Torcoxia BCD (Etoricoxib) 60 mg

I. THERAPEUTIC CLASS
ARCOXIA (etoricoxib) is a member of a class of arthritis / analgesis medications called Coxibs.  ARCOXIA is a highly selective inhibitor ofcyclooxygenase-2 (COX-2)

II. INDICATIONS
ARCOXIA is indicated for

• Acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA).
• 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.

The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patientis overall risks (see PRECAUTIONS)

III. DOSAGE AND ADMINISTRATION
ARCOXIA is administered orally. ARCOXIA may be taken with or without food

Arthritis
Osteoarthritis
The recommended dose is 60 mg once daily

Rheumatoid Arthritis
The recommended dose is 90 mg once daily

Acute Gouty Arthritis
The recommended dose is 120 mg once daily and should be used only for the acute symptomatic period, limited to a rnaxirnum of  8 days treatment

Analgesia
Acute Pain associated with dental surgery
The recommended dose is 120 mg once daily and should be used only for the acute symptomatic period, limited to a maximum of 8 days treatment.

Primary Dysmenorrhea
The recommended dose is 60 mg once daily

Chronic rnusculo-skeletal pain, including chow low back pain
The recommended dose is 60 mg once daily.

Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied. Therefore, the dose for each indication is the maximum recommended dose
As the cardiovascular risks of selective COX-2 inhibitors may increase with dose and duration of exposure. the shortest duration possible and the lowest effective daily dose should be used. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically (See PRECAUTIONS).

Elderly, Gender, Race
No dosage adjustment in ARCOXIA 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 every other day should not be exceeded. There are no clinical or pharmacokinetic data in patients with severe hepatic insufficiency (Child-Pugh score >9) (See PRECAUTIONS.)

Renal Insufficiency
In patients with advanced renal disease (creatinine clearance <30 mL/min), treatment with ARCOXIA is not recommenced. No dosage adjustment is necessary for patients with lesser degrees of renal insufficiency (creatinine clearance >30 mL/min) (See PRECAUTIONS)

IV. CONTRAINDICATIONS
ARCOXIA is contraindicated in:

• patients with known hypersensitivity to any component 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 anti-inflammatory drugs (NSAIDs)
  pregnancy and lactation
  children under 16 years of age
  patients with inflammatory bowel disease
  patients with congestive heart failure (NYHA II-1V)
  patients with hypertension whose blood pressure has not been adequately controlled
  patients with established ischernic heart disease, peripheral arterial disease and/or cerebrovasoiar disease including patients who have recently undergone coronary artery bypass graft surgery or angioplasty).

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