APO-METHYLPHENIDATE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

METHYLPHENIDATE HYDROCHLORIDE

Disponible depuis:

APOTEX INC

Code ATC:

N06BA04

DCI (Dénomination commune internationale):

METHYLPHENIDATE

Dosage:

5MG

forme pharmaceutique:

TABLET

Composition:

METHYLPHENIDATE HYDROCHLORIDE 5MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Schedule G (CDSA III)

Domaine thérapeutique:

Respiratory and CNS Stimulants

Descriptif du produit:

Active ingredient group (AIG) number: 0107548003; AHFS:

Statut de autorisation:

MARKETED

Date de l'autorisation:

2006-02-01

Résumé des caractéristiques du produit

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