Држава: Канада
Језик: Енглески
Извор: Health Canada
HALOPERIDOL (HALOPERIDOL DECANOATE)
SANDOZ CANADA INCORPORATED
N05AD01
HALOPERIDOL
50MG
LIQUID
HALOPERIDOL (HALOPERIDOL DECANOATE) 50MG
INTRAMUSCULAR
1 X 5ML
Prescription
BUTYROPHENONES
Active ingredient group (AIG) number: 0101774007; AHFS:
APPROVED
2005-08-05
_Haloperidol LA _ _ _ _Page 1 of 29 _ PRODUCT MONOGRAPH PR HALOPERIDOL LA (HALOPERIDOL DECANOATE INJECTION) STERILE 50 mg haloperidol/mL 100 mg haloperidol/mL For intramuscular injection only. NOT FOR intravenous use. Antipsychotic Agent Sandoz Canada Inc. Date of Revision: November 13, 2013 145 Jules-Léger Boucherville, QC, Canada J4B 7K8 SUBMISSION CONTROL NO: 167547 _Haloperidol LA _ _ _ _Page 2 of 29 _ HALOPERIDOL LA Haloperidol Decanoate Injection Sterile 50 mg/mL haloperidol 100 mg/mL haloperidol THERAPEUTIC CLASSIFICATION Antipsychotic Agent ACTION AND CLINICAL PHARMACOLOGY Haloperidol decanoate (intramuscular), an ester derivative of haloperidol, possesses the antipsychotic properties of haloperidol. When it is administered as an IM depot in sesame oil, esterases present in blood and tissues hydrolyze haloperidol decanoate to provide a slow release of the active neuroleptic haloperidol from the depot into the systemic circulation. The onset of action occurs within a few days after injection and the therapeutic effect continues for 2 to 4 weeks, although adequate control is frequently maintained with 1 injection every 4 weeks. Careful supervision is required throughout treatment due to the variations in individual patient response. Haloperidol 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 entirely elucidated, but has been attributed to the inhibition of the transport mechanism of cerebral monoamines by haloperidol, particularly by blocking the impulse transmission in dopaminergic neurons. The pharmacokinetics were studied in chronic psychotic patients receiving monthly injections for up to 2 years. The initial dose was based on the observation that the bioavailability of oral halo Прочитајте комплетан документ