Loading…
AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR is a brand name for Amoxicillin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Amoxicillin Sodium and Potassium Clavulanate for Injection (Co-Amoxiclav for injection) is indicated for the treatment of the following infections in adult and pediatric patients: • Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment. Safety and efficacy of Amoxicillin Sodium and Potassium Clavulanate for Injection in pediatric patients with renal impairment have not been evaluated in clinical trials.
Pediatrics (3 months – 12 years of age):
Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Amoxicillin Sodium and Potassium Clavulanate for Injection in pediatric patients has been established. Therefore, Health Canada has authorized an indication for pediatric use.
2 Geriatrics Geriatrics (> 65 years of age): No dose adjustment is considered necessary, unless there is evidence of renal impairment (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Renal and 4 DOSAGE AND ADMINISTRATION). 2 CONTRAINDICATIONS Amoxicillin Sodium and Potassium Clavulanate for Injection is contraindicated in: • patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
10/2024 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 ................................................................................................................. 5 2 CONTRAINDICATIONS ..................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 3 Reconstitution ......................................................................................................... 4 Administration .......................................................................................................
5 Missed Dose .......................................................................................................... 10 5 OVERDOSAGE.............................................................................................................
, Sensitivity/Resistance and 10 CLINICAL PHARMACOLOGY). 2 Recommended Dose and Dosage Adjustment. Safety and efficacy of Amoxicillin Sodium and Potassium Clavulanate for Injection in pediatric patients with renal impairment have not been evaluated in clinical trials.
Pediatrics (3 months – 12 years of age):
Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Amoxicillin Sodium and Potassium Clavulanate for Injection in pediatric patients has been established. Therefore, Health Canada has authorized an indication for pediatric use.
2 Geriatrics Geriatrics (> 65 years of age): No dose adjustment is considered necessary, unless there is evidence of renal impairment (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Renal and 4 DOSAGE AND ADMINISTRATION). 2 CONTRAINDICATIONS Amoxicillin Sodium and Potassium Clavulanate for Injection is contraindicated in: • patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. , penicillins, carbapenems, monobactams, or cephalosporins. • patients where infectious mononucleosis is either suspected or confirmed. • patients with a previous history of amoxicillin/clavulanic acid associated jaundice/hepatic dysfunction.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous reactions) have been reported in patients receiving beta-lactam antibacterials, including Amoxicillin Sodium and Potassium Clavulanate for Injection.
• Before therapy with Amoxicillin Sodium and Potassium Clavulanate for Injection is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta- lactam allergy, caution should be exercised, because cross sensitivity has been established.
Amoxicillin Sodium and Potassium Clavulanate for Injection is contraindicated in: • patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. , penicillins, carbapenems, monobactams, or cephalosporins. • patients where infectious mononucleosis is either suspected or confirmed. • patients with a previous history of amoxicillin/clavulanic acid associated jaundice/hepatic dysfunction.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Amoxicillin in Canada.
Know a brand we are missing in Canada? Suggest a brand →
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.
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 11 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations................................................................................................
1 Pregnant Women ............................................................................................ 2 Breast-feeding ................................................................................................. 3 Pediatrics .........................................................................................................
4 Geriatrics ......................................................................................................... 16 8 ADVERSE REACTIONS .................................................................................................
1 Adverse Reaction Overview ................................................................................... 5 Post-Market Adverse Reactions ............................................................................ 16 Amoxicillin Sodium and Potassium Clavulanate for Injection Page 3 of 41 9 DRUG INTERACTIONS .................................................................................................
3 Drug-Behavioral Interactions ................................................................................. 4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions..........................................................................................
6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions......................................................................... 20 10 CLINICAL PHARMACOLOGY ........................................................................................
1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics ......................................................................................... 3 Pharmacokinetics ............................................................................................
20 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 22 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 23 PART II: SCIENTIFIC INFORMATION ........................................................................................
24 13 PHARMACEUTICAL INFORMATION ............................................................................. 24 14 CLINICAL TRIALS .........................................................................................................
25 15 MICROBIOLOGY ......................................................................................................... 25 16 NON-CLINICAL TOXICOLOGY ......................................................................................
28 PATIENT MEDICATION INFORMATION ................................................................................... 34 Amoxicillin Sodium and Potassium Clavulanate for Injection Page 4 of 41 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Amoxicillin Sodium and Potassium Clavulanate for Injection (Co-Amoxiclav for injection) is indicated for the treatment of the following infections in adult and pediatric patients: • Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms) • Acute exacerbations of chronic bronchitis (adequately diagnosed) • Community acquired pneumonia • Cystitis • Pyelonephritis • Skin and soft tissue infections in particular cellulitis, animal bites, […]
• If an anaphylactic reaction to Amoxicillin Sodium and Potassium Clavulanate for Injection occurs, the drug should be discontinued and appropriate therapy instituted. See 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS and