POM: Prescription only medicine
This information is intended for use by health professionals
ElderlyAs for adults. Patients with impaired renal or hepatic function should be monitored as modifications of the dosage schedule may be required.
Paediatric populationThe usual dose is 25 to 50 mg/kg/day total, given in two or four equally divided doses. For otitis media daily doses from 75 to 100mg/kg in divided doses every 6 to 12 hours are recommended. Maximum dose 4g per day.Cefradine may be taken without regard to meals.All patients irrespective of age and weight: In the case of severe or chronic infection larger doses of up to 1g four times daily may be given. Administration should be continued for a minimum of 48-72 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. For infections caused by haemolytic strains of streptococci, a minimum of 10 days treatment is recommended to guard against the risk of rheumatic fever or glomerulo-nephritis. For the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Persistent infections may require treatment for several weeks. Smaller doses than those indicated above should not be used. Doses for children should not exceed those recommended for adults. As cefradine is available in both injectable and oral forms, patients may be changed from injection to capsules at the same dosage level.
Dosage in renal impairment:For patients not on dialysis: The following dosage schedule guideline is based on a dosage of 500mg 6 hourly and on creatinine clearance:
|Creatinine Clearance||Dose||Time interval|
|More than 20ml/min||500mg||6 hours|
|less than 5 ml/min||250mg||50-70 hours|
|250mg 250mg 250mg||6-12 hours after start 36-48 hours after start At start of next haemodialysis if >30 hours after previous dose. Further modification of the dosage schedule may be required in children.|
FertilityAlthough animal studies have shown no teratogenic effects, safety in pregnancy has not been established.
PregnancyAs with all medicines, use should be avoided in pregnancy especially in the first trimester, unless considered essential by the physician.
Breast-feedingCefradine is excreted in breast milk and therefore should be used with caution in lactating mothers.
|Infections and infestations|
|Rarely:Frequency unknown:||Antibiotic-associated colitisVaginitis, candidal overgrowth, candidiasis|
|Blood and lymphatic system disorders|
|Frequency unknown:||Eosinophilia, blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)|
|Immune system disorders|
|Frequency unknown:||Fever, athralgia, serum sickness-like reactions, anaphylaxis|
|Frequency unknown:||Confusion, sleep disturbances|
|Nervous system disorders|
|Frequency unknown:Rarely:||Hypersensitivity, hyperactivity, hypertonia, dizziness, nervousnessHeadache|
|Frequency unknown:Rarely:||Diarrhoea, nausea, glossitis, heartburnVomiting, abdominal discomfort,|
|Frequency unknown:||Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice|
|Skin and subcutaneous tissue disorders|
|Frequency unknown:||Rashes, toxic epidermal necrolysis, pruritis, urticaria, erythema multiforme, Stevens-Johnson syndrome, oedema|
|Renal and urinary disorders|
|Frequency unknown:||Reversible interstitial nephritis|
|General disorders and administration site conditions|
|Frequency unknown:||Tightness in the chest|
|Frequency unknown:||Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphates, positive direct Coombs' test|
|Musculoskeletal and connective tissue disorder|
|Frequency unknown:||joint pain|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Mechanism of actionCefradine is a broad-spectrum, bactericidal first generation cephalosporin antibiotic active against both Gram-positive and Gram-negative bacteria. It is also highly active against most strains of penicillinase producing Staphylococci. The anti-bacterial action of cefradine is through inhibition of bacterial cell wall synthesis, probably by acylation of membrane - bound transpeptidase enzymes. This prevents cross-linkage of peptidoglycan chains which is necessary for bacterial cell wall strength and rigidity.Susceptibility : The following organisms have shown in vitro sensitivity to Cefradine.Gram-positive Aerobes: Staphylococci (both penicillin sensitive and resistant strains), Streptococci, Streptococcus pneumoniae and Streptococcus pyogenes (beta haemolytic).Gram-negative Aerobes: Escherichia coli, Haemophilus influenzae, Klebsiella spp, Neisseria spp., Proteus mirabilis, Salmonella spp.(including Salmonella typhi) and. Shigella spp.Because Cefradine is unaffected by penicillinase, many strains of Escherichia coli and Staphylococcus aureus which produce this enzyme are susceptible to Cefradine but resistant to ampicillin.Insusceptible microorganisms:The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.In general, bacterial resistance to cephalosporins usually results both from the production of a β-lactamase and the presence of permeability barriers to the drug.
AbsorptionCefradine has a high degree of stability to many beta-lactamases. It has a low degree of protein binding and a large volume of distribution. Therefore, tissue levels are generally found to be high.Oral cefradine can be given twice or four times daily and is well absorbed. Cefradine is acid stable and is rapidly absorbed following oral administration in the fasting state.
DistributionFollowing doses of 250mg, 500mg and 1000mg average peak serum levels of approximately 9, 16.5, and 24.2 micrograms/ml, respectively, were obtained at one hour. The presence of food in the gastrointestinal tract delays the absorption but does not affect the total amount of cefradine absorbed. Measurable serum levels are present six hours after administration.
EliminationOver 90% of the drug is excreted unchanged in the urine within 6 hours. Peak urine concentrations are approximately 1600 micrograms/ml following a 250mg dose, 3200 micrograms/ml following a 500mg dose, and 4000 micrograms/ml following a 1000mg dose. After 48 hours administration of 100mg/kg/day of cefradine for the treatment of otitis media, cefradine has been measured in the middle ear exudate at an average level of 3.6 microgram/ml.
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