Country: Կանադա
language: անգլերեն
source: Health Canada
HALOPERIDOL
TEVA CANADA LIMITED
N05AD01
HALOPERIDOL
2MG
TABLET
HALOPERIDOL 2MG
ORAL
100/1000
Prescription
BUTYROPHENONES
Active ingredient group (AIG) number: 0101774004; AHFS:
APPROVED
2016-09-12
PRODUCT MONOGRAPH PR TEVA-HALOPERIDOL Haloperidol Tablets USP 0.5, 1, 2, 5, 10 and 20 mg Antipsychotic Teva Canada Limited Date of Revision: 30 Novopharm Court August 26, 2016 Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Control No.: 196054 2 ACTION Haloperidol is a butyrophenone derivative with antipsychotic properties that has been considered particularly effective in the management of hyperactivity, agitation, and mania. Haloperidol is an effective neuroleptic and also possesses antiemetic properties; it has a marked tendency to provoke extrapyramidal effects and has relatively weak alphaadrenolytic properties. It may also exhibit hypothermic and anorexiant effects and potentiates the reaction of barbiturates, general anesthetics and other CNS depressant drugs. As with other neuroleptics, the mechanism of action of haloperidol has not been entirely elucidated, but has been attributed to the inhibition of the transport mechanism of cerebral monoamines, particularly by blocking the impulse transmission in dopaminergic neurons. Peak plasma levels of haloperidol occur within 2 to 6 hours of oral dosing and about 20 minutes after intramuscular administration. The mean plasma (terminal elimination) half-life has been determined at 20.7 ± 4.6 (SD) hours, and although excretion begins rapidly, only 24 to 60% of ingested radioactive drug is excreted (mainly as metabolites in urine, some in feces) by the end of the first week, and very small but detectable levels of radioactivity persist in the blood and are excreted for several weeks after dosing. About 1% of the ingested dose is recovered unchanged in the urine. INDICATIONS AND CLINICAL USES TEVA-HALOPERIDOL (haloperidol) is indicated in the management of manifestations of acute and chronic psychosis, including schizophrenia and manic states. It may also be of value in the management of aggressive and agitated behavior in patients with chronic brain syndrome and mental retardation and in the symptomatic control of Gilles de la Tourette’s syndrome. CONTRAINDIC read_full_document