PMS-METHYLPHENIDATE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

METHYLPHENIDATE HYDROCHLORIDE

Διαθέσιμο από:

PHARMASCIENCE INC

Φαρμακολογική κατηγορία (ATC):

N06BA04

INN (Διεθνής Όνομα):

METHYLPHENIDATE

Δοσολογία:

20MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

METHYLPHENIDATE HYDROCHLORIDE 20MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Schedule G (CDSA III)

Θεραπευτική περιοχή:

Respiratory and CNS Stimulants

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0107548002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

1998-12-11

Αρχείο Π.Χ.Π.

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