DYNASTAT

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Unit dalam paket:

DUS, 1 VIAL @ 40 MG + 1 AMPUL PELARUT @ 2 ML

Tanggal Otorisasi:

2022-07-18

Karakteristik produk

Generic Name: Parecoxib
Trade Name: DYNASTAT
CDS Effective Date: September 16, 2021
Supersedes: November 01, 2019
Approved by BPOM:
2021-0068271; 2021-0071563
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PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Parecoxib
Trade Name: DYNASTAT
CDS Effective Date: September 16, 2021
Supersedes: November 01, 2019
CARDIOVASCULAR RISK
•
NSAIDs
may
cause
an
increased
risk
of
serious
cardiovascular
thrombotic
events,
myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration
of
use.
Elderly
patients
and patients
with
cardiovascular
disease or
risk factors for
cardiovascular disease may be at greater risk (see WARNINGS).
•
DYNASTAT is contraindicated for the treatment of peri-operative pain
in the setting of
coronary artery bypass graft (CABG) surgery (see WARNINGS).
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 WARNINGS).
ASTHMA AND SKIN REACTION
DYNASTAT
is
contraindicated
to
patients
who
have
experienced
asthma,
urticaria,
or
allergic-type
reactions
after
taking
aspirin
or
other
NSAIDs
(see
WARNINGS
and
PRECAUTIONS).
CONGESTIVE HEART FAILURE AND EDEMA
DYNASTAT should be used with caution in patients with fluid retention
or heart failure (see
WARNINGS).
HEPATIC EFFECTS
Patients with symptoms and/or signs suggesting liver dysfunction, or
in whom an abnormal
liver test has occurred, should be evaluated for evidence of the
development of a more severe
hepatic reaction while on therapy with DYNASTAT (see PRECAUTIONS).
RENAL EFFECTS
Long-term administration of NSAIDs has resulted in renal papillary
necrosis and other renal
injury. Renal toxicity has also been seen in patients in whom renal
prostaglandins have a
compensatory role in the maintenance of renal perfusion (see
WA