For the use of a Registered Medical Practionar or a Hospital or a Laboratory only
Composition
Each film coated tablet contains:
Etoricoxid 90 mg
Excipients: q.s.
Colour: Titanium Dioxide BP
Pharmacological Action
Etoricoxib Is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the cirical dose range. Across cinical pharmacology studies, dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily.
Etoricoxib did not inhibit gastric prostaglandin synthesis and had no effect on platelet function.
Therapeutic category:
Anti-Inflammatory and Antirheumatic drug.
Non-steroids, Coxibs.
Therapeutic Indications
Osteoarthritis (A)
Rheumatoid arthritis (RA)
Ankylosing spondylitis
Pain and signs of inflammation associated with acute gouty arthritis
For the short-term treatment of moderate pain associated with dental surgery
Posology and Method of Administration
Route of Administration: Oral
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.
In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
Rheumatoid Arthritis
The recommended dose is 90 mg once daily.
Ankylosing Spondylitis
The recommended dose is 90 mg once daily.
For acute pain conditions, etoricoxib should be used only for the acute symptomatic period.
Acute Gouty Arthritis
The recommended dose is 120 mg once daily.
In clinical trials for acute gouty anthritis, 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.
Elderly
No dosage adjustment is necessary for elderly patients.
As with other drugs, caution should be exercised in elderly patients.
Renal Insufficiency
No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min.
The use of etoricoxib in patients with creatinine clearance <30 ml/min is contra-indicated.
Paediatric Patients
Etoricoxib is contra-indicated in children and adolescents under 16 years of age.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Active peptic ulceration or active gastro-intestinal (GI) bleeding.
Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions.
Pregnancy and lactation.
Severe hepatic dysfunction.
Estimated renal creatinine clearance <30 ml/min.
Children and adolescents under 16 years of age.
Inflammatory bowel disease.
Congestive heart failure.
Warning & Precautions
Gastrointestinal Effects
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 history of gastrointestinal disease, such as ulceration and GI bleeding.
Cardiovascular Effects
Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, and smoking) should only be treated with etoricoxib after careful consideration.
Renal Effects
Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion.
Therefore, under conditions of compromised renal perfusion, administration of etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function.
Fluid Retention, Oedema and Hypertension
All Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including etoricoxib, can be associated with new onset or recurrent congestive heart failure.
Hepatic Effects
Any patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver 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.
Adverse Effects
The following undesirable effects were reported at an incidence greater than placebo in clinical trials in patients with OA, RA, chronic low back pain or ankylosing spondylitis treated with etoricoxib 30 mg, 60 mg or 90 mg for up to 12 weeks.
Frequency Definitions
Very Common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very Rare (<1/10,000)
Infections and Infestations
Common
Alveolar osteitis
Uncommon
Gastroenteritis
Upper respiratory infection
Urinary tract infection
Blood and Lymphatic System Disorders
Uncommon
Anaemia
Leukopenia
Thrombocytopenia
Immune System Disorders
Very Rare
Hypersensitivity reactions
Angioedema
Anaphylactic/anaphylactoid reactions including shock
Metabolism and Nutrition Disorders
Common
Oedema/fluid retention
Uncommon
Appetite increase or decrease
Weight gain
Psychiatric Disorders
Uncommon
Anxiety
Depression
Mental acuity decreased
Very Rare
Confusion
Hallucinations
Nervous System Disorders
Common
Dizziness
Headache
Uncommon
Dysgeusia
Insomnia
Paresthaesia/Hypaesthesia
Somnolence
Eye Disorders
Uncommon
Blurred vision
Conjunctivitis
Ear and Labyrinth Disorders
Uncommon
Tinnitus
Vertigo
Cardiac Disorders
Common
Palpitations
Uncommon
Atrial fibrillation
Congestive heart failure
Non-specific ECG changes
Angina pectoris
Myocardial infarction
Vascular Disorders
Common
Hypertension
Uncommon
Flushing
Cerebrovascular accident
Transient ischaemic attack
Respiratory, Thoracic and Mediastinal Disorders
Uncommon
Cough
Dyspnoea
Epistaxis
Very Rare
Bronchospasm
Gastrointestinal Disorders
Common
Gastrointestinal disorders
Diarrhoea
Dyspepsia
Epigastric discomfort
Nausea
Uncommon
Abdominal distention
Acid reflux
Bowel movement pattern change
Constipation
Dry mouth
Gastroduodenal ulcer
Irritable bowel syndrome
Very Rare
Peptic ulcers including gastrointestinal perforation and bleeding
Hepatobiliary Disorders
Common
ALT increased
AST increased
Very Rare
Hepatitis
Skin and Subcutaneous Tissue Disorders
Common
Ecchymosis
Uncommon
Facial oedema
Pruritus
Rash
Rare
Erythema
Very Rare
Urticaria
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Musculoskeletal and Connective Tissue Disorders
Uncommon
Muscular cramp/spasm
Musculoskeletal pain/stiffness
Renal and Urinary Disorders
Uncommon
Proteinuria
Serum creatinine increased
Very Rare
Renal insufficiency, including renal failure
General Disorders and Administration Site Conditions
Common
Asthenia/Fatigue
Flu-like disease
Uncommon
Chest pain
Drug Interactions
Oral Anticoagulants
Patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with etoricoxib is initiated or the dose of etoricoxib is changed.
Diuretics, ACE Inhibitors and Angiotensin II Antagonists
NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
Therefore, the combination should be administered with caution, especially in the elderly.
Acetylsalicylic Acid
Concomitant administration of etoricoxib with doses of acetylsalicylic acid above those for cardiovascular prophylaxis or with other NSAIDs is not recommended.
Methotrexate
Etoricoxib at 60 and 90 mg had no effect on Methotrexate plasma concentrations or renal clearance.
Adequate monitoring for Methotrexate-related toxicity is recommended when etoricoxid and Methotrexate are administered concomitantly.
Prednisone/Prednisolone
In drug-interaction studies, etoricoxib did not have clinically important effects on the pharmacokinetics of prednisone/prednisolone.
Etoricoxib 120 mg administered once daily for 10 days to healthy volunteers did not alter the steady-state plasma AUC 0–24 hr or renal elimination of digoxin.
There was an increase in digoxin C (approximately 33%). This increase is not generally important for most patients.
Voriconazole and Miconazole
Co-administration of either oral voriconazole or topical miconazole oral gel, strong CYP3A4 inhibitors, with etoricoxib caused a slight increase in exposure to etoricoxib but is not considered clinically meaningful based on published data.
Rifampicin
Co-administration of etoricoxib with rifampicin, a potent inducer of CYP enzymes, produced a 65% decrease in etoricoxib plasma concentrations.
This interaction may result in recurrence of symptoms when etoricoxib is co-administered with rifampicin.
Antacids
Antacids do not affect the pharmacokinetics of etoricoxib to a clinically relevant extent.
Overdosage
In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the GI tract, employ clinical monitoring, and institute supportive therapy, if required.
Pharmaceutical Information
Storage Conditions
Store in a cool and dry place below 30°C.
Protect from light and moisture.
Keep medicine away from children.
Pack Size
Alu-Alu blisters of 3 × 10 tablets packed in a carton with pack insert.
BPLEF1121
Manufactured for
Vitacura Pharmaceuticals
Porr, Chance - 600 116, INDIA
Website: www.wtacuruin
REDUN PHARMACEUTICALS LTE
Ver B. PagaN. N)./201 404. 1NOI*