Cefotaxime

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: 

• Streptococcal infections (Group D and beta-haemolytic Streptococci): Otitis media, sinusitis, pharyngitis, pneumonia, follicular tonsillitis, scarlet fever, urinary tract infections (enterococci), septic sore throat, cellulitis and meningitis in children
• Staphylococcal infections (including non-penicillinase and penicillinase producing strains): Bronchitis, impetigo, furunculosis and abscess
• Escherichia coli infections: Urinary tract infections (including acute uncomplicated cystitis by Klebsiella pneumoniae), meningitis in children and lobar pneumonia
• Haemophilus influenzae infections: Meningitis in children, otitis media and bronchitis of the larynx and trachea
• Gonococcal infections: Gonorrhoea
• Neisseria meningitidis: Meningitis in children
• Salmonella infections: Enteritis
• Shigella infections: Bacillary dysentery
• Pseudomonas aeruginosa (sensitive strains): Sepsis
• Pneumococcal infections: Cellulitis, lobar pneumonia, otitis media and bronchitis
• Prophylactically (peri-operatively) to reduce incidence of potentially contaminating post-operative infections

Contraindications 

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to penicillin or any other cephalosporins
• Cefotaxime constituted with lidocaine Injection must never be used:
  - By the intravenous route
  - In infants <30 months of age
  - In subjects with a previous history of hypersensitivity to lidocaine or other local anaesthetics of the amide type
  - In patients who have a non-paced heart block
  - In patients with severe heart failure

Cautions 

• Pregnancy
• Breastfeeding
• Renal impairment
• Prolonged use
• History of allergies or asthma
• Clostridium difficile-associated disease
• High doses
• Rapid intravenous administration (through a central venous catheter)
• Sodium-controlled diet
• Coadministration with aminoglycosides or other nephrotoxic agents
• May impair ability to drive or operate machinery (high doses and/or renal impairment)

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

Adult dosages below include:

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

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Infections caused by: Haemophilus influenzae, Leptospira sp., Viridans Streptococci, Yersinia enterocolitica, Staphylococcus aureus (Methicillin-susceptible), Group A Streptococci (including Streptococcus pyogenes), Group B Streptococci, β-hemolytic Streptococci (Group C, F, G), Haemophilus parainfluenzae,Moraxella catarrhalis, Neisseria gonorrhoeae,Neisseria meningitides,Proteus spp., Providencia spp.,Clostridium spp. (not Clostridium difficile), Peptostreptococcus spp., Propionibacterium spp.

General dose range 

• IV: 1-2g, 4-12hrly

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See additional prescribing points for administration directions

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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 registered indications and dosages

Streptococcal infections (Group D and beta-haemolytic Streptococci)
- Otitis media, sinusitis, pharyngitis, pneumonia, follicular tonsillitis, scarlet fever, urinary tract infections (enterococci), septic sore throat, cellulitis
Staphylococcal infections (including non-penicillinase and penicillinase producing strains)
- Bronchitis, impetigo, furunculosis and abscess
Escherichia coli infections
- Urinary tract infections (including acute uncomplicated cystitis by Klebsiella pneumoniae) and lobar pneumonia
Haemophilus influenzae infections
- Otitis media and bronchitis of the larynx and trachea
Gonococcal infections
- Gonorrhoea
Salmonella infections
- Enteritis
Shigella infections
- Bacillary dysentery
Pseudomonas aeruginosa (sensitive strains)
- Sepsis
Pneumococcal infections
- Cellulitis, lobar pneumonia, otitis media and bronchitis

• IV/IM: 2g/day, as 2 divided doses of 1g, 12hrly

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Cefotaxime can be administered as a deep IM injection, a slow IV injection over 3-5mins or an infusion over 20-60mins

See additional prescribing points for administration directions

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Beta-hemolytic streptococcal infections: A therapeutic dose must be administered for ≥10 days

