Coxia®

Etoricoxib

Prescribing Details



Description

Coxia® is the preparation of Etoricoxib, a non-steroidal anti­inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic activities. It is a potent, orally active, highly selective cyclooxygenase-2 (COX-2) inhibitor. 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 decreases the clinical signs and symptoms with decreased GI toxicity and without effects on platelet function.


Uses

No Data


Indications

Coxia® is indicated for relief of pain and inflammation in:

• Acute & chronic osteoarthritis                    • Chronic musculoskeletal disorders
• Acute & chronic rheumatoid arthritis      • Dysmenorrhoea
• Acute gout arthritis                                         • Chronic low back pain
• Ankylosing spondylitis                                  • Following dental surgery 


Dosage and administration

Adult and adolescent over 16 years:

• Osteoarthritis, chronic musculoskeletal disorders, dysmenorrhoea & chronic low back pain: 60 mg once daily.
• Rheumatoid arthritis and ankylosing spondylitis: 90 mg, once daily.
• Acute gout & pain following dental surgery: 120 mg, once daily. Safety and effectiveness of Etoricoxib under 16 years of age have not been         established.


Use in pregnancy & lactation

As with other drugs known to inhibit prostaglandin synthesis, use of Etoricoxib should be avoided in late pregnancy because it may cause uterine inertia and premature closure of the ductus arteriosus during the 3rd trimester . It should be used during the first two trimesters of pregnancy only if the potential benefit justifies the potential risk to the foetus.
It is not known whether this drug is excreted in human milk. Mothers who need to take this medicine should not breastfeed.


Geriatric use
No Data

Precautions

In patients with advanced renal disease, treatment with Etoricoxib is not recommended. If therapy with Etoricoxib is initiated in such patients, close monitoring of renal function is advisable. Caution should be used when initiating treatment with Etoricoxib in patients with considerable dehydration. It is advisable to rehydrate patients prior to starting therapy with Etoricoxib. The possibility of fluid retention, oedema or hypertension should be taken into consideration when it is used in patients with pre-existing oedema, hypertension, or heart failure. Independent of treatment, patients with a prior history of GI perforation, ulcers and bleeding (PUB) and patients greater than 65 years of age are known to be at a higher risk for a PUB.

A patient with liver dysfunction, or in whom an abnormal liver function test has occurred, should be evaluated for persistently abnormal liver function tests. If persistently abnormal liver function tests are detected, it should be discontinued. Etoricoxib should be used with caution in patients who have previously experienced acute asthmatic attacks, urticaria, or rhinitis, which were precipitated by salicylates or non-selective cyclooxygenase inhibitors. It may mask fever, which is a sign of infection. 


Side effects
The common side effects of Etoricoxib are dry mouth, taste disturbance, mouth ulcers, gastrointestinal disorder (e.g., abdominal pain, flatulence, heart burn ), nausea, constipation, appetite, fatigue, oedema, weight gain, chest pain, anxiety, hypertension, paraesthesia, influenza-like syndrome & myalgia.

Contraindications

Patients with known hypersensitivity to Etoricoxib, patients with active peptic ulceration or gastrointestinal (GI) bleeding, severe hepatic dysfunction, patients who have developed signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following the administration of acetylsalicylic acid or other NSAIDs, patient having inflammatory bowel disease, severe congestive heart failure.


Drug interactions

Oral anticoagulants (warfarin), diuretics and ACE inhibitors, Lithium, Methotrexate, Rifampicin, Oral contraceptives, Hormone replacement therapy; these drugs may be affected by Etoricoxib.


Overdose
No Data

Preparation

No Data


Pharmaceutical precautions

Store in a cool and dry place. Protect from light.


Presentation

Coxia® 60 mg tablet : Each coated tablet contains Etoricoxib INN 60 mg.
Coxia® 90 mg tablet : Each coated tablet contains Etoricoxib INN 90 mg.
Coxia® 120 mg tablet : Each coated tablet contains Etoricoxib INN 120 mg.


Package quantities

Coxia® 60 mg tablet: Carton of 30 tablets in blister pack.

Coxia® 90 mg tablet: Carton of 30 tablets in blister pack.

Coxia® 120 mg tablet: Carton of 20 tablets in blister pack.