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Requip XL

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Requip XL

Requip XL

INDICATIONS

Parkinson's Disease

REQUIP XL (ropinirole extended-release tablets) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

DOSAGE AND ADMINISTRATION

General Dosing Considerations

  • REQUIP XL (ropinirole extended release tablets) Extended-Release Tablets are taken once daily, with or without food. Taking REQUIP XL (ropinirole extended release tablets) with food may reduce the occurrence of nausea; this has not been established in controlled clinical trials [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 (ropinirole extended release tablets) has occurred, retitration of therapy may be warranted.

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]. Due to the flexible dosing design used in clinical studies, specific dose response information could not be determined.

When REQUIP XL (ropinirole extended release tablets) 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 (ropinirole extended release tablets) of 8 mg/day. Overall, L-dopa dose reduction was sustained in 93% of patients treated with REQUIP XL (ropinirole extended release tablets) 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]. REQUIP XL (ropinirole extended release tablets) should be discontinued gradually over a 7–day period.

Switching From Immediate-Release Ropinirole Tablets to REQUIP XL

Patients may be switched directly from immediate-release ropinirole to REQUIP XL (ropinirole extended release tablets) Tablets. The initial dose of REQUIP XL (ropinirole extended release tablets) 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 (ropinirole extended release tablets) , the dose may be adjusted depending on therapeutic response and tolerability [see DOSAGE AND ADMINISTRATION].

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"

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) and 90 (NDC 0007-4885-59).
  • 4 mg: light brown tablets debossed with “GS” and “WXG”, in bottles of 30 (NDC 0007–4887–13) and 90 (NDC 0007-4887-59).
  • 6 mg: white tablets debossed with "GS" and "11F", in bottles of 30 (NDC 0007-4883-13) and 90 (NDC 0007-4883-59).
  • 8 mg: red tablets debossed with “GS” and “5CC”, in bottles of 30 (NDC 0007-4888-13) and 90 (NDC 0007-4888-59).
  • 12 mg: green tablets debossed with "GS" and "YX7", in bottle 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.

Last reviewed on RxList: 4/30/2009
This monograph has been modified to include the generic and brand name in many instances.

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