CELEXIB Celecoxib 200mg Capsule 1's
RXDRUG-DRP-5502-1pc
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Features
Brand
Celexib
Full Details
Dosage Strength
200 mg
Drug Ingredients
- Celecoxib
Drug Packaging
Capsule 1's
Generic Name
Celecoxib
Dosage Form
Capsule
Registration Number
DRP-5502
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Celecoxib is used for pain and inflammation osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and in the adjunctive treatment of adenomatous colorectal polyps. Celecoxib is also used in the management of acute pain and dysmenorrhea.
Dosage/Direction for Use
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.
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.
Administration
May be taken with or without food: OA/RA: Take w/ or w/o meals. Adenomatous colorectal polyps: Take w/ meals.
Contraindications
Allergy to NSAIDs. Asthma. Patients w/ history of CVA, MI, CABG, uncontrolled HTN, CHF; ischemic heart disease & w/ risk factors for heart disease, HTN, hyperlipidemia, diabetes, smoking & w/ peripheral arterial disease. Potential GI & renal toxicities.
Warnings
Absolute contraindications: Not to be given to those patients who have a 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.
Warning statement should include potential gastrointestinal (gastric and liver) and renal toxicities.
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.
Warning statement should include potential gastrointestinal (gastric and liver) and renal toxicities.
Special Precautions
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.
Adverse Reactions
The most common adverse effects occurring during celecoxib therapy are generally gastrointestinal disturbances, such as gastrointestinal discomfort, nausea and diarrhea.
Drug Interactions
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 concentration of Celecoxib co-administration of Fluconazole has resulted in increased plasma concentrations of celecoxib. Celecoxib is an inhibitor of the isoenzyme CYP2D6 and the potential therefore exists for an effect on drugs metabolized by this enzyme.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: 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.
MedsGo Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
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