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APO-AMOXI CLAV is a brand name for Amoxicillin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-AMOXI CLAV (amoxicillin and clavulanate potassium tablets) is indicated for the treatment of the following infections when caused by APO-AMOXI CLAV-susceptible strains of the designated bacteria: • Sinusitis when caused by β-lactamase producing strains of H. influenzae or Moraxella (Branhamella) catarrhalis. •…
Verbatim from this product's HC label. Tap a section to expand.
5 Missed Dose 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 ...................................................................................... 2 Recommended Dose and Dosage Adjustment .........................................................
4 Administration ......................................................................................................... 5 Missed Dose .............................................................................................................
6 5 OVERDOSAGE ................................................................................................................... 6
). Cardiovascular Abnormal prolongation of prothrombin time (increased international normalized ratio (INR)) has been reported in patients receiving amoxicillin and clavulanate potassium and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.
Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. Kounis syndrome (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity Reactions). Hepatic/Biliary/Pancreatic Transient hepatitis and cholestatic jaundice have been reported rarely.
These events have been noted with other penicillins and cephalosporins. Hepatic injury events associated with amoxicillin and clavulanate potassium may be severe, and occur predominantly in males and elderly patients and may be associated with prolonged treatment.
These events have been very rarely reported in children. Signs and symptoms usually occur during or shortly after treatment, but in some cases may not become apparent until several weeks after treatment has ceased. Hepatic toxicity associated with the use of amoxicillin and clavulanate potassium is usually reversible.
On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide). 5 Post-Market Adverse Reactions, Liver). APO-AMOXI CLAV should be used with caution in patients with evidence of hepatic dysfunction.
, acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS)). These have been reported in patients on penicillin therapy, including amoxicillin and clavulanate potassium (see 8 ADVERSE REACTIONS).
• Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. Presenting symptoms of such reactions can include chest pain occurring in association with an allergic reaction to amoxicillin-clavulanate. • Drug-induced enterocolitis syndrome, an allergic reaction with the leading symptom of protracted vomiting (1 to 4 hours after medicinal product administration), in the absence of allergic skin or respiratory symptoms, has been reported mainly in children receiving amoxicillin-clavulanate.
5 Missed Dose 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 ...................................................................................... 2 Recommended Dose and Dosage Adjustment .........................................................
4 Administration ......................................................................................................... 5 Missed Dose .............................................................................................................
6 5 OVERDOSAGE ................................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................... 7 7 WARNINGS AND PRECAUTIONS ........................................................................................
APO-AMOXI CLAV is contraindicated in patients: • with a history of hypersensitivity to the penicillin, or cephalosporin group of β-lactams, or to any ingredients contained in the preparation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• where infectious mononucleosis is either suspected or confirmed. • with a previous history of amoxicillin and clavulanate potassium-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.
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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.
Further symptoms could comprise abdominal pain, lethargy, diarrhea, hypotension or leucocytosis with neutrophilia. In severe cases, drug- induced enterocolitis syndrome can progress to shock. 5 Post-Market Adverse Reactions) Although these reactions are more frequent following parenteral therapy, they have occurred in patients receiving penicillins orally.
These reactions are more apt to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of cephalosporin hypersensitivity who have experienced severe reactions when treated with penicillins.
Before initiating therapy with APO-AMOXI CLAV, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens (see 2 CONTRAINDICATIONS). If an allergic reaction occurs, the administration of APO-AMOXI CLAV should be discontinued and appropriate alternative therapy should be instituted.
Serious anaphylactic/anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids and airway management, including intubation should also be used as indicated. Monitoring and Laboratory Tests Periodic assessment of renal, hepatic, and hematopoietic function should be made during prolonged therapy with APO-AMOXI CLAV.
Renal APO-AMOXI CLAV is excreted mostly by the kidney. 2 Recommended Dose and Dosage Adjustment, Renal Insufficiency). In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy.
During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see 5 OVERDOSAGE). Sensitivity/Resistance Prescribing APO-AMOXI CLAV in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug- resistant bacteria.
Skin Severe cutaneous adverse reactions (SCAR) have been reported with amoxicillin and clavulanate potassium (see 7 WARNINGS and PRECAUTIONS, Hypersensitivity Reactions). 1 Pregnant Women In a single study in women with preterm, premature rupture of the fetal membranes (pPROM), it was reported that prophylactic treatment with amoxicillin and clavulanate potassium may be associated with an increased risk of necrotising enterocolitis in neonates.
Use should be avoided in pregnancy, unless considered essential by the physician. 2 Breast-feeding Penicillins (including ampicillin) have been shown to be excreted in human breast milk. It is not known whether clavulanic acid is excreted in breast milk.
Caution should be exercised if APO- AMOXI CLAV is to be administered to a nursing mother. 3 Pediatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Clinical Trial Adverse Reactions Clinical trials are […]
1 Special Populations ................................................................................................ 1 Pregnant Women ...................................................................................................
2 Breast-feeding ........................................................................................................ 3 Pediatrics................................................................................................................
11 8 ADVERSE REACTIONS ...................................................................................................... 2 Clinical Trial Adverse Reactions ..............................................................................
1 Clinical Trial Adverse Reactions - Pediatrics ........................................................... 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 ......................................................................... 14 10 CLINICAL PHARMACOLOGY ............................................................................................. 1 Mechanism of Action .............................................................................................
3 Pharmacokinetics ................................................................................................... 15 11 STORAGE, STABILITY AND DISPOSAL...............................................................................
17 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................ 17 PART II: SCIENTIFIC INFORMATION ........................................................................................
18 13 PHARMACEUTICAL INFORMATION ................................................................................. 18 14 CLINICAL TRIALS .............................................................................................................
2 Comparative Bioavailability Studies ....................................................................... 19 15 MICROBIOLOGY ..............................................................................................................
21 16 NON-CLINICAL TOXICOLOGY ........................................................................................... 24 17 SUPPORTING PRODUCT MONOGRAPHS ......................................................................... 30 PATIENT MEDICATION INFORMATION ...................................................................................
31 APO-AMOXI CLAV (Amoxicillin and Clavulanate Potassium Tablets) Page 4 of 38 Protected B / Protégé B PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-AMOXI CLAV (amoxicillin and clavulanate potassium tablets) is indicated for the treatment of the following infections when caused by APO-AMOXI CLAV-susceptible strains of the designated bacteria: • Sinusitis when caused by β-lactamase producing strains of H.
influenzae or Moraxella (Branhamella) catarrhalis. • Otitis Media when caused by β-lactamase producing strains of H. influenzae or Moraxella (Branhamella) catarrhalis. • Lower Respiratory Tract Infections when caused by β-lactamase producing strains of H.
influenzae, K. pneumoniae, S. aureus or Moraxella (Branhamella) […]