Celxib

Celxib

celecoxib

Manufacturer:

Unison

Distributor:

F.C.P.

Marketer:

F.C.P.
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Symptomatic treatment of OA, RA & ankylosing spondylitis. Management of acute & low back pain. Primary dysmenorrhea.
Dosage/Direction for Use
OA 200 mg as single dose, may be increased to 200 mg bid. RA 200 mg bid. Ankylosing spondylitis 200 mg as a single dose. Total dose: 400 mg daily. Acute pain & primary dysmenorrhea Initially 400 mg followed by an additional 200 mg on the 1st day, if needed; subsequently 200 mg bid or 400 mg daily. Low back pain 200 mg or 400 mg daily as a single dose 200 mg or as 100 mg or 200 mg bid.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to celecoxib &/or sulfonamide. History of asthma, urticaria or allergic-type reaction after taking aspirin or NSAIDs; MI or CHF. Treatment of peri-op pain in CABG surgery.
Special Precautions
Increased risk of serious thrombotic events, MI, stroke & HTN. Monitor BP during initiation of therapy. Patients w/ preexisting CHF or HTN; compromised cardiac function, preexisting edema or other conditions predisposing to or worsened by fluid retention; CV disease. Concomitant use w/ aspirin, glucocorticoids or other NSAIDs; anticoagulants; alcoholics. History of or active GI disease. Impaired renal function, heart failure, liver dysfunction. Dehydrated patients. Advanced renal disease. Discontinue use if skin rash, mucosal lesions or any sign of hypersensitivity occurs. Moderate to severe hepatic impairment (Child-Pugh class B or Child-Pugh C, respectively). Monitor anticoagulation/INR in patients taking warfarin-coumarin-type anticoagulant. Pregnancy & lactation. Elderly.
Adverse Reactions
HTN; diarrhea. Bronchitis, sinusitis, upper resp tract infection, UTI, pharyngitis, rhinitis; insomnia; dizziness; cough; vomiting, abdominal pain, dyspepsia, flatulence; pruritus; rash; peripheral oedema. Ear & fungal infection; MI, angina pectoris; dyspnoea; dysphagia, irritable bowel syndrome, GERD, nausea, diverticulum; increased hepatic enzymes; muscle spasms; nephrolithiasis; vag haemorrhage, prostatitis, BPH; increased blood creatinine, prostatic specific antigen & wt.
Drug Interactions
Increased plasma conc w/ CYP2C9 inhibitors, fluconazole. Decreased plasma conc w/ CYP2C9 inducers. Increased risk of bleeding w/ oral anticoagulants. Increased plasma levels of lithium, dextromethorphan & metoprolol. Diminished effect of antihypertensives. Increased risk of renal impairment w/ ACE inhibitors, AIIAs or diuretics. Increased risk of nephrotoxicity w/ cyclosporine. Reduced natriuretic effect of furosemide & thiazides.
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Form
Celxib cap 400 mg
Packing/Price
1 × 10's;10 × 10's
Form
Celxib cap 200 mg
Packing/Price
1 × 10's;10 × 10's
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