ROPINIROLE — ropinirole hydrochloride tablet, film coated, extended release
Actavis Elizabeh LLC
Ropinirole extended-release tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.
- Ropinirole extended-release tablets are taken once daily, with or without food. Taking ropinirole extended-release tablets with food may reduce the occurrence of nausea; this has not been established in controlled clinical trials [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.
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 (14.2)]. Due to the flexible dosing design used in clinical studies, specific dose response information could not be determined.
When ropinirole extended-release tablets are 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 ropinirole extended-release tablets of 8 mg/day. Overall, L-dopa dose reduction was sustained in 93% of patients treated with 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 ropinirole extended-release tablets [see Clinical Studies (14)].
Ropinirole extended-release tablets should be discontinued gradually over a 7-day period.
Patients may be switched directly from immediate-release ropinirole tablets to ropinirole extended-release 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.
|Immediate-Release Ropinirole Tablets||Ropinirole Extended-Release Tablets|
|Total Daily Dose (mg)||Total Daily Dose (mg)|
|0.75 to 2.25||2|
|3 to 4.5||4|
|7.5 to 9||8|
|15 to 18||16|
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 mg, pink, oval-shaped, film-coated tablets debossed with and 658 on one side and plain on the other side.
4 mg, blue, oval-shaped, film-coated tablets, debossed with and 659 on one side and plain on the other side.
6 mg, white to off-white, oval-shaped, film-coated tablets, debossed with and 640 on one side and plain on the other side.
8 mg, red, oval-shaped, film-coated tablets, debossed with and 660 on one side and plain on the other side.
12 mg, yellow, oval-shaped, film-coated tablets, debossed with and 661 on one side and plain on the other side.
Patients treated with ropinirole have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, 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 of these events have been reported 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% (14 of 202) of patients receiving ropinirole extended-release tablets compared with 4% (7 of 191) of patients receiving placebo. During the 36-week trial in early Parkinson’s disease, somnolence was reported in 11% (16 of 140) of patients receiving ropinirole extended-release tablets compared with 15% (22 of 149) of patients receiving the immediate-release formulation of ropinirole tablets [see Adverse Reactions (6)]. 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)].
Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of preexisting somnolence, although patients may not give such a history. For this reason, prescribers should continually 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, etc.), ropinirole extended-release tablets should ordinarily be discontinued [see Dosage and Administration for guidance in discontinuing ropinirole extended-release tablets (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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