Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
METHYLPHENIDATE HYDROCHLORIDE
APOTEX INC
N06BA04
METHYLPHENIDATE
5MG
TABLET
METHYLPHENIDATE HYDROCHLORIDE 5MG
ORAL
100
Schedule G (CDSA III)
Respiratory and CNS Stimulants
Active ingredient group (AIG) number: 0107548003; AHFS:
MARKETED
2006-02-01
Page 1 of 35 PRODUCT MONOGRAPH APO-METHYLPHENIDATE Methylphenidate Hydrochloride Tablets 5 mg, 10 mg and 20 mg tablets USP APO-METHYLPHENIDATE SR Methylphenidate Hydrochloride Extended-Release Tablets 20 mg tablets USP Central Nervous System Stimulant APOTEX INC. Date of Preparation: 150 Signet Drive March 31, 2005 Toronto, Ontario Date of Revision: M9L 1T9 October 5, 2023 Control No: 273392 C C Page 2 of 35 PRODUCT MONOGRAPH NAME OF DRUG APO-METHYLPHENIDATE Methylphenidate Hydrochloride Tablets 5 mg, 10 mg and 20 mg tablets USP APO-METHYLPHENIDATE SR Methylphenidate Hydrochloride Extended-Release Tablets 20 mg tablets USP THERAPEUTIC CLASSIFICATION Central Nervous System Stimulant ACTION AND CLINICAL PHARMACOLOGY Methylphenidate hydrochloride is a racemate consisting of a 1:1 mixture of d-methylphenidate (d-MPH) and l-methylphenidate (l-MPH). APO-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 to 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 Đọc toàn bộ tài liệu