Ampicillin

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: 

Indicated in the treatment of infections caused by susceptible strains of the following microorganisms:

• Infections of the genitourinary tract caused by E. coli, P. mirabilis and enterococci
• Respiratory tract and ENT infections e.g. pharyngitis, tonsillitis, sinusitis, laryngitis, otitis media, bronchitis, pneumonia caused by various bacteria including non-penicillinase producing H. influenzae, staphylococci, and streptococci including Streptococcus pneumoniae
• Infections of the gastrointestinal tract caused by Shigella, S.typhosa and other Salmonella, E. coli, P. mirabilis and enterococci
• Meningitis caused by N. meningitidis (after confirmation by sensitivity testing)
• Miscellaneous infections e.g. septicaemia, endocarditis and biliary tract infections, skin and soft tissue infections, bacteremia and as an adjunct in the treatment of sepsis caused by gram-negative bacteria
• Gram-positive non-penicillinase producing Staphylococci, haemolytic and non-haemolytic streptococci, Diplococcus pneumoniae, Clostridia sp. and Streptococcus faecalis 
• Gram-negative cocci (Neisseria sp), H. influenzae, E.coli, Proteus mirabilis and many strains of Brucellae, Salmonellae and Shigellae

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to beta-lactam antibiotics (e.g. penicillins, cephalosporins)
• Neonates born to mothers displaying hypersensitivity to beta-lactam antibiotics (inj)
• Infectious mononucleosis

Cautions

• Breastfeeding
• Moderate to severe renal impairment (eGFR (<50ml/min/1.73m²)
• Hepatic impairment
• Acute/chronic leukaemia of lymphoid origin
• Prolonged use (particularly with high doses)
• Syphilis (inj)
  - Cardiovascular syphilis
• High doses in pre-existing renal failure or congestive heart failure (inj)
• Neonates and young infants (inj)
• High doses in children (inj)
• HIV infection (inj)
• Optic atrophy (inj)

Forms avail. in SA and covered in this monograph: inj, cap, sus

Dosages below include:

• General dosing range
• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Actinomyces sp.; B. burgdoferi; E. faecalis (S); L. monoctogenes; N. meningitidis; P. multocida; Peptostreptococci 

General dosing range

• Oral (cap, sus): 250-500mg, 6hrly
• IV/IM: 1-2g, 4-6hrly

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See additional prescribing points for administration instructions

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Specific doses based on individual indications

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

Community-acquired pneumonia without features of severe pneumonia and without co-morbidity and in patients <65 years of age

• IV: 1g, 6hrly
  (STG, Adult 2019)

Infective endocarditis prophylaxis prior to dental extraction
- If patient can not take oral medication

• IV/IM: 2g, 1hr before procedure
  (STG, Adult 2019)

Preterm prelabour rupture of membranes (PPROM)

• IV: 1g, 6hrly; Treatment duration: 48hrs (Refer urgently)
  (STG, Adult 2023; PHC 2023)

Prelabour rupture of membranes at term (PROM)
- Prolonged prelabour rupture of membranes >12hrs/ suspected chorio-amnionitis (Additional agent required)

• IV: 1g, as a single dose (Refer urgently) 
  (STG, PHC 2023)

Acute meningitis
- During a listeria outbreak, ADD as a pre-referral dose

• IV/IM: 3g, immediately before referral. Administer second dose if referral delayed by 6hrs
  (STG, PHC 2020)

Listeria monocytogenes meningitis (Additional agent required)

• IV: 3g, 6hrly; Treatment duration: 21 days
  (STG, Adult 2019)

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South African registered indications and dosages

Infections of the genitourinary tract
- Caused by E. coli, P. mirabilis and enterococci
Respiratory tract and ENT infections
- Pharyngitis, tonsillitis, sinusitis, laryngitis, otitis media, bronchitis, pneumonia caused by various bacteria including non-penicillinase producing H. influenzae, staphylococci, and streptococci including Streptococcus pneumoniae
Infections of the gastrointestinal tract
- Caused by Shigella, S.typhosa and other Salmonella, E. coli, P. mirabilis and enterococci
Meningitis
- Caused by N. meningitidis (after confirmation by sensitivity testing)
Miscellaneous infections
- Septicaemia, endocarditis and biliary tract infections, skin and soft tissue infections, bacteremia and as an adjunct in the treatment of sepsis caused by gram-negative bacteria
Gram-positive infections
- Caused by non-penicillinase producing Staphylococci, haemolytic and non-haemolytic streptococci, Diplococcus pneumoniae, Clostridia sp. and Streptococcus faecalis 
Gram-negative infections
- Caused by (Neisseria sp), H. influenzae, E.coli, Proteus mirabilis and many strains of Brucellae, Salmonellae and Shigellae

