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PROLOPA CAP is a brand name for Levodopa, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................ 3 CONTRAINDICATIONS ................................................................................................. 4 ADVERSE REACTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview The most common serious adverse reactions occurring with PROLOPA (levodopa and benserazide capsules) are abnormal involuntary movements and dyskinesias. Dosage reduction can diminish those reactions though often at the expense of increasing parkinsonism.
Other serious adverse reactions are oscillations in performance, psychiatric disorders and, less frequently, cardiovascular effects. Involuntary Movements: choreiform, dystonic, athetotic and other involuntary movements. Muscle twitching and blepharospasm occur less often and may be taken as early signs of overdosage.
The appearance of these reactions can usually be eliminated or made tolerable by adjusting the dosage and by giving smaller single doses more frequently. The incidence of involuntary movements reported by several investigators was 30% to 40% in the first month and 50% to 60% or more by six to nine months.
Oscillations in Performance:
Periodic oscillations in performance constitute the most serious problem encountered after prolonged levodopa therapy and appear earlier with combined therapy than when levodopa is used alone.
Three types have been described:
End-of-dose akinesia: episodic re-emergence of Parkinsonian symptoms three or more hours after each dose of levodopa, often following a period of dyskinesia. This type of akinesia tends to occur progressively earlier after each dose during prolonged therapy and is regarded as resulting from a temporary insufficiency of dopamine at the appropriate receptor sites.
On-off phenomenon: a rapid alternation between a state of satisfactory motility, usually with oral- facial dyskinesias and a rigid akinetic state without dyskinesias. This oscillation of performance is also regarded as being associated with a temporary insufficiency of dopamine.
Akinesia paradoxica (hypotonic freezing): irregular episodes of sudden freezing, usually short duration, with the patient unable to move, accompanied by hypotonia and postural instability. These episodes are at times accompanied by autonomic symptoms.
Hypotonic freezing is regarded as possibly associated with a severe temporary deficiency in noradrenaline in progressively depleted and damaged noradrenaline pathways. Psychiatric Disorders: paranoid ideation, psychotic episodes, depression (with or without development of suicidal tendencies) and dementia.
General Before initiating therapy in patients already receiving levodopa, this drug should be discontinued at least 12 hours before PROLOPA (levodopa and benserazide capsules) is started. If converting from a non-combination levodopa formulation, therapy with PROLOPA should be instituted at a level that will provide approximately 15% of the previous dosage of levodopa alone.
(see DOSAGE AND ADMINISTRATION). Regular assessment of cardiovascular, hepatic, hematopoietic and renal function should be performed in all patients during the dosage stabilization period. Hypersensitivity reactions may occur in susceptible individuals.
Serious Warnings and Precautions Patients receiving treatment with PROLOPA (levodopa and benserazide capsules) and other dopaminergic agents have reported suddenly falling asleep while engaged in activities of daily living, including the driving of a car, which has sometimes resulted in accidents.
Although some of the patients reported somnolence while on PROLOPA, 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 and should be specifically asked about factors that may increase the risk with PROLOPA such as concomitant medications or the presence of sleep disorders.
Given the reported cases of somnolence and sudden onset of sleep (not necessarily preceded by somnolence), physicians should caution patients about the risk of operating hazardous machinery, including driving motor vehicles, while taking PROLOPA.
If drowsiness or sudden onset of sleep should occur, patients should be informed to immediately contact their physician. 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Levodopa in Canada.
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In depressed patients, levodopa may give rise to an improvement in mood in a small number of individuals. However, when administered to patients with bipolar depression, it tends regularly to produce hypomania. Various psychiatric disturbances have been reported in about 20% of patients.
Gastrointestinal Effects:
Undesirable gastrointestinal effects may occur mainly in the early stages of treatment. , biscuits or fruit juice) may be taken or the dose may be increased slowly to help control these effects (see DRUG INTERACTIONS, Drug-Food Interactions; DOSAGE AND ADMINISTRATION, Administration).
Page 10 of 30 Other adverse reactions that have been reported less frequently are:
Cardiovascular: arrhythmias, flushing and angina pectoris Dermatologic: dark sweat, sweating, edema, hair loss, pallor, rash, pruritus Gastrointestinal: nausea and vomiting, constipation, diarrhea, epigastric and abdominal distress or pain, flatulence, eructation, hiccups, sialorrhea, difficulty in swallowing, bitter taste, dry mouth, duodenal ulcer, gastrointestinal bleeding, burning sensation of the tongue General: fever, fatigue and malaise Genitourinary: dark urine, hematuria, nocturia and urinary frequency, retention or incontinence and changes in libido Hematologic: hemolytic anemia, transient leukopenia, agranulocytosis, thrombocytopenia Investigations: non-specific ECG changes, weight variation, body fluids or tissues may be discoloured or stained including saliva, the tongue, teeth or oral mucosa Metabolic and Nutritional: anorexia Musculoskeletal: low back pain, muscle spasm and twitching, musculoskeletal pain Neurologic: ataxia, faintness, impairment of gait, headache, increased hand tremor, akinetic episodes, torticollis, trismus, tightness of the mouth, lips or tongue, oculogyric crisis, weakness, numbness, bruxism and convulsions, loss of taste Ophthalmologic: blurred vision, diplopia, dilated pupils, activation of latent Horner’s syndrome Psychiatric: increased libido with serious antisocial behaviour, euphoria, lethargy, sedation, stimulation, confusion, insomnia, nightmares, hallucinations and/or delusions, agitation, temporal disorientation and anxiety, somnolence and very rarely excessive daytime sleepiness and sudden sleep onset episodes.
