Cefuroxime

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: 

•  Respiratory tract infections
  - Sinusitis caused by Streptococcus pneumoniae and Haemophilus influenzae
  - Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (methicillin-sensitive strains) and Heamophilus parainfluenzae (ampicillin-sensitive strains)
• Ear, nose and throat infections
  - Pharyngitis and tonsillitis caused by Streptococcus pyogenes
  - Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (methicillin-sensitive strains), Moraxella (Branhamella) catarrhalis, and Streptococcus pyogenes
• Urinary tract infections
  - Acute uncomplicated cystitis caused by Escherichia coli and Klebsiella pneumonia 
• Lyme Disease caused by spirochaete Borrelia burgdorferi
• Soft tissue infections
• Obstetrics and gynaecological infections
• Gonorrhoea
• Prophylaxis against infection in abdominal, gynaecological, cardiac and pulmonary surgery

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In the treatment of infections caused by Pseudomonas aeruginosa, an aminoglycoside should be administered concomitantly

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to cephalosporins
• History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems)

Cautions

• History of non-severe hypersensitivity to other beta-lactam agents
• Hypersensitivity to propylene glycol (E1520), benzyl alcohol (E1519), aspartame (sus)
• Pregnancy
• Breastfeeding
• Severe renal impairment
• Elderly
• Infections caused by Gram-negative non-fermenting bacteria
• Prolonged use
• Intracameral use
• Lyme disease (tab, sus)
• Diabetes mellitus (sus)
• Phenylketonuria (sus)
• Low sodium diet (inj)

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

Infections caused by: Some Gram-positive aerobes such as; Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae(excluding methicillin-resistant S. aureus); Some Gram-negative aerobes such as Haemophilus parainfluenza, Moraxella catarrhalis, B. burgdoferi

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

International manufacturer recommendations

IV/IM

Community-acquired pneumonia
Acute exacerbations of chronic bronchitis
Soft-tissue infections: cellulitis, erysipelas and wound infections
Intra-abdominal infections

• IV/IM: 750mg, 8hrly

Complicated urinary tract infections
Pyelonephritis

• IV/IM: 1.5g, 8hrly

Severe infections

• IV: 750mg, 6hrly OR 1.5g, 8hrly

Surgical prophylaxis 
- Gastrointestinal, gynaecological surgery (including caesarean section) and orthopaedic operations

• IV: 1.5g, at induction; May be supplemented with: 750mg (IM) after 8hrs, then 750mg (IM) after 16hrs

- Cardiovascular and oesophageal operations

• IV: 1.5g, at induction; then 750mg (IM) 8hrly for further 24hrs

Oral

Acute tonsillitis and pharyngitis
Acute bacterial sinusitis
Cystitis
Pyelonephritis
Uncomplicated skin and soft tissue infections

• Oral (tab, sus): 250mg, 12hrly; Treatment duration: 5-10 days

Acute otitis media
Acute exacerbation of chronic bronchitis

• Oral (tab, sus): 500mg, 12hrly; Treatment duration: 5-10 days

Lyme disease

• Oral (tab, sus): 500mg, 12hrly; Treatment duration: 14 days (range of 10-21 days)

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South African manufacturer recommendations

IV/IM

General dosing range

• IV/IM: 1.5-6g/day, in 3-4 divided doses

Gonorrhoea

• IV/IM: 1.5g, as a single dose; May be given as 2x750mg doses into different sites (e.g. each buttock)

Prophylaxis (surgical infections)
- Abdominal and gynaecological operations

• IV: 1.5g, at induction; May be supplemented with 750mg (IM) after 8hrs, then 750mg (IM) after 16hrs

- Cardiac and pulmonary operations

• IV: 1.5g, at induction; then 750 mg (IM) 8hrly for a further 24-48hrs

Oral

Sinusitis
Acute and chronic bronchitis

• Oral (tab, sus): 250mg, 12hrly; Treatment duration: 5-10 days

Acute uncomplicated cystits

• Oral (tab, sus): 125mg, 12hrly; Treatment duration: 5-10 days

Lyme disease 4

• Oral (tab, sus): 500mg, 12hrly; Treatment duration: 20 days

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See additional prescribing points

