Cefaclor

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:

• Upper and lower respiratory tract infections caused by Gram-positive organisms (M. catarrhalis and H. influenzae): Pneumonia, bronchitis, acute exacerbation of chronic bronchitis, streptococcal pharyngitis, tonsillitis
• Otitis media
• Skin and soft tissue infections caused by Gram-positive organisms
• Urinary tract infections including pyelonephritis and cystitis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 
• Hypersensitivity to other cephalosporins

Cautions

• Pregnancy
• Breastfeeding
• Moderate to severe renal impairment
• Penicillin allergy  
• Prolonged use
• History of gastrointestinal disease (sus)
• History of colitis (sus)
• Fructose intolerance (sus)
• Glucose-galactose malabsorption (sus)
• Sucrose-isomaltase insufficiency (sus)

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

Infections caused by: Gram positive aerobic cocci (excluding methicillin-resistant S. aureus); Gram negative aerobic bacilli (including E. coli, Klebsiella pneumonia and H. influenzae)

General dosing range

• Oral (ER tab, sus): 750mg-1500mg/day, in 2 divided doses; Treatment duration: Up to 28 days 

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If beta hemolytic Streptococcus or S. pyogenes confirmed, treat for at least 10 days

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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

Pharyngitis
Tonsillitis
Skin and soft tissue infections

• Oral (ER tab): 375mg, 12hrly

Acute bronchitis 
Acute exacerbation of chronic bronchitis

• Oral (ER tab): 375-500mg, 12hrly; Treatment duration: 7 days

Pneumonia 

• Oral (ER tab): 750mg, 12hrly

Lower urinary tract infections
- Pyelonephritis
- Cystitis

• Oral (ER tab): 375mg, 12hrly
  OR
• Oral (ER tab): 500mg, dly 

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

Infections caused by: Gram positive aerobic cocci (excluding methicillin-resistant S. aureus); Gram negative aerobic bacilli (including E. coli, Klebsiella pneumonia and H. influenzae)

General dosing range

Younger than 1 month 

• Not established for use 

Between 1 month-16 years 

•  Oral (sus): 20-40mg/kg/day, in divided doses; Max: 1g/24hrs 

Older than 16 years 

• Oral (ER tab): 500mg, 12hrly

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If beta hemolytic Streptococcus or S. pyogenes confirmed, treat for at least 10 days

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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

Acute bronchitis 
Acute exacerbation of chronic bronchitis
Pneumonia

Younger than 1 month 

• Not established for use

Older than 1 month 

• Oral (sus): 20mg/kg/day in 3 divided doses

Otitis media - mild to moderate
Pharyngitis

Younger than 1 month 

• Not established for use

Older than 1 month 

• Oral (sus): 20mg/kg/day in 2 divided doses

Otitis media - severe
Sinusitis

Younger than 1 month 

• Not established for use

Older than 1 month

• Oral (sus): 40mg/kg/day in divided doses

Pregnancy

• Caution; no evidence of risk in studies
• Although animal studies have shown no evidence of impaired fertility or harm to the foetus due to cefaclor, there are no adequate and well-controlled studies in pregnant women. Cefaclor should be used during pregnancy only if clearly needed. Use during labour and delivery should be given only if clearly needed

Breastfeeding

• Caution
• Small amounts of cefaclor have been detected in breast milk following administration of single 500mg doses. Average levels of about 0.2 micrograms/ml or less were detected up to 5 hours later. Trace amounts were detected at one hour. As the effect on nursing infants is not known, caution should be exercised when cefaclor is administered to a nursing woman. No studies have been done with cefaclor  

Renal Impairment

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

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness
• Somnolence
• Asthenia
• Paraesthesia
• Syncope
• Hyperactivity
• Agitation
• Nervousness
• Insomnia
• Confusion
• Hallucinations
• Hypertonia
• Seizures 

Cardiovascular Disorders

• Vasodilatation

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Dyspepsia
• Colitis

Hepatobiliary Disorders

• Increased hepatic enzymes
• Hepatic dysfunction
• Cholestasis

Genitourinary Disorders

• Proteinuria
• Vaginal moniliasis
• Vaginitis
• Increased creatinine 
• Increased blood urea nitrogen
• Abnormal urinalysis
• Genital pruritus
• Interstitial nephritis
• Renal dysfunction
• Toxic nephropathy

Musculoskeletal Disorders

• Arthritis
• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Pruritus
• Erythema multiforme
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Oedema
• Morbilliform eruptions

Immune, Blood and Lymphatic System Disorders

• Serum sickness-like reaction
• Lymphadenopathy
• Fever
• Eosinophilia
• Thrombocytopenia
• Leucopenia
• Lymphocytosis
• Neutropenia
• Anaphylaxis
• Positive direct Coombs' test
• Angioedema
• Aplastic anaemia
• Agranulocytosis
• Haemolytic anaemia

• Warfarin
• Probenecid
• Magnesium hydroxide (tab)
• Aluminum hydroxide (tab) 

Renal function

Cefaclor is a beta lactam antibiotic. It inhibits the third and last stage of bacterial cell wall synthesis by binding to specific penicillin-binding proteins located inside the bacterial cell wall. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes such as autolysins and murein hydrolases, while cell wall assembly is arrested.

Spectrum of activity: Gram positive aerobic cocci (excluding methicillin-resistant S. aureus); Gram negative aerobic bacilli (including E. coli, Klebsiella pneumonia and H. influenzae)

Tablet 375mg

• Vercef mr (Ranbaxy)

Suspension (per 5ml) 187mg

• Vercef granules for suspension (Ranbaxy)

Suspension (per 5ml) 375mg

• Vercef (Ranbaxy)