Ganaton Film Coated Tablet 50 mg

Country: Bahrain

Language: English

Source: الهيئة الوطنية لتنظيم المهن والخدمات الصحية، مملكة البحرين

Active ingredient:

Itopride HCl

Available from:

Bahrain Pharmacy

INN (International Name):

Itopride HCl

Dosage:

50

Pharmaceutical form:

Film Coated Tablet

Administration route:

Oral

Units in package:

100'

Product summary:

Shelf life: 36 months, Store below 30°C, protect from light & moisture

Authorization status:

Approved

Patient Information leaflet

COMPOSITION
•
Ganaton
(Itopride
hydrochloride)
is
an
orally
active
Gastroprokinetic agent.
•
Ganaton
film
coated
tablets
contain
50
mg
of
itopride
hydrochloride. Abbott specs
•
The tablet has been formulated to provide immediate release.
•
It
is
chemically
designated
as
N-[4-[2
(Dimethylamino)
ethoxy]benzyl]-3,4-dimethoxybenzamide
hydrochloride.
Itopride hydrochloride is a substituted benzamide. It has an
empirical formula of C H N O -HCI, molecular weight of
20
26
2
4
394.89 g/mol.
INDICATIONS
Ganaton (Itopride hydrochloride) is used in the treatment of
gastrointestinal symptoms of
• Functional Dyspepsia
• Non-Ulcer Dyspepsia (chronic gastritis) i.e.,
o Sensation of bloating,
o Early satiety,
o Upper abdominal pain or discomfort,
o Anorexia, o Heartburn,
o Nausea and
o Vomiting.
DOSAGE AND ADMINISTRATION
ADULTS
The recommended dose of Ganaton (Itopride hydrochloride) for
adult patients is 150 mg daily [one tablet (50 mg) taken orally
three times a day before meals].
The dose may be reduced according to the patient's age and
symptoms (see PRECAUTIONS).
PHARMACOLOGICAL PROPERTIES
_MECHANISM OF ACTION_
Ganaton
(Itopride
hydrochloride)
activates
gastrointestinal
propulsive motility due to its dopamine D2 antagonizing activity
and acetylcholinesterase inhibitory activity. Itopride activates
acetylcholine release and inhibits its degradation.
PHARMACODYNAMICS
• Ganaton (Itopride hydrochloride) also has antiemetic action
through
interaction
with
D2
receptors
located
in
the
chemoreceptor trigger zone.
• Ganaton (Itopride hydrochloride) has been shown to accelerate
gastric emptying in humans.
• The
action
of
Ganaton
is
highly
specific
for
the
upper
gastrointestinal tract. Ganaton does not affect serum gastrin
levels.
PHARMACOKMETIC PROPERTIES
_ABSORPTION_ : Ganaton (Itopride hydrochloride) is rapidly and
almost completely absorbed from the gastrointestinal tract.
Relative bioavailability is calculated to be 60% due to liver first
pass metabolism. There is no effect of food on bioavailability.
Peak plasm