Torixib

Torixib

etoricoxib

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Acute & chronic treatment of signs & symptoms of OA & RA. Ankylosing spondylitis (AS). Acute gouty arthritis. Primary dysmenorrhea. Moderate to severe acute post-op pain associated w/ abdominal gynecological surgery. Relief of chronic musculo-skeletal pain including chronic low back pain; acute pain including dental surgery.
Dosage/Direction for Use
OA 30 mg or 60 mg once daily. Max: 60 mg daily. RA & AS 60 mg or 90 mg once daily. Min effective daily dose: 60 mg once daily. Max: 90 mg daily. Acute gouty arthritis & primary dysmenorrhea Recommended & max dose: 120 mg once daily. Post-op gynecological pain 90 mg once daily. Administer initial dose shortly before surgery. May increase dose to max 120 mg once daily. Chronic musculo-skeletal pain including chronic low back pain Recommended & max dose: 60 mg once daily. Acute pain 90 mg or 120 mg once daily for max 8 days. Max: 120 mg daily. Post-op dental pain Recommended & max dose: 90 mg once daily. Mild hepatic insufficiency (Child-Pugh score 5-6) Max: 60 mg once daily, moderate hepatic insufficiency (Child-Pugh score 7-9) Max: 60 mg every other day. Consider 30 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active peptic ulceration or GI bleeding. Patients w/ estimated CrCl <30 mL/min; inflammatory bowel disease; CHF (NYHA II-IV); HTN whose BP has not been adequately controlled; established ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease (including patients who recently undergone CABG surgery or angioplasty); who have developed sign of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following administration of aspirin or other NSAIDs. Severe hepatic dysfunction (Child-Pugh score >9). Pregnancy & lactation. Childn <16 yr.
Special Precautions
Not to be used as substitute for aspirin for CV prophylaxis. Discontinue treatment w/ persistent or worsening renal function & abnormal LFTs (3x ULN); at 1st appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity; if patients w/ renal, hepatic, or cardiac dysfunction deteriorate. Exfoliative dermatitis, SJS & TEN. Contraindicated in patients w/ CV or cerebrovascular disease; uncontrolled HTN; MI. History of ischemic heart disease or of paralysis from cerebrovascular disease; history or risk of GI disease (bleeding or ulcers). Increased risk of thrombotic events eg, MI & stroke; GI ulceration or other GI complications. May occur fluid retention & edema. May mask fever. Patients w/ risk factors for CV events eg, HTN, hyperlipidemia, DM, smoking, elderly; dehydration; who have previously experienced acute asthmatic attacks, urticaria, or rhinitis; being treated for infection. Debilitated patients. Monitor renal function in patients w/ pre-existing significantly renal impairment, uncompensated heart failure, or cirrhosis; hepatic function in patients w/ previous abnormal hepatic function tests or sign/symptoms of hepatic dysfunction. Rehydrate patients prior to starting therapy. Maintain <140/90 mmHg BP prior to treatment initiation & consider BP monitoring during treatment. Concomitant use w/ aspirin or other NSAIDs, anticoagulants &/or corticosteroids; alcohol. May affect ability to drive or operate machines. Not recommended in advanced renal disease. Renal papillary necrosis & other renal injury in long-term administration. Not recommended in woman attempting to conceive.
Adverse Reactions
Asthenia/fatigue, flu-like disease, dizziness, headache, oedema/fluid retention, lower extremity edema, HTN, abdominal pain, flatulence, diarrhea, dyspepsia, heartburn, epigastric discomfort, nausea, increased ALT & AST, alveolar osteitis. SJS, TEN.
Drug Interactions
Increased risk of serious bleeding w/ anticoagulant. Reduced blood conc w/ potent CYP3A4 inducer eg, rifampin. Increased MTX plasma conc. Diminished antihypertensive effect of diuretics, ACE inhibitors & AIIAs. Increased lithium plasma levels. Increased rate of GI ulceration or other complications w/ low-dose aspirin. Increased nephrotoxic effect of cyclosporin or tacrolimus. Increased ethinyl estradiol & estrogenic conc. Increased risk of adverse events associated w/ HRT. Increased plasma conc & prolonged t½ of digoxin. Increased exposure of drugs primarily metabolized by human sulfotransferases eg, oral salbutamol & minoxidil.
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
Torixib FC tab 120 mg
Packing/Price
10 × 10's;3 × 10's
Form
Torixib FC tab 60 mg
Packing/Price
10 × 10's;3 × 10's
Form
Torixib FC tab 90 mg
Packing/Price
10 × 10's;3 × 10's
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