JAMP RASAGILINE is a brand name for Rasagiline, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS....................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations: The recommended and maximum dose in both monotherapy and adjunct therapy is 1 mg once daily. JAMP Rasagiline can be taken with or without food. There is no evidence that additional benefit will be obtained from the administration of doses higher than that recommended.
Furthermore, higher doses will likely result in a loss of selectivity of rasagiline towards MAO-B with an increase in the inhibition of MAO-A. There is an increased risk of adverse reactions with higher doses as well as an increased risk of hypertensive episode (“cheese reaction”) (see WARNINGS AND PRECAUTIONS, Tyramine/rasagiline interaction).
Monotherapy The recommended JAMP Rasagiline dose for the treatment of Parkinson’s disease patients is 1 mg administered once daily. Adjunctive Therapy to Dopamine Agonists The recommended JAMP Rasagiline dose as adjunctive therapy to dopamine agonists is 1 mg administered once daily.
5 – 1 mg once daily. 5 mg administered once daily. If a sufficient clinical response is not achieved, the dose may be increased to 1 mg administered once daily.
Change of levodopa dose in adjunct therapy:
When JAMP Rasagiline is used in combination with levodopa a reduction of the levodopa dosage may be considered based upon individual response. During the controlled trials of rasagiline mesylate as adjunct therapy to levodopa, levodopa dosage was reduced in some patients.
In clinical studies, dosage reduction of levodopa was allowed within the first 6 weeks if dopaminergic side effects, including dyskinesia and hallucinations, emerged. 5 mg/day and 1 mg/day rasagiline groups, respectively. 5 mg/day, and 1 mg/day groups, respectively.
In the LARGO study levodopa dosage reduction occurred in 6% of patients in the placebo group and in 9% in the rasagiline 1 mg/day group. In patients who had their levodopa dosage reduced, the dose was reduced on average by about 13% and 11% in the placebo and the rasagiline groups, respectively.
Patients with Hepatic Impairment:
JAMP Rasagilineplasma concentration will increase in patients with hepatic impairment. 5 mg daily of JAMP Rasagiline. JAMP Rasagiline should not be used in patients with moderate to severe hepatic impairment. If patients progress from mild to moderate hepatic impairment, JAMP Rasagiline should be stopped (see ACTION AND CLINICAL PHARMACOLOGY, Population pharmacokinetics, Hepatic Impairment and WARNINGS AND PRECAUTIONS, Product Monograph of Jamp Rasagiline Page 19 of 43 Hepatic Impairment).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Rasagiline in Canada.
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Patients with Renal Impairment:
Conclusive data are not available for renally impaired patients. As unconjugated rasagiline is not excreted by the kidney, rasagiline can be given at usual doses in patients with mild renal impairment. Due to the absence of adequate safety data, rasagiline should not be administered to patients with moderate to severe renal impairment.
Patients Taking Ciprofloxacin and Other CYP1A2 Inhibitors:
Rasagiline plasma concentrations are expected to double in patients taking concomitant ciprofloxacin and other CYP1A2 inhibitors. 5 mg daily of JAMP Rasagiline (see ACTION AND CLINICAL PHARMACOLOGY, Drug-Drug Interaction Ciprofloxacin and Effect of other drugs on the metabolism of JAMP Rasagiline; and WARNINGS, Ciprofloxacin and Other CYP1A2 Inhibitors).
OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre immediately. Symptoms Symptoms reported following overdose of rasagiline mesylate in doses ranging from 3 mg to 100 mg include dysphoria, hypomania, hypertensive crisis, and serotonin syndrome.
The following description of presenting symptoms and clinical course is based upon overdose descriptions of non-selective MAO inhibitors. Characteristically, signs and symptoms of non-selective MAOI overdose may not appear immediately.
Delays of up to 12 hours between ingestion of drug and the appearance of signs may occur. Importantly, the peak intensity of the syndrome may not be reached for upwards of a day following the overdose. Death has been reported following overdosage.
Therefore, immediate hospitalization, with continuous patient observation and monitoring for a period of at least two days following the ingestion of such drugs in overdose, is strongly recommended. The clinical picture of MAOI overdose varies considerably; its severity may be a function of the amount of drug consumed.
The central nervous and cardiovascular systems are prominently involved. Signs and symptoms of overdosage may include, alone or in combination, any of the following: drowsiness, dizziness, faintness, irritability, hyperactivity, agitation, severe headache, hallucinations, trismus, opisthotonos, convulsions, and coma; rapid and irregular pulse, hypertension, hypotension and vascular collapse; precordial pain, respiratory depression and failure, hyperpyrexia, diaphoresis, and cool, clammy skin.
In the post-marketing period, serotonin syndrome has been reported in a patient erroneously treated with a higher than recommended dose of rasagiline mesylate (4 mg daily) and tramadol. Product Monograph of Jamp Rasagiline Page 20 of 43 Treatment There is no specific antidote for rasagiline overdose.
The following suggestions are offered based upon the assumption that rasagiline overdose may be modeled after non-selective MAO inhibitor poisoning. Treatment of overdose with non-selective MAO inhibitors is symptomatic and […]