Occib

Occib

celecoxib

Manufacturer:

Medhaus

Distributor:

Medhaus
Full Prescribing Info
Contents
Celecoxib.
Description
Each capsule contains: Celecoxib 200 mg or 400 mg.
Action
Pharmacology: Pharmacokinetics: Celecoxib is absorbed from the gastrointestinal tract, peak plasma concentrations being achieved after about 3 hours. Protein binding is about 97%. Celecoxib is metabolised in the liver mainly by the cytochrome P450 isoenzyme CYP2C9; the three identified metabolites are inactive as inhibitors of COX-1 or COX-2 enzymes. It is eliminated mainly as metabolites in the faeces and urine; less than 3% is recovered as unchanged drug. The effective terminal half-life is about 11 hours.
Indications/Uses
For the treatment of rheumatoid arthritis (RA), osteoarthritis (OA), and ankylosing spondylitis.
Celecoxib is also used in the management of acute pain and dysmenorrhea.
Dosage/Direction for Use
Osteoarthritis, 200 mg daily in 1-2 divided doses, increased if necessary to a maximum of 200 mg twice daily; Child not recommended.
Rheumatoid arthritis, 100 mg twice daily, increased if necessary to 200 mg twice daily: Child not recommended.
Ankylosing spondylitis, 200 mg daily in 1-2 divided doses, increase if necessary to a maximum of 400 mg daily in 1-2 divided doses; Child not recommended.
Pain and dysmenorrhea, an initial dose of 400 mg followed by an additional dose of 200 mg if necessary is recommended on the first day; thereafter the dose is 200 mg twice daily.
Celecoxib (OCCIB) may be taken with or without food.
Contraindications
Celecoxib is contraindicated: In patients with known hypersensitivity to celecoxib, aspirin, or other NSAIDs.
In patients who have demonstrated allergic type reactions to sulfonamides.
In patients who have experienced asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Severe anaphylactoid reactions to NSAIDs, some of them fatal, have been reported in such patients.
For the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Warnings
Absolute contraindications: Not to be given to those patients who have history of: Stroke: Cerebrovascular accident, CVA; Heart attack: Myocardial infarction, MI; Coronary artery bypass graft: CABG; Uncontrolled hypertension; Congestive heart failure (CHF) NYHA II-IV.
COX-2 inhibitors are not to be given to patients with allergy to NSAIDs and those with asthma.
Exercise caution when prescribing Selective COX-2 inhibitors in patients with ischemic heart disease and those with risk factors for heart disease, hypertension, hyperlipidemia, diabetes, smoking and patients with peripheral arterial disease.
Considering association between cardiovascular risk and exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest duration of treatment.
Intake of COX-2 inhibitors should be stopped with appearance of skin rash and signs of hypersensitivity.
Celecoxib may cause potential gastrointestinal (gastric and liver) and renal toxicities.
Special Precautions
Ischemic heart disease; history/active GI disease e.g. ulceration; bleeding or inflammatory conditions; impaired renal function; impaired liver function (Child-Pugh class B); dehydration; at risk for heart disease; compromised cardiac function; preexisting edema/conditions predisposing to, or worsened by fluid retention; HTN; hyperlipidemia, diabetes, smoking, peripheral arterial disease; volume-depletion. Monitor anticoagulant activity after initiating treatment. Pregnancy & lactation. Elderly.
Use In Pregnancy & Lactation
Use with caution during pregnancy & lactation.
Adverse Reactions
Anaphylaxis, insomnia, dizziness, coughing, abdominal pain, chest pain, diarrhea, hallucinations, ageusia, anosmia, aseptic meningitis, vasculitis, GI hemorrhage, hepatitis, liver & acute renal failure, interstitial nephritis, hyponatremia, pruritus, rash, peripheral edema, serious skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis & drug rash w/ eosinophilia & systemic symptoms); pulmonary embolism.
Drug Interactions
Concomitant use of celecoxib and warfarin may result in increased risk of bleeding complications.
Concomitant use of celecoxib increases lithium plasma levels.
Concomitant use of celecoxib may reduce the antihypertensive effect of ACE Inhibitors and Angiotensin II Antagonist.
Use caution with drugs known to inhibit P450 2C9 or metabolized by 2D6 due to the potential for increased plasma levels.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Cap 200 mg x 100's. 400 mg x 100's.
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