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- Severe infections

• IV/IM: Max: 3-4g/day, in 2-4 divided doses; Max: 12g/24hrs 

Gonorrhoea 

• IV/IM: 1g, as a single dose

Surgical prophylaxis

• IV/IM: 1g, 30-90 mins prior to surgery

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Indications and dosages registered in other jurisdictions

Infections of the lower respiratory tract
Infections of the kidneys and urinary tract
Infections of the skin and soft tissue
Genital infections caused by gonococci, particularly when penicillin has failed or is unsuitable
Intra-abdominal infections (including peritonitis)
Acute meningitis in case of gram-negative microorganisms (additional agent required)
Sepsis of gram-negative microorganisms (additional agent required)
Endocarditis in case of gram-negative microorganisms (additional agent required) 

- Typical infections in which sensitivity is demonstrated and bacterium is proven or suspected

• IV/IM: 1g, 12hrly; Treatment duration: Until 3-4 days after improvement/ regression of symptoms; Daily dose: 2g/day

- Infections in which various bacteria with high to medium sensitivity are demonstrated or suspected

• IV/IM: 2g, 12hrly; Treatment duration: Until 3-4 days after improvement/ regression of symptoms; Daily dose: 4g/day

- Unclear bacterial illness which cannot be localised and where patient is critically ill

• IV/IM: 2-3g, 8hrly; Treatment duration: until 3-4 days after improvement/ regression of symptoms; Daily dose: 6g/day

OR

• IV/IM: 2-3g, 6hrly; Treatment duration: until 3-4 days after improvement/ regression of symptoms; Daily dose up to: 8g/day

OR

• IV/IM: 2-3g, 6hrly; Treatment duration: until 3-4 days after improvement/ regression of symptoms; Daily dose up to: 12g/day

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May be administered intravenously, by bolus injection or infusion, or intramuscularly

See additional prescribing points for administration directions

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Dosage and type of administration depend on the severity of the infection, the sensitivity of the causative organism and the condition of the patient

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The duration of the treatment depends on the course of the disease. Generally cefotaxime is administered for a further 3-4 days after improvement/ regression of the symptoms

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The clinician should consult published protocols for information on dosage regimens in specific conditions such as gonorrhoea, pseudomonas infections and CNS infections

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In severe cases, the dose can be increased up to 12g/24hrs. Daily doses up to 6g can be divided into at least two individual administrations at 12hrly intervals. Higher daily doses must be divided into at least 3 or 4 individual administrations at 8 or 6 hour intervals respectively

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Gonorrhoea

• IV/IM: 500mg-1000mg, as a single dose

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In most cases due to less sensitive infective bacteria, an increase may be necessary to 1000mg cefotaxime

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 Examination for syphilis needs to be carried out before commencing therapy

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Lyme borrelisosis

• IV/IM: 2g, 8hrly; Treatment duration: 14-21 days; Daily dose: 6g/day

Peri-operative prophylaxis (additional agent required)
- Colorectal, gastrointestinal, prostatic, urogenital and gynaecological surgery in patients who have a definite risk of post-operative infections

• IV/IM: 1-2g, 30-60mins prior to operation; Repeat dose if duration of operation exceeds 90mins

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Administration should usually be stopped within 24hrs since continuing use of any antibiotic in the majority of surgical procedures

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Protection is best insured by achieving adequate local tissue concentrations at the time contamination is likely to occur

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

Paed. dosages below include:

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

Infections caused by: Haemophilus influenzae, Leptospira sp., Viridans Streptococci, Yersinia enterocolitica, Staphylococcus aureus (Methicillin-susceptible), Group A Streptococci (including Streptococcus pyogenes), Group B Streptococci, β-hemolytic Streptococci (Group C, F, G), Haemophilus parainfluenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitides, Proteus spp., Providencia spp., Clostridium spp. (not Clostridium difficile), Peptostreptococcus spp., Propionibacterium spp.

