Arcoxia/Arcoxia Ac

Arcoxia/Arcoxia Ac

etoricoxib

Manufacturer:

Organon

Distributor:

Zuellig

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Acute & chronic treatment of signs & symptoms of OA & RA. Ankylosing spondylitis, acute gouty arthritis & primary dysmenorrhea. Relief of chronic low back pain (CLBP) & acute pain. Moderate to severe acute post-op pain associated w/ dental surgery & abdominal gynecological surgery.
Dosage/Direction for Use
OA 30 mg or 60 mg once daily. RA & ankylosing spondylitis 60 mg or 90 mg once daily. CLBP 60 mg daily. Acute pain 90 mg or 120 mg once daily, limited to a max of 8 days. Acute gouty arthritis & primary dysmenorrhea 120 mg once daily. Post-op dental pain 90 mg once daily. Post-op gynecological pain 90 mg once daily. Max: 120 mg once daily. Mild hepatic insufficiency (Child-Pugh score 5-6) 60 mg once daily. Moderate hepatic insufficiency (Child-Pugh 7-9) Dose should be reduced, should not exceed 60 mg every other day. The dose for post-op acute dental & gynecological surgery pain should not exceed 90 & 120 mg/day, respectively.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to etoricoxib & NSAIDs. Patients w/ history of CVA, MI, CABG. Active peptic ulceration or GI bleeding. Previous history of bronchospasm, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or allergic-type reactions after taking aspirin or NSAIDs including COX-2 inhibitors. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Estimated renal CrCl <30 mL/min. Inflammatory bowel disease. CHF (NYHA II-IV). Established ischemic heart disease, peripheral arterial &/or cerebrovascular disease. Inadequately controlled HTN. Pregnancy & lactation. Childn & adolescent <16 yr.
Special Precautions
Serious hypersensitivity reactions (eg, anaphylaxis & angioedema). Use at the shortest possible duration & the lowest effective daily dose to avoid CV risk. Not a substitute for aspirin for CV prophylaxis. Patients at risk of CV events (HTN, hyperlipidemia, DM, smoking), w/ peripheral arterial disease, or w/ preexisting edema, HTN, impaired renal function, uncompensated heart failure or cirrhosis; considerable dehydration. History of GI perforation, ulcers & bleeding. Elderly >65 yr.
Adverse Reactions
Asthenia/fatigue, dizziness, lower extremity edema, HTN, dyspepsia, heartburn, nausea, increased ALT & AST. Thrombocytopenia, hypersensitivity reactions including anaphylactic/anaphylactoid reactions including shock; hyperkalemia, anxiety, insomnia, confusion, hallucinations, depression, restlessness; dysgeusia, somnolence, blurred vision, CHF, palpitations, angina, arrhythmia, hypertensive crisis, bronchospasm, abdominal pain, oral ulcers, peptic ulcer including perforation or bleeding (elderly), vomiting, diarrhea, hepatitis, jaundice; hepatic failure, angioedema, pruritus, erythema, rash, SJS, TEN, urticaria; fixed-drug eruption, renal insufficiency including renal failure.
Drug Interactions
Warfarin, rifampin, MTX, ACE inhibitors & AIIAs, lithium, aspirin, OCs, HRT. Diuretics, NSAIDs.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH05 - etoricoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Form
Arcoxia Ac tab 120 mg
Packing/Price
30's (P87.25/tab)
Form
Arcoxia tab 30 mg
Packing/Price
30's (P62.75/tab)
Form
Arcoxia tab 60 mg
Packing/Price
30's (P62.75/tab)
Form
Arcoxia tab 90 mg
Packing/Price
30's (P70.25/tab)
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