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

Logo CEPODEM

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CEPODEM

CEPODEM 100 Tablets
CEPODEM 200 Tablets
CEPODEM Suspension 40 mg/5 mL (Powder for Oral Suspension)

COMPOSITION
Cepodem 100 Tablets
Each film coated tablet contains:
Cefpodoxime proxetil
equivalent to
cefpodoxime         100 mg
Sugar free.

Cepodem 200 Tablets
Each tablet contains:
Cefpodoxime proxetil
equivalent to cefpodoxime        200 mg
Sugar free.

Cepodem Suspension 40 mg/5 mL
Each 5 mL of the constituted suspension contains:
Cefpodoxime proxetil
equivalent to cefpodoxime        40 mg
Sodium benzoate        0,2% m/v
(as preservative)
Sugar        2,7 g

PHARMACOLOGICAL CLASSIFICATION
A. 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION
Mechanism of action
Cefpodoxime proxetil is a semi-synthetic beta-lactam antibiotic belonging to the third generation oral cephalosporin group. Cefpodoxime proxetil is the prodrug of the bactericidal antibiotic cefpodoxime.
The antibacterial action of cefpodoxime is through inhibition of bacterial cell wall synthesis probably by acylation of membrane bound transpeptidase enzymes; this prevents cross linkage of peptidoglycan chains, which is necessary for bacterial cell wall strength and rigidity.
Antibacterial spectrum
In vitro studies have demonstrated the
susceptibility of most strains of the following micro-organisms to cefpodoxime proxetil. However, such in vitro activity does not necessarily imply in vivo efficacy.
Gram-positive organisms
Streptococcus pneumoniae, S. pyogenes, S. agalactiae, S. mitis, S. sanguis and S. salivarius; Propionibacterium acnes; Corynebacterium diphtheriae; methicillin-sensitive penicillinase and non-penicillinase producing strains of S. aureus.
Gram negative organisms
Beta-lactamase and non-beta-lactamase producing strains of Haemophilus influenzae, Haemophilus para-influenzae, Moraxella catarrhalis (Branhamella catarrhalis) and Neisseria gonorrhoea; Escherichia coli; Klebsiella pneumoniae; Klebsiella oxytoca; Proteus mirabilis.
The following organisms are not sensitive: Group D streptococci, Methicillin-resistant staphylococci (S. aureus and S. epidermidis), Staphylococcus saprophyticus, Corynebacteria, groups J and K, Listeria monocytogenes, Pseudomonas aeruginosa and Pseudomonas spp., Acinetobacter baumanii, Clostridium difficile, Bacteroides fragilis and related species.

Pharmacokinetics
Cefpodoxime proxetil is absorbed orally and rapidly hydrolysed by non-specific esterases in the gastro-intestinal wall to cefpodoxime, the active acid. Absorption is decreased in conditions of low gastric acidity. After oral administration of a single dose of 200 mg of cefpodoxime, the maximum plasma concentration (Cmax) obtained is 2,23 mg/L. After oral administration of a single 5 mg/kg (200 mg maximum) dose of cefpodoxime proxetil suspension in children, the maximum plasma concentration (Cmax) obtained is on average 2,6 mg/L. With cefpodoxime proxetil tablets the time taken to reach the maximum concentration (Tmax) is about 2,7 hours. With the suspension the time taken to reach the maximum concentration (Tmax) is about 2 to 4 hours. The drug diffuses well into respiratory tissues. The serum half-life is about 2,46 hours. About 27% of cefpodoxime in the plasma is bound to plasma proteins. The volume of distribution is about 0,46 L/kg and the clearance is around 2,4 mL/min/kg. About 81% of unchanged cefpodoxime is excreted in the urine.

INDICATIONS
In Adults
Cepodem 100 Tablets
and Cepodem 200 Tablets are indicated for use in the short-term treatment of upper and lower respiratory tract infections due to susceptible micro-organisms:
Acute bronchitis and acute exacerbations of chronic bronchitis
Pharyngitis and tonsillitis
Community-acquired bronchopneumonia
Acute sinusitis.
In Children
Cepodem Suspension 40 mg/5 mL
is indicated for use in the short-term treatment of infections due to susceptible micro-organisms:
Upper and lower respiratory tract infections
Otitis media
Tonsillitis and pharyngitis
Pneumonia

CONTRA-INDICATIONS
Cefpodoxime proxetil is contra-indicated in patients who are allergic to the cephalosporin group of antibiotics. Safety of cefpodoxime proxetil for use in pregnancy and lactation has not been established.

WARNINGS
Before initiating therapy with cephalosporins, careful enquiry should be made concerning previous hypersensitivity reactions to penicillin and other beta-lactam antibiotics.
Cephalosporin cross reactivity has been observed in patients with a documented history of beta-lactam allergy. Extreme caution and strict medical supervision is recommended when cephalosporins are administered to patients with a history of beta-lactam anaphylaxis since serious occasionally fatal anaphylaxis may also occur after cephalosporin administration. If an allergic reaction occurs, treatment should be stopped immediately.

