Ország: Kanada
Nyelv: angol
Forrás: Health Canada
BRETYLIUM TOSYLATE
SANDOZ CANADA INCORPORATED
C01BD02
BRETYLIUM TOSILATE
50MG
SOLUTION
BRETYLIUM TOSYLATE 50MG
INTRAMUSCULAR
10ML
Prescription
CLASS III ANTIARRYTHMICS
Active ingredient group (AIG) number: 0107636001; AHFS:
CANCELLED POST MARKET
2021-04-21
PRODUCT MONOGRAPH PR BRETYLIUM TOSYLATE INJECTION USP 50 MG/ML ANTIARRHYTHMIC Sandoz Canada Inc. Date of preparation: July 4, 2007 145, Jules-Léger Date of revision: Boucherville, QC, Canada J4B 7K8 Control No: 115036 Page 2 of 11 BRETYLIUM TOSYLATE INJECTION USP 50 MG/ML THERAPEUTIC CLASSIFICATION Antiarrhythmic ACTIONS AND CLINICAL PHARMACOLOGY Bretylium, a quaternary ammonium compound is an adrenergic neuron blocking agent. It suppresses ventricular fibrillation and ventricular arrhythmias. The mechanisms of the antifibrillatory and antiarrhythmic actions of bretylium are not established. Bretylium selectively accumulates in sympathetic ganglia and their postganglionic adrenergic neurons where it inhibits norepinephrine release by depressing adrenergic nerve terminal excitability. Catecholamine stores are not depleted by bretylium and parenteral administration of the drug results in initial release of norepinephrine from the adrenergic postganglionic nerve terminals. Subsequently, bretylium blocks the release of norepinephrine in response to neuron stimulation. Reports indicate that the drug has a positive inotropic effect on the myocardium but it is not yet certain that the effect is direct or mediated by catecholamine release. Peripheral adrenergic blockade regularly causes orthostatic hypotension but has less effect on supine blood pressure. The plasma half-life of bretylium is 5 to 10 hours. In 4 normal volunteers who were given a single 4 mg/kg dose of IV bretylium, the half-life averaged 7.8 hours. Bretylium is eliminated intact by the kidneys. Seventy to 80% is excreted unchanged in the urine within 24 hours and an additional 10% excreted over the next 3 days. It is unknown whether bretylium crosses the placenta, but it does not cross the blood-brain barrier. The concentration of bretylium in plasma has not been correlated with the intensity of its antiarrhythmic action and cannot be used to guide individualization of dosage. Page 3 of 11 INDICATIONS AND CLINICAL USE Bretylium Tosylate Injection USP ma Olvassa el a teljes dokumentumot