Coxbit 200 mg Capsule

    Coxbit 200 mg

    Celecoxib

    Category: Capsule

    Manufacturer: Somatec Pharmaceuticals Ltd.

    Uses of Coxbit: - Pain relief - Osteoarthritis - Rheumatoid arthritis - Pain during menstruation Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis, Dysmenorrhea, Acute pain, Familial adenomatous polyposis Hypersensitivity including those in whom attacks of angioedema, rhinitis and urticaria have been precipitated by aspirin, NSAIDs or sulfonamides. Severe hepatic impairment; severe heart failure; inflammatory bowel disease; peptic ulcer; renal impairment (creatinine clearance <30 mL/min); pregnancy and lactation.
    Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    Celecoxib is a nonsteroidal anti-inflammatory drug that exhibits anti-inflammatory, analgesic and antipyretic activities. The mechanism of action of Celecoxib is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2) and at therapeutic concentrations in humans, Celecoxib does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme.
    How to use Celecoxib: Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Celecoxib may be taken with or without food, but it is better to take it at a fixed time. 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. Adult Dose: Oral Osteoarthritis Adult: 200 mg/day as a single dose or in 2 divided doses. May increase to 200 mg bid, if necessary. Rheumatoid arthritis Adult: 100-200 mg bid. Dysmenorrhoea; Pain relief Adult: Initially, 400 mg followed by 200 mg if necessary on the 1st day. Maintenance: 200 mg bid. Ankylosing spondylitis Adult: Initially, 200 mg/day as a single dose or in 2 divided doses. May increase to 400 mg/day after 6 wk. Hepatic impairment: Moderate (Child-Pugh category B): Reduce dose by 50%. Severe (Child-Pugh category C or ?10 score): Contraindicated. Child Dose: Juvenile idiopathic arthritis Child: >2 yr >10 kg to <25 kg: 50 mg bid; >25 kg: 100 mg bid.
    May increase plasma level w/ CYP2C9 isoenzymes (e.g. fluconazole). May increase serum level of lithium. May reduce effect of antihypertensives and diuretics. May increase anticoagulant effect of warfarin.
    Hypersensitivity including those in whom attacks of angioedema, rhinitis and urticaria have been precipitated by aspirin, NSAIDs or sulfonamides. Severe hepatic impairment; severe heart failure; inflammatory bowel disease; peptic ulcer; renal impairment (creatinine clearance <30 mL/min); pregnancy and lactation.
    Common - Stomach pain - Diarrhea - Flatulence - Flu-like symptoms - Peripheral edema >10% Headache (10-16%),Hypertension (13%) 1-10% Fever (9%),Dyspepsia (8.8%),Upper respiratory tract infection (8.1%),Arthralgia (7%),Cough (7%),Vomiting (6%),Diarrhea (5.6%),Gastroesophageal reflux (5%),Sinusitis (5%),Abdominal pain (4.1%),Nausea (3.5%),Back pain (2.8%),Insomnia (2.3%),Pharyngitis (2.3%),Flatulence (2.2%),Rash (2.2%),Dizziness (2%),Peripheral edema (2%) <1% Anemia,Erythema multiforme,Exfoliative dermatitis,Hepatitis,Jaundice,Stevens-Johnson syndrome,Toxic epidermal necrolysis Frequency Not Defined Increased serum asparate aminotransferase concentration Potentially Fatal: Serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
    Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to fetus. But in late pregnancy Celecoxib should be avoided because it may cause premature closure of ductus arteriosus. It is not known whether Celecoxib is excreted in human milk. Because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from Celecoxib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
    Precaution: History of GI bleeding; renal/hepatic insufficiency; asthma or allergic disorders; hypertension; monitor Hb or haematocrit levels for signs of anaemia. History of cerebrovascular disease or ischaemic heart disease (IHD). Lactation: Drug enters breast milk; use caution
    Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of Celecoxib by hemodialysis but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding.
    Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
    Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor primarily responsible to reduce mediators of pain and inflammation. Its action is due to inhibition of prostaglandin synthesis via inhibition of COX-2.
    Pregnancy category: C; D at >30 weeks' gestation (may cause premature closure of ductus arteriosus) Lactation: Drug enters breast milk; use caution
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