Land: Canada
Sprog: engelsk
Kilde: Health Canada
HALOPERIDOL
JUNO PHARMACEUTICALS CORP.
N05AD01
HALOPERIDOL
5MG
SOLUTION
HALOPERIDOL 5MG
INTRAMUSCULAR
100
Prescription
Active ingredient group (AIG) number: 0101774001; AHFS:
APPROVED
2023-08-04
- 1 - PRODUCT MONOGRAPH PR HALOPERIDOL INJECTION (Haloperidol) 5 MG/ML Mfr. Std. FOR INTRAMUSCULAR INJECTION ONLY. NOT FOR INTRAVENOUS USE. ANTIPSYCHOTIC AGENT Juno Pharmaceuticals Corp. 402 2233 Argentia Road Mississauga, Ontario L5N 2X7 Submission Control No.: 275660 Date of Preparation: August 04, 2023 - 2 - PR HALOPERIDOL INJECTION 5 MG/ML, 1 ML VIAL THERAPEUTIC CLASSIFICATION Antipsychotic Agent ACTION AND CLINICAL PHARMACOLOGY Haloperidol Injection (intramuscular) 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 alpha-adrenolytic properties. It may also exhibit hypothermic and anorexiant effects, and potentiate the action of barbiturates, general anesthetics, and other CNS depressant drugs. As with other neuroleptics, the mechanism of action of haloperidol has not been clearly established, but it has been shown to be a dopamine receptor antagonist. Peak plasma levels of haloperidol occur within about twenty minutes after intramuscular administration. Protein binding is 90% or more. Haloperidol is extensively metabolized by the liver and the metabolites are subsequently excreted in the urine and feces, _via_ the bile. The half- life of elimination is 21 hours (range 13 to 35 hours). INDICATIONS AND CLINICAL USE Haloperidol Injection (intramuscular) is indicated for the rapid control of the acute manifestations of schizophrenia and manic states. It may also be of value in the management of aggressive and agitated behaviour in patients with chronic brain syndrome and mental retardation and in the symptomatic control of Gilles de la Tourette’s syndrome. - 3 - CONTRAINDICATIONS ▪ Haloperidol Injection (intramuscular) is not to be used intravenously. ▪ Haloperidol Injection (intramuscular) is contraindicated in comatose states and Læs hele dokumentet