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

Infections caused by: Some Gram-positive aerobes such as; Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae(excluding methicillin-resistant S. aureus); Some Gram-negative aerobes such as Haemophilus parainfluenza, Moraxella catarrhalis, B. burgdoferi

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

International manufacturer recommendations

IV

Community-acquired pneumonia
Complicated urinary tract infections
Pyelonephritis
Soft-tissue infections: cellulitis, erysipelas and wound infections
Intra-abdominal infections

Birth - 3 weeks

• IV: 30-100mg/kg/day, in 2-3 divided doses

Older than 3 weeks and <40kg

• IV: 30-100mg/kg/day, in 3-4 divided doses

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A dose of 60 mg/kg/day is appropriate for most infections

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≥40kg

• See adult dosage

Oral

Younger than 3 months

• Not established for use

Older than 3 months

Acute tonsillitis and pharyngitis
Acute bacterial sinusitis

• Oral (tab, sus): <40kg: 10mg/kg, 12hrly; Max: 125mg/12hrly; ≥40kg: See adult dosage

Otitis media

• >2 years OR with more severe infections: Oral (tab, sus): <40kg: 15mg/kg, 12hrly; Max: 250mg/12hrly; ≥40kg: See adult dosage

Cystitis

• Oral (tab, sus): <40kg: 15mg/kg, 12hrly; Max: 250mg/12hrly; ≥40kg: See adult dosage

Pyelonephritis

• Oral (tab, sus): <40kg: 15mg/kg, 12hrly; Max: 250mg/12hrly; Treatment duration: 10-14 days; ≥40kg: See adult dosage

Uncomplicated skin and soft tissue infections

• Oral (tab, sus): <40kg: 15mg/kg, 12hrly; Max: 250mg/12hrly; ≥40kg: See adult dosage

Lyme disease

• Oral (tab, sus): <40kg: 15mg/kg, 12hrly; Max: 250mg/12hrly; Treatment duration: 14 days (range of 10-21 days); ≥40kg: See adult dosage

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See additional prescribing points 

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South African manufacturer recommendations

IV/IM

General dosing range

• Younger than 3 months: Not established for use
• Older than 3 months and children: IV/IM: 30-100mg/kg/day, in 3 or 4 divided doses; 60mg/kg/day being appropriate for most infections

Oral

Younger than 3 months

• Not established for use

Older than 3 months

General dosing range

• Oral (tab, sus): 125mg, 12hrly

Otitis media

• Younger than 2 years: Oral (tab, sus): 125mg, 12hrly
• Older than 2 years: Oral (tab, sus): 250mg, 12hrly

Lyme disease

• Younger than 3 months: Not established for use
• Between 3 months - 12 years: Oral (tab, sus): 125mg, 12hrly
• Older than 12 years: See adult dosage

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See additional prescribing points

Pregnancy

• Caution
• There are limited amounts of data from the use of cefuroxime in pregnant women. Studies in animals have shown no reproductive toxicity. Cefuroxime should be prescribed to pregnant women only if the benefit outweighs the risk
• Cefuroxime has been shown to cross the placenta and attain therapeutic levels in amniotic fluid and cord blood after intramuscular or intravenous dose to the mother

Breastfeeding 

• Caution
• Cefuroxime is excreted in human milk in small quantities. Adverse reactions at therapeutic doses are not expected, although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded
• A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from cefuroxime therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Fertility

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

Renal Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; dose adjustment recommended

Adults and children >40kg

Oral

CrCl (ml/min/1.73m2)	Recommended dose
≥30	No dose adjustment recommended
10-29	Standard individual dose, 24hrly
<10	Standard individual dose, 48hrly
Haemodialysis	An additional standard individual dose should be given at the end of each dialysis

