CEFACLOR

Posology Adult: 250mg every eight hours, may be doubled to 500mg every eight hours for more severe infections or those caused by less susceptible organisms. Total daily dosage should not exceed 4g.

Paediatric population:

The usual recommended dose is 20mg/kg/day in divided doses administered every eight hours. For bronchitis and pneumonia, the dosage is 20mg/kg/d in divided doses administered 3 times daily. The total daily dose may be administered in divided doses every twelve hours in otitis media and pharyngitis.

This dose may be increased to 40mg/kg/day in divided doses for more severe infections, caused by less susceptible organisms. The total daily dosage should not exceed 1g. In the treatment of beta-haemolytic streptococcal infections, therapy should be continued for at least 10 days.

5mg 1-5 years 125mg Over 5 years 250mg The safe use of Cefaclor in babies aged below one month has not been proven. 0ml tid Elderly: The normal adult dose is appropriate.

Patients with impaired renal function:

The normal adult dose is appropriate. (see special warnings and precautions for use) Patients Undergoing Haemodialysis: Due to a 25-30% decrease in plasma half-life, a loading dose of 250mg - lg before dialysis is recommended with a maintenance dose between dialysis sessions of 250mg - 500mg every six to eight hours.

Method of administration Oral administration.

Gastro-intestinal:

The most frequent side-effect has been diarrhoea, though it is rarely severe enough to warrant cessation of therapy. Colitis, including rare instances of pseudomembranous colitis, has been reported. Nausea and vomiting have also occurred.

Hypersensitivity:

Allergic reactions such as morbilliform eruptions, pruritus and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness-like reactions (erythema multiforme minor, rashes or other skin manifestations accompanied by arthritis/arthralgia, with or without fever) have been reported.

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. Such reactions are apparently due to hypersensitivity and have usually occurred during or following a second (or subsequent) course of therapy with cefaclor, and 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.

There are rare reports of erythema multiforme major (Stevens Johnson syndrome), toxic epidermal necrolysis, and anaphylaxis. Anaphylaxis may be more common in patients with a history of penicillin allergy. Anaphylactoid events may present as solitary symptoms, including angioedema, asthenia, oedema (including face and limbs), dyspnoea, paraesthesias, syncope, or vasodilatation.

Rarely, hypersensitivity symptoms may persist for several months.

Warnings Prior to treatment with cefaclor, every effort should be made to determine whether the patient has had previous hypersensitivity reactions to cefaclor, cephalosporins, penicillins or other drugs. Cefaclor should be given cautiously to penicillin-sensitive patients, as cross-hypersensitivity, including anaphylaxis, among beta-lactam antibiotics has been clearly documented.

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 Cefaclor should be administered with caution in the presence of markedly impaired renal function. 9 hours in normal subjects), dosage adjustments for patients with moderate or severe renal impairment are not usually required.

Clinical experience with cefaclor under such conditions is limited; therefore, careful clinical observation and laboratory studies should be made. Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastro-intestinal disease, particularly colitis.

Prolonged use of cefaclor may result in the overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken. Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics.

In haematological studies or in transfusion cross-matching procedures, when anti-globulin tests are performed on the minor side, or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognised that a positive Coombs' test may be due to the drug.

1 Hypersensitivity to cephalosporins