Celxib 200

Celxib 200

celecoxib

Manufacturer:

Unison

Distributor:

Health Alliance
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Symptomatic relief in the treatment of OA, RA & ankylosing spondylitis.
Dosage/Direction for Use
Adult OA 200 mg once daily or in 2 divided doses, may be increased to 200 mg bd. RA 200 mg in 2 divided doses, may be increased to 200 mg bd. Ankylosing spondylitis 200 mg once daily or in 2 divided doses, may be increased to 400 mg once daily or in 2 divided doses. Max recommended daily dose for all indications: 400 mg. Elderly Initially 200 mg daily, may be increased to 200 mg bd. Known or suspected CYP2C9 poor metabolizers Consider reducing dose to ½ the lowest recommended dose. Patient w/ moderate liver impairment (serum albumin 25-35 g/L) Initiate at ½ the recommended dose.
Administration
May be taken with or without food: Dose for OA/RA may be given w/ or w/o meals.
Contraindications
Hypersensitivity to celecoxib & sulfonamides. Active peptic ulceration or GI bleeding. Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic-type reactions after taking acetylsalicylic acid (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. Treatment of peri-operative pain in the setting of CABG surgery. Patients w/ severe heart failure. 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 effective method of contraception. Pregnancy & lactation.
Special Precautions
Skin & systemic hypersensitivity reactions. Upper & lower GI complications (perforations, ulcers or bleedings). Avoid concomitant use w/ a non-aspirin NSAID. CV risks may increase w/ dose & duration of exposure. Fluid retention & edema. Onset of new HTN or worsening of pre-existing HTN; closely monitor BP. Associated w/ serious liver injury. May cause renal toxicity. May be necessary to reduce dose of CYP2D6-metabolised medicinal products. May mask fever & other signs of inflammation. CYP2C9 poor metabolizers. Cirrhotic patients. Patients w/ mild or moderate renal impairment. Not recommended in patients w/ advanced renal disease. Elderly. Not indicated for use in childn.
Adverse Reactions
HTN (including aggravated HTN). Sinusitis, upper resp tract infection, pharyngitis, UTI; hypersensitivity; insomnia; dizziness, hypertonia, headache; MI; rhinitis, cough, dyspnea; nausea, abdominal pain, diarrhea, dyspepsia, flatulence, vomiting, dysphagia; rash, pruritus (includes pruritus generalized); arthralgia; flu-like illness, edema peripheral/fluid retention; injury (accidental injury).
Drug Interactions
Increased risk of bleeding w/ warfarin or other anticoagulants. Reduced effect of antihypertensives (eg, ACE inhibitors, angiotensin II receptor antagonists, diuretics, β-blockers). Increased risk of acute renal insufficiency w/ ACE inhibitors, angiotensin II receptor antagonists &/or diuretics. Increased nephrotoxic effect of ciclosporin or tacrolimus. Increased risk of GI ulceration/complications w/ low-dose acetylsalicylic acid. Increased plasma conc of CYP2D6 substrates (eg, antidepressants (tricyclics & SSRIs), neuroleptics, anti-arrhythmic medicinal products; dextromethorphan, metoprolol). Increased lithium exposure. Increased exposure w/ CYP2C9 inhibitors (eg, fluconazole). Reduced plasma conc w/ 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
Celxib 200 cap 200 mg
Packing/Price
10 × 10's
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