Страна: Канада
Език: английски
Източник: Health Canada
HALOPERIDOL (HALOPERIDOL DECANOATE)
STRIDES PHARMA CANADA INC
N05AD01
HALOPERIDOL
100MG
SOLUTION
HALOPERIDOL (HALOPERIDOL DECANOATE) 100MG
INTRAMUSCULAR
1ML/5ML
Prescription
BUTYROPHENONES
Active ingredient group (AIG) number: 0101774008; AHFS:
APPROVED
2020-05-27
PRODUCT MONOGRAPH PR HALOPERIDOL DECANOATE INJECTION (HALOPERIDOL DECANOATE INJECTION) 50 MG AND 100 MG HALOPERIDOL/ML STERILE SOLUTION FOR INTRAMUSCULAR INJECTION ANTIPSYCHOTIC AGENT STRIDES PHARMA CANADA INC. DATE OF REVISION: 1565, BOUL. LIONEL-BOULET MAY 27, 2020 VARENNES, QUEBEC CANADA J3X 1P7 SUBMISSION CONTROL NO.: 238030 1 PRODUCT MONOGRAPH Pr Haloperidol Decanoate Injection (Haloperidol Decanoate Injection) 50 mg and 100 mg haloperidol/mL THERAPEUTIC CLASSIFICATION Antipsychotic Agent ACTIONS AND CLINICAL PHARMACOLOGY Haloperidol decanoate, an ester derivative of haloperidol obtained from condensation of haloperidol with decanoic acid possesses the antipsychotic properties of haloperidol. When it is administered as an intramuscular (i.m.) 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 decanoate 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 decanoate 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. PHARMACOKINETICS The pharmacokinetics were studied in chronic psychotic patients receiving monthly injections for up to 2 years. The initial dose was based on the observ Прочетете целия документ