FLUPENTIXOL DECANOATE INJECTION BP SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FLUPENTIXOL DECANOATE

Disponible depuis:

SANDOZ CANADA INCORPORATED

Code ATC:

N05AF01

DCI (Dénomination commune internationale):

FLUPENTIXOL

Dosage:

20MG

forme pharmaceutique:

SOLUTION

Composition:

FLUPENTIXOL DECANOATE 20MG

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

10 ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

THIOXANTHENES

Descriptif du produit:

Active ingredient group (AIG) number: 0114584001; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2021-04-08

Résumé des caractéristiques du produit

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