• IV: Max: 12g/24hrs, in divided doses 4hrly
• Oral (cap, sus): 250-750mg, 6hrly

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IV: In the treatment of beta-haemolytic streptococcal infections, a therapeutic dose must be administered for at least 10 days

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Dosage varies with the type and the severity of the infection, renal function and age

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Parenteral administration is reserved for severe infections that cannot be treated by oral ampicillin

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Oral preparations should be taken 130-60min. before meals

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Indications and dosages registered in other jurisdictions

Ear, nose and throat infections

• Oral (cap): 250mg, 6hrly

Bronchitis
- Routine therapy

• Oral (cap): 250mg, 6hrly

- High-dosage therapy

• Oral (cap): 1g, 6hrly

Pneumonia

• Oral (cap): 500mg, 6hrly

Urinary tract infections

• Oral (cap): 500mg, 8hrly

Gonorrhoea (additional agent required)

• Oral (cap): 2g, as a single dose. Repeat doses are recommended for the treatment of females

Gastrointestinal infections

• Oral (cap): 500-750mg, 6-8hrly

Enteric
- Acute

• Oral (cap): 1-2g, 6hrly; Treatment duration: 14 days

- Carriers

• Oral (cap): 1-2g, 6hrly; Treatment duration: 4-12 weeks

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All recommended dosages are a guide only. In severe infections, the below dosages may be increased, or ampicillin be given by injection

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Oral doses of ampicillin should be taken 30-60mins before meals

Forms avail. in SA and covered in this monograph: inj, sus, cap

Paed. dosages below include:

• General dosing range
• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Actinomyces sp.; B. burgdoferi; E. faecalis (S); L. monoctogenes; N. meningitidis; P. multocida; Peptostreptococci 

General dosing range

>28 days

• IV/Oral (cap, sus): 200mg/kg/day, 6hrly

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See additional prescribing points for administration instructions

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Specific doses based on individual indications

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

Acute liver failure with sepsis (Additional agent required)
- Where sepsis is suspected, empiric antibiotic therapy

• IV: 50mg/kg, 6hrly
  (STG, Paed. 2017)

Acute diarrhoea (Additional agent required)
- Severe malnutrition

• IV: 50mg/kg, 6hrly; Treatment duration: 5 days
  (STG, Paed. 2017)

- Very young infants (Additional agent required)

• IV: 25-50mg/kg, 6hrly; Treatment duration: 5 days
  (STG, Paed. 2017)

Severe acute malnutrition (SAM) (Additional agent required)

• IV/IM: 50mg/kg, 6hrly; Treatment duration: 7 days, until there is a response and patient can tolerate oral medication; Avoid IV infusions, if possible. Use a heparin lock to avoid fluid overload because of poor cardiac reserves 
  (STG, Paed. 2017)

Infective endocarditis prophylaxis prior to dental extraction
- If patient can not take oral medication 

• IV: 50mg/kg, 30min before procedure; Max dose: 2g
  (STG, Paed. 2017)

Necrotising enterocolitis in the newborn (Additional agent required)
- Empiric antibiotic therapy

• Younger than 7 days: IV: 50mg/kg, 12hrly; Treatment duration: 7 days, reassess choice of antibiotics when the culture and sensitivity results become available 
• Between 7-21 days: IV: 50mg/kg, 8hrly; Treatment duration: 7 days, reassess choice of antibiotics when the culture and sensitivity results become available 
• Older than 21 days: IV: 50mg/kg, 6hrly; Treatment duration: 7 days, reassess choice of antibiotics when the culture and sensitivity results become available 
  (STG, Paed. 2017)

