RITALIN 20MG TABLET

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

सक्रिय संघटक:

METHYLPHENIDATE HYDROCHLORIDE

थमां उपलब्ध:

NOVARTIS PHARMACEUTICALS CANADA INC

ए.टी.सी कोड:

N06BA04

INN (इंटरनेशनल नाम):

METHYLPHENIDATE

डोज़:

20MG

फार्मास्यूटिकल फॉर्म:

TABLET

रचना:

METHYLPHENIDATE HYDROCHLORIDE 20MG

प्रशासन का मार्ग:

ORAL

पैकेज में यूनिट:

100/500

प्रिस्क्रिप्शन प्रकार:

Schedule G (CDSA III)

चिकित्सीय क्षेत्र:

Respiratory and CNS Stimulants

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

CANCELLED POST MARKET

प्राधिकरण की तारीख:

2019-11-07

उत्पाद विशेषताएं

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