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Celecox

Celecox

celecoxib

Manufacturer:

Centurion Lab

Distributor:

Philgen
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Management of signs & symptoms of OA, RA, juvenile RA (in patients ≥2 yr) & ankylosing spondylitis. Management of acute pain in adults & in primary dysmenorrhea.
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Dosage/Direction for Use
OA 200 mg once daily or in 2 divided doses. May be increased to 200 mg bid in patient w/ insufficient symptomatic relief. RA 200 mg bid in 2 divided doses. May be increased to 200 mg bid if needed. Juvenile RA Patient ≥2 yr weighing >25 kg 100 mg bid, ≥10-≤25 kg 50 mg bid. 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 patient w/ insufficient symptomatic relief. Acute pain & primary dysmenorrhea Initially 400 mg followed by an additional 200 mg if needed in the 1st day. Subsequently, 200 mg bid as needed. Moderate hepatic impairment (Child-Pugh class B) Reduce dose by 50%.
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Overdosage
View Celecox overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Dose for OA/RA may be given w/ or w/o meals, but doses for FAP must be given w/ meals.
Contraindications
Hypersensitivity to celecoxib or sulfonamides. Active peptic ulceration or GI bleeding. Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs including COX-2 inhibitors. Inflammatory bowel disease. CHF (NYHA II-IV). Established ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Patients w/ estimated CrCl <30 mL/min. Women of childbearing potential not using effective contraception. Pregnancy & lactation.
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Warnings
For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Celecox detailed prescribing information
Special Precautions
Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Serious skin reactions including exfoliative dermatitis, SJS & TEN. Not a substitute for aspirin for CV prophylaxis. May cause increased risk of serious CV thrombotic events, MI & stroke; serious GI adverse events including bleeding, ulceration & perforation of the stomach or intestines. May mask fever & other signs of inflammation. Patients w/ history of cardiac failure, left ventricular dysfunction or HTN & w/ preexisting edema from any other reason; taking diuretic or otherwise at risk of hypovolemia. Closely monitor BP during initiation & throughout course of therapy; prothrombin time in patients receiving concomitant warfarin/coumarin-type oral anticoagulants. Avoid concomitant use w/ a non-aspirin NSAID. Concomitant use w/ medicinal products metabolized by CYP2D6. CYP2C9 poor metabolizers. Compromised renal or hepatic function.
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Adverse Reactions
HTN (including aggravated HTN). Sinusitis, URTI, pharyngitis, UTI; hypersensitivity; insomnia; dizziness, hypertonia, headache; MI; rhinitis, cough, dyspnea; nausea, abdominal pain, diarrhea, dyspepsia, flatulence, vomiting, dysphagia; rash, pruritus; arthralgia; flu-like illness, peripheral edema/fluid retention; accidental injury.
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Drug Interactions
Bleeding events in association w/ increases in prothrombin time w/ warfarin. May reduce effect of antihypertensive medicinal products including ACE inhibitors, AIIAs, diuretics & β-blockers. May increase risk of acute renal insufficiency in patients w/ compromised renal function (eg, dehydrated patients, those on diuretics or elderly) w/ ACE inhibitors, AIIAs &/or diuretics. May increase nephrotoxic effect of ciclosporin or tacrolimus. Increased risk of GI ulceration or other GI complications w/ aspirin. May increase plasma conc of medicinal products metabolized by CYP2D6 eg, antidepressants (tricyclics & SSRIs), neuroleptics, anti-arrhythmic medicinal products. Increased Cmax & AUC of lithium. Increased exposure w/ fluconazole. Plasma conc may be reduced w/ CYP2C9 inducers eg, rifampicin, carbamazepine & barbiturates.
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Storage
View Celecox storage conditions for details to ensure optimal shelf-life.
Description
View Celecox description for details of the chemical structure and excipients (inactive components).
Action
View Celecox mechanism of action for pharmacodynamics and pharmacokinetics details.
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
Celecox cap 200 mg
Packing/Price
100's
Form
Celecox cap 400 mg
Packing/Price
100's;20's
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