PHL-LOXAPINE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

LOXAPINE (LOXAPINE SUCCINATE)

Dostępny od:

PHARMEL INC

Kod ATC:

N05AH01

INN (International Nazwa):

LOXAPINE

Dawkowanie:

25MG

Forma farmaceutyczna:

TABLET

Skład:

LOXAPINE (LOXAPINE SUCCINATE) 25MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS ANTIPSYCHOTICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0111557001; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2016-10-25

Charakterystyka produktu

PRODUCT MONOGRAPH
PR
PHL-LOXAPINE
Loxapine Succinate Tablets
2.5, 5, 10, 25, and 50 mg
Oral Concentrate
(Loxapine Hydrochloride Solution)
25 mg/ml
ANTIPSYCHOTIC
PHARMEL INC.
DATE OF PREPARATION:
8699 8th Avenue
February 25, 1997
Montréal, Canada
DATE OF REVISION:
H1Z 2X4
June 17, 2004
Control # : 092228, 092229
PRODUCT MONOGRAPH
2
PR
PHL-LOXAPINE
Loxapine Succinate Tablets
Oral Concentrate
(Loxapine Hydrochloride Solution)
THERAPEUTIC CLASSIFICATION
Antipsychotic
ACTION AND CLINICAL PHARMACOLOGY
Loxapine succinate, a tricyclic dibenzoxazepine antipsychotic agent,
which is clinically distinct from
the phenothiazines, thioxanthenes and butyrophenones, produces
pharmacologic responses in
various animal species which are characteristic of those seen with the
majority of anti-psychotic
drugs.
Loxapine succinate is an antipsychotic drug which exhibits many of the
actions common to this
broad class of drugs. Loxapine succinate has proven to be of value in
the management of both acute
and chronic schizophrenia. As in the case of other antipsychotics, the
mode of action has not been
clearly established, but is postulated to involve changes in synaptic
transmission at the subcortical
level of the brain, resulting in strong inhibition of spontaneous
motor activity.
Absorption of orally administered loxapine succinate tablets and oral
concentrate in man is rapid and
virtually complete following a single 25 mg dose. After administration
of the oral concentrate
somewhat higher and earlier peak serum levels may be expected
initially than after tablet
administration. The mean serum concentrations of unmetabolized
loxapine succinate during the
period of 1 to 4 hours after oral dosage were approximately half the
concentrations following
intramuscular injection of 25 mg. Signs of sedation in normal
volunteers appear generally within
30 minutes for oral and parenteral administration. Duration of
sedation with the tablets may last
through a 12-hour period; the average was found to be close to three
hours. When multiple doses
were gi