TEVA-TRYPTOPHAN CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

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제품 특성 요약 제품 특성 요약 (SPC)
11-05-2016

유효 성분:

TRYPTOPHAN

제공처:

TEVA CANADA LIMITED

ATC 코드:

N06AX02

INN (International Name):

TRYPTOPHAN

복용량:

500MG

약제 형태:

CAPSULE

구성:

TRYPTOPHAN 500MG

관리 경로:

ORAL

패키지 단위:

100/250

처방전 유형:

Prescription

치료 영역:

MISCELLANEOUS ANTIDEPRESSANTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2002-05-01

제품 특성 요약

                                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
                                
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