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PRO-AMOX-500 is a brand name for Amoxicillin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PRO-AMOX (amoxicillin) may be indicated in the treatment of infections due to susceptible strains of the following micro-organisms: Gram-negative organisms: H. influenzae, P. mirabilis and N. gonorrhoeae. Gram-positive organisms: Streptococci (including Streptococcus faecalis and Streptococcus pneumoniae). Amoxicillin…
Verbatim from this product's HC label. Tap a section to expand.
5 Missed dose 12/2025 7 WARNINGS AND PRECAUTIONS, General 12/2025 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 12/2025 7 WARNINGS AND PRECAUTIONS, Immune 12/2025 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 ......................................................................................... 1 Dosing Considerations .......................................................................................................
2 Recommended Dose and Dosage Adjustment .................................................................. 3 Reconstitution ....................................................................................................................
4 Administration ................................................................................................................... 5 Missed Dose .......................................................................................................................
7 5 OVERDOSAGE ..................................................................................................................... 8
1 Adverse Reaction Overview As with other penicillins, it may be expected that untoward reactions will be related to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and cephalosporins and in those with a history of allergy, asthma, hay fever or urticaria.
2 Clinical Trial Adverse Reactions The following adverse reactions have been reported as associated with the use of amoxicillin: Gastrointestinal: Nausea, vomiting and diarrhea, hemorrhagic and pseudomembranous colitis. Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including amoxicillin.
Glossitis, black "hairy" tongue and stomatitis, mucocutaneous candidiasis, tooth discoloration (brown, yellow or gray staining); most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
PRO-AMOX Product Monograph Page 13 of 31 Hypersensitivity Reactions:
Skin rashes have been reported frequently. Less commonly, a few cases of serum sickness like reactions including urticaria, erythema, erythema multiforme, angioneurotic edema, and pruritus have been reported. Rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, exfoliative dermatitis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis have been reported.
Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form.
NOTE:
Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and if necessary, systemic corticosteroids. Whenever such reactions occur, PRO- AMOX should be discontinued unless, in the opinion of the physician, the condition being treated is life threatening and amenable only to amoxicillin therapy.
5 Missed dose 12/2025 7 WARNINGS AND PRECAUTIONS, General 12/2025 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 12/2025 7 WARNINGS AND PRECAUTIONS, Immune 12/2025 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 ......................................................................................... 1 Dosing Considerations .......................................................................................................
2 Recommended Dose and Dosage Adjustment .................................................................. 3 Reconstitution ....................................................................................................................
4 Administration ................................................................................................................... 5 Missed Dose .......................................................................................................................
PRO-AMOX 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.
• Patients with a history of previous hypersensitivity reaction to any of the penicillins or cephalosporins. • Cases where infectious mononucleosis is either suspected or confirmed.
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.
Serious anaphylactic reactions require the immediate use of epinephrine, oxygen and intravenous steroids.
Hepatobiliary:
A moderate rise in serum glutamic oxaloacetic transaminase (SGOT) has been noted, particularly in infants, but the significance of this finding is not known. Transient increases in serum alkaline phosphatase and lactic dehydrogenase levels have also been observed but they returned to normal on discontinuation of amoxicillin.
Reports have also been seen of hepatic dysfunction including cholestatic jaundice, hepatic cholestasis, and acute cytolytic hepatitis.
Hemic and Lymphatic Systems:
Anemia thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, neutropenia and agranulocytosis have been reported during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be a hypersensitivity phenomena.
Reports have also been seen of anemia including hemolytic anemia.
Central Nervous System:
As with other penicillins, acute and chronic toxicity is not a clinical problem. Although penicillins do not normally cross the blood-brain barrier to any substantial extent, if massive doses are given (several grams per day) to elderly patients, patients with inflamed meninges or patients with impaired renal function, toxic reactions are likely to occur.
At extremely high doses, convulsions can occur. When penicillin reaches a high concentration in the cerebrospinal fluid, neurotoxic symptoms consisting of myoclonia, convulsive seizures and depressed consciousness may occur. Unless administration of the drug is stopped or its dosage reduced, the syndrome may progress to coma and death.
Dizziness, hyperkinesias, hyperactivity, agitation, anxiety, insomnia, confusion and behavioural changes have also been reported.
Skin and Appendages:
Erythematous maculopapular rash.
Renal:
Crystalluria (including acute renal injury) (see section 7 WARNINGS AND PRECAUTIONS and 5 OVERDOSAGE). Interstitial nephritis (oliguria, proteinuria, hematuria, hyaline casts, pyuria) and nephropathy are infrequent and usually associated with high doses of parenteral PRO-AMOX Product Monograph Page 14 of 31 penicillins; however, this has occurred with all of the penicillins.
Such reactions are hypersensitivity responses and are usually associated with fever, skin rash and eosinophilia. Elevations of creatinine or blood urea nitrogen may occur. 5 Post-Market Adverse Reactions Gastrointestinal: Drug-induced enterocolitis syndrome has been reported in patients receiving amoxicillin containing drug products.
(see 7 WARNINGS and PRECAUTIONS, Immune, Hypersensitivity) Central Nervous System: Amoxicillin can lead to cases of aseptic meningitis of unknown frequency.
Other immune system disorders:
Kounis syndrome.
Skin and subcutaneous tissue disorders:
Linear IgA disease has also been reported in patients receiving amoxicillin containing drug products.
7 5 OVERDOSAGE ..................................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................................... 8 7 WARNINGS AND PRECAUTIONS ..........................................................................................
1 Special Populations .......................................................................................................... 1 Pregnant Women..........................................................................................................
3 Pediatrics ...................................................................................................................... 4 Geriatrics.......................................................................................................................
12 8 ADVERSE REACTIONS ........................................................................................................ 1 Adverse Reaction Overview .............................................................................................
5 Post-Market Adverse Reactions ...................................................................................... 14 9 DRUG INTERACTIONS ........................................................................................................
4 Drug-Drug Interactions .................................................................................................... 5 Drug-Food Interactions ....................................................................................................
6 Drug-Herb Interactions .................................................................................................... 7 Drug-Laboratory Test Interactions ..................................................................................
15 10 ACTION AND CLINICAL PHARMACOLOGY......................................................................... 1 Mechanism of Action .....................................................................................................
3 Pharmacokinetics ........................................................................................................... 15 11 STORAGE, STABILITY AND DISPOSAL ...............................................................................
16 PART II: SCIENTIFIC INFORMATION ...................................................................................... 17 13 PHARMACEUTICAL INFORMATION ..................................................................................
17 14 CLINICAL TRIALS .............................................................................................................. 2 Comparative Bioavailability Studies ..............................................................................
18 15 MICROBIOLOGY .............................................................................................................. 20 16 NON-CLINICAL TOXICOLOGY ...........................................................................................
21 17 SUPPORTING PRODUCT MONOGRAPH ............................................................................ 24 PATIENT MEDICATION INFORMATION ................................................................................. 25 PRO-AMOX Product Monograph Page 4 of 31 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS PRO-AMOX (amoxicillin) may be indicated in […]