Cephalosporins.

Cefradine [cephradine]

Capsules 250mg: Opaque, orange body with opaque blue cap printed Squibb and 113 in white on each half. Each capsule contains 250mg cefradine. Capsules 500mg: Opaque blue printed in white with Squibb and 114 on each half. Each capsule contains 500mg cefradine. Syrup 250mg/5ml: When reconstituted contains 250mg cefradine per 5 ml.

Oral Capsules. Oral powder for reconstitution.

In the treatment of infections of the urinary and respiratory tracts and of the skin and soft tissues. These include: Upper respiratory infections - pharyngitis, sinusitis, otitis media, tonsillitis, laryngo-tracheo bronchitis. Lower respiratory infections - acute and chronic bronchitis, lobar and bronchopneumonia. Urinary tract infections - cystitis, urethritis, pyelonephritis.

Skin and soft tissue infections - abscess, cellulitis, furunculosis, impetigo. Cefradine has been shown to be effective in reducing the incidence of postoperative infections in patients undergoing surgical procedures associated with a high risk of infection. It is also of value where postoperative infections would be disastrous and where patients have a reduced host resistance to bacterial infection.

Protection is best ensured by achieving adequate local tissue concentrations at the time contamination is likely to occur. Thus, cefradine should be administered immediately prior to surgery and continued during the postoperative period. Bacteriology studies to determine the causative organisms and their sensitivity to cefradine should be performed. Therapy may be instituted prior to receiving the results of the sensitivity test.

For urinary tract infections the usual dose is 500mg four times daily or 1g twice daily; severe or chronic infections may require larger doses. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis. For respiratory tract infections and skin and soft tissue infections the usual dose is 250mg or 500mg four times daily or 500mg or 1g twice daily depending on the severity and site of infections.

All patients, irrespective of age and weight

Larger doses (up to 1g four times daily) may be given for severe or chronic infections. Therapy should be continued for a minimum of 48-72 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. In infections caused by haemolytic strains of streptococci, a minimum of 10 days' treatment is recommended to guard against the risk of rheumatic fever or glomerulonephritis. In 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 doses recommended for adults. As cefradine is available in both injectable and oral form, patients may be changed from the cefradine injectable to cefradine oral at the same dosage level.

Renal Impairment Dosage:

Patients not on dialysis:

The following dosage schedule is suggested as a guideline based on a dosage of 500mg Q6H and on creatinine clearance. Further modification in the dosage schedule may be required because of the dosage selected and individual variation.

Creatinine Clearance                                                  Dose                                             Time Interval
More than 20 ml/min                                                   500 mg                                         6 hours
5 - 20 ml/min                                                                250 mg                                         6 hours
Less than 5 ml/min                                                     250 mg                                        12 hours
 

Patients on chronic, intermittent haemodialysis:

250 mg                At start of haemodialysis
250 mg                6 - 12 hours after start
250 mg               36 - 48 hours after start
250 mg               At start of next haemodialysis if >30 hours after previous dose.

Further modification of the dosage schedule may be necessary in children.

 
 

 

 

The usual dose is from 25 to 50mg/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.

There are no specific dosage recommendations or precautions for use in the elderly except, as with other drugs, to monitor those patients with impaired renal or hepatic function.

Patients with known hypersensitivity to the cephalosporin antibiotics or to any component of the formulation.

There is evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Therefore cefradine should be used with caution in those patients with known hypersensitivity to penicillins. There have been instances of patients who have had reactions to both drug classes (including anaphylaxis).

Dosage should be reduced in renal failure.

After treatment with cefradine, a false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solution or with reagent tablets such as Clinitest*, but not with enzyme-based tests such as Clinistix* or Diastix*.

As with all antibiotics, prolonged use may result in overgrowth of non-susceptible organisms.

Loop diuretics may increase nephrotoxicity of cephalosporins.

Probenecid has been seen to raise serum concentrations of cefradine, by reducing renal clearance of the cephalosporins.

Limited essentially to gastro-intestinal disturbances and on occasion to hypersensitivity phenomena. The latter are more likely to occur in individuals who have previously demonstrated hypersensitivity and those with a history of allergy, asthma, hay fever or urticaria. The majority of reported side-effects have been mild and are rare, and include glossitis, heartburn, dizziness, tightness in the chest, headache, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candidal overgrowth. Skin and hypersensitivity reactions include urticaria, pruritus, skin rashes, fever, athralgia and oedema.

As with other cephalosporins, there have been rare reports of erythema multiforme, Stevens Johnson Syndrome, anaphylaxis and toxic epidermal necrolysis. Also, mild transient eosinophilia, leucopenia and neutropenia, rarely positive direct Coombs tests and pseudomembraneous colitis have been reported.

Elevations of BUN and serum creatinine and reversible interstitial nephritis have been reported. Transient hepatitis and cholestatic jaundice have been reported very rarely. Elevations of ALT, AST, total bilirubin and alkaline phosphatase have been observed.

Bristol-Myers Squibb

(POM)

25 June 2009