PREGNANCY AND LACTATION
See
Contra-indications.

DOSAGE AND DIRECTIONS FOR USE
In Adults
The dosage of Cepodem 100 Tablets and Cepodem 200 Tablets depends on the condition being treated and may be increased or decreased accordingly.
Tonsillitis, pharyngitis and acute bronchitis
One Cepodem 100 Tablet every 12 hours with meals (200 mg/day).
In the treatment of beta-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days.
Acute sinusitis, acute exacerbations of chronic bronchitis, pneumonia
OneCepodem 200 Tablet or twoCepodem 100 Tablets every 12 hours with meals (400 mg/day).

Elderly patients
Where renal function is normal, it is not necessary to adjust the dose.
Renal Insufficiency
For values below 40 mL/min, the daily dosage regimen should be reduced by half and administered as a single daily dose for values 10-39 mL/min, every second day for values below 10 mL/min, and after each dialysis session for haemodialysis patients.
In Children:
The constituted product contains cefpodoxime 8 mg/mL.
An average dose of 8 mg/kg/day may be administered in two equally divided doses at 12 hourly intervals without regard to food.
Cepodem Suspension 40 mg/5 mL is currently not indicated for use in children under one year of age.
Directions for reconstitution of the Suspension: Shake the bottle to loosen the granules. Add 33 mL and 66 mL water for 50 mL and 100 mL packs respectively in two divided portions to the dry mixture in the bottle. Shake well after each addition.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects
The following side-effects have been reported with the use of cefpodoxime proxetil.
Gastro-intestinal: Diarrhoea, nausea, vomiting and abdominal pains.
Central nervous system: Headache, dizziness, tinnitus, paresthesia, asthenia.
Hypersensitivity: Cutaneous eruptions and pruritus, urticaria and purpura and bullous erruptions. Anaphylactic reactions e.g. angioedoema, bronchospasm, malaise, possibly culminating in shock may rarely occur (see Warnings).
Haematological: Reduction of haemoglobin, thrombocytosis, thrombocytopenia, leucopenia and eosinophilia. Neutropenia and agranulocytosis may occur during treatment with cefpodoxime particularly if given over long periods.
Laboratory tests alterations: Elevations of AST, ALT and alkaline phosphatase, increase of blood urea and creatinine.
Precautions
Prolonged use may result in overgrowth of non-susceptible organisms and, as with other broad spectrum antibiotics, pseudomembranous colitis may develop. It is important to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Such colitis may range in severity from mild to life threatening. Treatment should be discontinued if symptoms suggestive of psuedomembranous colitis arise. Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. When the colitis does not improve after the drug has been discontinued, or when it is severe, oral vancomycin is the medicine of choice for antibiotic associated pseudomembranous colitis produced by C. difficile.
Cephalosporins should be given with caution to patients with renal impairment.
There may be a positive response to the Coombs’test during treatment with cephalosporins.
Paediatrics: No paediatrics-specific problems have been documented with the use of cefpodoxime proxetil to date. The safety and efficacy of cefpodoxime proxetil have not been established in children under one year of age.
Geriatrics: Cefpodoxime proxetil may be used at the normal recommended dosage in elderly patients even with mild to moderate renal impairment; however, appropriate modification in dosage is advised in patients with severe renal impairment (See Dosage and directions for use).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage with cefpodoxime proxetil may manifest in any of the symptoms described under Side-effects and special precautions. There is no specific antidote for cefpodoxime proxetil. Gastric lavage and other appropriate supportive treatment should be employed. Convulsions and other signs of CNS toxicity have been associated with high doses, especially in patients with severe renal impairment. Treatment is symptomatic and supportive.

IDENTIFICATION
Cepodem 100 Tablets
: White coloured, capsule shaped, film coated tablets imprinted with `RX520' on one side in black edible ink.
Cepodem 200 Tablets: White coloured, capsule shaped, film coated tablets imprinted with `RX521' on one side in black edible ink.
Cepodem Suspension 40 mg/5 mL: Off-white to yellow granular powder forming an off-white to yellow suspension on constitution with water. The resulting suspension has a characteristic fruity flavour.

PRESENTATION
Cepodem 100 Tablets
: Aluminium strip pack of 10 tablets.
Cepodem 200 Tablets: Aluminium strip pack of 10 tablets.
Cepodem Suspension 40 mg/5 mL: Natural translucent HDPE bottle pack of 50 mL and 100 mL.

STORAGE INSTRUCTIONS
Store below 25°C, protected from light and moisture.
After constitution of the suspension, the pack must be stored at 2-8°C in a refrigerator. The constituted suspension should be consumed within 10 days of preparation. Discard any unused portion of the constituted suspension after 10 days. Shake well before dosing.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS
Cepodem 100 Tablets
: 36/20.1.1/0225
Cepodem 200 Tablets: 36/20.1.1/0226
Cepodem Suspension 40 mg/5 mL: 36/20.1.1/0227

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.

DATE OF PUBLICATION OF THE PACKAGE INSERT
December 2003

New addition to this site: March 2004
Source: Pharmaceutical Industry

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