Cloxacillin

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:

• Treatment of infections caused by penicillinase-producing staphylococci that are resistant to benzylpenicillin
  - Skin and soft tissue infections, e.g. abscesses and cellulitis (including Gram-positive S. aureus infections)
  - Bacteraemia (septicaemia)
  - Endocarditis
  - Respiratory tract infections, e.g. pneumonia
  - Bone and joint infections, e.g. osteomyelitis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• History of penicillin allergy
• Hypersensitivity to cephalosporins
• Neonates born to mothers sensitive to penicillin
• Intrathecal administration
• Sub-conjunctival injection or use as an eye drop
• Coadministration with aminoglycosides, tetracyclines, erythromycin and polymyxin B

Cautions

• Breastfeeding
• Renal impairment
• Neonatal jaundice
• Porphyria
• High doses
• Prolonged therapy
• Oral administration as a substitute for parenteral treatment of serious infections
• Syphilis
• Cystic fibrosis

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

Dosages below include:

• General dosing range
• South African registered indications and dosages

Infections caused by: S. aureus (MSSA), S. epidermis (S), S. lugdunensis, Staph coag-neg 

General dosing range

• Oral (cap): 250-500mg, 6hrly

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

Treatment of infections caused by penicillinase-producing staphylococci that are resistant to benzylpenicillin
- Skin and soft tissue infections, e.g. abscesses and cellulitis (including Gram-positive S. aureus infections)
- Bacteraemia (septicaemia)
- Endocarditis
- Respiratory tract infections, e.g. pneumonia
- Bone and joint infections, e.g. osteomyelitis

• IM: 250mg, 4-6hrly
• IV: 500mg, 4-6hrly, as a slow injection over 3-4mins
• IV: 500mg, 4-6hrly, as an infusion (preferably injected directly into the drip tube) over 2-3mins

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Dosages may be doubled in severe infections

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• IV (intrapleural): 500mg, dly
• IV (intra-articular): 500mg, dly

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For intra-articular administration: 0,5% lignocaine hydrochloride may be used as a local anaesthetic, if desired

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See additional prescribing points for specific administration instructions for each route

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• Oral (cap): 500mg, 6hrly

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Capsules to be administered one hour before meals

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

Paed. dosages below include:

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

Infections caused by: S. aureus (MSSA), S. epidermis (S), S. lugdunensis, Staph coag-neg 

General dosing range

Older than 1 month

• Oral (cap): 50-200 mg/kg/day, in divided doses, 6hrly

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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 Guidelines indications and dosages

Infective endocarditis (Additional agents required)

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

Purulent pericarditis (Additional agent required)

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

Staphylococcal scalded skin syndrome

Between 7-14 days

• IV: 50mg/kg/dose, 12hrly; Treatment duration: 5 days

Between 14-28 days

• IV: 50mg/kg/dose, 8hrly; Treatment duration: 5 days

Older than 28 days

• IV: 50mg/kg/dose, 6hrly; Treatment duration: 5 days
  (STG, Paed. 2023)

Sensitive staphylococcal bone and joint infections
- Septic arthritis

• IV: 50mg/kg/dose, 6hrly can transition to oral therapy once there is sustained clinical improvement, resolution of fever and CRP<30mg/L: Treatment duration: 2-4 weeks
  (STG, Paed. 2017)

- Acute osteomyelitis

• IV: 50mg/kg/dose, 6hrly can transition to oral therapy once there is sustained clinical improvement, resolution of fever and CRP<30mg/L: Treatment duration: 4-6 weeks
  (STG, Paed. 2017)

Suspected staphylococcal infection in sepsis, e.g., osteomyelitis (Additional agent required)
Secondary infections if oral route cannot be used
- Erythema multiforme
- Stevens-Johnson syndrome
- Toxic epidermal necrosis

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

Cellulitis - severe
Erysipelas - severe

• IV: 50mg/kg/dose, 6hrly; Treatment duration: 5 days
  (STG, Paed. 2023)

Sensitive staphylococcal bacteraemia

• IV: 50mg/kg/dose, 6hrly; Treatment duration: 14 days, however, longer courses are often required
  (STG, Paed. 2017)

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

Younger than 7 days

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

Between 7-28 days

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

Older than 28 days

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

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South African registered indications and dosages

Treatment of infections caused by penicillinase-producing staphylococci that are resistant to benzylpenicillin
- Skin and soft tissue infections, e.g. abscesses and cellulitis (including Gram-positive S. aureus infections)
- Bacteraemia (septicaemia)
- Endocarditis
- Respiratory tract infections, e.g. pneumonia
- Bone and joint infections, e.g. osteomyelitis

General dosage range 

• IV/IM: 12.5 -25mg/kg, 6hrly

Younger than 2 years

• IM: 62.5mg, 4-6hrly
• IV: 125mg, 4-6hrly, as a slow injection over 3-4mins
• IV: 125mg, 4-6hrly, as an infusion (preferably injected directly into the drip tube) over 2-3mins

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Dosages may be doubled in severe infections

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• IV (intrapleural): 125mg, dly
• IV (intra-articular): 125mg, dly

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For intra-articular administration: 0,5% lignocaine hydrochloride may be used as a local anaesthetic, if desired

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See additional prescribing points for specific administration instructions for each route

