RITALIN-SR TAB 20MG TABLET (EXTENDED-RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

METHYLPHENIDATE HYDROCHLORIDE

Διαθέσιμο από:

NOVARTIS PHARMACEUTICALS CANADA INC

Φαρμακολογική κατηγορία (ATC):

N06BA04

INN (Διεθνής Όνομα):

METHYLPHENIDATE

Δοσολογία:

20MG

Φαρμακοτεχνική μορφή:

TABLET (EXTENDED-RELEASE)

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:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2022-07-11

Αρχείο Π.Χ.Π.

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