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

Logo CEFASYN Film-coated tablets

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

CEFASYN Film-coated tablets

CEFASYN 250 Film-coated tablets
CEFASYN 500 Film-coated tablets


COMPOSITION
Active ingredient
:
CEFASYN 250: Each film-coated tablet contains cefuroxime axetil equivalent to 250 mg
cefuroxime.
CEFASYN 500: Each film-coated tablet contains cefuroxime axetil equivalent to 500 mg cefuroxime.
Inactive ingredients:
Calcium carbonate, calcium stearate, colloidal silicon dioxide, croscarmellose sodium, crospovidone, hydroxy propyl methyl cellulose, microcrystalline cellulose, propylene glycol, sodium lauryl sulphate and titanium dioxide.

PHARMACOLOGICAL CLASSIFICATION
A 20.1.1 Broad and medium spectrum antibiotics

PHARMACOLOGICAL ACTION
Pharmacodynamic Properties:
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.
The following organisms show resistance to cefuroxime: Listeria monocytogenes, certain strains of enterococci, e.g. Enterococcus faecalis, methicillin-resistant staphylococci, Pseudomonas spp., Campylobacter spp., Acinebacter calcoaceticus, Legionella spp., most strains of Serratia spp., Proteus vulgaris, some strains of Morganella morganii, Enterobacter cloacae, Citrobacter spp., Clostridium difficile and most strains of Bacteroides fragilis.
Pharmacokinetic Properties:
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
CEFASYN
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 (penicillin is the usual medicine of choice in the treatment and prevention of streptococcal infections, including prophylaxis of rheumatic fever. CEFASYN is not indicated for the prophylaxis of subsequent rheumatic fever because data to support such use are not available).
Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (ampicillin-sensitive and ampicillin-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 in adults and children over 12 years old.  

CONTRAINDICATIONS
Hypersensitivity to cephalosporin antibiotics or to any components of CEFASYN.
Hypersensitivity to penicillin and other beta-lactam antibiotics.

WARNINGS AND SPECIAL PRECAUTIONS
CEFASYN
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, CEFASYN should be stopped immediately and appropriate therapy initiated.
Cross sensitivity between penicillins and cephalosporins exists.
Special Precautions:
Prolonged use of CEFASYN may result in the overgrowth of non-susceptible organisms (e.g. Candida, Enterococci or Clostridium difficile), which may require discontinuation of treatment.
Pseudomembranous colitis has been reported with the use of CEFASYN.
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 CEFASYN for Lyme disease. This reaction is a common and usually self-limiting consequence of antibiotic treatment for Lyme disease.

Effects on ability to drive and use machines:
As CEFASYN causes dizziness, patients should be warned to be cautious when driving or operating machinery.

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 CEFASYN.
CEFASYN may give false-negative test results with ferricyanide blood glucose test.
CEFASYN does not interfere in the alkaline picrate assay for creatinine.
A false-positive Coombs (antiglobulin) test reaction may appear in patients who receive large doses of CEFASYN.
CEFASYN may affect gut flora, leading to reduced oestrogen re-absorption and reduced efficacy of combined oral contraceptives.

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

DOSAGE AND DIRECTIONS FOR USE
Sinusitis and acute or chronic bronchitis
:
250 mg twice daily for seven days (range 5 - 10 days).
Acute, uncomplicated cystitis:
125 mg (use half of 250 mg tablet) 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.

CEFASYN should be taken half an hour after food for optimum absorption.
Because of the bitter taste of cefuroxime axetil, CEFASYN tablets should not be crushed.

SIDE-EFFECTS
Blood and lymphatic system disorders:
Frequent:        Eosinophilia.
Less frequent:         Positive Coombs (antiglobulin) test, thrombocytopenia, leukopenia and haemolytic anaemia.
Immune system disorders:
Less frequent:         Hypersensitivity reactions including skin rashes, urticaria, pruritus, bronchospasm, drug fever, serum sickness, and anaphylaxis.
Nervous system disorders:
Frequent:         Headache, dizziness.
Gastrointestinal disorders:
Frequent:         Gastrointestinal disturbances including: nausea, abdominal pain, diarrhoea, in some cases accompanied by blood in stools, which may be a symptom of enterocolitis.
Less frequent: Vomiting, pseudomembranous colitis (see "WARNINGS and SPECIAL PRECAUTIONS").
Hepatobiliary disorders:
Frequent:         Transient increases in hepatic enzyme levels (ALT, AST, LDH).
Less frequent:         Jaundice (predominantly cholestatic hepatitis).
Skin and subcutaneous tissue disorders:
Less frequent:         Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Renal and urinary disorders:
The following has been reported but the frequency is unknown:         Vaginal candidiasis.

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

IDENTIFICATION
CEFASYN 250: White to off-white, capsule shaped, biconvex, film-coated tablet with break line on one side and plain on the other side with dimensions of 8,1 x 15,1 mm.
CEFASYN 500: White to off-white, capsule shaped, biconvex, film-coated tablet with break line on one side and plain on the other side with dimensions of 9,2 x 19,2 mm.

PRESENTATION
One silver aluminium / aluminium blister strip of 10 tablets, placed in an outer carton.

STORAGE INSTRUCTIONS
Store at or below 25°C.
Keep the blister in the outer carton until required for use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS
CEFASYN 250
: 45/20.1.1/0216
CEFASYN 500: 45/20.1.1/0217

NAME AND BUSINESS ADDRESS OF THE HOLDER OF CERTIFICATE OF REGISTRATION
Alkem Laboratories (Pty) Ltd.
Route 21 Corporate Park,
Ground Floor, 33 Sovereign Drive
Irene Ext. 31, Centurion 0157

DATE OF PUBLICATION OF PACKAGE INSERT
Date of clinical approval
:        16 July 2012
Date of registration:         27 July 2012

PT 2548

New addition to this site: January 2017
Source: Pharmaceutical Industry
http://www.cipla.co.za/wp-content/uploads/2014/05/Cefasyn-Tablets-PI.pdf

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