INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CEROXIM 125 Tablets
CEROXIM 250 Tablets
CEROXIM 500 Tablets

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CEROXIM 125 Tablets
CEROXIM 250 Tablets
CEROXIM 500 Tablets

COMPOSITION:
Ceroxim 125 Tablets
Each tablet contains:
Cefuroxime axetil
equivalent to
cefuroxime: 125 mg
        Sugar 20 mg.

Ceroxim 250 Tablets
Each tablet contains:
Cefuroxime axetil
equivalent to cefuroxime: 250 mg
        Sugar 40 mg.

Ceroxim 500 Tablets
Each tablet contains:
Cefuroxime axetil
equivalent to cefuroxime: 500 mg
        Sugar 80 mg.

PHARMACOLOGICAL CLASSIFICATION
A 20.1.1. Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION
Cefuroxime axetil is an oral prodrug of the bactericidal cephalosporin antibiotic cefuroxime.
The bacterial action of cefuroxime results from inhibition of cell wall synthesis by binding to essential target proteins.
Pharmacokinetics
After oral administration, cefuroxime axetil is absorbed from the gastro-intestinal tract and rapidly hydrolysed in the intestinal mucosa and blood to release cefuroxime into the circulation. Optimum absorption occurs when it is administered after a meal. Peak serum levels (2-3 mg/mL for a 125 mg dose, 4-5 mg/mL for a 250 mg dose, 5-7 mg/mL for a 500 mg dose) occur approximately two to three hours after dosing when taken after food. The serum half-life is between 1 and 1.5 hours. Protein binding has been variously stated as 33-50% depending on the methodology used. Cefuroxime is not metabolised and is excreted by glomerular filtration and tubular secretion.
Concurrent administration of probenecid increases the area under the mean serum concentration time-curve by 50%. Serum levels of cefuroxime are reduced by dialysis.

INDICATIONS
Cefuroxime axetil is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases :
Pharyngitis and tonsillitis caused by Streptococcus pyogenes, (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefuroxime axetil is generally effective in the eradication of streptococci from the oral pharynx. Cefuroxime axetil is not indicated for the prophylaxis of subsequent rheumatic fever because data to support such use is not yet available).
Otitis media caused by Streptococcus pneumoniae. Haemophilus influenzae (ampicillin-susceptible and ampicillin-resistant strains), Moraxella (Branhamella) catarrhalis, and Streptococcus pyogenes.
Sinusitis caused by Streptococcus pneumoniae and H. influenzae.
Acute and chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (ampicillin-susceptible strains), and Haemophilus parainfluenzae (ampicillin-susceptible strains).
Acute uncomplicated cystitis caused by Escherichia coli and Klebsiella pneumoniae.
Lyme disease caused by the spirochaete Borrelia burgdorferi. Ceroxim is indicated for the treatment of early Lyme disease and subsequent prevention of late Lyme disease in adults and children over 12 years old.

CONTRA-INDICATIONS
Patients with known hypersensitivity to cephalosporin antibiotics.
Safety in pregnancy and lactation has not been established.

INTERACTIONS
Probenecid delays the excretion of cefuroxime by decreasing its renal tubular secretion.
Concomitant use of a nephrotoxic medicine such as the aminoglycoside gentamicin may increase the risk of kidney damage with cefuroxime. There may be antagonism between cefuroxime and bacteriostatic antibacterials.

PREGNANCY AND LACTATION
See Contra-indications.

