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APO-CEFUROXIME is a brand name for Cefuroxime, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-CEFUROXIME (cefuroxime axetil tablets) is indicated for the treatment of patients with mild to moderately severe infections caused by susceptible strains of the designated organisms in the following diseases: • Upper Respiratory Tract Infections: Pharyngitis and tonsillitis caused by Streptococcus pyogenes. Otitis…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 05/2023 7 WARNINGS AND PRECAUTIONS, Neurologic 05/2023 7 WARNINGS AND PRECAUTIONS, Renal 05/2023 7 WARNINGS AND PRECAUTIONS, General 02/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ........................................................................................... 2 TABLE OF CONTENTS .............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS ..............................................................................................................
1 Pediatrics ................................................................................................................... 2 Geriatrics....................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION.................................................................................
1 Dosing Considerations ............................................................................................... 2 Recommended Dose and Dosage Adjustment .......................................................... 4 Administration ...........................................................................................................
5 Missed dose ............................................................................................................... 6 5 OVERDOSAGE.............................................................................................................
7
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
The following adverse reactions have been reported:
Blood and lymphatic system disorders: Eosinophilia, very rarely hemolytic anemia. See 7 WARNINGS and PRECAUTIONS, Hemolytic Anemia. 3%). Reports of abdominal pain have occurred. 3% of patients): As with other cephalosporins, there have been rare reports of drug fever.
3% of patients): Hypersensitivity reactions to APO-CEFUROXIME may occur in patients who report delayed hypersensitivity to penicillins. See 7 WARNINGS AND PRECAUTIONS, Immune.
Investigations:
Increased erythrocyte sedimentation rate, decreased hemoglobin, positive Coomb’s test. Transient increases of hepatic enzyme levels [ALT, AST, LDH] (3% of patients). The following adverse reactions have been observed to occur, although infrequently, in association with parenteral cefuroxime sodium and may be potential adverse effects of oral cefuroxime axetil: Transient increases in serum bilirubin, creatinine, alkaline phosphatase, and urea nitrogen (BUN).
2% of patients): Headache and dizziness. The following adverse reactions have been observed to occur, although infrequently, in association with parenteral cefuroxime sodium and may be potential adverse effects of oral cefuroxime axetil: drowsiness Reproductive system and breast disorders: The following adverse reactions have been observed to occur, although infrequently, in association with parenteral cefuroxime sodium and may be potential adverse effects of oral cefuroxime axetil: Vaginitis.
4 Geriatrics 05/2023 7 WARNINGS AND PRECAUTIONS, Neurologic 05/2023 7 WARNINGS AND PRECAUTIONS, Renal 05/2023 7 WARNINGS AND PRECAUTIONS, General 02/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ........................................................................................... 2 TABLE OF CONTENTS .............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS ..............................................................................................................
1 Pediatrics ................................................................................................................... 2 Geriatrics....................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION.................................................................................
1 Dosing Considerations ............................................................................................... 2 Recommended Dose and Dosage Adjustment .......................................................... 4 Administration ...........................................................................................................
5 Missed dose ............................................................................................................... 6 5 OVERDOSAGE.............................................................................................................
APO-CEFUROXIME (cefuroxime axetil tablets) is contraindicated for patients who have shown Type 1 hypersensitivity to cefuroxime, to any of its components, or to any of the cephalosporin group of antibiotics. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Cefuroxime 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.
3% of patients): Shortness of breath and rare reports of bronchospasm. 2%). 5 Post-Market Adverse Reactions In addition to adverse events reported during clinical trials, the following events have been identified during clinical practice in patients treated with cefuroxime axetil and were reported spontaneously.
Data are generally insufficient to allow an estimate of incidence or to establish causation.
Blood and lymphatic system disorders:
Thrombocytopenia, and leucopenia (sometimes profound).
Cardiac Disorders:
Kounis syndrome.
Gastrointestinal disorders:
Pseudomembranous colitis. See 7 WARNINGS AND PRECAUTIONS, Gastrointestinal, Clostridium difficile-Associated Disease.
Hepatobiliary disorders:
Jaundice (predominantly cholestatic) and hepatitis have been reported very rarely.
Immune system disorders:
The following hypersensitivity reactions have been reported: Anaphylaxis, angioedema, serum sickness-like reaction.
Infections and Infestations:
Candida overgrowth.
Nervous system disorders:
Seizure. See 7 WARNINGS AND PRECAUTIONS, Neurologic.
Renal and urinary disorders:
Renal dysfunction.
Skin and subcutaneous tissue disorders:
Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
The following hypersensitivity reactions have been reported:
Pruritus, rash, urticaria.
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations ..................................................................................................
1 Pregnant Women..................................................................................................... 2 Breast-feeding .........................................................................................................
3 Pediatrics ................................................................................................................. 4 Geriatrics..................................................................................................................
10 APO-CEFUROXIME (Cefuroxime axetil tablets) Page 3 of 33 8 ADVERSE REACTIONS................................................................................................ 2 Clinical Trial Adverse Reactions ...............................................................................
5 Post-Market Adverse Reactions .............................................................................. 12 9 DRUG INTERACTIONS ............................................................................................... 4 Drug-Drug Interactions ............................................................................................
5 Drug-Food Interactions............................................................................................ 6 Drug-Herb Interactions ............................................................................................
7 Drug-Laboratory Test Interactions .......................................................................... 13 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ...............................................................................................
2 Pharmacodynamics.................................................................................................. 3 Pharmacokinetics.....................................................................................................
15 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 16 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 16 PART II: SCIENTIFIC INFORMATION ......................................................................................
17 13 PHARMACEUTICAL INFORMATION ........................................................................... 17 14 CLINICAL TRIALS .......................................................................................................
2 Comparative Bioavailability Studies ........................................................................ 17 15 MICROBIOLOGY .......................................................................................................
18 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 21 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 27 PATIENT MEDICATION INFORMATION ................................................................................
28 APO-CEFUROXIME (Cefuroxime axetil tablets) Page 4 of 33 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-CEFUROXIME (cefuroxime axetil tablets) is indicated for the treatment of patients with mild to moderately severe infections caused by susceptible strains of the designated organisms in the following diseases: • Upper Respiratory Tract Infections: Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
Otitis Media caused by Streptococcus pneumoniae, Streptococcus pyogenes (group A beta- hemolytic […]