Cefprozil

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:

• Pharyngitis/tonsillitis caused by Streptococcus pyogenes
• Otitis media caused by Streptococcus pneumoniae, Haemophilus influenza and Branhamella catarrhalis
• Secondary bacterial infection of acute bronchitis, and acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenza (beta-lactamase positive and negative strains) and Branhamella catarrhalis
• Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillanase-producing strains) and Streptococcus pyogenes
• Uncomplicated urinary tract infections, including acute cystitis in women caused by Escherichia coli, Klebsiella pneumonia and Proteus mirabilis

Contraindications

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

Cautions

• Breastfeeding
• Renal impairment
• History of penicillin allergy
• Prolonged use
• Gastrointestinal disease
• Neonates

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

Infections caused by: Gram positive aerobic cocci (excluding Methicillin-resistant Staphylococci and Enterococcus); Some Gram negative bacilli (excluding E.coli, P. mirabilis, Pseudomonas); Some anaerobes (Peptostreptococcus)

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

Upper respiratory infections

• Oral (tab, sus): 500mg, dly; Treatment duration: 10 days (Manufacturer recommendation)

Lower respiratory infections

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

Sinusitis

• Oral (tab, sus): 250-500mg, 12hrly; Treatment duration: 10 days (Manufacturer recommendation)

Uncomplicated urinary tract infections

• Oral (tab, sus): 500mg, dly; Treatment duration: 10 days (Manufacturer recommendation)

Skin infections

• Oral (tab, sus): 250-500mg, 12-24hrly; Treatment duration: 10 days (Manufacturer recommendation)

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

Infections caused by: Gram positive aerobic cocci (excluding Methicillin-resistant Staphylococci and Enterococcus); Some Gram negative bacilli (excluding E.coli, P. mirabilis, Pseudomonas); Some anaerobes (Peptostreptococcus)

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

Lower respiratory infections

Younger than 12 years

• Not established for use

Older than 12 years

• See adult dosage

Upper respiratory tract infections
Pharyngitis
Tonsillitis

Younger than 1 year

• Not established for use

Between 1 year - 12 years

• Oral (tab, sus): 7.5mg/kg, 12hrly; Treatment duration: 10 days

Older than 12 years

• See adult dosage

Otitis media

Younger than 1 year

• Not established for use

Between 1 year - 12 years

• Oral (tab, sus): 15mg/kg, 12hrly; Treatment duration: 10 days

Older than 12 years

• See adult dosage

Skin infections

Younger than 1 year

• Not established for use

Between 1 year - 12 years

• Oral (tab, sus): 20mg/kg, dly; Treatment duration: 10 days

Older than 12 years

• See adult dosage

Sinusitis

Younger than 1 year

• Not established for use

Between 1 year - 12 years

• Oral (tab, sus): 7.5-15mg/kg, 12hrly

Older than 12 years

• See adult dosage

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Beta-haemolytic Streptococcal infections should be treated for at least 10 days (manufacturer recommendation)

Pregnancy

• FDA Pregnancy Category B 

Breastfeeding

• Caution

Renal Impairment

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

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Central Nervous System Disorders

• Dizziness
• Confusion
• Drowsiness
• Headache
• Hyperactivity
• Insomnia

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Abdominal pain

Hepatobiliary Disorders

• Increased serum transaminases
• Cholestatic jaundice

Genitourinary Disorders

• Vaginitis
• Increased serum creatinine
• Pseudomembranous colitis

Endocrine and Metabolic Disorders

• Increased blood urea nitrogen

Musculoskeletal Disorders

• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Nappy rash
• Genital pruritus
• Erythema multiforme
• Rash
• Stevens-Johnson syndrome
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Superinfection
• Anaphylaxis
• Angioedema
• Eosinophilia
• Fever
• Leukopenia
• Serum sickness
• Thrombocytopenia

• Bacille Calmette-Guérin (BCG) immunotherapy
• Cholera vaccine
• Sodium picosulfate
• Typhoid vaccine

Renal function

Cefprozil disrupts bacterial cell wall synthesis by inhibiting the transpeptidation enzyme that crosslinks the peptide chains attached to the backbone of the peptidoglycan. Bacterial lysis then occurs due to the action of cell wall autolytic enzymes. 

Spectrum of activity: Gram positive aerobic cocci (excluding Methicillin-resistant Staphylococci); Some Gram negative bacilli (excluding E.coli, P. mirabilis, Pseudomonas)  and some anaerobes (Peptostreptococcus)

Tablet 250mg

• Auroprozil (Actor)
• Lizorp (Aurobindo)
• Prozef (Bristol-Myers) originator

Tablet 500mg

• Auroprozil (Actor)
• Lizorp (Aurobindo)
• Prozef (Bristol-Myers) originator

Suspension (per 5ml) 125mg

• Lizorp (Aurobindo)
• Prozef (Bristol-Myers) originator

Suspension (per 5ml) 250mg

• Lizorp (Aurobindo)
• Prozef (Bristol-Myers) originator