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PMS-ROPINIROLE is a brand name for Ropinirole, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE.............................................................................. 4 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Most Frequent Adverse Events Adverse events occurring with an incidence of greater than, or equal to, 10% were as follows: Early therapy: nausea, dizziness, somnolence, headache, peripheral oedema, vomiting, syncope, fatigue and viral infection.
Adjunct therapy: dyskinesia, nausea, dizziness, somnolence and headache. 3% in adjunct-therapy studies discontinued treatment due to adverse reactions. 3%). 4%). Patients over 75 years of age (n=130) showed slightly higher incidences of withdrawal due to hallucination, confusion and dizziness than patients less than 75 years of age.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Incidence of Adverse Events in Placebo Controlled Trials The incidence of postural hypotension, an event commonly associated with initiation of dopamine agonist therapy, was not notably different from placebo in clinical trials.
6% (> 75 years) of patients treated with ropinirole. The following table lists adverse events that occurred at an incidence of 1% or more among ropinirole-treated patients who participated in placebo-controlled trials for up to one year.
75 mg to 24 mg/day. Reported adverse events were classified using a standard World Health Organization Reaction Term Thesaurus (WHO-ART). 4 […]
The following Warnings and Precautions are listed in alphabetical order.
Carcinogenesis and Mutagenesis See PART II:
TOXICOLOGY, Carcinogenicity and Mutagenicity for discussion on animal data. Cardiovascular Patients with pre-existing cardiovascular conditions Since ropinirole has not been studied in patients with a history or evidence of significant cardiovascular disease including myocardial infarction, unstable angina, cardiac decompensation, cardiac arrhythmias, vaso-occlusive disease (including cerebral) or cardiomyopathy, it should be used with caution in such patients.
Serious Warnings and Precautions Sudden Onset of Sleep Patients receiving treatment with ropinirole hydrochloride and other dopaminergic agents have reported suddenly falling asleep while engaged in activities of daily living, including operating a motor vehicle, which has sometimes resulted in accidents.
Although some of the patients reported somnolence while on ropinirole hydrochloride, others perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event. Physicians should alert patients of the reported cases of sudden onset of sleep, bearing in mind that these events are NOT limited to initiation of therapy.
Patients should also be advised that sudden onset of sleep has occurred without warning signs. If drowsiness or sudden onset of sleep should occur, patients should immediately contact their physician. , operating machines). Episodes of falling asleep while engaged in activities of daily living have also been reported in patients taking other dopaminergic agents, therefore, symptoms may not be alleviated by substituting these products.
Presently, the precise cause of this event is unknown. It is known that many Parkinson's disease patients experience alterations in sleep architecture, which results in excessive daytime sleepiness or spontaneous dozing, and that dopaminergic agents can also induce sleepiness.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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There is insufficient information to determine whether this event is associated with ropinirole hydrochloride, all dopaminergic agents or Parkinson's disease itself. pms-ROPINIROLE Product Monograph Page 6 of 52 There is limited experience with ropinirole in patients treated with antihypertensive and antiarrhythmic agents.
Consequently, in such patients, the dose of ropinirole should be titrated with caution. Orthostatic hypotension Dopamine agonists appear to impair the systemic regulation of blood pressure with resulting orthostatic symptoms of dizziness or light headedness, with or without documented hypotension.
These symptoms appear to occur especially during dose initiation and escalation. Therefore, patients treated with ropinirole and other dopamine agonists should be carefully monitored for signs and symptoms of orthostatic hypotension, especially during dose initiation and escalation (see DOSAGE AND ADMINISTRATION) and should be informed of this risk (see PART III: CONSUMER INFORMATION).
Connective tissue Fibrotic Complications Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis, and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents.
While these complications may resolve when the drug is discontinued, complete resolution does not always occur. Although these adverse events are believed to be related to the ergoline structure of these compounds, whether other, nonergot-derived dopamine agonists can cause them is unknown.
A small number of reports have been received of possible fibrotic complications, including pleural effusion, pleural fibrosis, interstitial lung diseases, and cardiac valvulopathy, in the development program and postmarketing experience for ropinirole.
While the evidence is not sufficient to establish a causal relationship between ropinirole and these fibrotic complications, a contribution of ropinirole cannot be completely ruled out in rare cases. Neurologic Neuroleptic Malignant Syndrome A symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious aetiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in antiparkinsonian therapy.
A single spontaneous report of a symptom complex resembling the neuroleptic malignant syndrome has been observed in a 66 year old diabetic male patient with Parkinson's disease, who developed fever, muscle stiffness, and drowsiness 8 days after beginning ropinirole treatment.
The patient also experienced acute bronchitis, which did not respond to antibiotic treatment. Ropinirole was discontinued three days before the patient died. The reporting physician considered these events to be possibly related to ropinirole treatment (see DOSAGE AND ADMINISTRATION).
A single spontaneous report of severe muscle pain has been reported in a 66 year old male patient around his thigh. The reporting physician considered the event to be probably related to ropinirole pms-ROPINIROLE Product Monograph Page 7 of 52 treatment.
Dyskinesia with Adjunctive Levodopa Ropinirole may potentiate the dopaminergic side effects of levodopa and may cause or exacerbate pre-existing dyskinesia. Decreasing the dose of levodopa may ameliorate this side effect. 5, 15 and 50 mg/kg/day respectively.
The incidence was […]