General dose range

Older than 28 days

• IV: 150-200mg/kg, 6-8hrly

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Can be increased to 300mg/kg/day, in 4 divided doses, 6hrly for meningitis

See additional prescribing points for administration directions

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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

Neonatal bacterial meningitis (Additional agent required)

Preterm

• IV: 50mg/kg, 12hrly; Treatment duration: 4-6 weeks

First week of life

• IV: 50mg/kg, 8hrly; Treatment duration: 4-6 weeks

Older than 2 weeks

• IV: 50mg/kg, 6hrly; Treatment duration: 4-6 weeks
  (STG, Paed. 2017)

Sepstic shock 
- Antibiotic therapy

Younger than 1 month

• IV: 75mg/kg, 8hrly
  (STG, Paed. 2017)

Persistent diarrhoea
- Antibiotic therapy for Y. enterocolitica

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

Dysentery
- Antibiotic therapy where oral medication cannot be used

• IV: 75mg/kg, 8hrly; Treatment duration: 5 days
  (STG, Paed. 2017)

Acute liver failure (Additional agent required)
- Empiric antibiotic therapy until cultures known

• IV: 75mg/kg, 8hrly
  (STG, Paed. 2017)

Thrombotic thrombocytopenic purpura with infection
Haemolytic uraemic syndrome with infection
Aplastic anaemia (Additional agent required)
- For fever (T>38°C), with blood cultures taken first

Younger than 1 month

• IV: 25-50mg/kg, 6hrly
  (STG, Paed. 2017)

Septic (pyogenic) arthritis (Additional agent required)
Acute osteitis/osteomyelitis

Preterm

• IV: 50mg/kg, 12hrly; Treatment duration: 4-6 weeks

First week of life

• IV: 50mg/kg, 8hrly; Treatment duration: 4-6 weeks

Older than 2 weeks

• IV: 50mg/kg, 6hrly; Treatment duration: 4-6 weeks
  (STG, Paed. 2017)

Acute bacterial tracheitis
Preseptal and orbital cellulitis
- Initial management

Between 0-1 month 

• IV: 50mg/kg, 6-8hrly
  (STG, Paed. 2023) 

Non-typhoid salmonella
- Invasive disease

Younger than 1 month

• IV/IM: 50-75mg/kg, 8hrly
  (STG, Paed. 2017)

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South African registered indications and dosages 

Streptococcal infections (Group D and beta-haemolytic Streptococci)
- Otitis media, sinusitis, pharyngitis, pneumonia, follicular tonsillitis, scarlet fever, urinary tract infections (enterococci), septic sore throat, cellulitis and meningitis in children
Staphylococcal infections (including non-penicillinase and penicillinase producing strains)
- Bronchitis, impetigo, furunculosis and abscess
Escherichia coli infections
- Urinary tract infections (including acute uncomplicated cystitis by Klebsiella pneumoniae), meningitis in children and lobar pneumonia
Haemophilus influenzae infections
- Meningitis in children, otitis media and bronchitis of the larynx and trachea
Gonococcal infections
- Gonorrhoea
Neisseria meningitidis infections
- Meningitis in children
Salmonella infections
- Enteritis
Shigella infections
- Bacillary dysentery
Pseudomonas aeruginosa (sensitive strains)
- Sepsis
Pneumococcal infections
- Cellulitis, lobar pneumonia, otitis media and bronchitis

Between 0-7 days

• IV: 50mg/kg, 12hrly

Between 7-28 days

• IV: 50mg/kg, 8hrly

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Dosages are applicable to both premature and full term infants

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Infants and children

• IV/IM: 50-100mg/kg, 6-12hrly

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 Infants and children: Up to 200mg/kg/24hrs may be administered in exceptional cases

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Indications and dosages registered in other jurisdictions

Infections of the lower respiratory tract
Infections of the kidneys and urinary tract
Infections of the skin and soft tissue
Genital infections caused by gonococci, particularly when penicillin has failed or is unsuitable
Intra-abdominal infections (including peritonitis)
Acute meningitis in case of gram-negative microorganisms (additional agent required)
Sepsis of gram-negative microorganisms (additional agent required)
Endocarditis in case of gram-negative microorganisms (additional agent required) 

