Amoxicillin

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications: 

Infections due to susceptible non-penicillinase producing organisms including:

• Infections of the ear, nose and throat due to streptococci, pneumococci, non-penicillinase-producing staphylococci and H. influenzae
• Infections of the genitourinary tract due to E. coli, Proteus mirabilis and Streptococcus faecalis
• Infections of the skin and soft-tissues due to streptococci, susceptible staphylococci and E. coli
• Infections of the lower respiratory tract due to streptococci, pneumococci, non-penicillinase producing staphylococci and H. influenzae
• Gonorrhoea, acute uncomplicated ano-genital and urethral infections due to N. gonorrhoea (males and females)

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to any of the penicillins
• History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam)
• Patients with infectious mononucleosis since they are especially susceptible to amoxycillin-induced skin rashes
• Contraindicated in babies born to mothers hypersensitive to amoxicillin or any other penicillins, and in the neonatal period
• Patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol may also be at an increased risk of developing skin rashes

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to any of the penicillins
• History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam)

• Breastfeeding
• Renal impairment
• Hepatic impairment
• Atopic patients
• High doses
• Predisposition to seizures
  - History of seizures
  - Treated epilepsy
  - Meningeal disorders
• Suspected infectious mononucleosis
• Prolonged therapy
• Reduced urine output

Forms avail. in SA and covered in this monograph: sus

Dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages

Infections caused by: Susceptible non-penicillinase-producing organisms; beta-lactamase-negative Streptococcus spp. (alpha- and beta-haemolytic isolates only), Streptococcus faecalis, Streptococcus pneumoniae, Staphylococcus spp., Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Enterococcus faecalis, N. gonorrhoea

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guidelines indications and dosages

Hospital Level Adult Standard Treatment Guidelines and Essential Medicines List Chapters

• Click here for Alimentary Tract (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Adult, Jul. 2024 Edition)
• Click here for Cardiovascular System (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Adult, Nov. 2024 Edition)
• Click here for Obstetrics (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Adult, 2020-3 Edition)
• Click here for Respiratory Disorders (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Adult, Sept. 2024 Edition)
• Click here for Ear, Nose and Throat Disorders (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Adult, 2019 Edition)

Primary Healthcare Standard Treatment Guidelines and Essential Medicines List Chapters

• Click here for the Dental and Oral Conditions (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, 2020-3 Edition)
• Click here for the Cardiovascular Conditions (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, Nov. 2024 Edition)
• Click here for the Obstetrics & Gynaecology (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, Jul. 2024 Edition)
• Click here for Respiratory Conditions (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, Sept. 2024 Edition)
• Click here for Sexually Transmitted Infections (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, 2020 Edition)
• Click here for Ear, Nose and Throat Conditions (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, 2020 Edition)

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South African registered indications and dosages

Infections due to susceptible non-penicillinase producing organisms including:
Infections of the ear, nose and throat due to streptococci, pneumococci, non-penicillinase-producing staphylococci and H. influenzae
Infections of the genitourinary tract due to E. coli, Proteus mirabilis and Streptococcus faecalis
Infections of the skin and soft-tissues due to streptococci, susceptible staphylococci and E. coli
Infections of the lower respiratory tract due to streptococci, pneumococci, non-penicillinase producing staphylococci and H. influenzae
Gonorrhoea, acute uncomplicated ano-genital and urethral infections due to N. gonorrhoea (males and females)

• Oral (sus): 250-500mg, every 8hrs; Max: 4.5g/24hrs

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Adults who are not able to take capsules may be given Amoxicillin suspension

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For recommendations regarding capsule formulations, please refer to Amoxicillin (CAP)

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For instructions on reconstitution of the medicine before administration, see additional prescribing points

Paed. forms avail. and covered in this monograph: sus

Paed. dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages

Infections caused by: Susceptible non-penicillinase-producing organisms; beta-lactamase-negative Streptococcus spp. (alpha- and beta-haemolytic isolates only), Streptococcus faecalis, Streptococcus pneumoniae, Staphylococcus spp., Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Enterococcus faecalis, N. gonorrhoea​​​​​​

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guidelines indications and dosages

Hospital Level Paediatric Standard Treatment Guidelines and Essential Medicines List Chapters

• Click here for Alimentary Tract, Cardiovascular System, The Nervous System, Respiratory System, Ear, Nose and Throat (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Paediatrics, 2023 - Updated Feb. 2025 Edition)

Primary Healthcare Standard Treatment Guidelines and Essential Medicines List Chapters

