017
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Requip XL

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Requip XL




Indications
Dosage
How Supplied

INDICATIONS

REQUIP XL® is indicated for the treatment of Parkinson's disease.

DOSAGE AND ADMINISTRATION

General Dosing Recommendations

  • REQUIP XL extended-release tablets are taken once daily, with or without food [see CLINICAL PHARMACOLOGY].
  • 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.

Dosing For Parkinson's Disease

The recommended starting dose of REQUIP XL is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at weekly or longer intervals, based on therapeutic response and tolerability. Monitor patients at least weekly during dose titration. Too rapid a rate of titration may lead to the selection of a dose that does not provide additional benefit, but increases the risk of adverse reactions.

In fixed-dose studies designed to characterize the dose-response to REQUIP XL, there was no additional therapeutic benefit shown in patients with advanced stage Parkinson's disease taking daily doses greater than 8 mg/day, or with early stage Parkinson's disease taking doses greater than 12 mg/day [see Clinical Studies]. Although the maximum recommended dose of REQUIP XL is 24 mg, patients with advanced Parkinson's disease should generally be maintained at daily doses of 8 mg or lower and patients with early Parkinson's disease should generally be maintained at daily doses 12 mg or lower.

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.

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 approximately match the total daily dose of the immediate-release formulation of ropinirole, as shown in Table 1.

Table 1: Conversion from Immediate-Release Ropinirole Tablets 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 Dosing for Parkinson’s Disease].

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.

HOW SUPPLIED

Dosage Forms And Strengths

  • 2-mg, pink, biconvex, capsule-shaped, film-coated, tablets debossed with “GS” and “3V2”
  • 4-mg, light brown, biconvex, capsule-shaped, film-coated, tablets debossed with “GS” and “WXG”
  • 6-mg, white, biconvex, capsule-shaped, film-coated, tablets debossed with “GS” and “11F”
  • 8-mg, red, biconvex, capsule-shaped, film-coated, tablets debossed with “GS” and “5CC”
  • 12-mg, green, biconvex, capsule-shaped, film-coated, tablets debossed with “GS” and “YX7”

Storage And Handling

Each biconvex, capsule-shaped, film-coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:

2-mg: pink tablets debossed with “GS” and “3V2” in bottles of 30 (NDC 0007-4885-13)

4-mg: light brown tablets debossed with “GS” and “WXG” in bottles of 30 (NDC 00074887-13) and 90 (NDC 0007-4887-59).

6-mg: white tablets debossed with “GS” and “11F” in bottles of 30 (NDC 0007-4883-13).

8-mg: red tablets debossed with “GS” and “5CC” in bottles of 30 (NDC 0007-4888-13).

12-mg: green tablets debossed with “GS” and “YX7” in bottles of 30 (NDC 0007-4882-13).

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP.

GlaxoSmithKline: Research Triangle Park, NC 27709. For more information go to www.gsk.com or call 1-888-825-5249 (toll-free). Revised: Mar 2017

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/6/2017

Indications
Dosage
How Supplied

Requip XL - User Reviews

Requip XL User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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