Ropinirole

ROPINIROLE- ropinirole hydrochloride tablet, film coated
Accord Healthcare Inc.

1 INDICATIONS AND USAGE

1.1 Parkinson’s Disease

Ropinirole tablets are indicated for the treatment of Parkinson’s disease.

1.2 Restless Legs Syndrome

Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Recommendations

Ropinirole tablets can be taken with or without food [see Clinical Pharmacology (12.3) ] .

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

2.2 Dosing for Parkinson’s Disease

The recommended starting dose of ropinirole hydrochloride for Parkinson’s disease is 0.25 mg 3 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 3 times daily). Doses greater than 24 mg/day have not been tested in clinical trials.

Table 1. Ascending-Dose Schedule of Ropinirole Hydrochloride 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

Ropinirole tablets should be discontinued gradually over a 7-day period in patients with Parkinson’s disease. The frequency of administration should be reduced from 3 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 ropinirole tablets.

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 end-stage renal disease on hemodialysis is 0.25 mg 3 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 ropinirole hydrochloride in patients with severe renal impairment without regular dialysis has not been studied.

2.3 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 Ropinirole Hydrochloride 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 to 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

When discontinuing ropinirole hydrochloride in patients with RLS, gradual reduction of the daily dose is recommended [see Warnings and Precautions (5.9)] .

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 end-stage 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 ropinirole hydrochloride in patients with severe renal impairment without regular dialysis has not been studied.

3 DOSAGE FORMS AND STRENGTHS

  • 0.25 mg: White to off white, round, biconvex, film coated tablets debossed with “R6″ on one side and plain on other side.
  • 0.5 mg: Yellow, round, biconvex, film coated tablets debossed with “R7″ on one side and plain on other side.
  • 1 mg: Green, round, biconvex, film coated tablets debossed with “R1″ on one side and plain on other side.
  • 2 mg: Pink, round, biconvex, film coated tablets debossed with “R2″ on one side and plain on other side.
  • 3 mg: Purple to light purple, round, biconvex, film coated tablets debossed with “R3″ on one side and plain on other side.
  • 4 mg: Brown to pale brown, round, biconvex, film coated tablets debossed with “R4″ on one side and plain on other side.
  • 5 mg: Blue, round, biconvex, film coated tablets debossed with “R5″ on one side and plain on other side.

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