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Indications/Uses
It 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 dysmenorrhoea.
Dosage/Direction for Use
Adults: Osteoarthritis: The recommended dose of Celecoxib for treating the signs and symptoms of osteoarthritis is 200 mg administered as a single dose or as two divided doses. Doses up to 400 mg per day have been studied.
Rheumatoid arthritis: The recommended dose of Celecoxib for treating the signs and symptoms of rheumatoid arthritis is 100 or 200 mg twice per day. Doses up to 800 mg per day have been studied.
Elderly: No dosage adjustment is generally necessary. However, for elderly patients with a lower than average body weight (<50kg), it is advisable to initiate therapy at the lowest recommended dose.
Hepatic impairment: No dosage adjustment is necessary in patients with mild hepatic impairment. Introduce Celecoxib at the lowest effective dose in patients with moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
Renal impairment: No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is no clinical experience in patients with severe renal impairment.
Children: Celecoxib has not been studied in subjects under 18 years old. Reduced dose are recommended in patients with hepatic impairment.
In the treatment of pain and dysmenorrhoea, 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 daily.
Celecoxib is also used as an adjunct to standard therapy to reduce the number of adenomatous colorectal polyps in patients with familial adenomatous polyposis. For this purpose it may be given in doses of 400 mg twice daily with food.
Rheumatoid arthritis: The recommended dose of Celecoxib for treating the signs and symptoms of rheumatoid arthritis is 100 or 200 mg twice per day. Doses up to 800 mg per day have been studied.
Elderly: No dosage adjustment is generally necessary. However, for elderly patients with a lower than average body weight (<50kg), it is advisable to initiate therapy at the lowest recommended dose.
Hepatic impairment: No dosage adjustment is necessary in patients with mild hepatic impairment. Introduce Celecoxib at the lowest effective dose in patients with moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
Renal impairment: No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is no clinical experience in patients with severe renal impairment.
Children: Celecoxib has not been studied in subjects under 18 years old. Reduced dose are recommended in patients with hepatic impairment.
In the treatment of pain and dysmenorrhoea, 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 daily.
Celecoxib is also used as an adjunct to standard therapy to reduce the number of adenomatous colorectal polyps in patients with familial adenomatous polyposis. For this purpose it may be given in doses of 400 mg twice daily with food.
Overdosage
Symptoms following NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following an NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following large overdose.
Administration
May be taken with or without food: Dose for OA/RA may be given w/ or w/o meals.
Contraindications
Absolute contraindications: Not to be given to those patients who have history of:Stroke: Cerebrovascular accident, CVA; Heart attack: Myocardial infarction, MI; Coronary artery by pass graft: CABG; Uncontrolled hypertension; Congestive heart failure (CHF) NYHA II - IV.
Hypersensitivity to any ingredient of the product (lactose monohydrate, sodium lauryl sulphate, polyvidone, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, ferric oxide E172 and indigotine E132); known sulphonamide hypersensitivity. Patients who have experienced asthma, urticaria or allergic-type reactions after taking acetylsalicylic acid or NSAIDs.
Hypersensitivity to any ingredient of the product (lactose monohydrate, sodium lauryl sulphate, polyvidone, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, ferric oxide E172 and indigotine E132); known sulphonamide hypersensitivity. Patients who have experienced asthma, urticaria or allergic-type reactions after taking acetylsalicylic acid or NSAIDs.
Special Precautions
Contraindicated in patients with history of hypersensitivity to Ar4 or any other NSAIDs. NSAIDs are contraindicated in patients with previous or active peptic ulceration and use with caution in patients with cardiac, liver, and renal disease. Dose adjustment like uthe lowest to effective dose and monitoring of renal and liver functions should be instituted.
Fluid retention and oedema have been observed in some patients taking Celecoxib. Therefore, Celecoxib should be used with caution in patients with compromised cardiac function and other conditions predisposing to fluid retention. Celecoxib should be used only in exceptional circumstances and with close clinical monitoring in advanced kidney disease and advanced liver disease. As with NSAIDs in general, anaphylactoid reactions may occur in patients without known prior exposure to Celecoxib. In post-marketing experience, very rare cases of anaphylactic reactions and angioedema have been reported in patients receiving Celecoxib. (See Contraindications.)
Fluid retention and oedema have been observed in some patients taking Celecoxib. Therefore, Celecoxib should be used with caution in patients with compromised cardiac function and other conditions predisposing to fluid retention. Celecoxib should be used only in exceptional circumstances and with close clinical monitoring in advanced kidney disease and advanced liver disease. As with NSAIDs in general, anaphylactoid reactions may occur in patients without known prior exposure to Celecoxib. In post-marketing experience, very rare cases of anaphylactic reactions and angioedema have been reported in patients receiving Celecoxib. (See Contraindications.)
Use In Pregnancy & Lactation
Use in Pregnancy: No clinical data on exposed pregnancies are available for Celecoxib. Studies in animals have shown developmental toxicity. The potential risk for humans is unknown. Celecoxib should not be used during pregnancy unless clearly necessary. Since no studies have been conducted in humans to evaluate the effects on closure of the ductus arteriosus, Celecoxib should be avoided during the third trimester of pregnancy.
Use in Lactation: Studies in rats show that celecoxib is excreted in milk at concentrations similar to those in plasma. Since no studies have been conducted in humans Celecoxib should not be used during breast feeding.
Use in Lactation: Studies in rats show that celecoxib is excreted in milk at concentrations similar to those in plasma. Since no studies have been conducted in humans Celecoxib should not be used during breast feeding.
Adverse Reactions
Gastrointestinal side effects include abdominal discomfort, diarrhoea, dyspepsia, flatulence and nausea. Central nervous system (CNS) side effects include dizziness, headache and insomnia. Other side effects include upper respiratory tract infections, skin rash, back pain and peripheral oedema.
Drug Interactions
Clinical studies with celecoxib have identified potentially significant interactions with fluconazole and lithium. Experience with NSAIDs suggests the potential for interactions with furosemide and ACE inhibitors.
ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking celecoxib concomitantly with ACE inhibitors.
Furosemide: NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients.
Aspirin: Celecoxib can be used with low dose aspirin. However, concomitant administration of aspirin with celecoxib may result in an increased rate of GI ulceration or similar complications, compared to the use of celecoxib alone.
Fluconazole: Concomitant administration of fluconazole at 200 mg QD resulted in a two fold increase in celecoxib plasma concentration. Celecoxib should be introduced at the lowest recommended dose in patient receiving fluconazole.
Lithium: Patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.
Warfarin: Caution should be used when administering celecoxib with warfarin since these patients are at increased risk of bleeding complications.
ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking celecoxib concomitantly with ACE inhibitors.
Furosemide: NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients.
Aspirin: Celecoxib can be used with low dose aspirin. However, concomitant administration of aspirin with celecoxib may result in an increased rate of GI ulceration or similar complications, compared to the use of celecoxib alone.
Fluconazole: Concomitant administration of fluconazole at 200 mg QD resulted in a two fold increase in celecoxib plasma concentration. Celecoxib should be introduced at the lowest recommended dose in patient receiving fluconazole.
Lithium: Patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.
Warfarin: Caution should be used when administering celecoxib with warfarin since these patients are at increased risk of bleeding complications.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
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 metabolised 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 faeces 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)
Features
Brand
Euroflam
Full Details
Dosage Strength
200 mg
Drug Ingredients
- Celecoxib
Drug Packaging
Capsule 50's
Generic Name
Celecoxib
Dosage Form
Capsule
Registration Number
DRP-1531
Drug Classification
Prescription Drug (RX)