Country: Kanada
Tungumál: enska
Heimild: Health Canada
FLUPENTIXOL DECANOATE
SANDOZ CANADA INCORPORATED
N05AF01
FLUPENTIXOL
100MG
SOLUTION
FLUPENTIXOL DECANOATE 100MG
INTRAMUSCULAR
2ML
Prescription
THIOXANTHENES
Active ingredient group (AIG) number: 0114584002; AHFS:
CANCELLED POST MARKET
2021-04-08
PRODUCT MONOGRAPH Pr FLUPENTIXOL DECANOATE INJECTION BP FLUPENTIXOL INJECTION BP Flupentixol Decanoate BP, 20 mg/mL and 100 mg/mL Sterile ANTIPSYCHOTIC Sandoz Canada Inc. 145 Jules-Léger Boucherville, QC, Canada Date of Revision : July 20, 2011 J4B 7K8 Submission Control No: 141986 _Flupentixol Decanoate Injection BP Page 2 of 18 _ Pr FLUPENTIXOL DECANOATE INJECTION BP FLUPENTIXOL INJECTION BP Flupentixol Decanoate BP, 20 mg/mL and 100 mg/mL Sterile ACTION AND CLINICAL PHARMACOLOGY Flupentixol decanoate is the decanoate ester of a thioxanthene derivative with antipsychotic properties. The esterification of flupentixol results in the slow release of the drug from the injection site with consequent prolongation of duration of action. The onset of action usually occurs in the range of 24 to 72 hours after injection and the improvement of symptoms continues for two to four weeks. However, there is considerable variation in the individual response of patients to flupentixol decanoate and its use for maintenance therapy requires careful supervision. The exact mechanism of action of flupentixol has not been established. Its effects resemble those of the phenothiazine, fluphenazine, in that it belongs among the antipsychotic drugs which are less likely to cause sedation and hypotension, but have greater propensity for producing extrapyramidal reactions. PHARMACOKINETICS: In pharmacokinetic studies measuring flupentixol blood levels, peak concentrations of the drug were found between days 4 and 7, following intramuscular injections of 40 mg of flupentixol decanoate 2% or 10%. It could still be detected in the blood three weeks after injection. The metabolites of flupentixol appear to be inactive. INDICATIONS Flupentixol Decanoate Injection BP (flupentixol decanoate) is indicated in the maintenance therapy of chronic schizophrenic patients whose main manifestations do not include excitement, agitation or hyperactivity. CONTRAINDICATIONS Flupentixol decanoate is contraindicated in patients with known hypersensitivity to th Lestu allt skjalið