Ropinirole Hydrochloride

ROPINIROLE HYDROCHLORIDE- ropinirole hydrochloride tablet, film coated
Zydus Pharmaceuticals (USA) Inc.

1 INDICATIONS AND USAGE

1.1 Parkinson’s Disease

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

1.2 Restless Legs Syndrome

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

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

2.2 Dosing for Parkinson’s Disease

The recommended starting dose of ropinirole hydrochloride tablets 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 Ropinirole 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 hydrochloride tablets 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 ropinirole hydrochloride 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 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 ropinirole 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 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 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 in patients with severe renal impairment without regular dialysis has not been studied.

3 DOSAGE FORMS AND STRENGTHS

0.25 mg : White-colored, round-shaped, film-coated tablets, debossed with “ZF22” on one side and plain on the other side.

0.5 mg : Yellow-colored, round-shaped, film-coated tablets, debossed with “ZF23” on one side and plain on the other side.

1 mg : Green-colored, round-shaped, film-coated tablets, debossed with “ZF24” on one side and plain on the other side.

2 mg : Pink-colored, round-shaped, film-coated tablets, debossed with “ZF25” on one side and plain on the other side.

3 mg : Purple-colored, round-shaped, film-coated tablets, debossed with “ZF42” on one side and plain on the other side.

4 mg : Brown-colored, round-shaped, film-coated tablets, debossed with “ZF43” on one side and plain on the other side.

5 mg : Blue-colored, round-shaped, film-coated tablets, debossed with “ZF26” on one side and plain on the other side.

4 CONTRAINDICATIONS

Ropinirole hydrochloride tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients.

5 WARNINGS AND PRECAUTIONS

5.1 Falling Asleep during Activities of Daily Living and Somnolence

Patients treated with ropinirole have reported falling asleep while engaged in activities of daily living, including driving or operating machinery, which sometimes resulted in accidents. Although many of these patients reported somnolence while on ropinirole, some perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some have reported these events more than 1 year after initiation of treatment.

In controlled clinical trials, somnolence was commonly reported in patients receiving ropinirole and was more frequent in Parkinson’s disease (up to 40% ropinirole, 6% placebo) than in Restless Legs Syndrome (12% ropinirole, 6% placebo) [see Adverse Reactions (6.1)].

It has been reported that falling asleep while engaged in activities of daily living usually occurs in a setting of preexisting somnolence, although patients may not give such a history. For this reason, prescribers should reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.

Before initiating treatment with ropinirole, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with ropinirole such as concomitant sedating medications or alcohol, the presence of sleep disorders (other than RLS), and concomitant medications that increase ropinirole plasma levels (e.g., ciprofloxacin) [see Drug Interactions (7.1)]. If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., driving a motor vehicle, conversations, eating), ropinirole should ordinarily be discontinued [see Dosage and Administration (2.2, 2.3)]. If a decision is made to continue ropinirole, patients should be advised to not drive and to avoid other potentially dangerous activities. There is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

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