Celecoxib 200 mg - white to off-white free-flowing granules free from dirt and lumps encapsulated in empty gelatin capsule size #2 with orange cap and yellow body.
Each capsule contains: Celecoxib 200 mg.
Pharmacology: Pharmacodynamics: Celecoxib is an NSAID reported to be a selective inhibitor of cyclo-oxygenase-2 (COX-2), resulting in decreased prostaglandin synthesis, thereby reducing inflammation, fever and pain mechanism. Because celecoxib does not inhibit COX-1 at therapeutic levels, the reduction in symptoms of osteoarthritis and rheumatoid arthritis may have a lower risk of adverse peripheral effects.
Pharmacokinetics: Celecoxib is absorbed from the gastrointestinal tract, peak plasma concentrations being achieved after about 3 hours. Protein binding is approximately 97%. Celecoxib is metabolized predominantly 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 feces and urine; less than 3% is recovered as unchanged drug. The effective terminal half-life is about 11 hours.
Celecoxib is used in the treatment of rheumatoid arthritis and osteoarthritis and in the adjunctive treatment of adenomatous colorectal polyps. Celecoxib is also used in the management of acute pain and dysmenorrhea.
Osteoarthritis: Usual dose is 200 mg daily as a single dose or in 2 divided doses or as prescribed by the physician.
Rheumatoid arthritis: Usual dose is 100 mg to 200 mg given twice daily or as prescribed by the physician.
Treatment of pain and dysmenorrhea: Initial dose of 400 mg followed by an additional dose of 200 mg, if necessary, is recommended on the first day. 200 mg twice daily is given thereafter or as prescribed by the physician.
Treatment of adenomatous colorectal polyps: Usual dose is 400 mg twice daily with food or as prescribed by the physician.
Clinical experience of overdose is limited. Single dose up to 1,200 mg and multiple doses up to 1,200 mg twice daily have been administered to healthy subjects without clinically significant adverse effects. In the event of suspected overdose, appropriate supportive medical care should be provided. Dialysis is unlikely to be an efficient method of drug removal because of high protein-binding of the drug.
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.
Celecoxib should not be given to patients with history of hypersensitivity to sulfonamides. It is also contraindicated to patients with severe heart failure, inflammatory bowel disease and renal impairment associated with a creatinine clearance of less than 30 mL per minute.
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.
Has potential gastrointestinal (gastric and liver) and renal toxicities.
Pregnancy: There are no studies in pregnant women. Studies in animals have shown reproductive toxicity. The relevance of these data for humans is unknown. Celecoxib, as with other drugs inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus and should be avoided during the third trimester of pregnancy. Celecoxib should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss.
Lactation: Studies in rats show that celecoxib is excreted in milk at concentrations similar to those in plasma. Administration to lactating women has shown very low transfer of celecoxib into breastmilk. Because of the potential for 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 expected benefit of the drug to the mother.
The most common side effects occurring during celecoxib therapy are generally gastrointestinal disturbances, such as gastrointestinal discomfort, nausea and diarrhea.
The metabolism of celecoxib is mediated mainly by the cytochrome P450 isoenzyme CYP2C9. Concomitant administration of other drugs that inhibit or are metabolized by this isoenzyme may result in changes in plasma concentrations of celecoxib. Co-administration of fluconazole has resulted in increased plasma concentration of celecoxib. Celecoxib is an inhibitor of the isoenzyme CYP2D6 therefore, individuals with reduced CYP2D6 activity may exhibit potential CYP2D6-associated drug-drug interactions.
Store at temperatures not exceeding 30°C.
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Aubrex cap 200 mg
50's (P26/cap)
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