CEROXIM Tablet, Suspension Ref.[50620] Active ingredients: Cefuroxime

Ceroxim should be used with caution in patients with:

• a history of gastro-intestinal disease, especially ulcerative colitis, regional enteritis or pseudomembranous colitis.
• renal function impairment – A reduced dose may be required.
• porphyria, as safety has not been established.

Pseudomembranous colitis may occur. Patients who develop abdominal or stomach cramps, abdominal tenderness, severe and watery diarrhoea (which may be bloody) and fever should be investigated for this diagnosis. If the diagnosis of pseudomembranous colitis is suspected, Ceroxim should be stopped immediately and appropriate therapy initiated.

Patients who experience anaphylactoid reactions to penicillins may experience a similar reaction to cephalosporins (such as Ceroxim). Should anaphylaxis occur, Ceroxim should be discontinued and the patient treated with the appropriate medicines.

Use of Ceroxim may result in the overgrowth of candida. Prolonged use may also cause overgrowth of other non-susceptible organisms (e.g. Enterococci or Clostridium difficile), which may require discontinuation of treatment.

The Jarisch-Herxheimer reaction has been reported following treatment with Ceroxim for Lyme disease. This reaction is a common and usually self-limiting consequence of antibiotic treatment for Lyme disease.

Ceroxim Suspension contains 2,8 g of sucrose per 5 ml and Ceroxim Forte Suspension contains 2,5 g of sucrose per 5 ml. The sucrose content of Ceroxim should be taken into account when treating diabetic patients. Appropriate advice should be provided. Patients with rare hereditary problems of fructose intolerance or sucrase isomaltase insufficiency should not take Ceroxim.

Ceroxim and Ceroxim Forte suspensions contain aspartame, which is a source of phenylalanine and should be used with caution in patients with phenylketonuria.

Ceroxim and Ceroxim Forte suspensions contain mannitol which may have a mild laxative effect.

Concurrent administration of probenecid increases the area under the mean serum concentration time-curve by 50%.

Concomitant use of Ceroxim and furosemide should be avoided when possible, due to enhanced nephrotoxicity.

The combined use of cephalosporins and aminoglycosides should be undertaken with caution, due to nephrotoxicity.

The efficacy of combined oral contraceptives may be decreased by concomitant use with Ceroxim.

Interactions with Laboratory Tests

It is recommended that either glucose oxidase or hexokinase methods be used to determine blood/plasma glucose levels in patients receiving Ceroxim. Ceroxim may give false-negative test results with ferricyanide blood glucose test. Ceroxim does not interfere in the alkaline picrate assay for creatinine. A false-positive Coombs reaction may appear in patients who receive large doses of Ceroxim (see WARNINGS AND SPECIAL PRECAUTIONS).

Safety and efficacy in pregnancy and lactation have not been established.

As Ceroxim may cause dizziness, patients should be warned to be cautious when driving or operating machinery.

Infections and infestations

Frequent: Candida overgrowth, oral thrush, vaginitis.

Blood and lymphatic system disorders

Frequent: Eosinophilia.

Less frequent: Thrombocytopenia, leucopenia, haemolytic anaemia, neutropenia.

Immune system disorders

Less frequent: Hypersensitivity reactions including skin rashes, urticaria, pruritus, cutaneous vasculitis, bronchospasm, drug fever, serum sickness and anaphylaxis.

Nervous system disorders

Frequency unknown: Headache, convulsions.

Gastro-intestinal disorders

Frequent: Nausea, diarrhoea, abdominal pain.

Less frequent: A particular form of enterocolitis (pseudomembranous colitis) (see WARNINGS AND SPECIAL PRECAUTIONS).

Frequency unknown: Vomiting, diarrhoea accompanied by blood in the stools which may be a symptom of enterocolitis.

Ear and labyrinth disorders

Less frequent: Hearing loss in children with meningitis.

Hepato-biliary disorders

Frequency unknown: Transient increases in hepatic enzyme levels, alanine aminotransferase (serum glutamic pyruvic acid transaminase), aspartate aminotransferase (serum glutamic oxaloacetic transaminase), LDH (lactate dehydrogenase) levels, cholestatic jaundice, hepatitis, rise in bilirubin.

Skin and subcutaneous tissue disorders

Less frequent: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, porphyria.

Renal and urinary disorders

Less frequent: Acute interstitial nephritis, nephrotoxicity when Ceroxim is used in combination with aminoglycosides or furosemide.

Reproductive system and breast disorders

Frequency unknown: Vaginal candidiasis.

Investigations

Positive antiglobulin (Coombs') test.