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AURO-CEFIXIME is a brand name for Cefixime, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
Clinical Trials:
Five percent (5%) of patients in the clinical trials discontinued therapy because of drug-related adverse reactions. Thirty-six percent of the pediatric patient population experienced at least one adverse reaction (mild 25%, moderate 9%, severe 2%).
Forty-seven percent of the adult patients experienced at least one adverse reaction (mild 24%, moderate 19%, severe 4%). The most commonly seen adverse reactions in the clinical trials of the tablet formulation were gastrointestinal events, which were reported in 37% of all adult patients treated (mild 21%, moderate 13%, severe 3%).
5%), headache 11%, stool changes 12%, nausea 9%, abdominal pain 5%, dyspepsia 3%, flatulence (3%), dizziness (3%) and vomiting (2%). 9%) versus twice a day (8%). These symptoms usually responded to symptomatic therapy or ceased when cefixime tablets was discontinued.
Several patients developed severe diarrhea and/or documented pseudomembranous colitis, and a few required hospitalization. 9% (21/358) of patients. 9% of all patients and no adverse reactions were reported as severe. Individual event rates included diarrhea 1% and loose or frequent stools 1%.
Incidence rates for all other adverse reactions reported for adults in these trials were less than 1%.
Clinical Trial and Post-Market Adverse Drug Reactions:
The following adverse reactions have been observed during clinical trial studies and/or during marketed use.
Blood and lymphatic system disorders:
Thrombocytopenia, thrombocytosis, leucopenia, eosinophilia, neutropenia, agranulocytosis, immune hemolytic anemia (see WARNINGS, Hemolytic Anemia).
Gastrointestinal disorders:
Diarrhea, stool changes, nausea, abdominal pain, dyspepsia, flatulence, vomiting.
General disorders and administration site conditions:
Drug fever, face oedema.
Hepatobiliary disorders:
Jaundice (cholestatic and/or hepatocellular).
Page 8 of 29 Immune system disorders:
Serum sickness-like reaction, anaphylactic reactions (urticaria and angioedema).
Infections and infestations:
Vaginitis, candidiasis, pseudomembranous colitis.
Investigations:
Elevations of alanine aminotransferase (ALT or SGPT), aspartate aminotransferase (AST or SGOT), alkaline phosphatase and bilirubin. Elevations in Blood Urea Nitrogen (BUN) or creatinine. Prolongation in prothrombin time.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Cefixime in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Nervous system disorders:
Headaches, dizziness, convulsions.
Renal and urinary disorders:
Acute renal failure including tubulointerstitial nephritis.
Reproductive system and breast disorders:
Genital pruritus.
Respiratory, thoracic and mediastinal disorders:
Dyspnea, respiratory distress.
Skin and subcutaneous tissue disorders:
Skin rashes, pruritus, urticaria, toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), bullous skin reactions (erythema multiforme and Stevens-Johnson syndrome). In addition to the adverse reactions listed above which have been observed in patients treated with cefixime tablets the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: superinfection, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, elevated lactate dehydrogenase (LDH) and pancytopenia.
SYMPTOMS AND TREATMENT OF OVERDOSAGE Activated charcoal may be administered to aid in the removal of unabsorbed drug. General supportive measures are recommended. Page 9 of 29 For management of a suspected drug overdose, contact your regional Poison Control Centre immediately.
No specific antidote exists. General supportive measures are recommended. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis.
DOSAGE AND ADMINISTRATION Adults:
The recommended dose of AURO-CEFIXIME tablets (cefixime) is 400 mg once daily. When necessary, a dose of 200 mg (one-half of a 400 mg tablet) given twice daily may be considered except for urinary tract infections where once daily dosing must be used.
For treatment of uncomplicated gonococcal infections, a single oral dose of 400 mg is recommended. Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose.
Duration of Therapy:
Duration of dosage in clinical trials was 10 to 14 days. The duration of treatment should be guided by the patient's clinical and bacteriological response. In the treatment of infections due to Streptococcus pyogenes, a therapeutic dose of AURO- CEFIXIME tablets should be administered for at least 10 days.
Renal Impairment:
AURO-CEFIXIME tablets may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 40 mL/min or greater. Patients whose clearance is between 20 and 40 mL/min should be given 75% of the standard daily dosage.
Patients whose creatinine clearance is less than 20 mL/min should be given 50% of the standard daily dosage. Experience in children with renal impairment is very limited.
NOTE:
Neither hemodialysis, nor peritoneal dialysis remove significant amounts of cefixime from the body.
Page 10 of 29 PHARMACEUTICAL INFORMATION Chemistry:
Trade Name: Proper Name: Chemical Name: AURO-CEFIXIME Cefixime (6R,7R)-7-[[(Z)-2-(2-aminothiazol-4-yl)-2- […]