Hypoxia/ ischaemia of the newborn (perinatal hypoxia/ hypoxic-ischaemic encephalopathy) (Additional agent required)
- If infection is suspected or confirmed

• Younger than 7 days: IV: 50mg/kg, 12hrly 
• Between 7-21 days: IV: 50mg/kg, 8hrly 
• Older than 21 days: IV: 50mg/kg, 6hrly 
  (STG, Paed. 2017)

Short term intubation with infection in the newborn (Additional agent required)

• Younger than 7 days: IV: 50mg/kg, 12hrly; Treatment duration: 5-7 days, review after 72hrs - if infection is confirmed or very strongly suspected, continue for 10 days 
• Between 7-21 days: IV: 50mg/kg, 8hrly; Treatment duration: 5-7 days, review after 72hrs - if infection is confirmed or very strongly suspected, continue for 10 days 
• Older than 21 days: IV: 50mg/kg, 6hrly; Treatment duration: 5-7 days, review after 72hrs - if infection is confirmed or very strongly suspected, continue for 10 days 
  (STG, Paed. 2017)

Neonatal bacterial meningitis (Additional agent required)
- Empiric antibiotic therapy

• Younger than 7 days: IV: 50mg/kg, 12hrly; Treatment duration: 14 days, reconsider choice of antibiotic when the results of blood and CSF cultures become available or the child does not improve within 72-96hrs 
• Between 7-21 days: IV: 50mg/kg, 8hrly; Treatment duration: 14 days, reconsider choice of antibiotic when the results of blood and CSF cultures become available or the child does not improve within 72-96hrs 
• Older than 21 days: IV: 50mg/kg, 6hrly; Treatment duration: 14 days, reconsider choice of antibiotic when the results of blood and CSF cultures become available or the child does not improve within 72-96hrs 
  (STG, Paed. 2017)

Septicaemia of the newborn (Additional agent required)
- Empiric treatment (First line)

• Younger than 7 days: IV: 50mg/kg, 12hrly; Treatment duration: 10 days, if child is deteriorating and there are no culture positive results - switch to second line 
• Between 7-21 days: IV: 50mg/kg, 8hrly; Treatment duration: 10 days, if child is deteriorating and there are no culture positive results - switch to second line 
• Older than 21 days: IV: 50mg/kg, 6hrly; Treatment duration: 10 days, if child is deteriorating and there are no culture positive results - switch to second line
  (STG, Paed. 2017)

Acute meningitis
- During a listeria outbreak, ADD as a pre-referral dose

• IV/IM: 75mg/kg/dose, immediately before referral. Administer second dose if referral delayed by 6 hours
  (STG, PHC 2020)

Weight kg	Dose mg	Injection 500mg/ml (500mg diluted in 0.9ml water for injection)	Age months/years
>3.5-5.5	300	0.6	>1-3 months
>5-7	450	0.9	>3-6 months
>7-9	600	1.2	>6-12 months
>9-11	750	1.5	>12-18 months
>11-17.5	1000	2	>18 months-5 years
>17.5-25	1500	3	>5-7 years
>25-35	2000	4	>7-11 years
>35	3000	6	>11 years

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South African registered indications and dosages

Infections of the genitourinary tract
- Caused by E. coli, P. mirabilis and enterococci
Respiratory tract and ENT infections
- Pharyngitis, tonsillitis, sinusitis, laryngitis, otitis media, bronchitis, pneumonia caused by various bacteria including non-penicillinase producing H. influenzae, staphylococci, and streptococci including Streptococcus pneumoniae
Infections of the gastrointestinal tract
- Caused by Shigella, S.typhosa and other Salmonella, E. coli, P. mirabilis and enterococci
Meningitis
- Caused by N. meningitidis (after confirmation by sensitivity testing)
Miscellaneous infections
- Septicaemia, endocarditis and biliary tract infections, skin and soft tissue infections, bacteremia and as an adjunct in the treatment of sepsis caused by gram-negative bacteria
Gram-positive infections
- Caused by non-penicillinase producing Staphylococci, haemolytic and non-haemolytic streptococci, Diplococcus pneumoniae, Clostridia sp. and Streptococcus faecalis 
Gram-negative infections
- Caused by (Neisseria sp), H. influenzae, E.coli, Proteus mirabilis and many strains of Brucellae, Salmonellae and Shigellae

