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APO-AMOXICILLIN-CLAVULANATE 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-AMOXICILLIN-CLAVULANATE (amoxicillin / clavulanate potassium) is indicated for the treatment of the following infections when caused by APO-AMOXICILLIN-CLAVULANATE- susceptible strains of the designated bacteria: • Sinusitis when caused by β-lactamase producing strains of H. influenzae or Moraxella (Branhamella)…
Verbatim from this product's HC label. Tap a section to expand.
B. Since APO-AMOXICILLIN-CLAVULANATE 250 mg / 125 mg and APO-AMOXICILLIN- CLAVULANATE 500 mg / 125 mg tablets contain the same amount of clavulanic acid (125 mg as the potassium salt), two APO-AMOXICILLIN-CLAVULANATE 250 mg / 125 mg tablets are not equivalent to one APO-AMOXICILLIN-CLAVULANATE 500 mg / 125 mg tablet.
Therefore, two APO-AMOXICILLIN-CLAVULANATE 250 mg / 125 mg tablets should not be substituted for one APO-AMOXICILLIN-CLAVULANATE 500 mg / 125 mg tablet. For mild to moderate infections, the usual adult dose is 1 APO-AMOXICILLIN-CLAVULANATE 500 mg / 125 mg tablet every 12 hours or 1 APO-AMOXICILLIN-CLAVULANATE 250 mg / 125 mg tablet every 8 hours.
For more severe infections (including chronic and recurrent urinary tract infections and infections of the lower respiratory tract), the dose should be 1 APO- AMOXICILLIN-CLAVULANATE 875 mg / 125 mg tablet every 12 hours or 1 APO-AMOXICILLIN- CLAVULANATE 500 mg / 125 mg tablet every 8 hours.
The tablets should not be split or divided. APO-AMOXICILLIN-CLAVULANATE (Amoxicillin and Clavulanate Potassium Tablets) Page 6 of 42 Children weighing more than 38 kg should be dosed according to the adult recommendations. Renal Insufficiency Dosage adjustment in renal impairment is based on the maximum recommended level of amoxicillin.
e. the APO-AMOXICILLIN-CLAVULANATE 875 mg / 125 mg tablets) should be used only in patients with a creatinine clearance of more than 30 mL/min. Adults Creatinine clearance > 30 mL / min No adjustment necessary. Creatinine clearance 10 to 30 mL / min 500 mg / 125 mg given twice daily.
Creatinine clearance < 10 mL / min 500 mg / 125 mg given once daily. Hemodialysis One 500 mg / 125 mg tablet every 24 h, PLUS one 500 mg / 125 mg tablet during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased).
875 mg / 125 mg tablets (7:1 ratio amoxicillin:clavanulate) should only be used in patients with a creatinine clearance of more than 30 mL/min. 4 Administration While APO-AMOXICILLIN-CLAVULANATE can be given without regard to meals, absorption of clavulanic acid when taken with food is greater relative to the fasted state.
Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. The safety and efficacy of amoxicillin / clavulanate potassium have been established in clinical trials where amoxicillin / clavulanate potassium was taken without regard to meals.
). Cardiovascular Abnormal prolongation of prothrombin time (increased international normalized ratio (INR)) has been reported in patients receiving amoxicillin / 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 APO- AMOXICILLIN-CLAVULANATE 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 APO-AMOXICILLIN-CLAVULANATE 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-AMOXICILLIN-CLAVULANATE (Amoxicillin and Clavulanate Potassium Tablets) Page 10 of 42 APO-AMOXICILLIN-CLAVULANATE 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 / clavulanate potassium.
• 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.
, Immune 08/2024 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 ................................................................................................................... 4 2 CONTRAINDICATIONS ....................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................... 2 Recommended Dose and Dosage Adjustment ..........................................................
4 Administration ........................................................................................................... 6 5 OVERDOSAGE ................................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................... 7 7 WARNINGS AND PRECAUTIONS ..................................................................................... 1 Special Populations..................................................................................................
APO-AMOXICILLIN-CLAVULANATE 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. APO-AMOXICILLIN-CLAVULANATE is contraindicated in patients where infectious mononucleosis is either suspected or confirmed. APO-AMOXICILLIN-CLAVULANATE is contraindicated in patients with a previous history of amoxicillin / clavulanate potassium-associated jaundice/hepatic dysfunction.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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To minimize potential gastrointestinal intolerance, administer at the start of a meal.
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-AMOXICILLIN-CLAVULANATE, 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-AMOXICILLIN-CLAVULANATE 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-AMOXICILLIN-CLAVULANATE.
APO-AMOXICILLIN-CLAVULANATE (Amoxicillin and Clavulanate Potassium Tablets) Page 11 of 42 Renal Amoxicillin / clavulanate potassium 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-AMOXICILLIN-CLAVULANATE 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 / 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 / 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- AMOXICILLIN-CLAVULANATE 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.
8 ADVERSE REACTIONS APO-AMOXICILLIN-CLAVULANATE (Amoxicillin […]
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 APO-AMOXICILLIN-CLAVULANATE (Amoxicillin and Clavulanate Potassium Tablets) Page 3 of 42 9 DRUG INTERACTIONS .................................................................................................. 4 Drug-Drug Interactions ............................................................................................
5 Drug-Food Interactions............................................................................................ 6 Drug-Herb Interactions ............................................................................................
7 Drug-Laboratory Test Interactions........................................................................... 15 10 CLINICAL PHARMACOLOGY .......................................................................................... 1 Mechanism of Action ...............................................................................................
3 Pharmacokinetics .................................................................................................... 15 11 STORAGE, STABILITY AND DISPOSAL............................................................................
18 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 18 PART II: SCIENTIFIC INFORMATION .......................................................................................
19 13 PHARMACEUTICAL INFORMATION .............................................................................. 19 14 CLINICAL TRIALS ..........................................................................................................
2 Comparative Bioavailability Studies......................................................................... 20 15 MICROBIOLOGY ...........................................................................................................
24 16 NON-CLINICAL TOXICOLOGY ........................................................................................ 28 17 SUPPORTING PRODUCT MONOGRAPHS ...................................................................... 34 PATIENT MEDICATION INFORMATION ..................................................................................
35 APO-AMOXICILLIN-CLAVULANATE (Amoxicillin and Clavulanate Potassium Tablets) Page 4 of 42 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-AMOXICILLIN-CLAVULANATE (amoxicillin / clavulanate potassium) is indicated for the treatment of the following infections when caused by APO-AMOXICILLIN-CLAVULANATE- 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) catarrhalis. • Skin and Soft Tissue Infections when caused by β-lactamase producing strains of S. aureus. • Urinary Tract Infections when caused by β-lactamase producing strains of E.
coli. While APO-AMOXICILLIN-CLAVULANATE […]