Cefalexin

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 caused by Streptococcus pneumoniae and group A beta-haemolytic streptococci
• Otitis media due to Streptococcus pneumonia, H. influenza, staphylococci, streptococci and N. catarrhalis
• Dental infections caused by staphylococci and/or streptococci
• Skin and soft tissue infections caused by staphylococci and/or streptococci
• Genito-urinary tract infections, including acute prostatitis caused by E. coli, P. mirabilis and Klebsiella sp.

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Known allergy to the cephalosporins group of antibiotics

Cautions

• Penicillin-sensitive patients
• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment 
• Porphyria
• Prolonged use
• Coadministration with aminoglycosides, other cephalosporins, or furosemide, and similar potent diuretics
• Fructose intolerance (sus)
• Glucose-galactose malabsorption (sus)
• Sucrase-isomaltase insufficiency (sus)

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

Dosages below include:

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

Infections caused by: S. saprophyticus, Beta-haemolytic streptococci, Staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae, Branhamella catarrhalis

General dosing range 

• Oral (cap, tab, sus): 250-1000mg, 6hrly; Max: 4g/24hrs

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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

Cellulitis
Erysipelas
Abscess
- In those who are immunocompromised or diabetic
Boil
- In those who are immunocompromised or diabetic
Impetigo
Furuncular otitis externa
Moist or weeping acute eczema with secondary infection

• Oral (tab, cap, sus): 500mg, 6hrly; Treatment duration: 5 days
  (STG, Adult 2019; PHC 2020) 

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South African registered indications and dosages

Respiratory tract infections
Otitis media
Dental infections

• Oral (tab, cap, sus): 250mg, 6hrly

Skin and soft tissue infections
Streptococcal pharyngitis and tonsilitis
Genitourinary tract infections - mild, uncomplicated
- Including acute prostitis

• Oral (tab, cap, sus): 250mg, 6hrly OR 500mg, 12hrly

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For more severe infections or those caused by less susceptible organisms, larger doses may be needed. Parenteral cephalosporin therapy in appropriate doses, should be considered if daily doses higher than 4g of cefalexin are required

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In the treatment of β-haemolytic streptococcal infections, antibiotic therapy should continue for ≥10 days

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Indications and dosages registered in other jurisdictions

Most infections caused by susceptible organisms
- Respiratory tract infections
- Otitis media
- Bone and joint infections
- Dental infections

• Oral (cap, tab, sus): 500mg, 8hrly

Skin and soft tissue infections
Streptococcal pharyngitis
Genitourinary tract infections - mild, uncomplicated
- Including acute prostatitis

• Oral (cap, tab, sus): 250mg, 6hrly OR 500mg, 12hrly

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For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cefalexin greater than 4g are required, parenteral cephalosporins in appropriate doses, should be considered

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

Paed. dosages below include:

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

Infections caused by: S. saprophyticus, Beta-haemolytic streptococci, Staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae, Branhamella catarrhalis

General dosing range

Younger than 28 days

• No information available

Older than 28 days

• Oral (tab, cap, sus): 25-100mg/kg/day, in 4 divided doses, 6hrly; Max: 4g/24hrs

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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

Abscess
- In those who are neonates, immunocompromised, or diabetic
Boil
- In those who are neonates, immunocompromised, or diabetic
Impetigo
Cellulitis
Moist or weeping acute eczema with secondary infection
Furuncular otitis externa

Younger than 7 years

• Oral (tab, cap, sus): 12-25mg/kg/dose, 6hrly; Treatment duration: 5 days
  (STG, PHC 2020)

Older than 7 years

•  Oral (tab, cap, sus): 500mg, 6hrly; Treatment duration: 5 days
  (STG, PHC 2020)

Varicella with secondary skin infection

• Oral (tab, cap, sus): 12.5mg/kg, 6hrly; Treatment duration: 5 days
  (STG, Paed. 2017)

Purulent effusion
- As an oral switch option from iv amoxicillin/clavulanate OR cefazolin if there is evidence of good clinical response

• Oral (tab, cap, sus): 6.25-12.5mg/kg/dose, 6hrly
  (STG, Paed. 2023)

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For the indication of purulent effusion, if pathogens are cultured in blood from sanctuary sites, e.g., bone, heart valves, etc., treat according to sensitivity for prolonged period of 21-42 days

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Staphylococcal scalded skin syndrome
Cellulitis - non-severe
Erysipelas - non-severe
Secondary infection
- Erythema multiforme
- Stevens-Johnson Syndrome 
- Toxic epidermal necrosis

Oral (tab, cap, sus)

Weight known

• 25mg/kg/dose, 6hrly; Treatment duration: 7 days
  (STG, Paed. 2023)

Weight unknown

• Younger than 2 years: 125mg, 6hrly; Treatment duration: 7 days
• Between 2–10 years: 250mg, 6hrly; Treatment duration: 7 days
• Older than 10 years: 500mg, 6hrly; Treatment duration: 7 days
  (STG, Paed. 2023)

Secondary bacterial infection in eczema

• Oral (tab, cap, sus): 25mg/kg/dose, 6hrly; Treatment duration: 7 days
  (STG, Paed. 2023)

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South African registered indications and dosages

Respiratory tract infections
Otitis media
Dental infections
Skin and soft tissue infections
Streptococcal pharyngitis and tonsilitis
Genitourinary tract infections - mild, uncomplicated
- Including acute prostitis

• Oral (cap, sus): 25-50mg/kg/day, in 4 divided doses, 6hrly

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The use of the capsules is not feasible in young children

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In the treatment of beta-haemolytic streptococcal infections, a therapeutic dose should be administered for ≥10 days

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Indications and dosages registered in other jurisdictions

