Celecoxib indicated for relief of the signs and symptoms of osteoarthritis, for relief of the signs and symptoms of rheumatoid arthritis; for relief of pain after dental extraction; for reduction of colorectal polyps in Familial Adenomatous Polyposis (FAP)
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.
Dosage & Administration
Osteoarthritis: The recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.
Rheumatoid arthritis: The recommended oral dose is 100 to 200 mg twice daily.
Familial adenomatous polyposis (FAP): The recommended oral dose is 400 mg twice daily to be taken with food.
Dental pain: Single dose of Celecoxib 100 mg to 400 mg
Furosemide: NSAIDs can reduce the matriuretic effect of furosemide and thiazides in some patients.
Fluconazole: Concomitant administration of fluconazole at 200 mg QD resulted in a two-fold increase in celecoxib plasma concentration.
Warfarin: Caution should be exercised when administering Celecoxib with warfarin since these patients are at increased risk of bleeding complications.
Celecoxib is contraindicated in patients with known hypersensitivity to Celecoxib, who have demonstrated allergic type reactions to sulfonamide or who have experienced asthma, urticaria or allergic type reactions after taking aspirin or other NSAIDs.
Gastrointestinal side effects include abdominal pain, diarrhoea, dyspepsia, flatulence and nausea. Central nervous system side effects include dizziness, headache and insomnia. Other side effects include upper respiratory tract infection, skin rash, back pain and peripheral edema.
Pregnancy & Lactation
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.
Precautions & Warnings
Celecoxib cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. Celecoxib should be prescribed with extreme caution in patients with a prior history of G.I. ulcer-disease or G.I. bleeding, hepatic and renal insufficiency, heart failure, those taking diuretics and ACE inhibitors, pre-existing asthma, elderly patients.
Use in Special Populations
Geriatric: Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose.
Paediatric: The safety and efficacy of Celecoxib is not established in paediatric patients.
Hepatic insufficiency: Celecoxib should be introduced at a reduced dose in patients with moderate hepatic impairment. The use of Celecoxib in patients with severe hepatic impairment is not recommended.
Patients should be managed by symptomatic and supportive care following an NSAID overdose. No specific antidote is available.
Store at 15 to 30° C.
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