• IV: Max: 400mg/kg/24hrs, in divided doses, 4hrly

Oral (cap, sus): 

• 0-6 years: 62.5-187.5mg, 6hrly
• 6-10 years: 125-375mg, 6hrly
• >10 years: See adult dosage

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Doses for children should not exceed doses recommended for adults

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The recommended IV/IM doses for children are ¼-¾ of the adult dose and are increased in relation to the age from infants to 15 years

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IV administration to neonates and young infants should be limited to the lowest dosages compatible with an effective therapeutic regimen

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Dosage varies with the type and the severity of the infection, renal function and age

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Parenteral administration is reserved for severe infections that cannot be treated by oral ampicillin

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Indications and dosages registered in other jurisdictions

Below 10 years

Ear, nose and throat infections

• Oral (cap): 125mg, 6hrly

Bronchitis
- Routine therapy

• Oral (cap): 125mg, 6hrly

- High-dosage therapy

• Oral (cap): 500mg, 6hrly

Pneumonia

• Oral (cap): 250mg, 6hrly

Urinary tract infections

• Oral (cap): 250mg, 8hrly

Gonorrhoea (additional agent required)

• Oral (cap): 1g, as a single dose. Repeat doses are recommended for the treatment of females

Gastrointestinal infections

• Oral (cap): 250-375mg, 6-8hrly (consider available capsule formulations)

Enteric
- Acute

• Oral (cap): 500mg-1g, 6hrly; Treatment duration: 14 days

- Carriers

• Oral (cap): 500mg-1g, 6hrly; Treatment duration: 4-12 weeks

10 years and older

Ear, nose and throat infections
Bronchitis
Pneumonia
Urinary tract infections
Gonorrhoea (additional agent required)
Gastrointestinal infections
Enteric

• No information available

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All recommended dosages are a guide only. In severe infections, the below dosages may be increased, or ampicillin be given by injection

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Oral doses of ampicillin should be taken 30-60mins before meals

Pregnancy

• Safe; no evidence of risk in studies
• Animal studies with ampicillin have shown no teratogenic effects. The product has been in extensive clinical use since 1961 and its use in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, ampicillin may be considered appropriate

Breastfeeding

• Caution
• During breastfeeding, trace quantities of penicillins can be detected in breast milk. Adequate human and animal data on the use of ampicillin during breastfeeding are not available

Renal Impairment

• eGFR ≥50ml/min/1.73m²: No dose adjustment recommended
• eGFR 10-49ml/min/1.73m²: Caution; no dose adjustment recommended
  Increase dosing frequency to 6-12hrly
• eGFR <10ml/min/1.73m² or on intermittent haemodialysis (IHD): Caution; dose adjustment recommended
  Increase dosing frequency to 12-24hrly. Since ampicillin is 'dialyzable', a total dose reduction by up to 25% may or may not be required. On haemodialysis days, administer after haemodialysis session
• eGFR <10ml/min/1.73m² or on peritoneal haemodialysis: Caution; dose adjustment recommended 
  Increase dosing frequency to 12-24hrly. Since ampicillin is 'not dialyzable', a total dose reduction by up to 50% is required. On haemodialysis days, administer after haemodialysis session

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Cerebral irritation in children (inj)  
• Seizures in children (inj)
• Headaches

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Heartburn
• Pseudomembranous colitis
• Haemorrhagic colitis
• Sore mouth or tongue (inj)
• Black, hairy tongue (inj)

Hepatobiliary Disorders

• Hepatitis
• Cholestatic jaundice
• Increased transaminase levels

Genitourinary Disorders

• Interstitial nephritis

Musculoskeletal Disorders

• Swollen joints

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritis
• Urticaria
• Purpura
• Erythema multiforme
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Vasculitis
• Angioneurotic oedema
• Jarisch-Herxheimer reaction

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Transient leucopenia
• Transient thrombocytopenia
• Haemolytic anaemia
• Prolonged bleeding time
• Prolonged prothrombin time
• Thrombocytopenic purpura (inj)
• Eosinophilia (inj)
• Granulocytopenia (inj)
• Anaphylaxis
• Overgrowth of non-susceptible organisms
• Fever
• Chills
• Defective platelet function (inj)

