SWICH Cefpodoxime Proxetil 200mg Film-Coated Tablet 1's
RXDRUG-DRP-10069-02-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Cefpodoxime is indicated for the treatment of the following infections when caused by susceptible pathogens (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Dosage/Direction for Use
Route of administration: Oral.
The tablets should be taken with food for optimum absorption.
Adults and adolescents with normal renal function: Upper respiratory tract infections: Acute bacterial sinusitis: 200 mg twice daily.
Lower respiratory tract infections: Acute exacerbation of chronic bronchitis: 200 mg twice daily.
Bacterial Pneumonia: 200 mg twice daily.
Elderly: It is not necessary to modify the dose in elderly patients with normal renal function.
Children: Pediatric formulation of cefpodoxime is available for infants and children.
Hepatic Impairment: The dosage does not require modification in cases of hepatic impairment.
Renal Impairment: The dosage of cefpodoxime does not require modification if creatinine clearance exceeds 40 mL/min.
Below this value, pharmacokinetic studies indicate an increase in plasma elimination half-life and the maximum plasma concentrations, and hence the dosage should be adjusted appropriately. See Table 3.
The tablets should be taken with food for optimum absorption.
Adults and adolescents with normal renal function: Upper respiratory tract infections: Acute bacterial sinusitis: 200 mg twice daily.
Lower respiratory tract infections: Acute exacerbation of chronic bronchitis: 200 mg twice daily.
Bacterial Pneumonia: 200 mg twice daily.
Elderly: It is not necessary to modify the dose in elderly patients with normal renal function.
Children: Pediatric formulation of cefpodoxime is available for infants and children.
Hepatic Impairment: The dosage does not require modification in cases of hepatic impairment.
Renal Impairment: The dosage of cefpodoxime does not require modification if creatinine clearance exceeds 40 mL/min.
Below this value, pharmacokinetic studies indicate an increase in plasma elimination half-life and the maximum plasma concentrations, and hence the dosage should be adjusted appropriately. See Table 3.
Overdosage
In the event of overdosage with Cefpodoxime, supportive and symptomatic therapy is indicated. In cases of overdosage, particularly in patients with renal insufficiency, encephalopathy may occur. The encephalopathy is usually reversible once cefpodoxime plasma levels have fallen.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to cefpodoxime, any other cephalosporins or to any of the excipients. Patients with rare hereditary problems of galactose intolerance. the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Special Precautions
Cefpodoxime is not a preferred antibiotic for the treatment of staphylococcal pneumonia and should not be used in the treatment of atypical pneumonia caused by organisms such as Legionella, Mycoplasma and Chlamydia. Cefpodoxime is not recommended for the treatment of pneumonia due to S.pneumoniae (see Pharmacology: Pharmacodynamics under Actions).
As with all beta-lactam antibacterial agents serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with cefpodoxime must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to cefpodoxime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if cefpodoxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents. In cases of severe renal insufficiency it may be necessary to reduce the dosage regimen dependent on the creatinine clearance (see Dosage & Administration). Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all anti-bacterial agents, including cefpodoxime, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of cefpodoxime (see Overdosage). Discontinuation of the therapy with cefpodoxime and the administration of specific treatment for Clostridium difficile should be considered.
Medicinal products that inhibit peristalsis should not be given. Cefpodoxime should always be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis. As with all beta-lactam antibiotics, neutropenia and more rarely agranulocytosis may develop particularly during extended treatment. For cases of treatment lasting longer than 10 days, the blood count should be monitored and treatment discontinued if neutropenia is found. Cephalosporins may be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug. This can produce a positive Coomb's test and very rarely, haemolytic anaemia. Crossreactivity may occur with penicillin for this reaction. Changes in renal function have been observed with cephalosporin antibiotics, particularly when given concurrently with potentially nephrotoxic drugs such as aminoglycosides and/or potential diuretics. In such cases renal function should be monitored. As with other antibiotics, prolonged use of cefpodoxime may result in the overgrowth of non-susceptible organisms (candida and Clostridium difficile), which may require interruption of treatment.
Interactions with Laboratory Tests: A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solution or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions. Patients with rare hereditary problems of galactose malabsorption should not take this medicine. Sunset yellow (E110) may cause allergic reactions.
As with all beta-lactam antibacterial agents serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with cefpodoxime must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to cefpodoxime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if cefpodoxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents. In cases of severe renal insufficiency it may be necessary to reduce the dosage regimen dependent on the creatinine clearance (see Dosage & Administration). Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all anti-bacterial agents, including cefpodoxime, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of cefpodoxime (see Overdosage). Discontinuation of the therapy with cefpodoxime and the administration of specific treatment for Clostridium difficile should be considered.
Medicinal products that inhibit peristalsis should not be given. Cefpodoxime should always be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis. As with all beta-lactam antibiotics, neutropenia and more rarely agranulocytosis may develop particularly during extended treatment. For cases of treatment lasting longer than 10 days, the blood count should be monitored and treatment discontinued if neutropenia is found. Cephalosporins may be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug. This can produce a positive Coomb's test and very rarely, haemolytic anaemia. Crossreactivity may occur with penicillin for this reaction. Changes in renal function have been observed with cephalosporin antibiotics, particularly when given concurrently with potentially nephrotoxic drugs such as aminoglycosides and/or potential diuretics. In such cases renal function should be monitored. As with other antibiotics, prolonged use of cefpodoxime may result in the overgrowth of non-susceptible organisms (candida and Clostridium difficile), which may require interruption of treatment.
