Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
FLUOXETINE (FLUOXETINE HYDROCHLORIDE)
SEPRACOR PHARMACEUTICALS INC
N06AB03
FLUOXETINE
40MG
CAPSULE
FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 40MG
ORAL
100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0116847004; AHFS:
CANCELLED POST MARKET
2011-08-03
PRODUCT MONOGRAPH FXT 40 FLUOXETINE CAPSULES USP 40 MG (AS FLUOXETINE HYDROCHLORIDE) ANTIDEPRESSANT/ANTIOBSESSIONAL/ANTIBULIMIC MANUFACTURED BY: Sepracor Pharmaceuticals, Inc. 6790 Century Ave., Suite 100 Mississauga, ON CANADA L5N 2V8 Control#: 132258 DATE OF PREPARATION: September 2, 2009 2 NAME OF DRUG FXT 40 Fluoxetine Capsules USP 40 mg (as fluoxetine hydrochloride) THERAPEUTIC CLASSIFICATION Antidepressant/Antiobsessional/Antibulimic Agent ACTIONS The antidepressant, antiobsessional, and antibulimic actions of FXT (Fluoxetine Capsules USP) are presumed to be linked to its ability to selectively inhibit the neuronal reuptake of serotonin. At clinically relevant doses fluoxetine blocks the uptake of serotonin into human platelets. Antagonism of muscarinic, histaminergic and α 1 -adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative and cardiovascular effects of classical tricyclic antidepressant drugs. In vitro receptor binding studies have demonstrated that fluoxetine binds to these and other membrane receptors [opiate, serotonergic (5-HT 1 , 5-HT 2 ), adrenergic (α 1 , α 2 , β) and dopaminergic] much less potently than do the tricyclic drugs. PHARMACOKINETICS: Fluoxetine is well absorbed after oral administration. In man, following a single oral 40 mg dose, peak plasma concentrations of fluoxetine from 15 to 55 ng/mL are observed after 6 to 8 hours. Food does not appear to affect the systemic bioavailability of fluoxetine, although it may delay its absorption inconsequentially. Thus fluoxetine may be administered with or without food. Fluoxetine is extensively metabolized in the liver to norfluoxetine, and other unidentified metabolites. The pharmacological activity of norfluoxetine, which is formed by demethylation of fluoxetine appears to be similar to that of the parent drug. Norfluoxetine contributes to the long 3 duration of action of fluoxetine. The primary route of elimination appears to be hepatic metabolism to inactive metabolites excreted by the kid Perskaitykite visą dokumentą