FLUOXETINE-20 - CAP CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE)

Pieejams no:

PRO DOC LIMITEE

ATĶ kods:

N06AB03

SNN (starptautisko nepatentēto nosaukumu):

FLUOXETINE

Deva:

20MG

Zāļu forma:

CAPSULE

Kompozīcija:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 20MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100/500

Receptes veids:

Prescription

Ārstniecības joma:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0116847001; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2010-07-13

Produkta apraksts

PRODUCT MONOGRAPH
FLUOXETINE-10
FLUOXETINE-20
FLUOXETINE HYDROCHLORIDE CAPSULES USP
10 mg and 20 mg
Antidepressant/Antiobsessional/
Antibulimic Agent
Pro Doc Ltée
DATE OF PREPARATION:
2925 boul. Industriel
June 11, 1996
Laval PQ
DATE OF REVISION:
H7L 3W9
September 23, 2005
Control# 096622
1
PRODUCT MONOGRAPH
FLUOXETINE-10 and FLUOXETINE-20
Fluoxetine Hydrochloride Capsules USP
10 mg and 20 mg
THERAPEUTIC CLASSIFICATION
Antidepressant/Antiobsessional/Antibulimic Agent
ACTIONS AND CLINICAL PHARMACOLOGY
The antidepressant, antiobsessional and antibulimic actions of
fluoxetine 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 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
2
duration of action of fluoxetine. The primary route of elimination
appears to be hepatic meta-
bolism to inactive