• Bacteriostatic agents
• Oral contraceptives
• Probenecid
• Allopurinol

Other interactions

• Laboratory testing of glucose in urine (see additional prescribing points)

None routine. Specific cases may require

• Renal function
• Hepatic function
• Full blood count

Additional observations

• Signs and symptoms of anaphylaxis during first dose

Injection 250mg, Injection 500mg - EML (Primary)
Capsule 250mg, Suspension 125mg/5ml, Suspension 250mg/5ml - Non EML

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Administration directions (Parenteral formulations)

Route of administration	Reconstitution and administration directions
Intramuscular	100mg: Add 0.5ml water for injection
	250mg, 500mg, 1g: Add 1.5-2ml water for injection
Intravenous	250mg: 5ml water for injection
	500mg: 10ml water for injection
	1-5g: 20-30ml water for injection
	Administer by slow injection over a period of 3-4mins. Alternatively, if fluids are being given by intravenous infusion, the solution may be injected into the drip tubing
Intrathecal	Infants 0-2 years: 5-10mg, dly; dissolve in 0.5ml sterile water for injection/ sterile normal saline or CSF (Single injection daily)
	Children 2-12 years: 10-20mg, dly; dissolve in 0.5-1ml sterile water for injection/ sterile normal saline/ CSF (Single injection daily)
	Adults: Up to 40mg, dly; dissolve in up to 2ml sterile water for injection/ sterile normal saline/ CSF (Single injection daily)
Intraperitoneal	Dialysis: 50mg per litre of dialysate
Therapeutic	500mg dissolved in 5-10ml water for injection
Intrapleural	500mg dissolved in 5-10ml water for injection
Intra-articular	50-100mg/ml of water for injection or 0.5% lignocaine hydrochloride to make up to a volume of 2.5ml
Sub-conjunctival	100mg dissolved in 0.5ml water for injection
Topical	Sprinkle 500mg-1g dry powder extraperitoneally before closure and suturing

Interference with laboratory testing

• It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used
• Due to the high urinary concentrations of ampicillin, false positive readings are common with chemical methods

Ampicillin is a broad spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin sensitive organisms.

Spectrum of activity: Actinomyces sp.; B. burgdoferi; E. faecalis (S); L. monoctogenes; N. meningitidis; P. multocida; Peptostreptococci 

Capsule 250mg

• Ampipen (Caps Pharma)
• Ampouleipen (Caps Pharmaceuticals)
• Be-Ampicil (Be-tabs)
• Be-Ampouleicil (Be-Tabs)
• Spectracil C (Alliance)

Suspension (per 5ml) 125mg

• Be-Ampicil (Be-Tabs)
• Be-Ampouleicil (Be-Tabs)
• Spectracil S (Alliance)

Suspension (per 5ml) 250mg

• Spectracil SF (Alliance)

Injection (per vial) 250mg

• Ampicillin Fresenius (Fresenius)
• Ampicillin 250 Injection Unimed (Unimed Healthcare)
• RanAmpoule  (Ranbaxy)

Injection (per vial) 500mg

• Ampicillin Fresenius (Fresenius)
• Ampicillin 500 Injection Unimed (Unimed Healthcare)
• Auro Ampicillin (Aurobindo)
• RanAmpoule (Ranbaxy)

COMBINATION PREPARATIONS

Ampicillin/Cloxacillin

Injection (per 7.5ml) 125mg/125mg

• Ampoxin 250 (Unichem)

Injection (per 7.5ml) 250mg/250mg

• Ampoxin 500 (Unichem)

Injection (per 10ml) 500mg/500mg

• Ampoxin 1000 (Unichem)

Suspension (per 5ml) 125mg/125mg

• Megamox S (Pharmacare)

Suspension (per 5ml) 250mg/250mg

• Ampiclox (Pharmacare) 

Capsule 250mg/250mg

• Megamox (Pharmacare)
• Cloxam (Pharmacare)

Ampicillin/Flucloxacillin

Suspension (per 5ml) 125mg/125mg

• Megapen S (Pharmacare)

Capsule 250mg/250mg

• Megapen 500 (Pharmacare)