INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
CEFU-HEXAL™ 250 mg film-coated tablets
CEFU-HEXAL™ 500 mg film-coated tablets

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CEFU-HEXAL™ 250 mg film-coated tablets
CEFU-HEXAL™ 500 mg film-coated tablets

COMPOSITION
CEFU-HEXAL 250 mg film-coated tablets:
Each tablet contains cefuroxime 250 mg (as cefuroxime axetil).
CEFU-HEXAL 500 mg film-coated tablets:
Each tablet contains cefuroxime 500 mg (as cefuroxime axetil).

PHARMACOLOGICAL CLASSIFICATION
A 20.1.1 Broad and medium spectrum antibiotics

PHARMACOLOGICAL ACTION
Cefuroxime is a bactericidal second-generation cephalosporin. The antibacterial action of cefuroxime results from inhibition of bacterial cell wall synthesis by binding to essential target proteins in bacterial cytoplasmic membranes. Cefuroxime has bactericidal activity against a wide range of bacterial organisms, including beta-lactamase producing strains.
Pharmacokinetics:
Cefuroxime axetil is an oral prodrug of cefuroxime. After oral absorption, cefuroxime axetil is hydrolysed in the intestinal mucosa and blood to release cefuroxime into the plasma. Oral absorption is optimal when administered with food. Peak serum levels of cefuroxime occur approximately 2 to 3 hours after oral dosing, when taken with food. Protein binding is approximately 33% to 50%. Cefuroxime is not metabolised and is excreted unchanged in the urine by glomerular filtration and tubular secretion. The elimination half-life is between 1 and 1,5 hours after oral dosing. The elimination half-life is prolonged with renal impairment. Serum levels of cefuroxime are reduced by dialysis.

INDICATIONS
CEFU-HEXAL is indicated for the treatment of infections caused by susceptible strains of the following organisms in the following infections:

•	Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
•	Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (ampicillin- sensitive and resistant strains), Moraxella (Branhamella) catarrhalis and Streptococcus pyogenes.
•	Sinusitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
•	Acute and chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae(ampicillin-sensitive strains) and Haemophilus parainfluenzae (ampicillin-sensitive strains).
•	Acute uncomplicated cystitis caused by Escherichia coli and Klebsiella pneumoniae.
•	Lyme disease caused by Borrelia burgdorferi.

CONTRA-INDICATIONS
Hypersensitivity to cephalosporin antibiotics or to any components of the formulation. Hypersensitivity to penicillin and other beta-lactam antibiotics.

WARNINGS
CEFU-HEXAL should be used with caution in patients with;

•	A history of gastrointestinal disease, especially ulcerative colitis, regional enteritis or pseudomembranous colitis.
•	Renal function impairment - A reduced dose may be required.
•	Porphyria: 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, CEFU-HEXAL should be stopped immediately and appropriate therapy initiated.

INTERACTIONS
Concurrent administration of probenecid increases the area under the mean serum concentration time-curve by 50%.
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 CEFU-HEXAL.
This medicine may give false-negative test results with ferricyanide blood glucose test. CEFU-HEXAL does not interfere in the alkaline picrate assay for creatinine.
A false-positive Coombs reaction may appear in patients who receive large doses of CEFU-HEXAL.

PREGNANCY AND LACTATION
Safety and efficacy in pregnancy and lactation have not been established.

DOSAGE AND DIRECTIONS FOR USE
Adults:
Sinusitis & acute or chronic bronchitis:
250 mg twice daily for seven days (Range 5-10 days)
Acute - uncomplicated cystitis:
125 mg twice daily for seven days (Range 5-10 days)
Lyme disease:
Adults and children over 12 years of age: 500 mg twice daily for 20 days
Children:
There is no experience with CEFU-HEXAL in children under 3 months of age.

•	3 months to 2 years of age: 125 mg twice daily
•	Over 2 years of age: 250 mg twice daily

CEFU-HEXAL should be taken half an hour after food for optimum absorption.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side effects:
Haematological:

•	Eosinophilia

Neurological:
• Headache
Gastrointestinal:
• Nausea, vomiting, abdominal pain, diarrhoea, in some cases accompanied by blood in stools, which may be a symptom of enterocolitis. A particular form of enterocolitis is pseudomembranous colitis (see WARNINGS).
Kidney/Genitourinary:
• Vaginal candidiasis
Liver:
• Transient increases in hepatic enzyme levels
Skin:
• Erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis
Other:

•	Hypersensitivity reactions including skin rashes, urticaria, pruritus, bronchospasm, drug fever, serum sickness, anaphylaxis

Special precautions:
Prolonged use of CEFU-HEXAL may result in the overgrowth of non-susceptible organisms (e.g. Candida, Enterococci or Clostridium difficile).
Pseudomembranous colitis has been reported with the use of CEFU-HEXAL. 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.
The Jarisch-Herxheimer reaction has been reported following treatment with CEFU-HEXAL for Lyme disease. This reaction is a common and usually self-limiting consequence of antibiotic treatment for Lyme disease.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
(See SIDE EFFECTS AND SPECIAL PRECAUTIONS)
Symptoms of overdose:
Seizures have been reported.
Treatment of overdose:
Treatment is symptomatic and supportive. Serum levels of CEFU-HEXAL can be reduced by haemodialysis or peritoneal dialysis.

IDENTIFICATION
CEFU-HEXAL tablets 250 mg: White, round film-coated tablets

	Diameter:
	11,2mm + 0,3mm (10,9mm –11,5mm)
	Height:
	5,9mm + 0,3mm (5.6mm –6.2mm)

CEFU-HEXAL tablets 500 mg: White, oblong film-coated tablets

	Length:
	20,5mm + 0,2mm (20,3mm –20,7mm)
	Height:
	8,5mm ± 0,4mm (8,1mm –8,9mm)
	Width:
	9,8mm + 0,2mm (9,6mm –10mm)

PRESENTATION

CEFU-HEXAL tablets 250 mg:	PVC/PVDC/Aluminium blister strips containing 10 tablets each.
CEFU-HEXAL tablets 500 mg:	PVC/PVDC/Aluminium blister strips containing 10 tablets each.

STORAGE
Do not store above 25°C. Store in an airtight container, protected from light.
Do not remove blisters from carton until required for use.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBERS
CEFU-HEXAL 250 mg film coated tablets: A38/20.1.1/0694
CEFU-HEXAL 500 mg film coated tablets: A38/20.1.1/0695

NAME AND BUSINESS ADDRESS OF APPLICANT
HEXAL Pharma (SA) Pty LTD
46 Mahogany Road
Mahogany Ridge
Pinetown
3610

DATE OF PUBLICATION OF PACKAGE INSERT
July 2005

New addition to this site: September 2005
Source: Pharmaceutical Industry
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