Land: Kanada
Tungumál: enska
Heimild: Health Canada
TRYPTOPHAN
PHARMASCIENCE INC
N06AX02
TRYPTOPHAN
1G
TABLET
TRYPTOPHAN 1G
ORAL
100/250
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0111038001; AHFS:
APPROVED
1997-05-15
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 _ _ _ _Page 2 of 13 _ _ _ 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 _ _ _ _Page 3 of 13 _ _ _ A comparative bioavailability study was performed using pms-TRYPTOPHAN 1 g tablets (Pharmascience Inc.) _versus _TRYPTAN ® 1 g Lestu allt skjalið