Zobrex

Zobrex

celecoxib

Manufacturer:

MacroPhar

Distributor:

MacroPhar Lab
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Relief of signs & symptoms of ankylosing spondylitis. Symptomatic treatment of OA & RA. Management of acute pain & low back pain. Primary dysmenorrhea.
Dosage/Direction for Use
Adult Ankylosing spondylitis 200 mg as single dose; may be increased to 400 mg daily if no response after 6 wk. OA 200 mg as single dose; may be increased to 200 mg bid. RA 200 mg bid. 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 once daily, as needed. Low back pain 200 mg or 400 mg daily as a single 200-mg dose or as 100 or 200 mg bid up to total daily dose of 400 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to celecoxib or sulfonamides. History of asthma, urticaria, rhinitis, nasal polyps, angioneurotic edema or allergic-type reaction after taking aspirin or other NSAIDs & COX-2 inhibitors. GI ulceration & bleeding. Severe hepatic impairment (serum albumin <25 g/L or Child-Pugh score ≥10); renal impairment (CrCl <30 mL/min). Gastroenteritis. Severe heart failure (NYHA III-IV). Pregnancy (especially in the 3rd trimester) & lactation. Childn <18 yr.
Special Precautions
History of GI disease, GIT bleeding & perforation. Do not substitute for aspirin for CV prophylaxis. MI. Hepatic impairment, cardiac disease, HTN; erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome.
Adverse Reactions
Abdominal pain, diarrhea, dyspepsia, flatulence, nausea, constipation, gastroenteritis, vomiting, intestinal ulceration, intestinal perforation, esophagitis, gastric bleeding, pancreatitis, aggravated intestinal perforation symptom; headache, vertigo; insomnia, somnolence, confusion, anxiety; bronchitis, rhinitis, sinusitis, upper resp tract infection; rash, photosensitivity, dermatitis, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome; HTN, aggravated HTN, cerebral stroke, vasculitis; MI, heart failure, palpitation; ecchymosis, epistaxis, thrombocytopenia, anemia; edema, blurred vision, acute renal failure, flushing.
Drug Interactions
May diminish antihypertensive effect of ACE inhibitors. Reduce natriuretic effect of furosemide & thiazides. Increased rate of GI ulceration or other complications w/ aspirin. Increased plasma conc w/ fluconazole. Increase plasma level of lithium. Increased risk of bleeding complications w/ warfarin.
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Form
Zobrex cap 200 mg
Packing/Price
10 × 10's;12 × 10's
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