APO-RANITIDINE 150MG TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

RANITIDINE

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

RANITIDINE

Unit dalam pakej:

60Tablet Tablets

Dikeluarkan oleh:

APOTEX INC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
APO-RANITIDINE TABLET
_ _
Ranitidine (150mg, 300mg)
1
WHAT IS IN THIS LEAFLET
1. What Apo-Ranitidine is used for
2. How Apo- Ranitidine works
3. Before you use Apo- Ranitidine
4. How to use Apo- Ranitidine
5. While you are using it
6. Side Effects
7. Storage and Disposal of Apo-
Ranitidine
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
WHAT APO-RANITIDINE IS USED FOR
Apo-Ranitidine
is
used
for
the
treatment of
•
ulcers
in
the
stomach,
or
the
duodenum including the ulcers
caused by the medicines used in
the treatment of arthritis (non-
steroidal
anti-inflammatory
drugs - NSAIDs).
•
acid
in
the
food
pipe
(oesophagus) or too much acid in
the stomach.
•
Zollinger-Ellison
Syndrome
(a
disease
of
the pancreas
which
causes excess acid production in
the stomach).
•
ulcer after an operation.
•
other conditions where reduction
of gastric secretion is desirable.
In
addition,
Apo-Ranitidine
is
indicated
for
the
prevention
and
maintenance treatment of duodenal or
benign
gastric
ulcer
in
individuals
with a history of recurrent ulceration.
HOW APO-RANITIDINE WORKS
Apo-Ranitidine
works
by
reducing
the amount of acid produced in your
stomach,
relieving
symptoms
associated
with
the
condition
mentioned above.
BEFORE YOU USE APO-RANITIDINE
_ _
_-When you must not use it _
Do not take Apo-Ranitidine if you are
allergic
to
ranitidine
or
any
other
ingredients
of
this
product
(refer
ingredients
under
PRODUCT
DESCRIPTION
).
_-Before you start to use it _
Before you use Apo-Ranitidine, your
doctor needs to know:
1.
if
you
are
allergy
to
any
other
medicines or any other substances
_ _
2. if you have or have had medical
condition especially stomach cancer
and kidney disease.
3. if you are pregnant or intent to
become pregnant
4. if you are breast-feeding or intent to
breast-feed
_-Taking other medicines _
Tell your doctor or pharmacist if you
are
taking
any
other
medicines,
especially
•
Sucralfate (treatment of duodenal
ulcer)
•
W

Ciri produk

APO‐RANITIDINE TABLETS
RANITIDINE HYDROCHLORIDE 150MG AND 300MG
HISTAMINE H
2
‐RECEPTOR ANTAGONIST
PHARMACOLOGY:
Ranitidine is a highly selective histamine H
2
‐receptor antagonist, and a potent inhibitor of gastric acid
secretion. Thus, ranitidine inhibits both basal gastric secretions and
gastric acid secretion induced by
histamine, pentagastrin and other secretagogues. On a weight basis,
ranitidine is between 4 and 9 times
more potent than cimetidine. Inhibition of gastric acid secretion has
been observed following intravenous,
intraduodenal and oral administration of ranitidine and it is dose
related, a maximum response being
achieved at an oral dose of 150mg.
PHARMACOKINETICS:
Ranitidine is rapidly absorbed after oral administration, peak plasma
concentration being achieved within
2 to 3 hours. Plasma concentrations are not significantly influenced
by the
presence of food in the
stomach at the time of oral administration, nor by the presence of
antacids.
Bioavailability of oral ranitidine is approximately 50%. Serum protein
binding of ranitidine in man is in the
range of 10 to 19%. The elimination half‐life is approximately 3
hours. The principal route of excretion is
the urine (cumulative urinary excretion of free and metabolized
ranitidine during 24 hours after an oral
dose of 100mg was approximately 33%).
There is a significant linear correlation between the dose
administered and the inhibitory effect upon
gastric acid secretion for doses up to 150mg. A plasma
ranitidine concentration of 93.6ng/mL (range 48 ‐
125) has an inhibitory effect upon stimulated gastric acid secretion
of approximately 50%. The IC50 of
ranitidine is likely to be in the region of 100ng/mL. Following the
administration of 150mg ranitidine orally,
plasma concentrations in excess of the IC50 (100ng/mL) lasted for more
than 8 hours, and after 12 hours
the plasma concentrations were sufficiently high as to have a
significant inhibitor effect upon gastric acid
secretion. In patients with duodenal ulcer, 150mg ranitidine given b