PONSTAN FCT

Država: Indonezija

Jezik: indonezijščina

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

Aktivna sestavina:

MEFENAMIC ACID

Dostopno od:

PFIZER INDONESIA - Indonesia

INN (mednarodno ime):

MEFENAMIC ACID

Odmerek:

500 MG

Farmacevtska oblika:

TABLET SALUT SELAPUT

Enote v paketu:

DUS, 10 BLISTER @ 10 TABLET SALUT SELAPUT

Izdeluje:

PFIZER INDONESIA - Indonesia

Datum dovoljenje:

2019-01-21

Lastnosti izdelka

Generic Name: Mefenamic acid
Trade Name: PONSTAN
CDS Effective Date: November 01, 2019
Supersedes: August 15, 2018
Approved by BPOM:
2019-0053577
Page 1 of 8
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Mefenamic acid
Trade Name: PONSTAN
CDS Effective Date: November 01, 2019
Supersedes: August 15, 2018
CARDIOVASCULAR RISK
•
NSAIDs may cause an increased risk of serious cardiovascular (CV)
thrombotic
events, myocardial infarction, and stroke, which can be fatal. This
risk may increase with
duration of use. The relative increase of this risk appears to be
similar in those with or
without known CV disease or CV risk factors. However, patients with
known CV disease or
CV risk factors may be at greater risk in terms of absolute incidence,
due to their increased
rate at baseline (see SECTION WARNINGS AND PRECAUTIONS).
•
PONSTAN is contraindicated for the treatment of peri-operative pain in
the setting of
coronary
artery
bypass
graft
(CABG)
surgery
(see
SECTION
WARNINGS
AND
PRECAUTIONS).
GASTROINTESTINAL RISK
•
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including
bleeding, ulceration, and perforation of the stomach or intestines,
which can be fatal. These
events can occur at any time during use and without warning symptoms.
Elderly patients
are at greater risk for serious gastrointestinal events (see SECTION
WARNINGS AND
PRECAUTIONS).
DRUG PRESENTATION
Film-coated tablet.
COMPOSITION
Film-coated tablet: Mefenamic acid 500 mg.
DRUG LIST CLASSIFICATION
Prescription drug.
ACTIONS
Mefenamic
acid
is
non-steroid
anti-inflammation
that
act
by
inhibiting
prostaglandin
synthesis process in body tissue by inhibiting cyclo-oxygenase enzymes
therefore it has
analgesic, anti-inflammation, and anti-pyretic effects.
METABOLISM
Mefenamic acid metabolism is predominantly mediated via cytochrome
P450 (CYP) 2C9 in
the liver. Patients who are known or suspected to be poor CYP2C9
metabolizers based on
previous
history/experience
with
other
CYP2C9
substrates
should
be
administered
mefenamic a