Aclexa

Aclexa

celecoxib

Manufacturer:

KRKA

Distributor:

Uni Drug
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Symptomatic relief of OA, RA & ankylosing spondylitis in adults.
Dosage/Direction for Use
Adult OA 200 mg once daily, may increase to 200 mg bd. Max: 400 mg daily. RA Initially 200 mg once daily, may increase to 200 mg bd if needed. Max: 400 mg daily. Ankylosing spondylitis 200 mg once daily, may increase to 400 mg once daily or in 2 divided doses. Max: 400 mg daily. Moderate liver impairment ½ the recommended dose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to celecoxib or suphonamides. Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs including cyclooxygenase-2 inhibitors. Active peptic ulceration or GI bleeding. Inflammatory bowel disease. CHF (NYHA II-IV). Established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Treatment of peri-op pain in CABG surgery. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Patients w/ estimated CrCl <30 mL/min. Women of childbearing potential (unless using an effective contraceptive method). Pregnancy & lactation.
Special Precautions
Patients most at risk of developing GI complication w/ NSAIDs; those w/ CV disease; concomitantly using glucocorticoids, antiplatelets (eg, aspirin) or other NSAIDs; those w/ prior history of GI disease (eg, ulceration, GI bleeding or inflammatory conditions). Avoid concomitant use w/ non-aspirin NSAID. May increase risk of serious CV thrombotic events, MI & stroke; inform patients about signs & symptoms of serious CV toxicity. Carefully consider patients w/ significant risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking). Not a substitute for acetylsalicylic acid for CV thromboembolic disease prophylaxis. May result in renal function deterioration & fluid retention in patients w/ history of cardiac failure, left ventricular dysfunction or HTN, preexisting oedema; patients taking diuretics or at risk of hypovolaemia. Closely monitor BP during initiation & throughout the course of therapy. Maintain medically appropriate supervision for possible compromised renal or hepatic function & especially cardiac dysfunction (more likely in the elderly). May cause renal toxicity; carefully monitor those w/ renal impairment, heart failure, liver dysfunction, those taking diuretics, ACE inhibitors, AIIA. Possible severe hepatic reactions including fulminant hepatitis, liver necrosis & hepatic failure. Consider discontinuation of therapy & take appropriate measures in any deterioration of organ system functions during treatment. Dehydrated patients. May reduce dose for individually dose-titrated drugs metabolised by CYP2D6. Possible serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis; discontinue use at the 1st appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity. May mask fever & other signs of inflammation. Concurrent therapy w/ warfarin & other oral anticoagulants. Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Increased risk of dose-dependent AR in patients who are known, or suspected to be CYP2C9 poor metabolizers or previous history w/ other CYP2C9 substrates. Patients who experience dizziness, vertigo or somnolence should refrain from driving or operating machinery. Not indicated for childn <18 yr. Elderly (particularly w/ body wt <50 kg).
Adverse Reactions
Bronchitis, sinusitis, upper resp tract infection, UTI; insomnia; dizziness; HTN (including aggravated HTN); cough; vomiting, abdominal pain, diarrhea, dyspepsia, flatulence; pruritus (including generalized pruritus), rash; peripheral oedema.
Drug Interactions
Increased risk of bleeding complications w/ warfarin or other anticoagulants. May reduce effects of diuretics & antihypertensives. Possible increased nephrotoxic effect of ciclosporin & tacrolimus. Potential increased risk of GI ulceration or other GI complications in concomitant use w/ low-dose acetylsalicylic acid. Increased plasma conc of CYP2D6 substrate metabolised drug ie, dextromethorphan; may increase plasma conc of other CYP2D6 substrate metabolised drugs [eg, antidepressants (eg, TCAs & SSRIs), neuroleptics, anti-arrhythmics]. Potential inhibition of drugs metabolised by CYP2C19 (eg, diazepam, citalopram & imipramine). Consider monitoring for methotrexate-related toxicity when used in combination w/ methotrexate, in patients w/ RA. Increased Cmax & AUC of lithium. Possible further increased systemic exposure in patients who are CYP2C9 poor metabolisers & demonstrate increased systemic exposure to celecoxib. Increased Cmax & AUC by potent CYP2C9 inhibitor (eg, fluconazole). Plasma conc may be reduced by CYP2C9 inducers (eg, rifampicin, carbamazepine & barbiturates).
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Form
Aclexa hard cap 200 mg
Packing/Price
30 × 1's
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