Zepilen Special Precautions

Administer with caution to patients who have had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs. There is some evidence of partial cross, allergenicity between cephalosporins and penicillins.
Susceptible patients may have severe reactions, including anaphylaxis. Serious acute hypersensitivity reactions may need adrenaline and other emergency measures.
Absorption of cephalosporins to red cell membrane surface may occur, with reaction to antibodies against Zepilen. This may result in a false positive Coombs' test, very rarely in haemolytic anaemia. It is possible for cross-reactivity with penicillins to occur for this reaction. This reaction may also occur in neonates where cephalosporin was administered to the mother predelivery.
Patients who develop diarrhoea may have pseudomembranous colitis, which has been reported with all broad spectrum antibiotics. Severity can range from mild to life-threatening.
Drug withdrawal is usually satisfactory for mild cases, more severe cases need appropriate measures.
Cefazolin should be discontinued if an allergic reaction occurs, and treatment with adrenaline, antihistamines or corticosteroids initiated as required.
In patients with a history of gastrointestinal disease, especially colitis, caution should be exercised in the use of broad spectrum antibiotics.
Prolonged use of cefazolin may lead to overgrowth of non susceptible organisms, in the case of such superinfection, appropriate measures should be taken. Patients should be carefully observed during long-term therapy for signs of superinfection.
Dosage reduction is necessary in patients with impaired renal function (see Dosage & Administration).
Administration of cefazolin by the intrathecal route is not an approved route of administration, use of this route of administration has resulted in severe central nervous system toxicity, including seizures.
Use in pregnancy & lactation: There are inadequate studies in pregnant women. There is no evidence of impaired fertility or teratogenicity from animal studies. Caution should be exercised in use in pregnancy, and the benefits weighed against the potential hazard. In cases where cefazolin was administered prior to caesarean section, cord blood levels were 25-33% maternal levels. There appeared to be no adverse effect on the foetus.
Very low concentrations of cefazolin have been found in breast milk. Caution should be exercised, and it is preferable to discontinue breastfeeding.