APO-TRYPTOPHAN TABLET

Country: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

TRYPTOPHAN

থেকে পাওয়া:

APOTEX INC

এটিসি কোড:

N06AX02

INN (International Name):

TRYPTOPHAN

ডোজ:

250MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

TRYPTOPHAN 250MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

Therapeutic area:

ANTIDEPRESSANTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0111038004; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2003-12-09

পণ্য বৈশিষ্ট্য

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PRODUCT MONOGRAPH
APO-TRYPTOPHAN
L-TRYPTOPHAN TABLETS
250 MG, 500 MG, 750 MG AND 1 G
L-TRYPTOPHAN CAPSULES
500 MG
ADJUNCT IN THE MANAGEMENT OF AFFECTIVE DISORDERS
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
December 4, 2003
TORONTO, ONTARIO
DATE OF REVISION:
M9L 1T9
November 2, 2016
CONTROL NO: 193855
Page 2 of 15
PRODUCT MONOGRAPH
APO-TRYPTOPHAN
L-Tryptophan Tablets
250 mg, 500 mg, 750 mg and 1 g
L-Tryptophan Capsules
500 mg
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.
Comparative Bioavailability
Tablets: A comparative bioavailability study was performed using
healthy human
volunteers. The rate and extent of absorption of L-tryptophan was
measured and
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