Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Aurogen South Africa (Pty) Ltd, 53 Phillip Engelbrecht Avenue, Woodhill Office Park, Building 1, Meyersdal, Extension 12, 1448, Johannesburg, South Africa
REPOCEF is contraindicated in patients who have had previous hypersensitivity reactions to the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics or any component of the formulation.
Children below the age of 1 year.
Pregnancy and lactation.
Before therapy with REPOCEF is instituted, careful inquiry should be made to determine whether the patients have had previous hypersensitivity reactions to LIZORP, other cephalosporins, penicillins, or other medicine. If REPOCEF is to be given to penicillin-sensitive patients, caution should be exercised because cross-sensitivity among beta-lactam antibiotics has been documented. If an allergic reaction to REPOCEF occurs, discontinue LIZORP. Serious acute hypersensitivity reactions may require emergency treatment measures.
Pseudomembranous colitis can occur.
Paediatric Use: Safety and efficacy in children below the age of 1 year have not been established. Accumulation of other cephalosporin antibiotics in newborn infants (resulting from prolonged medicine half-life in this age group) has been reported.
Evaluation of renal status before and during therapy is recommended, especially in seriously ill patients. In patients with known or suspected renal impairment (see "DOSAGE AND DIRECTIONS FOR USE"), careful clinical observation and appropriate laboratory studies should be done prior to and during therapy. The total daily dose of REPOCEF should be reduced in these patients because high and/or prolonged plasma antibiotic concentrations can occur in such individuals from usual doses. Cephalosporins, including LIZORP, should be given with caution to patients receiving concurrent treatment with potent diuretics since these agents are suspected of adversely affecting renal function.
Prolonged use of REPOCEF 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.
Positive direct Coombs tests have been reported during treatment with cephalosporin antibiotics.
Phenylketonurics: REPOCEF (125 mg/5 ml and 250 mg/5 ml) contains phenylalanine (from aspartame) 8,4 mg per 5 ml reconstituted suspension.
REPOCEF can inhibit vitamin K synthesis by suppressing gut flora. Prophylactic vitamin K therapy is recommended when REPOCEF are used for long periods in malnourished or seriously ill patients. Concomitant administration of REPOCEF and aminoglycoside antibiotics causes nephrotoxicity.
REPOCEF may produce a false positive reaction for glucose in the urine with copper reduction tests (Benedict's or Fehling's solution or with Clinitest tablets), but not with enzyme-based tests (glucose oxidase) for glycosuria. A false negative reaction may occur in the ferricyanide test for blood glucose. The presence of REPOCEF in the blood does not interfere with the assay of plasma or urinecreatinine by the alkaline picrate method.
Safety of use in pregnancy and lactation has not been established.
REPOCEF may cause dizziness which may affect ability to drive or use machinery. These activitiesshould not be performed until the influence of REPOCEF on the individual has been determined.
Frequent: Eosinophilia.
Less frequent: Neutropenia, thrombocytopenia. Prolonged PT/INR has been observed.
Less frequent: Anaphylaxis, fever, serum sickness and pseudomembranous colitis.
Frequency unknown: Angioedema
The following side effects have been reported and frequencies are unknown: Dizziness, hyperactivity, headache, nervousness, insomnia, confusion and somnolence.
Frequent: Nausea, vomiting, diarrhoea and abdominal pain.
Less frequent: Cholestatic jaundice.
The following side effects have been reported and frequencies are unknown: Elevations of AST, ALT, alkaline phosphatase, bilirubin values.
Less frequent: Erythema multiforme, Stevens-Johnson syndrome, superinfection, rash, urticaria.
The following side effects have been reported and frequencies are unknown: Elevations in blood urea and serum creatinine.
Less frequent: General pruritus and vaginitis.
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