Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
TRYPTOPHAN
TEVA CANADA LIMITED
N06AX02
TRYPTOPHAN
500MG
CAPSULE
TRYPTOPHAN 500MG
ORAL
100/250
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0111038003; AHFS:
APPROVED
2002-05-01
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 Perskaitykite visą dokumentą