MUCOSTA

Kraj: Indonezja

Język: indonezyjski

Źródło: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Składnik aktywny:

REBAMIPIDE

Dostępny od:

OTSUKA INDONESIA - Indonesia

INN (International Nazwa):

REBAMIPIDE

Dawkowanie:

100.0 MG

Forma farmaceutyczna:

TABLET SALUT SELAPUT

Sztuk w opakowaniu:

DUS, 10 BLISTER @ 10 TABLET SALUT SELAPUT

Wyprodukowano przez:

OTSUKA INDONESIA - Indonesia

Data autoryzacji:

2020-05-15

Charakterystyka produktu

MUC-PI-0615-001.02
DESCRIPTION
1.
COMPOSITION
Each MUCOSTA Tablet contains 100 mg of rebamipide.
2. PRODUCT DESCRIPTION
BRAND NAME
MUCOSTA TABLETS 100 MG
DESCRIPTION
White film-coated tablets
APPEARANCE
DIAMETER
(MM)
THICKNESS
(MM)
WEIGHT
(MG)
CODE
8.1
3.4
Approx
175
OG
33
INDICATIONS
•
Gastric ulcers
In combination with offensive factor inhibitors (Proton
Pump Inhibitors, Anticholinergic, H
2
-antagonist).
•
Gastritis
CONTRAINDICATIONS
(MUCOSTA
TABLETS
ARE
CONTRAINDICATED IN THE FOLLOWING PATIENTS)
Patients with a history of hypersensitivity to any ingredient of
this drug.
DOSAGE AND ADMINISTRATION
•
Gastric
ulcers:
In
combination
with
offensive
factor
inhibitors the usual adult dosage of rebamipide is 100 mg
(1 tablet of MUCOSTA TABLETS 100 MG) taken by the
oral route three times daily, in the morning, in the evening,
and before at bedtime.
•
Gastritis: The usual adult dosage of rebamipide is 100 mg
(1 tablet of MUCOSTA TABLETS 100 MG) three times
daily taken by the oral route.
PHARMACOLOGY
1.
PREVENTIVE OR HEALING EFFECTS IN GASTRIC ULCER MODELS
Rebamipide inhibited gastric mucosal injury in various
experimental rat models of ulcers, including ulcers induced
by water-immersion restraint stress, aspirin, indomethacin,
histamine, serotonin, and pyloric ligation. The drug also
protected
the
mucosa
from
injury
caused
by
other
ulcerogenic
conditions
that
presumably
yield
reactive
oxygen species, including mucosal ischemia-reperfusion,
administration
of
platelet
activating
factor
(PAF)
or
diethyldithiocarbamate
(DDC),
and
administration
of
indomethacin under stressed conditions.
In a rat acetic acid-induced ulcer model, the drug promoted
healing of gastric ulcers and was seen to suppress the
recurrence and relapse of ulcers 120-140 days after ulcer
induction.
2.
PREVENTIVE OR HEALING EFFECTS IN GASTRITIS MODELS
Rebamipide inhibited the development of taurocholic acid
(one of the main ingredients of bile acid)-induced gastritis
and
promoted
healing
of
the
mucosal
inflammation
associated with gastritis in rat