• Click here for Dental and Oral Conditions (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, 2020-3 Edition)
• Click here for Nutrition and Anaemia (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, 2020-3 Edition)
• Click here for the Cardiovascular Conditions (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, Nov. 2024 Edition)
• Click here for Infections and Related Conditions (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, Jan. 2025 Edition)
• Click here for Respiratory Conditions (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, Sept. 2024 Edition)
• Click here for Standard Paediatric Dosing Tables (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, Oct. 2024 Edition)
• Click here for Ear, Nose and Throat Conditions (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Primary Healthcare, 2020 Edition)

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South African registered indications and dosages

Infections due to susceptible non-penicillinase producing organisms including:
Infections of the ear, nose and throat due to streptococci, pneumococci, non-penicillinase-producing staphylococci and H. influenzae
Infections of the genitourinary tract due to E. coli, Proteus mirabilis and Streptococcus faecalis
Infections of the skin and soft-tissues due to streptococci, susceptible staphylococci and E. coli
Infections of the lower respiratory tract due to streptococci, pneumococci, non-penicillinase producing staphylococci and H. influenzae
Gonorrhoea, acute uncomplicated ano-genital and urethral infections due to N. gonorrhoea (males and females)

Infants up to 6kg body weight

• Oral (sus): 25-50mg, every 8hrs

Infants 6-8kg body weight

• Oral (sus): 50-100mg, every 8hrs

Infants and children 8-20kg body weight

• Oral (sus): 6.7-13.3mg per kg body weight, every 8hrs

Children 20kg of body weight and over

• Oral (sus): 250-500mg, every 8hrs

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For instructions on reconstitution of the medicine before administration, see additional prescribing points

Pregnancy

• Safe; no evidence of risk in studies
• Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased risk of congenital malformations. Amoxicillin may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment

Breastfeeding

• Caution 
• Amoxicillin is excreted into breast milk in small quantities with the possible risk of sensitisation. Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breastfed infant, so that breastfeeding might have to be discontinued. Amoxicillin should only be used during breastfeeding after benefit/risk assessment by the physician in charge

Fertility

• There are no data on the effects of amoxicillin on fertility in humans. Reproductive studies in animals have shown no effects on fertility

Renal Impairment

• eGFR>30ml/min/1.73m²: No dose adjustment recommended
• eGFR≤30ml/min/1.73m²: Caution; dose adjustment recommended

GFR (ml/min)	Adults and children ≥40kg	Children <40kg
>30	No adjustment necessary	No adjustment necessary
10-30	Max: 500mg, 12hrly	15mg/kg, 12hrly; Max: 500mg, 12hrly
<10	Max: 500mg/24hrs	15mg/kg, given as a single daily dose; Max: 500mg/24hrs
Haemodialysis	Max: 500mg/24hrs Prior to haemodialysis: one additional dose of 500mg should be admin. After haemodialysis: Another dose of 500mg should be admin.	15mg/kg/day, given as a single daily dose; Max: 500mg/24hrs Prior to haemodialysis: one additional dose of 15mg/kg should be admin. After haemodialysis: Another dose of 15mg/kg should be admin.

Hepatic Impairment

• Caution; no dose adjustment recommended 
  Dose with caution and monitor hepatic function at regular intervals

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Hyperkinesia
• Dizziness
• Seizures

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Antibiotic-associated colitis
  - Pseudomembraneous colitis
  - Haemorrhagic colitis
• Black hairy tongue
• Superficial tooth discolouration

Hepatobiliary Disorders

• Hepatitis
• Cholestatic jaundice
• Moderate rise in aspartate aminotransferase and/or alanine aminotransferase

Genitourinary Disorders

• Interstitial nephritis
• Crystalluria

Skin and Subcutaneous Tissue Disorders

• Skin rash
• Pruritus
• Urticaria
• Erythema multiforme  
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Bullous and exfoliative dermatitis
• Acute generalised exanthematous pustulosis
• Drug reaction with eosinophilia and systemic symptoms

Immune, Blood and Lymphatic System Disorders

• Mucocutaneous candidiasis
• Reversible leucopenia
  - Severe neutropenia
  - Agranulocytosis
• Reversible thrombocytopenia
• Haemolytic anaemia
• Prolongation of bleeding time and prothrombin time  
• Severe allergic reactions
  - Angioneurotic oedema
  - Anaphylaxis
  - Serum sickness
  - Hypersensitivity vasculitis
• Jarisch-Herxheimer reaction

• Oral anticoagulants
• Acenocoumarol
• Warfarin
• Oral contraceptives (see additional prescribing points)
• Probenecid
• Allopurinol
• Tetracyclines
• Other bacteriostatic agents
• Methotrexate

