TEVA-TRYPTOPHAN CAPSULE

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TRYPTOPHAN

Disponível em:

TEVA CANADA LIMITED

Código ATC:

N06AX02

DCI (Denominação Comum Internacional):

TRYPTOPHAN

Dosagem:

500MG

Forma farmacêutica:

CAPSULE

Composição:

TRYPTOPHAN 500MG

Via de administração:

ORAL

Unidades em pacote:

100/250

Tipo de prescrição:

Prescription

Área terapêutica:

MISCELLANEOUS ANTIDEPRESSANTS

Resumo do produto:

Active ingredient group (AIG) number: 0111038003; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2002-05-01

Características técnicas

PRODUCT MONOGRAPH
PR
TEVA-TRYPTOPHAN
L-TRYPTOPHAN
500 MG AND 1 G TABLETS
500 MG CAPSULES
ADJUNCT IN THE MANAGEMENT OF AFFECTIVE DISORDERS
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
May 9, 2016
CONTROL NO: 194017
Page 2
PRODUCT MONOGRAPH
PR
TEVA-TRYPTOPHAN
L-TRYPTOPHAN
500 MG AND 1 G TABLETS
500 MG CAPSULES
ADJUNCT IN THE MANAGEMENT OF
AFFECTIVE DISORDERS
ACTION AND CLINICAL PHARMACOLOGY
The rationale for the use of L-tryptophan in affective disorders is
based on clinical
findings more than 20 years ago, that L-tryptophan increases 5-HT
(serotonin)
synthesis in the central nervous system of humans. It has been
demonstrated in clinical
trials that oral ingestion of L-tryptophan in humans caused a
significant increase in the
level of the serotonin metabolite, 5-hydroxyindoleacetic acid
(5-HIAA), in the lumbar
cerebrospinal fluid, indicating an increased turnover of serotonin in
the CNS.
L-tryptophan is one of the eight essential amino acids. The minimum
daily requirements
are said to be 0.25 g for males and 0.15 g for females. It is present
in the hydrolysates
of most proteins, the average western diet containing between 1 and 3
grams per day.
There are two major metabolic pathways for L-tryptophan, the first to
serotonin, the
second to nicotinic acid. Approximately 98% of dietary L-tryptophan is
metabolized into
nicotinic acid and only a very small amount is being metabolized to
serotonin via the
intermediary stage of 5-hydroxy-tryptophan (5-HTP). Tryptophan
hydroxylase, the
enzyme responsible for this step, is the rate-limiting enzyme for
serotonin production
and is normally only about half-saturated. Central nervous system
serotonin is
metabolized by monoamine oxidase to 5-HIAA.
Page 3
INDICATIONS AND CLINICAL USE
L-tryptophan is used as a valuable adjunct to antidepressant drug
treatment in the
management of patients suffering from depressive disorders (bipolar
affective
disorders). An adjunctive effect has been observed in some case when
L-tryptop