Ecopain

Ecopain

celecoxib

Manufacturer:

Yung Shin

Distributor:

Yung Shin
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Symptomatic relief in the treatment of OA, RA & ankylosing spondylitis in adults.
Dosage/Direction for Use
OA 200 mg once daily or in 2 divided doses; may be increased to 200 mg bd in case of insufficient relief from symptoms. RA Initially 200 mg in 2 divided doses; may be increased to 200 mg bd if needed. Ankylosing spondylitis 200 mg once daily or in 2 divided doses; may be increased to 400 mg once daily or in 2 divided doses in case of insufficient relief from symptoms. Max for all indications: 400 mg daily.
Administration
May be taken with or without food: Dose for OA/RA may be given w/ or w/o meals.
Contraindications
Hypersensitivity to celecoxib or to sulfonamides. Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking ASA or NSAIDs including COX-2 inhibitors. Patients w/ severe heart failure; active peptic ulceration or GI bleeding; severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10); estimated CrCl <30 mL/min; inflammatory bowel disease; CHF (NYHA II-IV); established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Treatment of peri-operative pain in the setting of CABG surgery. Women of childbearing potential unless using an effective method of contraception. Pregnancy & lactation.
Special Precautions
Use lowest effective dose for shortest possible time. Discontinue at the 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Risk of upper & lower GI complications (perforations, ulcers or bleedings), especially in patients w/ risk factors for GI complication. Increased risk of CV thrombotic events, MI, & stroke, especially in long-term use & in patients w/ risk factors for CV events. Long-term administration of NSAIDs has resulted in renal papillary necrosis & other renal injury. Risk of renal toxicity, especially in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Not recommended in patients w/ advanced renal disease. Risk of fluid retention & oedema. Can lead to onset of new HTN or worsening of pre-existing HTN; closely monitor BP during treatment initiation & throughout course of therapy. Reports of severe hepatic reactions including fulminant hepatitis, liver necrosis & hepatic failure. May mask fever & other signs of inflammation. Concomitant use w/ CYP2D6 substrates; warfarin or other oral anticoagulants, including novel anticoagulants (eg, apixaban, dabigatran, rivaroxaban). Avoid concomitant non-aspirin NSAIDs. CYP2C9 poor metabolisers; patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; moderate liver impairment w/ serum albumin 25-35 g/L; mild or moderate renal impairment; elderly, especially those w/ body wt <50 kg. Patients who experience dizziness, vertigo or somnolence while taking celecoxib should refrain from driving or operating machinery. May delay or prevent rupture of ovarian follicles, which has been associated w/ reversible infertility in some women. Not indicated for use in childn.
Adverse Reactions
HTN (including aggravated HTN). Sinusitis, URTI, pharyngitis, UTI; hypersensitivity; insomnia; dizziness, hypertonia, headache; MI; rhinitis, cough, dyspnoea; nausea, abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting, dysphagia; rash, pruritus; arthralgia; flu-like illness, peripheral oedema/fluid retention; injury (accidental injury).
Drug Interactions
Increased risk of bleeding w/ warfarin or other anticoagulants. Reduced antihypertensive effects of antihypertensive drugs including ACE inhibitors, AIIA, diuretics & β-blockers. Risk of acute renal insufficiency w/ ACE inhibitors, AIIA &/or diuretics in patients w/ compromised renal function. Increased nephrotoxic effect of ciclosporin or tacrolimus. Increased risk of GI ulceration or other GI complications w/ low-dose ASA. Increased plasma conc of CYP2D6 substrates (eg, dextromethorphan, metoprolol). Consider adequate monitoring for methotrexate-related toxicity when celecoxib & methotrexate are co-administered. Increased Cmax & AUC of lithium. Increased Cmax & AUC w/ potent CYP2C9 inhibitor (eg, fluconazole), especially in individuals who are CYP2C9 poor metabolisers. Reduced plasma conc w/ CYP2C9 inducers eg, rifampicin, carbamazepine, barbiturates.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Form
Ecopain cap 200 mg
Packing/Price
4 × 7's
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