Cefazolin

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 due to: Strep. pneumoniae, Klebsiella pneumoniae, Haemophilus influenza, Staph. aureus (including penicillinase-producing species), Group A β-hemolytic streptococci, Strep. pyogenes, anaerobic Streptococci
• Genito-urinary tract infections due to: Strep. bovis, E. coli, Proteus mirabilis, Klebsiella pneumoniae, Some strains of Enterobacter and enterococci
• Skin and skin structure infections due to: Staph. aureus (including penicillinase-producing species), Group A β-hemolytic streptococci, and other strains of streptococci, anaerobic streptococci
• Bone and joint infections due to: Staph. aureus
• Septicaemia due to: S. pneumoniae, Staph. aureus (penicillin-sensitive and penicillin-resistant), E. coli., Klebsiella species, Streptococcus agalactiae, Proteus mirabilis
• Endocarditis due to: Staph. aureus  (penicillin-sensitive and penicillin-resistant), Group A β-hemolytic streptococci, Streptococcus of the viridans group, anaerobic Streptococcus, Strep. pneumoniae
• Pre-, intra- and post-operative prophylaxis in abdominal hysterectomy

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Cefazolin is not first-line therapy for S.aureus endocarditis or septicemia. Culture and sensitivity studies to determine the susceptibility of the causative organisms to cefazolin are necessary

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Premature infants or infants <1 month
• Intrathecal administration is not an approved route of administration

Cautions

• Previous hypersensitivity reaction to cephalosporins or penicillins
• Renal impairment (Crcl <55ml/min)
• Hepatic impairment
• Porphyria
• Prolonged use
• History of gastrointestinal disease, especially colitis

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

Dosages below include:

• General dosing range
• South African Standard Treatment Guideline indications and dosages
• South African registered indications and dosages

Infections caused by: Methicillin-susceptible Staphylococcus aureus, S. epidermidis (S), S. lugdunensis, S. saprophyticus, Staph coag-neg (S)

General dosing range

• IV/IM: 1000-2000mg, 8hrly; Max: 12g/24hrs

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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 Standard Treatment Guideline indications and dosages

Surgical prophylaxis

• <60kg: IV: 1g, within 60min of 1st incision
• 60-120kg and BMI≤35: IV: 2g, within 60min of 1st incision
• ≥120kg OR BMI>35: IV: 3g, within 60min of 1st incision
  (STG, Adult 2019)

Surgical prophylaxis in pregnancy

• <60kg: IV: 1g, within 60min of 1st incision
• 60-100kg: IV: 2g, within 60min of 1st incision
• >100kg: IV: 3g, within 60min of 1st incision
  (STG, Adult 2019)

Infective endocarditis
- Empiric therapy (native valve) if staphylococcal infection is suspected (acute onset) (Additional agent may be required)

• IV: 2g, 8hrly
  (STG, Adult 2019)

- Directed therapy (native valve) for staphylococcal (cloxacillin/methicillin-sensitive) (Additional agent may be required)

• IV: 2g, 8hrly; Treatment duration: 4 weeks 
  (STG, Adult 2019)

Erysipelas - severe
Cellulitis - severe

• IV: 1g, 8hrly; Treatment duration: 5 days, treatment should be extended if the infection has not improved within this time period 
  (STG, Adult 2019)

Furuncle
Cutaneous abscess

• IV: 1g, 8hrly; Treatment duration: 5-10 days
  (STG, Adult 2019)

Septic arthritis
- Empiric antibiotic therapy
Acute osteomyelitis
- Empiric antibiotic therapy

• IV: 2g, 8hrly; Treatment duration: 4 weeks
  (STG, Adult 2019)

Surgical wound infections
- Empiric antibiotic therapy (If surrounding cellulitis or systemic sepsis not involving the GI or female genital tract)

• IV: 1g, 8hrly; Treatment duration: ≤7 days, follow with oral therapy as soon as patient can swallow and the temperature is <37.8°C for 24hrs
  (STG, Adult 2019)

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South African registered indications and dosages

