CEPOREX

d. s. d. For prophylaxis of recurrent urinary tract infections in adults, a dose of 125mg each night is recommended and may be continued for several months (the 125mg/5ml Suspension is suitable for this purpose).

Children:

Ideally, dosage should be calculated on a body-weight basis, particularly in infants. The following dosage recommendations for children are derived from a normal dosage of 25 to 60mg/kg/day. For chronic, severe or deep-seated infections, this should be increased to 100mg/kg/day (maximum 4g/day).

d. d. d. ) is recommended. 5g probenecid for females is usually effective. Concurrent administration of probenecid delays excretion of cefalexin and raises the serum levels by 50 to 100%. Ceporex has not been shown to have a toxic effect on the kidney, but as with other antibiotics which are excreted mainly by the kidneys, unnecessary accumulation may occur in the body when renal function is below about half of normal.

e. Adults 6g/day, children 4 g/day) should be reduced proportionately in these patients. In elderly patients, the possibility of renal impairment should be considered. , a total dosage of up to 1g on that day. Children should receive an additional 8mg per kg.

Blood and Lymphatic System Disorders:

Adverse effects common to the cephalosporin group are the blood and lymphatic system disorders: eosinophilia, thrombocytopenia, leucopenia, neutropenia to agranulocytosis, and aplastic anaemia. Haemolytic anaemia has been reported but rarely occurs.

Cefalexin does not contain an N-methylthiotetrazole side chain and therefore the risk of bleeding complications due to impaired vitamin-K dependent clotting factor synthesis is low.

Nervous System Disorders:

Nervous system disorders that have been reported are headache, dizziness, confusion, hallucinations, hyperactivity, nervousness, sleep disturbances. 7. There are some reports of patients suffering from hypertonia after cephalosporin treatment.

Gastrointestinal Disorders:

Gastrointestinal adverse effects such as nausea, vomiting, abdominal discomfort and diarrhoea have been reported. Dyspepsia has also occurred. As with other broad-spectrum antibiotics, prolonged use may result in the overgrowth of non-susceptible organisms and pseudomembranous colitis may develop.

There has been some evidence from clinical trials of some cephalosporins that the incidence of diarrhoea and pseudomembranous colitis are dose related and therefore the Committee for the Safety of Medicines has recommended that higher doses should be reserved for severe infections and that in any case, treatment should be discontinued if symptoms suggestive of pseudomembranous colitis arise.

Cephalosporins may cause disturbances in liver enzymes, transient hepatitis and cholestatic jaundice. Normal liver function should return following discontinuation of the medication.

Acute generalised exanthematous pustulosis (AGEP) has been reported in association with cefalexin treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, cefalexin should be withdrawn immediately and an alternative treatment considered.

Most of these reactions occurred most likely in the first week during treatment. Cefalexin should be given cautiously to patients who have shown hypersensitivity to other drugs. Cephalosporins should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross- allergenicity between the penicillins and cephalosporins.

Patients have had severe reactions (including anaphylaxis) to both drugs. Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics, including macrolides, semisynthetic 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 of pseudomembranous colitis usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken. If the patient experiences an allergic reaction cefalexin should be discontinued and treatment with the appropriate agents initiated.

Prolonged use of cefalexin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. Cefalexin should be administered with caution in the presence of markedly impaired renal function as it is excreted mainly by the kidneys.

Careful clinical and laboratory studies should be made because the safe dosage may be lower than that usually recommended. In patients receiving Ceporex, a false-positive reaction for glucose in the urine may be given, with Benedict's or Fehling's solution, or with 'Clinitest' tablets, but not with enzyme-based tests.

Cefalexin is contra-indicated in patients with known allergy to the cephalosporin group of antibiotics.