CEFACLOR FLYNN

Posology Adults and the elderly:

Pharyngitis, tonsillitis, skin and skin structure infections: 375mg twice daily. Lower urinary tract infections: 375mg twice daily or 500mg once daily. Bronchitis: 375mg or 500mg twice daily Pneumonia: 750mg twice daily. 5g/day of Cefaclor prolonged-release tablets have been administered safely for 14 days.

Doses of 4g/day of cefaclor have been administered safely, to normal subjects, for 28 days. Elderly subjects with normal renal function do not require dosage adjustment. Paediatric population The safety and efficacy of Cefaclor prolonged-release tablets in children have not been established.

No data are available. Cefaclor suspensions are available (see Cefaclor data sheet for dosages). In the treatment of infections caused by S. pyogenes (group A streptococci), a therapeutic dosage should be administered for at least 10 days.

Method of administration Cefaclor prolonged-release tablets are administered orally. Cefaclor prolonged-release tablets are well absorbed from the gastro-intestinal tract. Since absorption is enhanced by administration with food, Cefaclor prolonged-release tablets should be taken with meals.

The tablets should not be cut, crushed or chewed. There is no evidence of metabolism in humans.

The majority of adverse reactions observed in clinical trials of Cefaclor prolonged- release tablets were mild and transient. 7% of patients. The following adverse reactions were reported in clinical trials. 5%), vomiting and dyspepsia.

7% of patients. 03%) was reported among the 3,272 patients treated with Cefaclor prolonged-release during the controlled clinical trials. Serum sickness-like reactions (erythema multiforme minor, rashes or other skin manifestations accompanied by arthritis/arthralgia, with or without fever) have been reported with cefaclor.

Lymphadenopathy and proteinuria are infrequent, there are no circulating immune complexes and no evidence of sequelae. Occasionally, solitary symptoms may occur, but do not represent a serum sickness-like reaction. Serum sickness-like reactions are apparently due to hypersensitivity and have usually occurred during or following a second (or subsequent) course of therapy with cefaclor.

Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and usually subside within a few days of cessation of therapy. Antihistamines and corticosteroids appear to enhance resolution of the syndrome.

No serious sequelae have been reported.

Haematological and lymphatic systems:

Eosinophilia. 7%). The following adverse effects have been reported, but causal relationship is uncertain: Central nervous system: Headache, dizziness and somnolence.

Hepatic:

Transient elevations in AST, ALT and alkaline phosphatase.

Renal:

Transient increase in BUN or creatinine. There have been reports of neurological sequelae including tremor, myoclonia, convulsions, encephalopathy with drugs belonging to the class of cephalosporins. Most cases occurred in patients with renal impairment who received doses that exceeded the recommended dose and resolved following discontinuation of treatment.

Laboratory tests:

Transient thrombocytopenia, leucopenia, lymphocytosis, neutropenia and abnormal urinalysis. In addition to the adverse reactions listed above that have been observed in patients taking Cefaclor prolonged-release tablets, the following have been reported in patients treated with cefaclor: Erythema multiforme, fever, anaphylaxis (may be more common in patients with a history of penicillin allergy), Stevens-Johnson syndrome, positive direct Coombs' test and genital pruritus.

Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Anaphylactoid events may present as solitary symptoms, including angioedema, asthenia, oedema (including face and limbs), dyspnoea, paraesthesias, syncope, orvasodilatation.

Rarely, hypersensitivity symptoms may persist for several months. The following reactions have been reported rarely in patients treated with cefaclor: Toxic epidermal necrolysis, reversible interstitial nephritis, hepatic dysfunction, including cholestasis, increased prothrombin time in patients receiving cefaclor and warfarin concomitantly, reversible hyperactivity, agitation, nervousness, insomnia, confusion, hallucinations, hypertonia, aplastic anaemia, agranulocytosis and haemolytic anaemia.

The following adverse reactions have been reported in patients treated with other beta-lactam antibiotics: Colitis, renal dysfunction and toxic nephropathy. Several beta-lactam antibiotics have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced.

If seizures associated with drug therapy should occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continues monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

Warnings Before instituting therapy with cefaclor, every effort should be made to determine whether the patient has had previous hypersensitivity reactions to the cephalosporins, penicillins or other drugs. Cefaclor should be given cautiously to penicillin-sensitive patients and to any patient who has demonstrated some form of allergy, particularly to drugs.

If an allergic reaction to cefaclor occurs, the drug should be discontinued and the patient treated with the appropriate agents. Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics, including macrolides, semi-synthetic penicillins and cephalosporins.

It is important, therefore, to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Such colitis may range in severity from mild to life-threatening. Mild cases usually respond to drug discontinuance alone.

In moderate to severe cases, appropriate measures should be taken. Precautions Prolonged use of cefaclor may result in the overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.

A false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets. Reports of neurotoxicity have been identified in association with cephalosporin treatment. Symptoms may include encephalopathy, myoclonus and seizures.

Elderly patients, patients with severe renal impairment or central nervous system disorders are particularly at risk. If cefaclor associated neurotoxicity is suspected, discontinuation of cefaclor should be considered.

1. Hypersensitivity to other cephalosporins.