Ezy

Ezy200mg

Type:Capsule

Generic Name:Celecoxib

Manufacturer:Eskayef Pharmaceuticals Ltd.

Price:8.00

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Indication

Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis, Dysmenorrhea, Acute pain, Familial adenomatous polyposis

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.

Contraindication

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.

Mode of Action

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.

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

Side Effect

>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.

Pregnancy Category Note

Pregnancy category: C; D at >30 weeks' gestation (may cause premature closure of ductus arteriosus) Lactation: Drug enters breast milk; use caution

Interaction

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.

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