Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
METHYLPHENIDATE HYDROCHLORIDE
NOVARTIS PHARMACEUTICALS CANADA INC
N06BA04
METHYLPHENIDATE
20MG
TABLET (EXTENDED-RELEASE)
METHYLPHENIDATE HYDROCHLORIDE 20MG
ORAL
100
Schedule G (CDSA III)
Respiratory and CNS Stimulants
Active ingredient group (AIG) number: 0107548002; AHFS:
CANCELLED POST MARKET
2022-07-11
PRODUCT MONOGRAPH RITALIN ® (methylphenidate hydrochloride) 10 mg tablets Novartis Standard RITALIN ® SR (methylphenidate hydrochloride extended-release tablets) 20 mg tablets Novartis Standard Central Nervous System Stimulant Novartis Pharmaceuticals Canada Inc. DATE OF PREPARATION: 385 Bouchard Blvd. August 31, 1984 Dorval, Quebec H9S 1A9 REVISION DATE: June 22, 2022 Control No.: 260742 RITALIN is a registered trademark 2 PRODUCT MONOGRAPH NAME OF DRUG RITALIN ® (methylphenidate hydrochloride) Novartis Standard RITALIN ® SR (methylphenidate hydrochloride extended-release tablets) Novartis Standard THERAPEUTIC CLASSIFICATION Central Nervous System Stimulant ACTION AND CLINICAL PHARMACOLOGY RITALIN (methylphenidate hydrochloride) is a racemate consisting of a 1:1 mixture of d- methylphenidate (d-MPH) and l-methylphenidate (l-MPH). RITALIN 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. 3 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 Đọc toàn bộ tài liệu