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warnings and cautions
5 WARNINGS AND PRECAUTIONS Sudden onset of sleep and somnolence may occur ( 5.1 ) Syncope may occur ( 5.2 ) Hypotension, including orthostatic hypotension may occur ( 5.3 ) May cause hallucinations and psychotic-like behaviors ( 5.4 ) May cause or exacerbate dyskinesia ( 5.5 ) May cause problems with impulse control or compulsive behaviors ( 5.6 ) 5.1 Falling Asleep during Activities of Daily Living and Somnolence Patients treated with ropinirole tablets 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 tablets, 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 tablets and was more frequent in Parkinson's disease (up to 40% ropinirole tablets, 6% placebo) than in RLS (12% ropinirole tablets, 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 pre-existing 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 tablets, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with ropinirole tablets 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 tablets should ordinarily be discontinued [se...
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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the label: Hypersensitivity [see Contraindications (4) ] Falling asleep during activities of daily living and somnolence [see Warnings and Precautions (5.1) ] Syncope [see Warnings and Precautions (5.2) ] Hypotension/orthostatic hypotension [see Warnings and Precautions (5.3) ] Hallucinations/psychotic-like behavior [see Warnings and Precautions (5.4) ] Dyskinesia [see Warnings and Precautions (5.5) ] Impulse control/compulsive behaviors [see Warnings and Precautions (5.6) ] Withdrawal-emergent hyperpyrexia and confusion [see Warnings and Precautions (5.7) ] Withdrawal Symptoms [see Warnings and Precautions (5.8) ] Augmentation and early-morning rebound in RLS [see Warnings and Precautions (5.9) ] Fibrotic complications [see Warnings and Precautions (5.10) ] Retinal pathology [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence with ropinirole tablets at least 5% greater than placebo) in the respective indications were: Early PD: Nausea, somnolence, dizziness, syncope, asthenic condition, viral infection, leg edema, vomiting, and dyspepsia. ( 6.1 ) Advanced PD: Dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, sweating, and headache. ( 6.1 ) RLS: Nausea, vomiting, somnolence, dizziness, and asthenic condition. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice. Parkinson's Disease During the premarketing development of ropinirole tablets, patients received ropinirole tablets either without L-dopa (early Parkinson's disease trials) or as concomitant therapy with L-dopa (advanced Parkinson's disease trials). Because these 2 populations may have differential risks for various adverse reactions, this section will in general present adverse reaction data for these 2 populations separately. Early Parkinson's Disease (without L-dopa): In the double-bl...
adverse reactions table
Table 3. Treatment-Emergent Adverse Reaction Incidence in Double-blind, Placebo-Controlled Early Parkinson’s Disease (without L-dopa) Trials (Events ≥2% of Patients Treated with Ropinirole Tablets and Numerically More Frequent than the Placebo Group) aa Patients may have reported multiple adverse reactions during the trial or at discontinuation; thus, patients may be included in more than one category. b Asthenic condition (i.e., asthenia, fatigue, and/or malaise). Body System/Adverse ReactionRopinirole Tablets (n = 157) (%)Placebo (n = 147) (%)Autonomic nervous system Flushing 31 Dry mouth 53 Increased sweating 64Body as a whole Asthenic condition b165 Chest pain 42 Dependent edema 63 Leg edema 71 Pain 84Cardiovascular general Hypertension 53 Hypotension 20 Orthostatic symptoms 65 Syncope 121Central/peripheral nervous system Dizziness 4022 Hyperkinesia 21 Hypesthesia 42 Vertigo 20Gastrointestinal Abdominal pain63 Anorexia41 Dyspepsia105 Flatulence31 Nausea6022 Vomiting127Heart rate/rhythm Extrasystoles21 Atrial fibrillation20 Palpitation32 Tachycardia20Metabolic/nutritional Increased alkaline phosphatase 31Psychiatric Amnesia 31 Impaired concentration 20 Confusion 51 Hallucination 51 Somnolence 406 Yawning 30Reproductive male Impotence 31Resistance mechanism Viral infection 113Respiratory Bronchitis 31 Dys