Composition Zycel 100 Each hard gelatin capsule contains Celecoxib 100mg. Approved colors used in capsule shell. Zycel 200 Each hard gelatin capsule contains Celecoxib 200mg. Approved colors used in capsule shell.
Description: Celecoxib is a selective inhibitor of cyclo-oxygenase enzyme (COX-2 isoform) and possesses anti-inflammatory activity with little or no gastric side effects. It is 375-fold more effective as an inhibitor of COX-2 than of COX-1 isoform. Celecoxib is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1 H-pyrazol-1-yl] benzene sulfonamide and is a diary substituted pyrazole. The empirical formula for celecoxib is C17 H14 F3 N3 O2S, and the molecular is 381.38.
Indications: Zycel is indicated for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis in adults.
Contraindications: Zycel is contraindicated in patients with known hypersensitivity to celecoxib. It should not be given to patients who have demonstrated allergic-type reactions to sulfonamides. Zycel should also not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Zycel is also contraindicated for use in patients immediately post-operative from coronary artery bypass (CABG) surgery.
Drug Interactions: ACE-inhibitors: Reports suggest that NSAIDs may diminish the antihyper- tensive effect of Angiotensin Converting Enzyme (ACE) inhibitors. This interaction should be given consideration in patients taking Celecoxib concomitantly with ACE-inhibitors. Furosemide: Clinical studies, as well as post marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. 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 other complications, compared to use of Celecoxib alone. Fluconazole: Concomitant administration of fluconazole at 200 mg QD resulted in a two-fold increase in Celecoxib plasma concentration. This increase is due to the inhibition of Celecoxib metabolism via P450 2C9 by fluconazole. Celecoxib should be introduced at the lowest recommended dose in patients receiving fluconazole. Lithium: Mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg BID with Celecoxib 200 mg BID as compared to subjects receiving lithium alone. Patients on lithium treatment should be closely monitored when Celecoxib is introduced or withdrawn. Warfarin: Celecoxib did not alter the anticoagulant effect of warfarin as determined by prothrombin time. However, caution should be used when administering Celecoxib with warfarin since these patients are at increased risk of bleeding complications.
Overdosage: Symptoms following acute NSADIs overdose 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 NSAID overdose. There are no specific antidotes. No information is available regarding the removal of Celecoxib by hemodialysis but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. 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 a large overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
Manufactured by: Cadila Healthcare Limited