Maa: Kanada
Kieli: englanti
Lähde: Health Canada
METHYLPHENIDATE HYDROCHLORIDE
PHARMASCIENCE INC
N06BA04
METHYLPHENIDATE
5MG
TABLET
METHYLPHENIDATE HYDROCHLORIDE 5MG
ORAL
100/500
Schedule G (CDSA III)
Respiratory and CNS Stimulants
Active ingredient group (AIG) number: 0107548003; AHFS:
MARKETED
1997-10-24
PRODUCT MONOGRAPH PMS-METHYLPHENIDATE Methylphenidate Hydrochloride Tablets, USP 5 mg, 10 mg, and 20 mg CENTRAL NERVOUS SYSTEM STIMULANT PHARMASCIENCE INC. DATE OF REVISION: 6111 Royalmount Ave. Suite #100 October 17, 2022 Montreal, Quebec H4P 2T4 www.pharmascience.com Submission Control No: 267021 _pms-METHYLPHENIDATE Product Monograph _ _Page 2 of 34_ PRODUCT MONOGRAPH PMS-METHYLPHENIDATE Methylphenidate Hydrochloride Tablets, USP 5 mg, 10 mg, and 20 mg THERAPEUTIC CLASSIFICATION Central Nervous System Stimulant ACTION AND CLINICAL PHARMACOLOGY pms-METHYLPHENIDATE (Methylphenidate Hydrochloride Tablets) is a racemate consisting of a 1:1 mixture of d-methylphenidate (d-MPH) and l-methylphenidate (l-MPH). pms-METHYLPHENIDATE is a mild central nervous system stimulant with more prominent effects on mental than motor activities. The mode of action in man is not completely understood, but its stimulant effects are thought to be due to cortical stimulation and possibly to stimulation of the reticular activating system. There is neither specific evidence, which clearly establishes the mechanism whereby methylphenidate produces its mental and behavioural effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system (CNS). PHARMACOKINETICS ABSORPTION Methylphenidate hydrochloride is rapidly and extensively absorbed from the tablets following oral administration; however, owing to extensive first-pass metabolism, bioavailability is low (approx. 30%) and large individual differences exist (11-52%). In one study, the administration of methylphenidate hydrochloride with food accelerated absorption, but had no effect on the amount absorbed. DISTRIBUTION Peak plasma concentrations of 10.8 and 7.8 ng/mL were observed, on average, 2 hours after administration of 0.30 mg/kg in children and adults, respectively. Peak plasma concentrations showed marked variability between subjects. Both the area under the concentration-time curve (AUC), and the peak plasma concentra Lue koko asiakirja