Alkem Lab


Getz Bros
Full Prescribing Info
Cefpodoxime proxetil.
Each film coated tablet contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 200 mg.
Pharmacology: Pharmacodynamics: 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.
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, rhe 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 around 2.4 mL/min/kg. About 81% of unchange Cefpodoxime is excreted in the urine.
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. mills, 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.
In Adults: Cefpodoxime proxetil is 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 and acute sinusitis.
Dosage/Direction for Use
In Adults: The dosage of Cefpodoxime proxetil 200 mg tablet depends on the condition being treated and may be increased or decreased accordingly.
Tonsillitis, pharyngitis and acute bronchitis: One Cefpodoxime proxetil 100 mg tablet 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.
One Cefpodoxime proxetil 200 mg tablet or two Cefpodoxime proxetil 100 mg tablet every 12 hours with meals.
Elderly patients where renal function is normal, it is not necessary to adjust the dose.
Overdosage with Cefpodoxime Proxetil may manifest in any of the symptoms described under Adverse Effects and 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.
Cefpodoxime Proxetil is contraindicated 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.
Before initiating therapy with cephalosporins, careful enquiry should be made concerning previous hypersensitivity reactions to penicillin and other beta-lactam antibiotics.
Cephalosporins 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.
Special 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 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.
Use in Children: 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.
Use in Elderly: 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 & Administration).
Use In Pregnancy & Lactation
See Contraindications.
Adverse Reactions
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.
Store at temperatures not exceeding 30°C.
Store in a dry place and protect from light.
MIMS Class
ATC Classification
J01DD13 - cefpodoxime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
FC tab 200 mg x 10's, 50's.
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