ARCOXIA

Kraj: Indonezja

Język: indonezyjski

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

Składnik aktywny:

ETORICOXIB

Dostępny od:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (International Nazwa):

ETORICOXIB

Dawkowanie:

90.0 MG

Forma farmaceutyczna:

TABLET SALUT SELAPUT

Sztuk w opakowaniu:

DRUM, MAKSIMUM @ 30 KG

Wyprodukowano przez:

ROVI PHARMA INDUSTRIAL SERVICES - Spain

Data autoryzacji:

2021-07-17

Charakterystyka produktu

LOCAL PRODUCT CIRCULAR
TABLETS
ARCOXIA™ (ETORICOXIB, MSD)
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).
• ARCOXIA 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
Arcoxia is contraindicated to patients who have experienced asthma,
urticaria, or allergic-type
reactions after taking aspirin or other NSAID (SEE PRECAUTIONS).
CONGESTIVE HEART FAILURE AND EDEMA
ARCOXIA should be used with caution in patients with fluid retention
or heart failure (see
WARNINGS)
HEPATIC EFFECTS
A 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 ARCOXIA (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 PRECAUTIONS)
THERAPEUTIC CLASS
ARCOXIA* (etoricoxib) is a member of a class of arthritis/analgesia
medications called
Coxibs. ARCOXIA is a highly selective inhibitor of cyclooxygenase-2
(COX-2).
COMPOSITION
Each film coated tablet contains etoricoxib 60 mg (ARCOXIA 60), 90 mg
(ARCO