CEFRADINE Capsule, hard Ref.[9831] Active ingredients: Cefradine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland

Therapeutic indications

Cefradine 250mg Capsules are used in the treatment of bacterial infections of the respiratory and urinary tracts and of the skin and soft tissues. These include the following:

Upper respiratory tract infections – sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media.

Lower respiratory tract infections – acute and chronic bronchitis, lobar and bronchopneumonia.

Urinary tract infections – cystitis, urethritis and pyelonephritis.

Skin and soft tissue infections – impetigo, abscess, cellulitis, furunculosis.

Cefradine 250mg Capsules are also used in the prophylaxis of postoperative infections following surgical procedures associated with a high risk of infection and for patients with a reduced host resistance to bacterial infection. Cefradine should be administered immediately prior to surgery in order to ensure sufficient local tissue concentrations at the time that contamination is likely to occur. Treatment should be continued during the post operative period.

Laboratory testing should be carried out to determine the causative agents and their sensitivity to cefradine. However, therapy may commence prior to receipt of the sensitivity test results.

Posology and method of administration

Posology

Adults

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 infection.

Urinary tract infections: the usual dose is 500mg four times daily or 1g twice daily. This may need to be increased for severe or chronic infections. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis.

Elderly

As for adults. Patients with impaired renal or hepatic function should be monitored as modifications of the dosage schedule may be required.

Paediatric population

The 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 ClearanceDoseTime interval
More than 20ml/min500mg6 hours
5-20ml/min250mg6 hours
Less than 5 ml/min250mg12 hours

Adjustments to the dosage schedule provided may be necessary because of the dosage selected and individual variation.

For patients on chronic, intermittent haemodialysis:

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

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

Overdose

The symptoms of cefradine overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.

Shelf life

Shelf life: 24 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

PVC/PVDC blister foil, 0.25 +/- 5% mm thick with an aluminium lidding foil 0.025 mm thick containing 10, 20 or 100 capsules.

Special precautions for disposal and other handling

No special instructions.

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