DOSAGE AND DIRECTIONS FOR USE
Adults:
Sinusitis        250 mg twice daily
Acute and chronic bronchitis        250 mg twice daily
Acute uncomplicated cystitis        125 mg twice daily
Lyme disease        500 mg twice daily for 20 days

Children:
Usual dose        125 mg twice daily
For otitis media in children less than 2 years of age the usual dose is 125 mg twice daily and in children over 2 years of age 250 mg twice daily.
For Lyme disease in children over the age of 12 years the usual dose is 500 mg twice daily for 20 days.
There is no experience in children under the age of 3 months.
Because of the bitter taste of cefuroxime axetil, tablets should not be crushed.
The usual course of therapy is seven days (range 5 –10 days).
Note: Cefuroxime axetil should be taken half an hour after food for optimum absorption.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
There have been few reports of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis) and sensitivity reactions including skin rashes, urticaria, pruritis, drug fever, serum sickness and anaphylaxis.
Gastrointestinal disturbances, including diarrhoea, nausea and vomiting may occur. Headache has also been reported. Eosinophilia and transient increase of hepatic enzyme level, alanine aminotransferase (serum glutamic pyruvic acid transaminase), aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and LDH levels have been noted during cefuroxime axetil therapy. A positive Coombs' test has been reported during treatment with cefuroxime axetil - this phenomenon can interfere with cross-matching of blood.
Patients, who experience anaphylactoid reactions to penicillins may experience a similar reaction when cephalosporins (such as cefuroxime) are administered. Should anaphylaxis occur, cefuroxime axetil should be discontinued and the patient treated with the usual agents (adrenaline, corticosteroids and antihistamines).
Neutropenia and thrombocytopenia have been less frequently reported. Nephrotoxicity, hepatitis and cholestatic jaundice have occurred less frequently.
Prolonged use of cefuroxime axetil may result in the overgrowth of non-susceptible organisms (eg. Candida, Enterococci, Clostridium difficile), which may require discontinuation of treatment.
Pseudomembranous colitis has been reported with the use of broad spectrum antibiotics, therefore, it is important to consider its diagnosis in patients who develop serious diarrhoea during or after antibiotic use.
Some patients with syphilis and other spirochaete infections may experience a Jarisch-Herxheimer reaction shortly after starting treatment with cefuroxime. Symptoms include fever, chills, headache, and reactions at the site of lesions. This reaction can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as with optic atrophy.
The Jarisch-Herxheimer reaction has been seen following cefuroxime axetil treatment of Lyme disease. It results directly from the bactericidal activity of cefuroxime axetil on the causative organism of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease.
It is recommended that either glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil. This antibiotic does not interfere in the alkaline picrate assay for creatinine.
Serum levels of cefuroxime are reduced by dialysis.
Should be given with caution to patients with renal impairment and a dosage reduction may be necessary. Renal and haematological status should be monitored especially during prolonged and high dose therapy.
Laboratory value alterations
A positive Coombs' reaction may occur in patients who receive cephalosporins. Cefuroxime axetil may produce false-positive results for glucose with copper reduction tests (Benedict's, Fehling's, or Clinitest tablets). Glucose enzymatic tests, such as Clinistix and Tes-Tape, are not affected.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See “Side effects and Special Precautions”. Treatment is symptomatic and supportive.
Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.

IDENTIFICATION
Ceroxim 125 Tablets:
White coloured, uncoated caplets, engraved with 'RX750' on one side and plain on the other.
Ceroxim 250 Tablets: White coloured, uncoated caplets, engraved with 'RX751' on one side and plain on the other.
Ceroxim 500 Tablets: White coloured, uncoated caplets, engraved with 'RX752' on one side and plain on the other.

PRESENTATION
Ceroxim 125 Tablets:
Carton containing PVC/ Aclar Blister strip of 10 or 5x10 tablets.
Ceroxim 250 Tablets: Carton containing PVC/Aclar Blister strip of 10 or 5x10 tablets.
Ceroxim 500 Tablets: Carton containing PVC/Aclar Blister strip of 10 or 5x10 tablets.

STORAGE INSTRUCTIONS
Store below 25°C, protected from moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS
Ceroxim 125 Tablets:
34/20.1.1/0348
Ceroxim 250 Tablets: 34/20.1.1/0349
Ceroxim 500 Tablets: 34/20.1.1/0350

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
RANBAXY (SA) (PTY) LTD
Third Floor, Outspan House,
1006 Lenchen Avenue North,
Centurion,
Pretoria.

DATE OF PUBLICATION OF THE PACKAGE INSERT
July 2004

Updated on this site: September 2004
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2006