RITALIN 20MG TABLET

Երկիր: Կանադա

Լեզու: անգլերեն

Աղբյուրը: Health Canada

Ակտիվ բաղադրիչ:

METHYLPHENIDATE HYDROCHLORIDE

Հասանելի է:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC կոդը:

N06BA04

INN (Միջազգային անվանումը):

METHYLPHENIDATE

Դոզան:

20MG

Դեղագործական ձեւ:

TABLET

Կազմը:

METHYLPHENIDATE HYDROCHLORIDE 20MG

Կառավարման երթուղին:

ORAL

Միավորները փաթեթում:

100/500

Ռեկվիզորի տեսակը:

Schedule G (CDSA III)

Թերապեւտիկ տարածք:

Respiratory and CNS Stimulants

Ապրանքի ամփոփագիր:

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

Լիազորման կարգավիճակը:

CANCELLED POST MARKET

Հաստատման ամսաթիվը:

2019-11-07

Ապրանքի հատկությունները

PRODUCT MONOGRAPH
RITALIN
®
(methylphenidate hydrochloride)
10 mg and 20 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 19, 2020
Control No.: 237335
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 concentratio