ZEFURIME 250mg (tablets)
ZEFURIME 500mg (tablets)
SCHEDULING STATUS:
S4
PROPRIETARY NAME
(and dosage form):
ZEFURIME 250mg (tablets)
ZEFURIME 500mg (tablets)
COMPOSITION:
ZEFURIME 250mg (tablets):
Each tablet contains Cefuroxime 250mg (as Cefuroxime Axetil).
ZEFURIME 500mg (tablets):
Each tablet contains Cefuroxime 500mg (as Cefuroxime Axetil).
PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.
PHARMACOLOGICAL ACTION:
Cefuroxime is a bactericidal second-generation cephalosporin. The anti-bacterial 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 3hours 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 1,5hours after oral dosing. The elimination half-life is prolonged with renal impairment. Serum levels of cefuroxime are reduced by dialysis.
INDICATIONS:
ZEFURIME 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 AND SPECIAL PRECAUTIONS:
ZEFURIME 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, ZEFURIME 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 ZEFURIME. This medicine may give false-negative test results with ferricyanide blood glucose test. ZEFURIME does not interfere in the alkaline picrate assay for creatinine. A false-positive Coombs reaction may appear in patients who receive large doses of ZEFURIME.
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:
250mg twice daily for seven days (Range 5-10days).
Acute, uncomplicated cystitis:
125mg twice daily for seven days (Range 5-10days).
Lyme disease:
|
• |
Adults and children over 12years of age: 500mg twice daily for 20days. |
|
• |
Children: There is no experience with ZEFURIME in children under 3 months of age. |
|
• |
3 months to 2years of age:125mg twice daily. |
|
• |
Over 2years of age: 250mg twice daily. |
ZEFURIME should be taken half anhour after food for optimum absorption.
SIDE-EFFECTS:
Side-effects:
Heamatological:
Frequent: Eosinophilia.
Neurological:
The following side-effect has been reported and frequency is unknown: Headache.
Gastrointestinal:
Less frequent: Nausea, vomiting, 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).
The following side-effect has been reported and frequency is unknown: Abdominal pain.
Kidney/Genitourinary:
The following side-effect has been reported and frequency is unknown: Vaginal candidiasis.
Liver:
The following side-effect has been reported and frequency is unknown: Transient increases in hepatic enzyme levels.
Skin:
Less frequent: Erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis.
Other:
Frequent: Hypersensitivity reactions including skin rashes, urticaria, pruritus, drug fever, serum sickness, anaphylaxis.
The following side-effect has been reported and frequency is unknown: Bronchospasm.
Special precautions:
Prolonged use of ZEFURIME 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 ZEFURIME.
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 ZEFURIME 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 ZEFURIME can be reduced by haemodialysis or peritoneal dialysis.
IDENTIFICATION:
ZEFURIME 250mg (tablets): White to off-white capsule shaped uncoated tablet with "LUPIN" debossed on one side and "302" on the other side.
ZEFURIME 500mg (tablets): White to off-white capsule shaped uncoated tablet with "LUPIN" debossed on one side and "303" on the other side.
PRESENTATION:
ZEFURIME 250 and 500mg are packed in blister packs, inside an outer carton, in pack sizes of 10 and 60.
STORAGE INSTRUCTIONS:
Store below 25ºC.
KEEP OUT OF THE REACH OF CHILDREN.
REGISTRATION NUMBER:
ZEFURIME 250mg (tablets): 41/20.1.1/0721
ZEFURIME 500mg (tablets): 41/20.1.1/0722
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148
DATE OF PUBLICATION OF THE PACKAGE INSERT:
23 January 2007
212693Ro
New addition to this site: March 2010
Source: Pharmaceutical Industry |