Other interactions

• Interference with diagnostic tests (see additional prescribing points)

None routine. Specific cases may require

• Renal function
• Hepatic function
• Haematologic function

Additional observations

• Assessment for infection at the start of and during the course of therapy
• Signs of anaphylaxis during first dose

Instructions on reconstitution for powder for suspension (before administration)

• Check cap seal is intact before use
• Invert and shake bottle to loosen powder
• Add 64ml and 85ml water for 75ml and 100ml pack respectively in two portions to the dry mixture in the bottle. Shake well after each addition
• Any unused product or waste material should be disposed of in accordance with local requirements

Oral Contraceptives

• Amoxicillin may decrease the efficacy of combined oral contraceptives
• It is advisable for patients to use a barrier method of contraception during antibiotic therapy and for seven days after
• If the course of antibiotics runs into the seven-day break from pill taking then the patient should start the next pack immediately and skip the pill free break. The patient should again use a barrier method of contraception during antibiotic therapy and for seven days after completing the course of antibiotics

Interference with diagnostic tests

• Elevated serum and urinary levels of amoxicillin are likely to affect certain laboratory tests. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods
• It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used

• The presence of amoxicillin may distort assay results for oestriol in pregnant women

Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death. Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes.

Spectrum of activity: Susceptible non-penicillinase-producing organisms; beta-lactamase-negative Streptococcus spp. (alpha- and beta-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae, Escherichia coli, Proteus mirabilis, or Enterococcus faecalis

Drops (per 1.25ml) 125mg

• Amoxil D (GSK) originator

Capsule 250mg

• Adco-Amoxycillin (Adcock Ingram)
• Allmox (Innovata)
• Amocillin (Caps Pharm)
• Amoxicap (Gulf)
• Amoxil (GSK) originator
• Amoxycillin (Oethmaan Biosims)
• Amocas (Be-Tabs)
• Amyn (Dezzo Trading)
• Auro-Amoxycillin (Aurobindo)
• Austell-Amoxicillin (Austell)
• Betamox (Ranbaxy)
• Indo Amoxycillin ( SVIZERA SA)
• Moxan (Pharmacare)
• Moxymax (Dezzo Trading)
• Moxypen (Litha Pharma)
• Mymox (Unichem)
• Promoxil (Medpro) 
• Ranmoxy (Ranbaxy)
• Spectramox C (Alliance)
• Lomax (Actor)
• Yomax (Actor)
• Zaloxy (Medicine Dev)
• Zoxil (Xixia)

Capsule 500mg

• Adco-Amoxycillin (Adcock Ingram)
• Allmox (Innovata)
• Amocillin (Caps Pharm)
• Amoxil (GSK) originator
• Amyn (Dezzo Trading)
• Auro-Amoxycillin (Aurobindo)
• Austell Amoxicillin (Austell)
• Betamox (Ranbaxy)
• Indo Amoxycillin ( SVIZERA SA)
• Moxan (Pharmacare)
• Moxymax (Dezzo Trading)
• Moxypen (Litha Pharma)
• Mymox (Unichem)
• Promoxil (Medpro) (Discontinued: 23/8/2021)
• Ranmoxy (Ranbaxy)
• Ultramox (Oethmaan Biosims)
• Yomax (Actor)
• Zaloxy (Medicine Dev)
• Zoxil (Xixia)

Suspension (per 5ml) 125mg

• Adco-Amoxycillin (Adcock Ingram)
• Allmox S (Innovata)
• Amocillin (Caps Pharmaceuticals)
• Amoxicillin Unimed (Unimed Healthcare)
• Amoxil S (GSK) originator
• Amyn S (Dezzo Trading)
• Betamox S (Ranbaxy)
• Dyna-Amoxycillin (Thebe)
• Moxan S (Pharmacare)
• Moxymax (Dezzo Trading)
• Moxypen S (Litha Pharma)
• Promoxil S (Medpro) (Discontinued: 23/8/2021)
• Ranmoxy (Ranbaxy)
• Saltermox S (Adcock)
• Spectramox S (Alliance)
• Zaloxy (Medicine Dev)
• Zoxil S (Xixia)

