Source: Health Products Regulatory Authority (ZA) Publisher: sanofi-aventis south africa (pty) ltd., 2 Bond Street, Midrand, 1685, South Africa
Preliminary enquiry as to an allergic diathesis and particularly hypersensitivity of betalactam antibiotics should precede treatment with ORELOX.
The use of ORELOX is strictly contraindicated in subjects with a previous history of immediate type hypersensitivity to cephalosporins.
ORELOX should be used with extreme caution in patients sensitive to penicillin and other β-lactam antibiotics as cross-allergy may develop. Strict medical supervision is required throughout the treatment.
Hypersensitivity reactions (anaphylaxis) observed with ORELOX can be serious and occasionally fatal. Treatment should be stopped immediately, should an allergic reaction occur.
Diarrhoea, particularly if severe and/or persistent, occurring during treatment or in the initial weeks following treatment with ORELOX, may be symptomatic of Clostridium difficile-associated disease, the most severe form of which is pseudomembranous colitis. The diagnosis of this possibly fatal condition is confirmed by endoscopy and/or histology. Screening of faeces for this pathogen, and its cytotoxin is the best way to diagnose Clostridium difficile associated disease.
If a diagnosis of pseudomembranous colitis is suspected, ORELOX should be stopped immediately and appropriate specific therapy should be started without delay (e.g. vancomycin or metronidazole).
Clostridium difficile-associated disease can be favoured by faecal stasis.
Use with care in patients with renal impairment. Changes in renal function have been observed with antibiotics of the same class as ORELOX, particularly when given concurrently with potentially nephrotoxic agents such as aminoglycosides and/or potent diuretics. In such cases, renal function should be monitored.
ORELOX may be absorbed onto the surface of red cell membranes and react with antibiotics directed against the medicine. This can produce a positive antiglobulin test and haemolytic anaemia. Cross-reactivity may occur with penicillin for this reaction.
The use of ORELOX, especially if prolonged, may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken (see SIDE EFFECTS: Infections and Infestations).
ORELOX JUNIOR must not be given to children with phenylketonuria, since the formulation contains aspartame (20 mg/5ml) (see CONTRAINDICATIONS).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take ORELOX 100 or ORELOX 200, as the tablets contain lactose.
Patients with rare hereditary problems of galactose intolerance, fructose intolerance e.g. galactosemia, the Lapp lactase deficiency, glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take ORELOX JUNIOR, as it contains lactose and sucrose.
The bioavailability of ORELOX is increased if the product is administered during meals (acid pH).
Histamine H2 antagonists (such as ranitidine) and antacids reduce the bioavailability of ORELOX.
Probenecid reduces the excretion of ORELOX. ORELOX potentially enhances the anticoagulant effect of warfarin and reduces the contraceptive effect of oestrogens. Cases showing development of a positive Coombs' test have been reported (see WARNINGS and SPECIAL PRECAUTIONS).
A false positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solution or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions.
Safety of ORELOX in pregnant women has not been established, it is therefore advisable not to administer ORELOX during pregnancy (see CONTRAINDICATIONS). Since ORELOX is excreted in human breast milk, either breastfeeding or treatment of the mother should be discontinued in mothers who are breastfeeding their infants.
Dizzy sensations may occur, which should be taken into account when driving a vehicle or operating machinery.
The following side effects have been reported:
Less frequent: reduction of haemoglobin, thrombocytosis, thrombocytopenia, leucopenia, haemolytic anaemia and eosinophilia. Neutropenia and agranulocytosis may occur during treatment with ORELOX.
Less frequent: anaphylactic reactions: e.g. angioedema, bronchospasm, malaise, possibly culminating in shock may occur (see WARNINGS and SPECIAL PRECAUTIONS)
Less frequent: headache, dizzy sensations, paraesthesia
Less frequent: tinnitus
Frequent: diarrhoea, nausea, vomiting, abdominal pains
Less frequent: diarrhoea may sometimes be a symptom of enterocolitis, which may, in some cases, be accompanied by blood in stools. A particular form of enterocolitis than can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium difficile) (see WARNINGS and SPECIAL PRECAUTIONS)
Less frequent: increases in liver enzymes (AST, ALT and alkaline phosphatase), and/or bilirubin
These laboratory abnormalities exceed twice the upper limit of the normal range and elicit a pattern of drug induced hepatitis, usually cholestatic
Less frequent: cutaneous eruptions, rash, pruritus, urticaria and purpura. Cases of bullous eruptions (erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis) have been reported
Less frequent: increase of blood urea and creatinine.
Changes in renal function have been observed with antibiotics from the same group as ORELOX, particularly when co-prescribed with aminoglycosides and/or potent diuretics (see WARNINGS and SPECIAL PRECAUTIONS)
Less frequent: asthenia
Frequent: superinfections, overgrowth of non-susceptible organisms (see WARNINGS and SPECIAL PRECAUTIONS)
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