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Between 2-10 years

• IM: 125mg, 4-6hrly
• IV: 250mg, 4-6hrly, as a slow injection over 3-4mins  
• IV: 250mg, 4-6hrly as an infusion (preferably injected directly into the drip tube) over 2-3mins

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Dosages may be doubled in severe infections

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• IV (intrapleural): 250mg, dly
• IV (intra-articular): 250mg, dly

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For intra-articular administration: 0,5% lignocaine hydrochloride may be used as a local anaesthetic, if desired

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See additional prescribing points for specific administration instructions for each route

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• Oral (cap): 250mg, 6hrly

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Capsules to be administered one hour before meals

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Older than 10 years

• See adult dosage

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No specific dosages provided for children older than 10 years in South African manufacturer recommendations

Pregnancy

• Safe
• Penicillin-type antibiotics, like cloxacillin, are known to cross the placenta. However, these antibiotics are commonly used during pregnancy and are thus considered compatible for use

Breastfeeding

• Caution
• Penicillins, including cloxacillin, pass into the breastmilk. Even though only small amounts may pass into breastmilk, allergic reactions associated with penicillin side effects may occur

Renal Impairment

• Caution; no dose adjustment recommended
  Renal function should be monitored during prolonged and high dose therapy

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Seizures
• Central nervous system toxicity
• Cerebral irritation (children)

Cardiovascular Disorders

• Phlebitis
• Thrombophlebitis
• Congestive heart failure (high doses in renal impairment)

Gastrointestinal Disorders

• Nausea
• Transient diarrhoea
• Sore mouth and tongue
• Diarrhoea
• Black hairy tongue
• Heartburn
• Pruritus ani
• Pseudomembranous colitis

Hepatobiliary Disorders

• Increased hepatic enzyme values
• Hepatitis
• Cholestatic jaundice

Endocrine and Metabolic Disorders

• Electrolyte imbalances (high doses)

Skin and Subcutaneous Tissue Disorders

• Pain at IM injection site
• Sterile inflammatory reaction at IM injection site
• Erythema multiforme type rash

Immune, Blood and Lymphatic System Disorders

• Overgrowth of non-susceptible organisms (Aerobacter aerogenes, Pseudomonas, Candida, etc)
• Leucopenia
• Defective platelet function
• Haemolytic anaemia
• Prolonged bleeding time
• Allergic and sensitivity reactions
  - Urticaria
  - Skin rashes, including maculopapular rashes
  - Exfoliative dermatitis
  - Interstitial nephritis
  - Vasculitis
  - Eosinophilia
  - Angioneurotic oedema
  - Fever
  - Swollen or painful joints
  - Eosinophilia
  - Bronchospasm
  - Serum sickness
  - Anaphylaxis
• Jarisch-Herxheimer reaction (patients with syphilis)
  - Fever
  - Chills
  - Headache
  - Reactions at lesion site

• Aminoglycosides
• Tetracyclines
• Erythromycin
• Polymyxin B
• Bacteriostatic antibacterials
• Chloramphenicol
• Tetracyclines
• Probenecid

None routine. Specific doses may require

• Renal function
• Full blood count
• Electrolytes
• Periodic urinalysis
• Boold urea nitrogen (BUN)
• Hepatic function

Additional observations

• Signs and symptoms of anaphylaxis (during first dose)

Injection 250mg, Injection 500mg - EML (Hospital)

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Administration directions

• IM: Reconstitute with 1.5ml water for injection
• IV infusion: Compatible with sodium chloride 0,9% and dextrose 5% in water and may be added to the drip container, or preferably, injected directly into the drip tube over a period of 2-3 minutes
• Slow IV injection: Reconstitute 500mg with 10-20ml water for injection; Inject over 3-4min
• Intrapleural injection: Reconstitute with 2-5ml of water for injection
• Intra-articular injection: Reconstitute with 2-5ml of water for injection. 0,5% lignocaine hydrochloride may be used as a local anaesthetic, if desired  
• Oral: administer 1 hour before meals

Cloxacillin is an isoxazolyl penicillin and is stable to penicillinase. Cloxacillin inhibits synthesis of the bacterial cell wall by binding to one or more of the penicillin-binding proteins (PBPs) which inhibit the transpeptidation step of peptidoglycan synthesis. Bacteria lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while the cell wall assembly is arrested.

Spectrum of activity: S. aureus (MSSA), S. epidermis (S), S. lugdunensis, Staph coag-neg

Capsule 250mg

• Cloxin (Pharmacare)

Capsule 500mg

• Cloxin (Pharmacare)
• Sandoz cloxacillin (Sandoz)

Injection (per vial) 250mg

• Cloxacillin Fresenius (Fresenius Kabi)

Injection (per vial) 500mg

• Cloxacillin Fresenius (Fresenius Kabi)

COMBINATION PREPARATIONS

Ampicillin/ Cloxacillin

Capsule 250mg/250mg

• Ampiclox 500 (Pharmacare)
• Apen 500 (Xixia)
• Cloxam (Pharmacare)
• Megamox (Pharmacare)

Suspension (per 5ml) 125mg/125mg

• Apen S (Xixia)
• Megamox S (Pharmacare)

Injection (per vial) 125mg/125mg

• Ampoxin 250 (Unichem)

Injection (per vial) 250mg/250mg

• Ampoxin 500 (Unichem)

Injection (per vial) 500mg/500mg

• Ampoxin 1000 (Unichem)