Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
TRYPTOPHAN
APOTEX INC
N06AX02
TRYPTOPHAN
500MG
CAPSULE
TRYPTOPHAN 500MG
ORAL
100
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0111038003; AHFS:
APPROVED
2003-12-09
Page 1 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 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 Page 3 of 15 Perskaitykite visą dokumentą