IV/IM

CrCl (ml/min/1.73m2)	Recommended dose
>20	No dose adjustment recommended
10-20	750mg, 12hrly
<10	750mg, 24hrly
Haemodialysis	An additional 750mg dose should be given at the end of each dialysis Cefuroxime sodium can be incorporated into the peritoneal dialysis fluid (usually 250mg for every 2L of dialysis fluid)

Children <40kg

CrCl (ml/min/1.73m2)	Recommended dose
≥30	No dose adjustment recommended
10-29	Oral: 15mg/kg/dose, 12hrly IV: 25-50mg/kg/dose, 12hrly
<10	Oral: 15mg/kg/dose, 24hrly  IV: 25-50mg/kg/dose, 24hrly
Intermittent hemodialysis	Oral: 15mg/kg/dose, 24hrly IV:  25-50mg/kg/dose, 24hrly
Peritoneal dialysis	Oral: 15mg/kg/dose, 24hrly IV:  25-50mg/kg/dose, 24hrly
Continuous renal replacement therapy	IV:  25-50mg/kg/dose, 8hrly

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended
  The elderly are more likely to have decreased renal function, care should be taken in cefuroxime dose selection, and it may be useful to monitor renal function

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness

Gastrointestinal Disorders

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

Genitourinary Disorders

• Interstitial nephritis
• Elevations in serum creatinine
• Elevations in blood urea nitrogen
• Decreased creatinine clearance

Hepatobiliary Disorders

• Transient increase in hepatic enzymes 
• Transient increase in bilirubin
• Jaundice (predominantly cholestatic) 
• Hepatitis

Skin and Subcutaneous Tissue Disorders

• Skin rash
• Urticaria
• Pruritus
• Erythema multiforme
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis (exanthematic necrolysis) 
• Angioneurotic oedema
• Cutaneous vasculitis
• Injection site reactions (inj)
  - Pain
  - Thrombophlebitis

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis
• Candida overgrowth
• Clostridium difficile overgrowth
• Eosinophilia
• Neutropenia
• Decreased haemoglobin
• Thrombocytopaenia
• Leukopaenia
• Positive Coombs test
• Haemolytic anaemia
• Drug fever
• Serum sickness
• Jarisch-Herxheimer reaction

• Probenecid
• Oral anticoagulants
• Combined oral contraceptives
• Oestrogen
• Strong diuretic agents
• Furosemide
• Nephrotoxic agents
• Aminoglycoside antibiotics
• Agents that reduce peristalsis
• Agents that reduce gastric acidity (tab, sus)

Other interactions

• Coomb's test
• Ferricyanide test
• Copper reduction methods
  - Benedict's test
  - Fehling's test
  - Clinitest

None routine. Specific cases may require

• Renal function
• Hepatic function
• Haematologic function
• Prothrombin time

Additional observations

• Signs and symptoms of anaphylaxis (after first dose)

Method of administration

Injection

• Cefuroxime should be administered by IV injection over a period of 3-5mins directly into a vein or via a drip tube or infusion over 30-60mins, or by deep IM injection
• IM injections should be injected well within the bulk of a relatively large muscle and not more than 750 mg should be injected at one site. For doses >1.5 g, IV administration should be used
• Solutions and suspensions range in colour from clear to yellow coloured depending on concentration, diluent and storage conditions used. When made up for intramuscular use, it becomes off-white and opaque. When made up for intravenous administration, it may be yellowish

Tablets

• Cefuroxime tablets should be taken after food for optimum absorption
• Cefuroxime tablets should be taken whole (not crushed) and are therefore unsuitable for the treatment of patients who cannot swallow tablets

Suspension

• Cefuroxime suspension should be taken with food for optimum absorption
• Shake the bottle well before use to loosen granules
• The reconstituted suspension when refrigerated between 2-8°C can be kept for up to 10 days

