Arcona

Etoricoxib.

Pharmacology: Pharmacodynamics/Pharmacokinetics: Etoricoxib is well absorbed from gastrointestinal tract after oral dose. Peak plasma concentration occurred in about 1 hour in fasted adults; food delays absorption by about 2 hours. Plasma protein binding is about 92%. At steady state the half-life of etoricoxib is about 22 hours. Etoricoxib is extensively metabolized with less than 2% of a dose recovered in the urines in the parent drug. The major route of metabolism is via cytochrome P450 isoenzymes including CYP3A4 to form the 6'-hydroxymethyl derivative of etoricoxib, which is then oxidized to the 6'-carboxylic acid derivative, the major metabolite. Both are inactive or only weak cyclooxygenase-2 (COX-2) inhibitor. Excretion is mainly via the urine (70%) with only 20% of a dose appearing in the faeces. Studies in animals suggest that etoricoxib may cross the placenta and that some is distributed into breast milk.

ARCONA (120 mg) is non-steroidal anti-inflammatory drug (NSAIDs) in a member of a class called coxibs. ARCONA (120 mg) is a highly selective inhibitor of cyclooxygenase-2 (COX-2).
ARCONA (120 mg) is indicated for: Acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA); Treatment of ankylosing spondylitis; Treatment of acute gouty arthritis; Relief of chronic musculo-skeletal pain, including chronic low back pain; Relief of acute pain associated with dental surgery; Treatment of primary dysmenorrhea; Treatment of postoperative gynecological surgery pain.
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see PRECAUTIONS).

ARCONA (120 mg) is administered orally and may be taken with or without food.
Osteoarthritis: 30 mg or 60 mg once daily.
Rheumatoid Arthritis (Acute & Chronic): 90 mg once daily.
Ankylosing spondylitis: 90 mg once daily.
Acute Gouty arthritis: 120 mg once daily. Used only for the acute symptomatic period limited to a maximum of 8 days.
Relief of chronic musculo-skeletal pain, including chronic low back pain: 60 mg once daily.
Primary dysmenorrhea: 120 mg once daily, limited to a maximum of 8 days treatment.
Relief of acute pain associated with dental surgery: 90 mg once daily, limited to a maximum of 3 days treatment.
Postoperative gynecological surgery pain: 90 mg once daily, limited to a maximum of 5 days treatment.

In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. Etoricoxib is not dialyzable by hemodialysis; it is not known whether etoricoxib is dialyzable by peritoneal dialysis.

ARCONA (120 mg) is contraindicated in: Patients with known hypersensitivity to any components of this product.
Patients with active peptic ulceration or gastro-intestinal (GI) bleeding.
Patients with severe hepatic dysfunction (Child-Pugh score > 9).
Patients with estimated creatinine clearance < 30 ml/min.
Patients who have developed signs of asthma, acute rhinitis, nasal polyps angioneurotic oedema or urticaria following the administration of aspirin or other non-steroidal anti­inflammatory drugs (NSAIDs).
Pregnancy and lactation.
Children under 16 years of age.
Patients with inflammatory bowel disease.
Patients with congestive heart failure (NYHA II-IV).
Patients with hypertension whose blood pressure has not been adequately controlled.
Patients with established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass graft surgery or angioplasty).

Based on the Ministry of public Health Announcement: Contraindicated in patients with known hypersensitivity to any components of this product, pregnancy and lactation.
Contraindicated in patients who have recently undergone coronary artery bypass graft surgery (immediately postoperative period).
Contraindicated in patients with cardiovascular or cerebrovascular disease.
Contraindicated in patients with un-controlled hypertension.
Contraindicated in patients with myocardial infarction or congestive heart failure NYHA II-IV.
Contraindicated in patients with history of ischemic heart disease or history of paralysis from cerebrovascular disease.
Caution should be used in patients with risk factors for cardiovascular events e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking, elderly etc.
Caution should be used in patients with liver and kidney disorders.

Contraindicated in pregnancy. Discontinue nursing or discontinue the drug because etoricoxib is excreted in the milk of lactating rats.

Cardiovascular: Edema, hypertension, palpitation.
Central nervous system: Dizziness, fatigue, headache.
Dermatologic: Bruising.
Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, flatulence, heartburn, nausea.
Hepatic: ALT increased, AST increased.
Neuromuscular & skeletal: Weakness.
Miscellaneous: Alveolar osteitis, flu-like syndrome.

Concomitant use with anticoagulants such as warfarin may cause bleeding.
Concomitant use with NSAIDs such as ibuprofen, diclofenac, naproxen may cause gastro-intestinal (GI) bleeding.
Patients at high risk of digoxin toxicity should be monitored for this effect when etoricoxib and digoxin are administered concomitantly.
Selective COX-2 inhibitors may increase plasma lithium levels, when taking concomitantly.

Store below 30°C.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AH05 - etoricoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.

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