Suspension (per 5ml) 250mg

• Adco-Amoxycillin (Adcock Ingram)
• Allmox SF (Innovata)
• Amocillin (Caps Pharmaceuticals)
• Amoxicillin Unimed (Unimed Healthcare) 
• Amoxil SF (GSK) originator
• Amyn SF (Dezzo Trading)
• Betamox SF (Ranbaxy)
• Moxan SF (Pharmacare)
• Moxymax SF (Dezzo Trading)
• Moxypen (Litha Pharma)
• Promoxil SF (Medpro) (Discontinued: 23/8/2021)
• Ranmoxy (Ranbaxy)
• Saltermox SF (Adcock Ingram)
• Spectramox SF (Alliance)
• Zaloxy (Medicine Dev)
• Zoxil SF (Xixia)

COMBINATION PREPARATIONS

Amoxicillin/ Clavulanic acid

Tablet 250mg/125mg

• Adco Amoclav (Adcock Ingram)
• Amoclan (Cipla Medpro)
• Apex Clavutin (Camox)
• Augmaxcil 375 (Litha Pharma)
• Augmentin (GSK) originator
• Austell-Co-Amoxiclav (Austell)
• Auro Amoxiclav (Aurbindo)
• Betaclav (Ranbaxy)
• Bio-Amoksiklav (Biotech)
• Clamentin (Mylan)
• Sandoz Co-Amoxyclav (Sandoz)
• Ranclav (Ranbaxy)

Tablet 500mg/125mg

• Adco Amoclav  (Adcock Ingram)
• Amoclan Forte (Cipla Medpro)
• Apex-Clavutin (Camox)
• Augmaxcil 625 (Litha Pharma)
• Austell-Co-Amoxiclav (Austell)
• Auro Amoxiclav (Aurbindo)
• Betaclav (Ranbaxy)
• Bio-Amoksiklav (Biotech)
• Curam (Sandoz)
• Ranclav (Ranbaxy)
• Sandoz Co-Amoxyclav (Sandoz)

Tablet dispersible 500mg/125mg

• Sandoz Co-Amoxyclav (Sandoz)

Tablet 875mg/125mg

• Adco Amoclav BD (Adcock Ingram)
• Amoclan BD (Cipla Medpro)
• Auro Amoxiclav (Aurbindo)
• Augmentin BD (GSK) originator
• Betaclav (Ranbaxy)
• Bio-Amoksiklav (Biotech)
• Clamentin (Mylan)
• Curam (Sandoz)
• Ranclav (Ranbaxy)
• Sandoz Co-Amoxyclav (Sandoz)

Tablet dispersible 875mg/125mg

• Forced Solutab (Arrow)
• Klavimaxcil (Sandoz)

Tablet 1000mg/62.5mg

• Augmenting SR (GSK) originator

Suspension (per 5ml) 125mg/31,25mg

• Adco Amoclav S (Adcock Ingram)
• Amoclan S (Cipla Medpro)
• Augmaxcil S (Litha Pharma)
• Augmentin S (GSK) originator
• Auro-Amoxiclav (Aurobindo)
• Bio-Amoksiklav S (Biotech)
• Clamentin S (Mylan)
• Clavumox S (Pharmacare)
• Ranclav S (Ranbaxy)
• Sandoz Co-Amoxyclav S (Sandoz)

Suspension (per 5ml) 250mg/62,5mg

• Adco Amoclav Forte (Adcock Ingram)
• Amoclan SF (Cipla Medpro)
• Apex-Clavutin SF (Camox)
• Augmaxcil SF (Litha Pharma)
• Augmentin SF (GSK) originator
• Bio-Amoksiklav SF (Biotech)
• Clamentin SF (Mylan)
• Clavumox SF (Pharmacare)
• Ranclav Forte (Ranbaxy)
• Sandoz Co-Amoxyclav SF (Sandoz)

Suspension (per 5ml) 200mg/28.5mg

• Augmentin BD (GSK) originator
• Sandoz Co-Amoxiclav BD (Sandoz)

Suspension (per 5ml) 400mg/57mg

• Augmentin BD SF (GSK) originator
• Curam BD (Sandoz)
• Sandoz Co-Amoxiclav BD (Sandoz)

Suspension (per 5ml) 600mg/42.9mg

• Augmentin ES (GSK) originator
• Austell Co-Amoxiclav ES 600 (Camox)
• Camox Co-Amoxiclav ES 600 (Camox)

Injection (per vial) 500mg/100mg

• Augmentin IV 0.6 (GSK) originator
• Gulf Amoxy Co (Gulf)
• Sandoz Co-Amoxyclav 0.6 (Sandoz)

Injection (per vial) 1000mg/200mg

• Augmaxcil (Pharmacare)
• Augmentin IV 1.2 (GSK) originator
• Clamentin (Mylan)
• Gulf Amoxy Co (Gulf)
• Sandoz Co-Amoxyclav 1.2 (Sandoz)