Ropinirole

ROPINIROLE — ropinirole hydrochloride tablet, film coated, extended release
Alembic Pharmaceuticals Limited

1 INDICATIONS AND USAGE

1.1 Parkinson’s Disease

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

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Recommendations

· Ropinirole extended-release tablets are taken once daily, with or without food [see Clinical Pharmacology (12.3)].

· Tablets must be swallowed whole and must not be chewed, crushed, or divided.

· If a significant interruption in therapy with ropinirole extended-release tablets has occurred, retitration of therapy may be warranted.

2.2 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, based on therapeutic response and tolerability. The maximum recommended dose of ropinirole extended-release tablets is 24 mg/day.

In clinical trials, dosage was initiated at 2 mg/day and gradually titrated based on individual patient 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. Monitor patients 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 (14.2)]. Due to the flexible dosing design used in clinical trials, specific dose-response information could not be determined.

Ropinirole extended-release tablets 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 ropinirole extended-release tablets 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 ropinirole extended-release tablets in patients with severe renal impairment without regular dialysis has not been studied.

2.3 Switching from Immediate-Release Ropinirole Tablets to Extended-Release Ropinirole Tablets

Patients may be switched directly from immediate-release ropinirole to extended-release ropinirole tablets. The initial dose of ropinirole extended-release tablets should most closely match the total daily dose of the immediate-release formulation of ropinirole tablets, as shown in Table 1.

Table 1. Conversion from Immediate-Release Ropinirole Tablets to Extended-Release Ropinirole Tablets

Immediate-Release Ropinirole Tablets Total Daily Dose (mg) Extended-Release Ropinirole 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 ropinirole extended-release tablets, the dose may be adjusted depending on therapeutic response and tolerability [see Dosage and Administration (2.2)].

2.4 Effect of Gastrointestinal Transit Time on Medication Release

Ropinirole extended-release tablets are 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.

3 DOSAGE FORMS AND STRENGTHS

  • 2 mg, pink, capsule shaped, film coated tablet, debossed with ‘L191’ on one side and plain on other side.
  • 4 mg, light brown, capsule shaped, film coated tablet, debossed with ‘L193’ on one side and plain on other side.
  • 6 mg, white to off white, capsule shaped, film coated tablet, debossed with ‘L321’ on one side and plain on other side.
  • 8 mg, dark brown to red, capsule shaped, film coated tablet, debossed with ‘L194’ on one side and plain on other side.
  • 12 mg, light green, capsule shaped, film coated tablet, debossed with ‘L195’ on one side and plain on other side.

4 CONTRAINDICATIONS

Ropinirole extended-release tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction including urticaria, angioedema, rash, pruritus) to ropinirole or 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 machinary, 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.

Among the 613 patients who received ropinirole extended-release tablets in clinical trials, there were 5 cases of sudden onset of sleep and 2 cases of motor vehicle accident in which it is not known if falling asleep was a contributing factor.

During the 6-month trial in advanced Parkinson’s disease, somnolence was reported in 7% of patients receiving ropinirole extended-release tablets compared with 4% of patients receiving placebo. During the 36-week trial in early Parkinson’s disease, somnolence was reported in 11% of patients receiving ropinirole extended-release tablets compared with 15% of patients receiving the immediate-release formulation of ropinirole tablets[see Adverse Reactions (6.1)]. However, because dose-response was not systematically studied with ropinirole extended-release tablets, the occurrence of somnolence at the highest recommended doses may be higher than these reported frequencies [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 extended-release tablets, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with ropinirole extended-release tablets such as concomitant sedating medications, the presence of sleep disorders, 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 extended-release tablets should ordinarily be discontinued [see Dosage and Administration (2.2)]. If a decision is made to continue ropinirole extended-release tablets, 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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