Infants and children younger than 12 years

• IV/IM: 50-150mg/kg, in divided (equal) doses, 6-12hrly

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In neonates and infants, doses of 50mg/kg/24hrs should not be exceeded in view of not fully matured kidney clearance

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Older than 12 years

• IV/IM: See adult dosage

- Life-threatening situations

Between 0-7 days

• IV: 50mg/kg, 12hrly

Between 7 days-1 month

•  IV: 50mg/kg, 8hrly

Older than 1 month

• IV: 75mg/kg, 8hrly

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 Infants and children up to 12 years: In individual cases, particularly in life threatening situations, it may be necessary to increase the dose to 200mg/kg/24hrs 

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It is not necessary to differentiate between premature and normal-gestational age infants

Pregnancy

• Caution
• The safety of cefotaxime has not been established in human pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. There are however no adequate and well-controlled studies in pregnant women
• Cefotaxime passes through the human placenta. Therefore, Cefotaxime should only be used during pregnancy if the anticipated benefit outweighs any potential risks

Breastfeeding

• Caution
• Cefotaxime is excreted in human milk in low concentrations
• Use during breastfeeding can lead to an effect on the physiological intestinal flora with diarrhoea, colonisation by yeast-like fungi and may also lead to sensitisation of the infant. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue therapy, taking into account the benefit of breastfeeding to the child and the benefit of therapy to the mother

Renal Impairment

• CrCl >20ml/min: Caution; no dose adjustment recommended
• CrCl ≤20ml/min; Caution; dose adjustment recommended
  The recommendations below are based on experiences with adults:

CrCl (ml/min)	Dose
>20	No dose adjustment recommended
6 - 20	Reduce maintenance dose by 50%
≤5	IV: 500mg, 12hrly; Max: 1000mg/24hrs
Haemodialysis	An additional dose should be administered after dialysis

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended
  No dose adjustments are needed in patients with normal renal function

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Seizures
• Headache
• Dizziness
• Encephalopathy
  - Impairment of consciousness
  - Abnormal movements

Cardiovascular Disorders

• Arrhythmia (following rapid bolus infusion through central venous catheter)

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Abdominal pain
• Pseudomembranous colitis

Hepatobiliary Disorders

• Increase in hepatic enzymes:
  - Alanine transaminase
  - Aspartate aminotransferase
  - Lactate dehydrogenase
  - Gamma-glutamyl transferase
  - Alkaline phosphatase
• Increased bilirubin
• Hepatitis (sometimes with jaundice)

Genitourinary Disorders

• Decrease in renal function
• Increase of creatinine
• Interstitial nephritis

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Urticaria
• Erythema multiforme
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Pain at the injection site
• Inflammatory reactions at the injection site
  - Thrombophlebitis
  - Phlebitis

Immune, Blood and Lymphatic System Disorders

• Superinfection
• Leucopoenia
• Eosinophilia
• Thrombocytopenia
• Neutropenia
• Agranulocytosis
• Haemolytic anaemia
• Jarisch-Herxheimer reaction
  - Skin rash
  - Itching
  - Fever
  - Leucopenia
  - Increased hepatic enzymes
  - Difficulty in breathing
  - Joint discomfort
• Anaphylactic reactions
• Angioedema
• Bronchospasm
• Anaphylactic shock
• Fever

Other

• Systemic reactions to lidocaine (if reconstituted with lidocaine)

• Bacteriostatic antibiotic agents
• Tetracycline
• Erythromycin
• Chloramphenicol
• Other cephalosporins(See additional prescribing points)
• Sulfonamides
• Aminoglycosides
• Probenecid
• Nephrotoxic agents
• Polymyxin B
• Colistin
• Potent diuretics
• Furosemide

Other

• Coombs' test
• Non-enzymatic glucose tests (urine and blood)