Agitation, anxiety, insomnia, hallucinations, delusions and temporal disorientation may occur particularly in geriatric patients and in patients with a history of such disorders. Dopamine dysregulation syndrome (DDS) has been reported.
Respiratory: cough, hoarseness, bizarre breathing pattern, post nasal drip Skin: pruritus, rash Urogenital: urine discoloration Vascular: orthostatic hypotensive episodes, hypertension, phlebitis Progressive impairment of intellectual and autonomic functions has been described, particularly in akinetic patients, after prolonged levodopa therapy.
Pathological (compulsive) gambling has been reported in post-marketing data, including those in the literature, for antiparkinsoninan drugs. Sporadic cases of pathological (compulsive) gambling have been reported in patients treated with dopaminergic agents including levodopa.
Dosage adjustments should be considered in the management of this behaviour. Page 11 of 30 Abnormal Hematologic and Clinical Chemistry Findings Elevations of BUN, serum uric acid, SGOT, SGPT, LDH, bilirubin, alkaline phosphatase or PBI have been observed.
Increase of GGT has also been reported. Positive Coombs’ tests have been observed during extended therapy, both with PROLOPA and with levodopa alone but hemolytic anemia is extremely […]
Currently, 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.
There is insufficient information to determine whether this event is associated specifically with PROLOPA, all dopaminergic agents, or Parkinson´s disease itself. Page 6 of 30 Patients with severe parkinsonism who improve on therapy with PROLOPA should be advised to resume normal activities gradually and with caution as rapid mobilization may increase the risk of injury, especially in those patients with osteoporosis or phlebothrombosis.
Physiotherapy and appropriate safeguards may be useful during this phase. Cardiovascular Care should be exercised in administering PROLOPA to patients with a history of myocardial infarction or who have atrial, nodal or ventricular arrhythmias.
Patients with cardiac abnormalities should have their treatment with PROLOPA initiated in a facility with adequate monitoring equipment and provision for intensive care. Dependence/Tolerance/Abuse PROLOPA may induce dopamine dysregulation syndrome (DDS) resulting in excessive use of the product: A small number of patients suffer from cognitive and behavioural disturbance that can be directly attributed to taking increasing quantities of dopaminergic medication against medical advice and well beyond the dose required to treat their motor disabilities (see WARNINGS AND PRECAUTIONS: Psychiatric, Behavioural Changes).
Endocrine and Metabolism Patients with diabetes should undergo frequent blood sugar tests, and the dosage of antidiabetic agents should be adjusted to blood sugar levels. Gastrointestinal The possibility of upper gastrointestinal hemorrhage occurring in patients with a history of peptic ulcer must be borne in mind when treating them with PROLOPA.
Neurologic PROLOPA is not indicated in the management of intention tremor, Huntington’s chorea, or drug- induced extrapyramidal effects. Since PROLOPA may induce central nervous system side effects shortly after beginning its use, and at lower doses than levodopa alone, it is important to administer the dosage in careful increments and to observe patients carefully for the development of abnormal involuntary movements.
These movements and oscillations in performance may appear earlier with combination therapy. Should they occur, a reduction of dosage is indicated. Patients with a history of convulsive disorders should be treated cautiously if PROLOPA is incorporated into their treatment regimen.
Neuroleptic Malignant-like Syndrome:
PROLOPA must not be withdrawn abruptly. A symptom complex resembling the neuroleptic malignant syndrome, characterized by elevated temperature, muscular rigidity, altered consciousness, autonomic instability, possible psychological changes and elevated serum creatinine phosphokinase has been reported in association with rapid dose reduction, withdrawal of, or changes in antiparkinsonian therapy.
Therefore, withdrawal of treatment should proceed slowly and patients should be monitored carefully when the dosage of PROLOPA is reduced or discontinued. Should a combination of Page 7 of 30 such symptoms occur, the patient should be kept under medical surveillance, hospitalized if necessary, and appropriate symptomatic treatment given.
This may include resumption of therapy with PROLOPA after appropriate evaluation. Ophthalmologic Patients with chronic wide-angle glaucoma can be treated cautiously with PROLOPA, provided the intraocular pressure is well controlled.
The intraocular pressure should be monitored carefully during therapy as levodopa theoretically has the potential to raise intraocular pressure. Rarely pupillary dilatation and activation of latent Horner’s syndrome […]