Source: Υπουργείο Υγείας (CY) Revision Year: 2013 Publisher: Codal Synto Ltd, 33 Theklas Lysioti Street, 3030 Limassol, Cyprus
Hypersensitivity to the active substance, cephalosporins or to any of the excipients listed in section 6.1.
It is important that efforts are made to determine if the patient has had previous hypersensitivity reactions to cefaclor, cephalosporins or penicillins before starting treatment. Due to the fact that cross sensitivity, including anaphylactic reactions, can occur with beta lactam antibiotics, caution should be exercised in administering cefaclor to penicillin sensitive patients.
Should the patient prove allergic to cefaclor, cefaclor should be withdrawn and an appropriate non cephalosporin therapy instituted.
In patients who develop diarrhoea in association with cefaclor therapy, the possibility of pseudomembranous colitis should be considered. Drug discontinuation may be adequate in mild cases, more severe cases may require other appropriate measures. Pseudomembranous colitis can be life threatening.
Caution should be exercised in administering cefaclor in severe renal impairment as the half life is prolonged. Careful clinical supervision and appropriate laboratory tests is advised.
Caution should be exercised in administering cefaclor to patients with a history of gastro-intestinal disease, especially colitis.
Overgrowth of non susceptible organisms may occur with prolonged administration of cefaclor. Appropriate measures should be taken if any such superinfection occurs.
Coomb’s test: 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.
False positive results for glucose in the urine may occur when using copper sulphate test tablets, Benedict’s reagent or Fehling’s solution.
Syntoclor contains azorubine which may cause allergic reactions.
Probenecid: Inhibits the renal excretion of cefaclor.
Warfarin: Concomitant administration has led to rare reports of increased prothrombin time, with and without clinical bleeding. Regular monitoring of prothrombin time is advised, with warfarin dosage adjustment if necessary.
Cefaclor administered with food is absorbed to the same extent as when administered in the fasting state, but the peak serum levels and/or the time to peak levels are reduced.
No evidence of fertility impairment or teratogenicity was found in animal studies, however such studies are not always predicative of behaviour in man. There are no adequate or well controlled studies in pregnancy. Caution should therefore be exercised, and the benefit to the mother versus the unknown potential risk to the foetus carefully considered.
Cefaclor is excreted in breast milk in small amounts, following administration of single 500mg doses. Average levels of about 0.2 micrograms/ml or less were detected up to 5 hours later. Trace amounts were detected at one hour. As the effect on nursing infants is not known, caution should be exercised when cefaclor is administered to a nursing woman.
No known effects.
Positive Coomb’s test. Eosinophilia, rare reports of thrombocytopenia. Transient lymphocytosis and leucopenia. Rare reports of haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia.
Hypersensitivity reactions, characterised by morbilliform eruptions, pruritus and urticaria have occurred, following treatment withdrawal they usually subside. Erythema multiforme, rashes and other skin manifestations, arthritis and arthralgia, both with and without fever, characteristic of serum sickness syndrome, have been reported. Infrequent reports of lymphadenopathy and proteinuria.
Serum sickness like syndrome usually occurs during or after a second therapeutic course of cefaclor, and are more frequent in children. Symptoms occur shortly after starting treatment and usually disappear shortly after stopping treatment.
Steven’s-Johnson syndrome is rarely reported, as are anaphylaxis and toxic epidermal necrosis. Anaphylaxis may be indicated by solitary symptoms, such as angioedema, asthenia, dyspnoea, face and limb oedema, paraesthesia, syncope and vasodilation. It is more common in penicillin sensitive patients. On rare occasions it may last for several months.
Rare reports of agitation, confusion, dizziness, hallucinations, reversible hyperactivity, hypertonia, insomnia, nervousness and somnolence.
Diarrhoea is the most frequently reported side effect, but is rarely severe enough to necessitate therapy withdrawal. Nausea and vomiting have been reported. Colitis, with rare reports of pseudomembranous colitis, has been reported.
Alkaline phosphatase, alkaline transferase (ALT) and (AST) values reported to be slightly elevated, transient hepatitis and cholestatic jaundice have rarely been reported.
Abnormal urinalysis, slight elevation of blood urea or serum creatinine, reversible interstitial nephritis, these are rare.
Genital pruritus, vaginitis and vaginal candidiasis.
Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.
None known.
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