None routine. Specific cases may require

• Renal function
• Full blood count

Additional observations

• Signs and symptoms of anaphylaxis (during first dose)

Administration directions

• IV: Cefotaxime 500mg is dissolved in at least 2ml water for injection, cefotaxime 1g is dissolved in at least 4ml and subsequently injected directly into the vein over 3-5mins or after clamping the infusion tube into the distal end of the tube
• Infusion: For brief infusion, 2g of cefotaxime is dissolved in 100ml of isotonic sodium chloride or glucose solution and subsequently IV infused over 50-60 minutes. Another compatible infusion solution can also be used for the solution (See Compatibility with diluents)
• IM: Cefotaxime 500mg is dissolved in 2ml and cefotaxime 1g in 4ml water for injection respectively. Afterwards the injection should take place deep into the gluteal muscle. Pain with the IM injection can be avoided by dissolving cefotaxime 500mg in 2ml or cefotaxime 1g in 4ml 1% lidocaine solution. An IV injection is to be avoided in this case as since with IV administration, lidocaine may lead to unrest, tachycardia, disturbances of cardiac conduction as well as vomiting and cramp. Cefotaxime reconstituted with lidocaine should not be administered to infants under 30 months
• It is recommended that no more than 4ml be injected unilaterally. If the daily dose exceeds 2g cefotaxime or if cefotaxime is injected more frequently than twice per day, the IV route is recommended

Compatibility with diluents

• Following reconstitution, cefotaxime is compatible with the following diluents:
  - Water for injection
  - Sodium chloride 0.9%
  - Dextrose 5% and 10%
  - Ringer's Solution
  - Ringer-Lactate Solution
  - Lignocaine 1% (only freshly prepared solutions should be used)

Influence on laboratory tests

• As with other cephalosporins, a positive Coombs' test has been found in some patients treated with cefotaxime. This phenomenon can interfere with the cross-matching of blood
• Urinary glucose testing with non-specific reducing agents may yield false positive results. This phenomenon is not seen when a glucose-oxidase specific method is used

Increased risk of ototoxicity and nephrotoxicity

• An increased risk of ototoxicity and nephrotoxicity has been reported when cefotaxime has been used concomitantly with cephalosporins or aminoglycosides. Dose adjustment may be necessary, and the kidney function must be monitored

Cefotaxime exerts its action by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thereby inhibiting cell wall synthesis.

Spectrum of activity: Haemophilus influenzae, Leptospira sp., Viridans Streptococci, Yersinia enterocolitica, Staphylococcus aureus (Methicillin-susceptible), Group A Streptococci (including Streptococcus pyogenes), Group B Streptococci, β-hemolytic Streptococci (Group C, F, G), Haemophilus parainfluenzae,Moraxella catarrhalis, Neisseria gonorrhoeae,Neisseria meningitides,Proteus spp., Providencia spp.,Clostridium spp. (not Clostridium difficile), Peptostreptococcus spp., Propionibacterium spp.

Injection (per vial) 500mg

• Adco Cefotaxime (Adcock)
• Aspen Cefotaxime (Pharmacare)
• Austell-Cefotaxime (Austell lab)
• Cefotaxime 0.5g Oethmaan (Oethmaan Biosims)
• Cefotaxime-Fresenius (Fresenius)
• Clatax (Sandoz SA)
• Kefotax (Pharmacare)
• Klafotaxim (Be-tabs)
• Oritaxim (Pharma-Q)
• Taxokef (Dezzo Trading)

Injection (per vial) 1g

• Adco Cefotaxime (Adcock)
• Aspen Cefotaxime (Pharmacare)
• Austell-Cefotaxime (Austell lab)
• Cefotaxime 1g Oethmaan (Oethmaan Biosims)
• Cefotaxime-Fresenius (Fresenius)
• Clatax (Sandoz SA)
• Kefotax (Pharmacare)
• Klafotaxim (Be-tabs)
• Oritaxim (Pharma-Q)
• Taxokef (Dezzo Trading)