Etocox 120

Indications of Etocox 120

• Rheumatoid arthritis (RA)
• The pain and signs of inflammation associated with acute gouty arthritis.
• Etoricoxib is indicated for the symptomatic relief of-
• Osteoarthritis (OA)
• Ankylosing spondylitis, and
• For the short-term treatment of moderate pain associated with dental surgery.

 

Pharmaceutical Name of Etocox 120

General Pharmaceuticals Ltd.

 

Pharmacology

Within and much above the clinical dosing range, etoricoxib is a strong, orally active cyclooxygenase-2 (COX-2) selective inhibitor. Cyclooxygenase has two isoforms: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) (COX-2). COX-1 is responsible for normal physiologic processes mediated by prostaglandins, such as gastric cytoprotection and platelet aggregation. Nonselective NSAIDs that inhibit COX-1 have been linked to stomach damage and platelet aggregation inhibition. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. At doses up to 150 mg daily, etoricoxib provided dose-dependent inhibition of COX-2 without inhibiting COX-1. Etoricoxib had no effect on the production of stomach prostaglandins.

 

Dosage & Administration

• Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy
• Adult and adolescent over 16 years:
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib 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, especially in patients with osteoarthritis.

 

Interactions of Etocox 120

With food & others: Take without regards to meals.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

 

Contraindications

Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.

• Hypersensitivity to the active substance or to any of the excipients.
• Active peptic ulceration or active gastro-intestinai (Gl) bleeding.
• Pregnancy and lactation.
• Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score 10).
• Estimated renal creatinine clearance <30 ml/min.
• Children and adolescents under 16 years of age.
• Inflammatory bowel disease.
• Congestive heart failure (NYHA ll-IV).
• Patients with hypertension whose blood pressure is persistently elevated above 140/90 mmHg and has not been adequately controlled.
• Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.

 

Side-Effects of Etocox 120

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

 

Pregnancy & Lactation

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

 

Precautions & Warnings

• Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Etoricoxib may mask fever and other signs of inflammation. Caution should be exercised when co-administering Etoricoxib with warfarin or other oral anticoagulants.
• Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and Gl bleeding.
• Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with Etoricoxib after careful consideration.

 

Therapeutic Class

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

 

Storage Conditions

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

 

Generic of Etocox 120

Etoricoxib