Pneumococcal pneumonia

• IV: 500-1000mg, 6-12hrly, given as a slow injection over 3-5mins or as an infusion; Max: 6g/24hrs
• IM: 500-1000mg, 6-12hrly, after reconstitution; Max: 6g/24hrs

Mild infections caused by susceptible Gram-positive cocci 

• IV: 250-500mg, 8hrly, given as a slow injection over 3-5mins or as an infusion; Max: 6g/24hrs
• IM: 250-500mg, 8hrly, after reconstitution; Max: 6g/24hrs 

Acute uncomplicated urinary tract infections

• IV: 1g, 12hrly, given as a slow injection over 3-5mins or as an infusion; Max: 6g/24hrs
• IM: 1g, 12hrly, after reconstitution; Max: 6g/24hrs 

Moderate to severe infections 

• IV: 500-1000mg, 6-8hrly, given as a slow injection over 3-5mins or as an infusion; Max: 6g/24hrs
• IM: 500-1000mg, 6-8hrly, after reconstitution; Max: 6g/24hrs 

Severe, life-threatening infections 
- Endocarditis
- Septicaemia

• IV: 1000-1500mg, 6hrly, given as a slow injection over 3-5mins or as an infusion; Max: 6g/24hrs
• IM: 1000-1500mg, 6hrly, after reconstitution; Max: 6g/24hrs

Peri-operative prophylactic use
- To prevent post-operative infection in contaminated or potentially contaminated abdominal hysterectomy

• IV/IM: 1000mg, 30-60min. prior surgery; Lengthy operative procedures (2 hours or longer): 1000mg, during surgery (administration modified according to the duration of the operative procedure)

Post-operative use

• IV/IM: 1000mg, 6-8hrly; Max duration: 24hrs after operation

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The pre-operative dose should be given 30-60min prior surgery to achieve adequate antibiotic levels in the serum and tissues at the time of initial surgical incision

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If exposure to infectious organisms is likely, cefazolin must be administered at appropriate intervals during surgery in order for sufficient levels of the antibiotic to be present when needed

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Intrathecal administration is not a registered route of administration for cefazolin

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

Paed. dosages below include:

• General dosing range
• South African Standard Treatment Guideline indications and dosages
• South African registered indications and dosages

Infections caused by: Infections caused by: Methicillin-susceptible Staphylococcus aureus, S. epidermidis (S), S. lugdunensis, S. saprophyticus, Staph coag-neg (S)

General dosing range

28 days and younger

• Not established for use

Older than 28 days

• IV/IM: 50-150mg/kg/day, in 3-4 divided doses; Max: 6g/24hrs

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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 Standard Treatment Guideline indications and dosages

Surgical prophylaxis

• IV: 30mg/kg, within 60min before 1st incision; Max dose: 2g
  (STG, Paed. 2023)

Purulent effusion

• IV: 25mg/kg, 8hrly
  (STG, Paed. 2023)

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South African registered indications and dosages

Mild to severe infections

Younger than month

• Not established for use

1 month and older

• IV: Mild to moderate: 25-50mg/kg/day, in 3-4 divided doses, given as a slow injection over 3-5mins or as an infusion; Severe: Max: 100mg/kg/24hrs
• IM: Mild to moderate: 25-50mg/kg/day, in 3-4 divided doses, after reconstitution; Severe: Max: 100mg/kg/24hrs

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Intrathecal administration is not a registered route of administration for cefazolin

Pregnancy

• Contraindicated
• Cefazolin readily crosses the placental barrier into the umbilical cord and amniotic fluid. The safety of the cefazolin has not been established during pregnancy

Breastfeeding

• Contraindicated 
• Cefazolin is excreted into human breast milk in small amounts. The safety of the cefazolin has not been established during breastfeeding

Renal Impairment

• CrCl ≥55ml/min: No dose adjustment recommended
• CrCl <55ml/min: Caution; dose adjustment recommended