Most infections caused by susceptible organisms
- Respiratory tract infections
- Otitis media
- Bone and joint infections
- Dental infections

Younger than 5 years

• Oral (cap, tab, sus): 25-50mg/kg/day, in divided doses
  OR
• Oral (cap, tab, sus): 125mg, 8hrly

5 years and older

• Oral (cap, tab, sus): 25-50mg/kg/day, in divided doses
  OR
• Oral (cap, tab, sus): 250mg, 8hrly

Skin and soft tissue infections
Streptococcal pharyngitis
Genitourinary tract infections - mild, uncomplicated
- Including acute prostatitis

• Oral (cap, tab, sus): 25-50mg/kg/day, in 2 divided doses

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In severe infections, the dosage may be doubled. In the therapy of otitis media, clinical studies have shown that a dosage of 75-100mg/kg/day in 4 divided doses is required

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In the treatment of beta-haemolytic streptococcal infections, a therapeutic dose should be administered for ≥10 days

Pregnancy

• Caution
• Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for the pregnant patient

Breastfeeding

• Caution
• The excretion of cefalexin in human breast milk increased up to 4 hours following a 500mg dose. The drug reached a maximum level of 4μg/ml, then decreased gradually and had disappeared 8 hours after administration. Caution should be exercised when cefalexin is administered to a breastfeeding woman, since the neonate is presented with the risk of candidiasis and CNS toxicity due to immaturity of the blood-brain barrier. There is a theoretical possibility of later sensitisation

Renal Impairment

Adults dosages

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

eGFR (ml/min/1.73m2)	Adults
≥30-89	No dose adjustment recommended; Max: 1000mg/24hrs
11-29	Oral (cap, tab, sus): 250mg, 12hrly OR 500mg, dly; Max: 500mg/24hrs
≤10	Oral (cap, tab, sus): 250mg, dly; Max: 250mg/24hrs
Haemodialysis	Oral (cap, tab, sus): 250-500mg, 12-24hrly; Max: 1000mg/24hrs; Dose after dialysis

Paediatric dosages 

• Mild: Caution; no dose adjustment recommended
• Moderate to severe: Caution; dose adjustment recommended

CrCl (ml/min)	Children
>50	No dose adjustment recommended
30-50	Oral (tab, cap, sus): 5-10mg/kg/dose, 8hrly; Max: 500mg/dose
10-29	Oral (tab, cap, sus): 5-10mg/kg/dose, 12hrly; Max: 500mg/dose
<10	Oral (tab, cap, sus): 5-10mg/kg/dose, dly; Max: 500mg/dose
Haemodialysis	Oral (tab, cap, sus): 5-10mg/kg/dose, dly; Max: 500mg/dose; Dose after dialysis
Peritoneal dialysis	Oral (tab, cap, sus): 5-10mg/kg/dose, dly; Max: 500mg/dose

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Fatigue
• Headache
• Agitation
• Confusion
• Hallucinations

Gastrointestinal Disorders

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

Hepatobiliary Disorders

• Transient hepatitis
• Cholestatic jaundice
• Increased alanine aminotransferase
• Increased aspartate aminotransferase

Genitourinary Disorders

• Genital pruritus
• Anal pruritus
• Genital candidiasis
• Vaginitis
• Vaginal discharge
• Reversible interstitial nephritis

Musculoskeletal Disorders

• Arthralgia
• Arthritis
• Joint disorder

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Angioedema
• Erythema multiforme
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Acute generalised exanthematous pustulosis (AGEP)

Immune, Blood and Lymphatic System Disorders

• Allergic reactions
• Anaphylaxis
• Eosinophilia
• Neutropenia
• Thrombocytopenia
• Haemolytic anaemia

• Probenecid
• Metformin
• Gentamicin 

Other interactions

• Coombs' test
• Benedict's solution
• Fehling's solutions
• Copper sulphate test tablets

None routine. Specific cases may require

• Renal function
• Hepatic function
• Haematologic function

Additional observations

• Signs and symptoms of:
  - Anaphylaxis
  - Skin reactions

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

Tablet 1000mg - Non EML

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Interaction with laboratory tests

• Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In haematological studies, or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side, or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognised that a positive Coombs' test may be due to the drug
• A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets

Cephalexin inhibits bacterial cell wall synthesis, probably by acylation of the membrane-bound enzyme transpeptidase. This prevents cross-linkage of peptidoglycan chains which is necessary for bacterial cell wall strength and rigidity. Cell division and growth are also inhibited and lysis of susceptible bacteria frequently occurs.

Spectrum of activity: S. saprophyticus, Beta-haemolytic streptococci, Staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae, Branhamella catarrhalis

Tablet 500mg

• Auro Cefalexin (Aurobindo)
• Belex (Gulf Drug)
• Cpl Alliance Cefalexin (Alliance)

Tablet 1000mg

• Auro-Cefalexin 1000mg (Aurobindo) (Discontinued: 01/04/2018)

Capsule 250mg

• Belex (Gulf Drug)
• Cefalexin 250 Alkem (Alkem Laboratories)
• Cephalexin 250 Pharma-Q (Pharma-Q)
• Ranceph (Ranbaxy Pharmaceuticals)

Capsule 500mg

• Auro Cefalexin (Aurobindo)
• Belex 500 (Gulf drug)
• Cefalexin 500 Alkem (Alkem Laboratories)
• Cephalexin 500 Pharma-Q (Pharma-Q)
• Ranceph (Ranbaxy Pharmaceuticals)

Suspension (per 5ml) 125mg

• Cephalexin Dry Syrup Pharma-Q (Pharma-Q)
• Ranceph (Ranbaxy Pharmaceuticals)

Suspension (per 5ml) 250mg

• Ranceph (Ranbaxy Pharmaceuticals)