PMS-TRYPTOPHAN TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

TRYPTOPHAN

Доступно од:

PHARMASCIENCE INC

АТЦ код:

N06AX02

INN (Међународно име):

TRYPTOPHAN

Дозирање:

1G

Фармацеутски облик:

TABLET

Састав:

TRYPTOPHAN 1G

Пут администрације:

ORAL

Јединице у пакету:

100/250

Тип рецептора:

Prescription

Терапеутска област:

MISCELLANEOUS ANTIDEPRESSANTS

Резиме производа:

Active ingredient group (AIG) number: 0111038001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

1997-05-15

Карактеристике производа

PRODUCT MONOGRAPH
PMS-TRYPTOPHAN
(L-Tryptophan)
500 mg & 1 g Tablets
500mg Capsules
ADJUNCT IN THE MANAGEMENT OF AFFECTIVE DISORDERS
PHARMASCIENCE INC.
Date of Revision:
May 27, 2016
6111 Royalmount Avenue, Suite #100
Montreal, Quebec
H4P 2T4
www.pharmascience.com
CONTROL NUMBER: 194904
_pms-TRYPTOPHAN Product Monograph _
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_Page 2 of 13 _
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PRODUCT MONOGRAPH
PMS-TRYPTOPHAN
(L-Tryptophan) 500 mg & 1 g Tablets
500mg Capsules
THERAPEUTIC CLASSIFICATION
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.
_pms-TRYPTOPHAN Product Monograph _
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_Page 3 of 13 _
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A comparative bioavailability study was performed using pms-TRYPTOPHAN
1 g tablets (Pharmascience
Inc.) _versus _TRYPTAN
®
1 g