Etoxib 90

Indications of Etoxib 90

Etoricoxib is used to treat the symptoms of-

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

 

Pharmaceutical Name of Etoxib 90

Globe Pharmaceuticals Ltd.

 

Pharmacology

Within and substantially above the therapeutic dosage range, etoricoxib is a strong, orally active cyclooxygenase-2 (COX-2) selective inhibitor. There are two isoforms of cyclooxygenase: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) (COX-2). COX-1 is in charge of typical physiologic activities 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 found to be the primary synthase of prostanoid mediators of pain, inflammation, and fever.Etoricoxib's selective inhibition of COX-2 (within the therapeutic dosage range) reduces these clinical signs and symptoms while lowering the risk of Gl toxicity and platelet aggregation. At dosages up to 150 mg daily, etoricoxib showed dose-dependent inhibition of COX-2 but not COX-1 inhibition. Etoricoxib had no effect on the production of prostaglandins in the stomach.

 

Dosage & Administration

Adult and adolescent over 16 years:

• 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.
• 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.

 

Interaction of Etoxib 90

When it comes to medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• 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.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With relation to food and others: Take without consideration to meals.

 

Contraindications

• Hypersensitivity to the active substance or to any of the excipients.
• Active peptic ulceration or active gastro-intestinai (Gl) bleeding.
• 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.
• 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 Etoxib 90

Palpitation, fatigue, influenza-like symptoms, ecchymosis; less frequently, 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 hallucination.

 

Pregnancy & Lactation

Etoricoxib, like any other medication known to suppress COX-2, should not be used by women who are trying to conceive. Etoricoxib is not known to be eliminated in human milk. Etoricoxib is secreted in nursing rats' milk. Breastfeeding is not permitted for women who use Etoricoxib.

 

Precautions & Warnings

• 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.
• Administration of Etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function. Monitoring of renal function in such patients should be considered.
• Caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing edema from any other reason.
• Any patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormalliver function test has occurred, should be monitored. If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times the upper limit of normal) are detected, Etoricoxib should be discontinued.
• 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.

 

Therapeutic Class

Nonsteroidal anti-inflammatory drugs (NSAIDs) 

 

Storage Conditions

Store at a temperature below 30°C and keep away from light and moisture. Keep out of children's reach.

 

Generic of Etoxib 90

Etoricoxib