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AURO-AMOXICLAV 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: Auro-Amoxiclav (amoxicillin and clavulanate potassium tablets) is indicated for the treatment of the following infections when caused by Auro-Amoxiclav -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 01/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 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 .......................................................................................................................
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). 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). Auro-Amoxiclav 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.
Auro-Amoxiclav Product Monograph Page 10 of 37 • 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.
, Hepatic/Biliary/Pancreatic. Auro-Amoxiclav Product Monograph Page 5 of 37 2 CONTRAINDICATIONS Auro-Amoxiclav 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.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Hypersensitivity: Serious and occasionally fatal hypersensitivity (anaphylactic) and severe cutaneous adverse reactions (SCAR) have been reported in patients receiving therapy with beta-lactams, including amoxicillin.
See 7 WARNINGS AND PRECAUTIONS, Hypersensitivity Reactions and 7 WARNINGS AND PRECAUTIONS, Skin. B. Since both the AURO-AMOXICLAV 250 / 125mg and AURO-AMOXICLAV 500 / 125 mg tablets contain the same amount of clavulanic acid (125 mg as the potassium salt) two AURO- AMOXICLAV 250/125 mg tablets are not equivalent to one AURO-AMOXICLAV 500 / 125 mg tablet.
Therefore, two AURO-AMOXICLAV 250 / 125 mg tablets should not be substituted for one AURO-AMOXICLAV 500 / 125 mg tablet. For mild to moderate infections, the usual adult dose is 1 AURO-AMOXICLAV 500 / 125 mg tablet every 12 hours or 1 AURO-AMOXICLAV 250 / 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 AURO-AMOXICLAV 875 / 125 mg tablet every 12 hours or 1 AURO-AMOXICLAV 500 / 125 mg tablet every 8 hours.
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 Auro-Amoxiclav Product Monograph Page 6 of 37 amoxicillin.
Auro-Amoxiclav 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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• Drug-induced enterocolitis syndrome, an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after medicinal product administration), in the absence of allergic skin or respiratory symptoms, has been reported mainly in children receiving amoxicillin-clavulanate.
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 Auro-Amoxiclav, 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 Auro-Amoxiclav 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 Auro-Amoxiclav.
Renal Auro-Amoxiclav 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 Auro-Amoxiclav 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.
Auro-Amoxiclav Product Monograph Page 11 of 37 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 Auro- Amoxiclav 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 conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates […]
e. the Auro- Amoxiclav -875 / 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 - 30 ml / min 500 / 125 mg given twice daily.
Creatinine clearance < 10 ml / min 500 / 125 mg given once daily. Hemodialysis One 500 / 125 mg tablet every 24 h, PLUS one 500 / 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 / 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 Auro-Amoxiclav 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 and clavulanate potassium have been established in clinical trials where amoxicillin and clavulanate potassium was taken without regard to meals.
To minimize potential gastrointestinal intolerance, administer at the start of a meal. 5 Missed Dose If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose. The dose should not be doubled to make up for a missed dose.
5 OVERDOSAGE Activated charcoal may be administered to aid in the removal of unabsorbed drug. General supportive measures are also recommended. Many patients have been asymptomatic following overdosage or have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea.
Rash, hyperactivity, or drowsiness have also been observed in a small number of patients. Auro-Amoxiclav Product Monograph Page 7 of 37 Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see 7 WARNINGS AND PRECAUTIONS).
In the case of overdosage, discontinue Auro-Amoxiclav, treat symptomatically, and institute supportive measures as required. If gastrointestinal symptoms and disturbance of the fluid and electrolyte balances are evident, they may be treated symptomatically.
Auro-Amoxiclav can be removed from the circulation by hemodialysis. A prospective study of 51 pediatric patients at a poison center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.
Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of both amoxicillin and clavulanate.
Both amoxicillin and clavulanate are removed from the circulation by hemodialysis. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 Route of Administration, Dosage Forms, Strengths and Non-medicinal Ingredients Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablets AURO-AMOXICLAV-250 / 125 mg: 250 mg amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (in a ratio of 2:1) AURO-AMOXICLAV-500 / 125 mg: 500 mg amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (in a ratio of 4:1) AURO-AMOXICLAV-875 / 125mg: 875 mg amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (in a ratio of 7:1) Cellulose microcrystalline, Crospovidone, Colloidal Silicon Dioxide, Ethyl cellulose […]