PRESCRIBING INFORMATION
For the use of a Registered Medical Practitioner, Hospital, or Laboratory only
ETCOX - 90
Etoricoxib Tablets 90 mg
Composition
Each film-coated tablet contains:
Etoricoxib 90 mg
Excipients: q.s.
Colour: Titanium Dioxide BP
Pharmacological Action
Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the clinical dose range.
Dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily.
Does not inhibit gastric prostaglandin synthesis.
No effect on platelet function.
Therapeutic category: Anti-inflammatory and antirheumatic drug (Non-steroidal, Coxibs).
Therapeutic Indications
Osteoarthritis (OA)
Rheumatoid arthritis (RA)
Ankylosing spondylitis
Pain and inflammation associated with acute gouty arthritis
Short-term treatment of moderate pain associated with dental surgery
Posology and Method of Administration
Route: Oral
Osteoarthritis: 30 mg once daily; may increase to 60 mg if insufficient relief.
Rheumatoid arthritis: 90 mg once daily.
Ankylosing spondylitis: 90 mg once daily.
Acute gouty arthritis: 120 mg once daily for up to 8 days.
Dental surgery pain: 90 mg once daily, maximum 3 days.
Special populations:
Elderly: No adjustment required, but caution advised.
Renal insufficiency: Contraindicated if creatinine clearance <30 ml/min.
Paediatric: Contraindicated under 16 years of age.
Contraindications
Hypersensitivity to etoricoxib or excipients
Active peptic ulceration or GI bleeding
History of bronchospasm, rhinitis, nasal polyps, angioedema, urticaria, allergic reactions
Pregnancy and lactation
Severe hepatic dysfunction
Renal clearance <30 ml/min
Children/adolescents under 16 years
Inflammatory bowel disease
Congestive heart failure
Warnings & Precautions
Gastrointestinal: Risk of complications in elderly or those with GI history.
Cardiovascular: Use cautiously in patients with risk factors (hypertension, diabetes, smoking).
Renal: May impair renal function under compromised perfusion.
Fluid retention: Risk of oedema and hypertension.
Hepatic: Discontinue if abnormal liver function persists.
Adverse Effects
Very Common, Common, Uncommon, Rare, Very Rare (as per clinical trials):
Infections: Common – alveolar osteitis; Uncommon – gastroenteritis, UTI.
Blood disorders: Uncommon – anaemia, leukopenia, thrombocytopenia.
Immune system: Very rare – hypersensitivity, angioedema, anaphylaxis.
Metabolism: Common – oedema; Uncommon – appetite changes, weight gain.
Psychiatric: Uncommon – anxiety, depression; Very rare – confusion, hallucinations.
Nervous system: Common – dizziness, headache; Uncommon – insomnia, paresthesia.
Cardiac: Common – palpitations; Uncommon – atrial fibrillation, angina, MI.
Vascular: Common – hypertension; Uncommon – flushing, stroke, TIA.
Respiratory: Uncommon – cough, dyspnoea; Very rare – bronchospasm.
GI: Common – diarrhoea, dyspepsia, nausea; Very rare – peptic ulcers, perforation, bleeding.
Hepatic: Common – ALT/AST increase; Very rare – hepatitis.
Skin: Common – ecchymosis; Very rare – Stevens-Johnson syndrome, TEN.
Renal: Uncommon – proteinuria; Very rare – renal insufficiency/failure.
General: Common – fatigue, flu-like illness.
Drug Interactions
Oral anticoagulants: Monitor INR closely.
Diuretics/ACE inhibitors/ARBs: May reduce antihypertensive effect.
Aspirin/NSAIDs: Concomitant use not recommended.
Methotrexate: No significant effect, but monitor toxicity.
Prednisone/prednisolone: No clinically important interaction.
Digoxin: Slight increase in plasma concentration.
Voriconazole/Miconazole: Slight increase in exposure, not clinically significant.
Rifampicin: Reduces plasma concentration by ~65%.
Antacids: No clinically relevant effect.
Overdosage
Supportive measures:
Remove unabsorbed material from GI tract
Clinical monitoring
Symptomatic therapy
Pharmaceutical Information
Storage: Store below 30°C, protected from light and moisture. Keep out of reach of children.
Pack size: Alu-Alu blisters of 3 × 10 tablets in carton with insert.
Code: BPLEF1121
Manufacturer
Vitacura Pharmaceuticals Porr, Chance – 600 116, India Website: www.wtacuruin
REDUN Pharmaceuticals Ltd. Ver B. PagaN. N)./201 404, India
Would you like me to also prepare a one-page summary sheet for quick clinical reference, similar to the Diazepam format?