CrCL (ml/min)	Dose
≥55	No dose adjustment recommended
35-54	100% dose; Reduce dose frequency to every 8hrs
11-34	Reduce dose by 50%; Reduce dose frequency to every 12hrs
≤10	Reduce dose by 50%; Reduce dose frequency to every 18-24hrs
All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Confusion
• Stupor
• Encephalopathy
• Seizures
• Other signs of CNS toxicity (high doses)

Gastrointestinal Disorders

• Nausea and vomiting
• Mild diarrhoea
• Oral candidiasis
• Pseudomembranous colitis

Hepatobiliary Disorders

• Increased liver transaminases
• Increased alkaline phosphatase levels
• Hepatitis
• Cholestatic jaundice

Genitourinary Disorders

• Interstitial nephritis
• Nephrotoxicity
• Renal function impairment
• False-positive reaction for urinary glucose using copper reducing agents
• Other renal disorders (manifestation of hypersensitivity)

Skin and Subcutaneous Tissue Disorders

• Skin rash
• Urticaria
• Valvular pruritus
• Pain at injection site (IM)
• Phlebitis at injection site

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Drug fever
• Eosinophilia
• Fever
• Reactions resembling serum sickness
• Anaphylaxis
• Neutropenia
• Leukopenia
• Thrombocytopenia
• Haemolytic anaemia
• Thrombophlebitis (IV infusion)
• Positive Coomb's test
• Agranulocytosis
• Hypoprothrombinaemia
• Overgrowth of non-susceptible organisms

• Probenecid
• Warfarin
• Nephrotoxic agents
• Aminoglycosides
• Potassium
• Loop diuretics

Other interactions

• Alcohol
• Benedict's solution
• Fehling's solution
• Clinitest tablets
• Coomb's test

None routine. Specific cases may require

• Renal function
• Hepatic function
• Full blood count

Additional observations

• Signs and symptoms of anaphylaxis

Administration directions

• IM: Reconstitute 10ml sterile water for injection; Shake well until dissolved; Inject into a large muscle mass
• IV administration: May be administered by IV injection or by continuous or intermittent infusion
• Intermittent IV infusion: Dilute with 50-100ml of one of the following solutions: 0.9% sodium chloride injection, 5 or 10% dextrose injection, 5% dextrose in lactated Ringer's injection, 5% dextrose and 0.9% sodium chloride injection (also 5% dextrose and 0.45% or 0.2% sodium chloride injection), Lactated Ringer's injection 5% or 10% invert sugar in sterile water for injection, Ringer's injection or Plasma-lyte with 5% dextrose
• IV injection (administer directly into vein or through tubing): Dilute reconstituted cefazolin injection (1g) in at least 10ml sterile water for injection; Inject slowly over 3-5min. Do not inject in less than 3min

Cefazolin sodium is a first-generation cephalosporin and is bactericidal, acting by inhibiting synthesis of the bacterial cell wall. Cefazolin sodium is 84% bound to plasma proteins. It has a half-life of about 1,8 hours. Cefazolin sodium diffuses into bone and ascitic, pleural and synovial fluid, crosses the placenta, but not into the cerebrospinal fluid. High biliary concentrations have been reported.

Spectrum of activity: Methicillin-susceptible Staphylococcus aureus, S. epidermidis (S), S. lugdunensis, S. saprophyticus, Staph coag-neg (S)

Injection (per vial) 500mg

• Adco Cefazolin (Adcock Ingram)
• Aspen Cefazolin (Litha Pharma)
• Cefazolin-Fresenius (Fresenius Kabi)
• Cefazolin 500mg Oethmaan (Oethmaan Biosims)
• Kefzol (Sandoz)
• Ranzol (Ranbaxy)
• Zefkol ( Acino Pharma)

Injection (per vial) 1g

• Aspen Cefazolin (Litha Pharma)
• Cefazolin-Fresenius (Fresenius Kabi)
• Cefazolin 1g Oethmaan (Oethmaan Biosims)
• Kefzol (Sandoz)
• Mylan-Cefazolin (Mylan)
• Ranzol (Ranbaxy)
• Sabax Cefazolin (Adcock Ingram)
• Zefkol ( Acino Pharma)