Ritemed Celecoxib

Ritemed Celecoxib

celecoxib

Manufacturer:

Lek Pharma

Distributor:

RiteMED
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Symptomatic relief of OA, RA & ankylosing spondylitis.
Dosage/Direction for Use
OA 200 mg once daily or in 2 divided doses. May be increased to 200 mg bid in some patient. RA Initially 200 mg in 2 divided doses. May increase up to 200 mg bid for 2 wk. Ankylosing spondylitis 200 mg once daily or in 2 divided doses; may increase to 400 mg once daily or in 2 divided doses for 2 wk. All indications Max daily dose: 400 mg. Younger adult Initially 200 mg/day, may be increased to 200 mg bid. Hepatic impairment ½ the dose in patient w/ established moderate liver impairment (serum albumin 25-35 g/L).
Administration
May be taken with or without food: Dose of OA/RA may be given w/ or w/o meals.
Contraindications
Hypersensitivity to celecoxib or sulphonamides. History of stroke, CVA; heart attack, MI; CABG; uncontrolled HTN; CHF (NYHA II-IV). Active peptic ulceration or GI bleeding; severe hepatic dysfunction (serum bilirubin <25 g/L or Child-Pugh score score ≥10); inflammatory bowel disease; established ischaemic heart, peripheral arterial &/or cerebrovascular disease. Patients w/ history of asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic reactions after taking acetylsalicylic acid (ASA) or NSAIDs including COX-2 inhibitors. Renal impairment (CrCl <30 mL/min). Pregnancy.
Special Precautions
Upper GI complications (perforations, ulcers or bleedings); fluid retention & edema; renal toxicity; severe hepatic reactions including fulminant hepatitis, liver necrosis & hepatic failure. Not a substitute for ASA for prophylaxis of CV thromboembolic diseases. Patients w/ CV events (eg, HTN, hyperlipidaemia, DM); preexisting edema, onset of new or worsening of existing HTN; known to be CYP2C9 poor metabolisers; history of GI disease, cardiac failure, left ventricular dysfunction or HTN; galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; smoking. Discontinue at the 1st sign of skin rash, mucosal lesions or other signs of hypersensitivity. Avoid concomitant use w/ non-aspirin NSAID & warfarin. Mild or moderate renal impairment. Monitor patients w/ impaired renal, heart & liver function. May mask fever & other signs of inflammation. May affect ability to drive or operate machinery. Not to be used during lactation. Not indicated for childn. Elderly (<50 kg).
Adverse Reactions
HTN. Aggravated allergy; sinusitis, upper resp tract infection, UTI; insomnia; dizziness, hypertonia; MI; pharyngitis, rhinitis, cough, dyspnea; abdominal pain, diarrhea, dyspepsia, flatulence, vomiting, dysphagia; rash, pruritus; peripheral edema/fluid retention, flu-like symptoms.
Drug Interactions
Increased risk of bleeding w/ warfarin or other oral anticoagulants. May reduce effect of diuretics & antihypertensives (eg, ACE inihibitors & angiotensin II receptor antagonists). May increase nephrotoxic effect of ciclosporin & tacrolimus. Increased risk of GI ulceration or other GI complications w/ low-dose ASA. Increased plasma conc of CYP2D6 eg, antidepressants (tricyclics & SSRIs), neuroleptics, antiarrhythmic. Increased Cmax & AUC w/ fluconazole. May increase Cmax & AUC of lithium. May reduce plasma conc w/ CYP2C9 inhibitors 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
Ritemed Celecoxib cap 200 mg
Packing/Price
60's (P19.5/cap, P1,170/box)
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