Ricoxa

Etoricoxib.

Each film-coated tablet contains: Etoricoxib 60 mg, 90 mg, 120 mg.

Relief of symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
Treatment of pain and signs of inflammation associated with acute gouty arthritis.
Relief of chronic musculoskeletal pain and acute pain associated with dental surgery.

RICOXA should be given for the shortest possible duration and the lowest effective daily dose should be used.
Osteoarthritis: The recommended dose is 60 mg once daily.
Rheumatoid arthritis: The recommended dose is 60 mg once daily. In some patients with persistent symptoms, the dose may be increased to 90 mg.
Ankylosing spondylitis: The recommended dose is 60 mg once daily. In some patients with persistent symptoms, the dose may be increased to 90 mg.
Chronic Musculoskeletal Pain: The recommended dose is 60 mg once daily.
Acute Gouty Arthritis: The recommended dose is 120 mg once daily. RICOXA should be used only for periods of acute symptoms limited to a maximum of 8 days.
Postoperative Toothache: The recommended dose is 90 mg once daily.
Doses greater than those recommended for each indication have not shown additional efficacy or have not been studied. Therefore, the dose for each indication is the maximum recommended dose.
Elderly, Gender, Race: No dose adjustment of RICOXA is necessary for the elderly or based on gender or race.
Hepatic insufficiency: In patients with mild hepatic insufficiency (Child-Pugh score 5-6), a dose of 60 mg once daily should not be exceeded. In patients with moderate hepatic insufficiency (Child-Pugh score 7-9), the dose should be reduced; a dose of 60 mg daily should not be exceeded. There are no clinical or pharmacokinetic data in patients with severe hepatic insufficiency (Child-Pugh score >9).
Renal insufficiency: In patients with advanced renal disease (creatinine clearance <30 mL/min), treatment with RICOXA is not recommended. No dose adjustment is necessary for patients with lesser degrees of renal insufficiency (creatinine clearance ≥30 mL/min).

RICOXA is contraindicated in patients with: Hypersensitivity to any component of this product.
Congestive heart failure (NYHA II-IV).
Pre-existing ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass grafting or angioplasty).

Selective COX-2 inhibitors may be associated with an increased risk of thrombotic events (especially MI and stroke). Because the cardiovascular risk of selective COX-2 inhibitors may increase with dose and duration of exposure, the shortest possible duration and lowest effective daily dose should be used. The patient's need for symptom relief and response to therapy should be re-evaluated periodically. Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking) or peripheral arterial disease should only be treated with Etoricoxib after careful consideration.

The following adverse drug reactions were reported in clinical studies in patients with osteoarthritis, rheumatoid arthritis, or chronic low back pain treated for up to 12 weeks. They occurred in ≥1% of patients treated with Etoricoxib and were greater in incidence than placebo: Asthenia/fatigue, dizziness, lower extremity edema, hypertension, dyspepsia, heartburn, nausea, headache, increased alanine aminotransferase, increased aspartate aminotransferase.
These adverse reactions were similar in patients with osteoarthritis or rheumatoid arthritis treated with Etoricoxib for 1 year or longer.
Other adverse reactions: Blood and lymphatic system disorders: Thrombocytopenia.
Immune system disorders: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions including shock.
Metabolic and nutritional disorders: Hyperkalemia.
Psychiatric disorders: Anxiety, insomnia, confusion, hallucinations, depression, poor rest.
Nervous system disorders: Dysgeusia, somnolence.
Eye disorders: Blurred vision.
Cardiac disorders: Congestive heart failure, palpitations, angina, arrhythmias.
Vascular disorders: Hypertensive crisis.
Respiratory, thoracic and mediastinal disorders: Bronchospasm.
Gastrointestinal disorders: Abdominal pain, mouth ulcers, gastric ulcers including perforation and bleeding (especially in elderly patients), vomiting, diarrhea.
Hepatobiliary disorders: Hepatitis, jaundice, liver failure.
Skin and subcutaneous tissue disorders: Angioedema, pruritus, erythema, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, fixed drug eruption.
Renal and urinary tract disorders: Renal insufficiency, including renal failure.

Warfarin, rifampin, methotrexate, angiotensin-converting enzyme inhibitor, lithium, aspirin, oral contraceptives, diuretics, inhibitors & angiotensin II antagonist.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

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

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