Resistance

• Organisms that have acquired resistance to other injectable cephalosporins are expected to be resistant to cefuroxime
• Depending on the mechanism of resistance, organisms with acquired resistance to penicillins may demonstrate reduced susceptibility or resistance to cefuroxime

Incompatibilities

• A positive Coombs' test has been reported during treatment with cephalosporins - this phenomenon can interfere with cross-matching of blood
• Cefuroxime (inj) is compatible with most commonly used intravenous fluids and electrolyte solutions
• The pH of 2.74% w/v sodium bicarbonate injection BP considerably affects the colour of solutions and therefore this solution is not recommended for the dilution of cefuroxime. However, if required, for patients receiving sodium bicarbonate injection by infusion the cefuroxime may be introduced into the tube of the giving set
• Cefuroxime should not be mixed in the syringe with aminoglycoside antibiotics

Cefuroxime inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.

Spectrum of activity: Some Gram-positive aerobes such as; Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae(excluding methicillin-resistant S. aureus); Some Gram-negative aerobes such as Haemophilus parainfluenza, Moraxella catarrhalis, B. burgdoferi

Tablet 125mg

• Sandoz Cefuroxime (Sandoz SA)
• Zinnat (GSK) originator

Film-coated tablet 250mg

• Cefuroxime 250 Oethmaan (Oethmaan Biosims)

Tablet 250mg

• Alkoxime 250mg (Alkem)
• Auroprozil (Actor Pharma)
• Auroxime (Aurobindo)
• Betaroxime T (Be-Tabs)
• Cefasyn (Cipla Medpro)
• Cefu-Hexal (Sandoz)
• Ceroxim (Ranbaxy)
• Furocsem (Innovata Pharmaceuticals)
• Orchid Cefuroxime (Watson)
• Poxim (Alkem)
• Sandoz Cefuroxime (Sandoz SA)
• Zefurime (Pharmacare)
• Zefroxe (Ranbaxy)
• Zinnat (GSK) originator
• Zinoxime (Actor)

Film-coated tablet 500mg

• Cefuroxime 500 Oethmaan (Oethmaan Biosims)

Tablet 500mg

• Alkoxime 500mg (Alkem)
• Auroprozil (Actor Pharma)
• Auroxime (Aurobindo)
• Betaroxime T 500 (Be-Tabs)
• Cefasyn (Cipla Medpro)
• Cefu-Hexal (Dezzo Trading)
• Ceroxim (Ranbaxy)
• Furocsem (Innovata Pharmaceuticals)
• Orchid Cefuroxime (Watson)
• Poxim (Alkem)
• Sandoz Cefuroxime (Sandoz SA)
• Zefurime (Pharmacare)
• Zefroxe (Ranbaxy)
• Zinnat (GSK) originator
• Zinoxime (Actor)

Suspension (per 5ml) 125mg

• Cefuroxime Oethmaan (Oethmaan Biosims)
• Ceroxim Suspension (Ranbaxy)
• Sandoz Cefuroxime (Sandoz SA)
• Zinnat (GSK) originator

Suspension (per 5ml) 250mg

• Ceroxim Forte Suspension (Ranbaxy)

Injection (per vial) 250mg

• Adco-Cefuroxime (Adcock Ingram)
• Aspen Cefuroxime (Pharmacare)
• Betaroxime (Be-Tabs)
• Medaxime (Specpharm)
• Zefurime (Pharmacare)
• Zinacef (GSK)

Injection (per vial) 750mg

• Adco-Cefuroxime (Adcock Ingram)
• Aspen Cefuroxime (Pharmacare)
• Betaroxime (Be-Tabs)
• FKSA Cefuroxime (Bodene)
• Gulf Cefuroxime (Gulf Drug)
• Medaxime (Specpharm)
• Zinacef (GSK) originator

Injection (per vial) 1.5g

• Adco-Cefuroxime (Adcock Ingram)
• Aspen Cefuroxime (Pharmacare)
• FKSA Cefuroxime (Bodene)
• Medaxime (Specpharm)
• Zinacef (GSK) originator