February 10, 2016
Recommended Topic Related To:

Requip

"June 14, 2011 -- The FDA has issued an alert about medication errors involving patients who were mistakenly given the antipsychotic risperidone, (brand name Risperdal) instead of ropinirole (Requip), which is used to treat Parkinson's disease and"...

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Requip




Indications
Dosage
How Supplied

INDICATIONS

Parkinson's Disease

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

Restless Legs Syndrome

REQUIP is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

DOSAGE AND ADMINISTRATION

General Dosing Recommendations

REQUIP can be taken with or without food [see CLINICAL PHARMACOLOGY].

If a significant interruption in therapy with REQUIP has occurred, retitration of therapy may be warranted.

Dosing For Parkinson's Disease

The recommended starting dose for Parkinson's disease is 0.25 mg three times daily. Based on individual patient therapeutic response and tolerability, if necessary, the dose should then be titrated with weekly increments as described in Table 1. After Week 4, if necessary, the daily dose may be increased by 1.5 mg/day on a weekly basis up to a dose of 9 mg/day, and then by up to 3 mg/day weekly up to a maximum recommended total daily dose of 24 mg/day (8 mg three times daily). Doses greater than 24 mg/day have not been tested in clinical trials.

Table 1: Ascending-dose Schedule of REQUIP for Parkinson's Disease

Week Dosage Total Daily Dose
1 0.25 mg 3 times daily 0.75 mg
2 0.5 mg 3 times daily 1.5 mg
3 0.75 mg 3 times daily 2.25 mg
4 1 mg 3 times daily 3 mg

REQUIP should be discontinued gradually over a 7-day period in patients with Parkinson's disease. The frequency of administration should be reduced from three times daily to twice daily for 4 days. For the remaining 3 days, the frequency should be reduced to once daily prior to complete withdrawal of REQUIP.

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 ropinirole for patients with endstage renal disease on hemodialysis is 0.25 mg three times a day. 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 in patients with severe renal impairment without regular dialysis has not been studied.

Dosing For Restless Legs Syndrome

The recommended adult starting dose for RLS is 0.25 mg once daily 1 to 3 hours before bedtime. After 2 days, if necessary, the dose can be increased to 0.5 mg once daily, and to 1 mg once daily at the end of the first week of dosing, then as shown in Table 2 as needed to achieve efficacy. Titration should be based on individual patient therapeutic response and tolerability, up to a maximum recommended dose of 4 mg daily. For RLS, the safety and effectiveness of doses greater than 4 mg once daily have not been established.

Table 2: Dose Titration Schedule of REQUIP for Restless Legs Syndrome

Day/Week Dose to be taken once daily 1 to 3 hours before bedtime
Days 1 and 2 0.25 mg
Days 3 - 7 0.5 mg
Week 2 1 mg
Week 3 1.5 mg
Week 4 2 mg
Week 5 2.5 mg
Week 6 3 mg
Week 7 4 mg

In clinical trials of patients treated for RLS with doses up to 4 mg once daily, REQUIP was discontinued without a taper.

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 ropinirole for patients with endstage renal disease on hemodialysis is 0.25 mg once daily. Further dose escalations should be based on tolerability and need for efficacy. The recommended maximum total daily dose is 3 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of REQUIP in patients with severe renal impairment without regular dialysis has not been studied.

HOW SUPPLIED

Dosage Forms And Strengths

  • 0.25 mg, white, film-coated tablet, imprinted with “SB” and “4890”
  • 0.5 mg, yellow, film-coated tablet, imprinted with “SB” and “4891”
  • 1 mg, green, film-coated tablet, imprinted with “SB” and “4892”
  • 2 mg, pale yellowish-pink, film-coated tablet, imprinted with “SB” and “4893”
  • 3 mg, pale to moderate reddish-purple, film-coated tablet, imprinted with “SB” and “4895”
  • 4 mg, pale brown, film-coated tablet, imprinted with “SB” and “4896”
  • 5 mg, blue, film-coated tablet imprinted with “SB” and “4894”

Storage And Handling

Each pentagonal film-coated TILTAB® tablet with beveled edges contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:

0.25 mg: white tablets imprinted with “SB” and “4890” in bottles of 100 (NDC 0007-4890- 20)

0.5 mg: yellow tablets imprinted with “SB” and “4891” in bottles of 100 (NDC 0007-4891- 20)

1 mg: green tablets imprinted with “SB” and “4892” in bottles of 100 (NDC 0007-4892-20)

2 mg: pale yellowish-pink tablets imprinted with “SB” and “4893” in bottles of 100 (NDC 0007-4893-20)

3 mg: pale to moderate reddish-purple tablets, imprinted with “SB” and “4895” in bottles of 100 (NDC 0007-4895-20)

4 mg: pale brown tablets imprinted with “SB” and “4896” in bottles of 100 (NDC 0007- 4896-20)

5 mg: blue tablets imprinted with “SB” and “4894” in bottles of 100 (NDC 0007-4894-20)

Storage

Store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP]. Protect from light and moisture. Close container tightly after each use.

GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: August 2014

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

Last reviewed on RxList: 1/8/2016

Indications
Dosage
How Supplied

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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