Interactions with Laboratory Tests: A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solution or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions. Patients with rare hereditary problems of galactose malabsorption should not take this medicine. Sunset yellow (E110) may cause allergic reactions.
Use In Pregnancy & Lactation
Studies carried out in several animal species have not shown any teratogenic or foetotoxic effects. However, the safety of cefpodoxime proxetil in pregnancy has not been established and, as with all drugs, it should be administered with caution during the early months of pregnancy.
Cefpodoxime is excreted in human milk. Either breastfeeding or treatment of the mother should be stopped.
Cefpodoxime is excreted in human milk. Either breastfeeding or treatment of the mother should be stopped.
Drug Interactions
No clinically significant drug interactions have been reported during the course of clinical studies. Histamine H2 antagonists and antacids reduce the bioavailability of cefpodoxime.
Probenecid reduces the excretion and the contraceptive effect of estrogens.
Oral anticoagulants: Simultaneous administration of cefpodoxime with warfarin may augment its anticoagulant effects. There have been many reports of increase in oral anti-coagulant activity in patients receiving antibacterial agents, including cephalosporins.
Probenecid reduces the excretion and the contraceptive effect of estrogens.
Oral anticoagulants: Simultaneous administration of cefpodoxime with warfarin may augment its anticoagulant effects. There have been many reports of increase in oral anti-coagulant activity in patients receiving antibacterial agents, including cephalosporins.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacotherapeutic Group: Beta-lactam antibacterial, 3rd generation cephalosphorin.
Pharmacology: Pharmacodynamics: Mode of action: Cefpodoxime inhibits bacterial cell wall synthesis following attachment to penicillinbinding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan)biosynthesis, which leads to bacterial cell lysis and death.
PK/PD relationship: For cephalosphorins, the most important pharmacokinetic-pharmacodynamic index correlating with in vivo efficacy has been shown to be the percentage of the dosing interval that the unbound concentration remains above the minimum inhibitory concentration (MIC) of cefpodoxime for the individual target species (i.e. %T>MIC).
Mechanism/s of resistance: Resistance to cephalosphoris results from a variety of mechanism: 1. Alteration of the cell-wall permeability of gram-negative bacteria.
2. Alteration of the penicillin binding proteins (PBPs).
3. ß-lactamase production.
4. Bacterial efflux pumps.
See Table 1.
Pharmacology: Pharmacodynamics: Mode of action: Cefpodoxime inhibits bacterial cell wall synthesis following attachment to penicillinbinding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan)biosynthesis, which leads to bacterial cell lysis and death.
PK/PD relationship: For cephalosphorins, the most important pharmacokinetic-pharmacodynamic index correlating with in vivo efficacy has been shown to be the percentage of the dosing interval that the unbound concentration remains above the minimum inhibitory concentration (MIC) of cefpodoxime for the individual target species (i.e. %T>MIC).
Mechanism/s of resistance: Resistance to cephalosphoris results from a variety of mechanism: 1. Alteration of the cell-wall permeability of gram-negative bacteria.
2. Alteration of the penicillin binding proteins (PBPs).
3. ß-lactamase production.
4. Bacterial efflux pumps.
See Table 1.
Susceptibility: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. See Table 2.
Pharmacokinetics: Cefpodoxime is taken up in the intestine and is hydrolysed to the active metabolite cefpodoxime. When cefpodoxime proxetil is administered orally to fasting subjects as a tablet corresponding to 100 mg of cefpodoxime, 51.5% is absorbed and absorption is increased by food intake. The volume of distribution is 32.3 L and peak levels of cefpodoxime occur 2 to 3 hrs after dosing. The maximum plasma concentration is 1.2 mg/L and 2.5 mg/L after doses of 100 mg and 200 mg respectively. Following administration of 100 mg and 200 mg twice daily over 14.5 days, the plasma pharmacokinetic parameters of cefpodoxime remain unchanged.
Serum protein binding of cefpodoxime, 40% principally to albumin. This binding is non saturable in type.
Concentrations of cefpodoxime in excess of the minimum inhibitory levels (MIC) for common pathogens can be achieved in lung parenchyma, bronchial mucosa, pleural fluid, tonsils, interstitial fluid and prostate tissue.
As the majority of cefpodoxime is eliminated in the urine, the concentration is high (concentrations in 0-4, 4-8, 8-12 hr fractions after a single dose exceed MIC90 of common urinary pathogens). Good diffusion of cefpodoxime is also seen into renal tissue, with concentrations above MIC90 of the common urinary pathogens, 3-12 hrs after an administration of a single 200 mg dose (1.6-3.1 μg/g). Concentrations of cefpodoxime in the medullary and cortical tissues is similar.
Studies in healthy volunteers show median concentrations of cefpodoxime in the total ejaculate 6-12 hrs following administration of a single 200 mg dose to be above the MIC90 of N. gonorrhoeae.
The main route of excretion is renal, 80% is excreted unchanged in the urine, with an elimination half-life of approx. 2.4 hours.
Serum protein binding of cefpodoxime, 40% principally to albumin. This binding is non saturable in type.
Concentrations of cefpodoxime in excess of the minimum inhibitory levels (MIC) for common pathogens can be achieved in lung parenchyma, bronchial mucosa, pleural fluid, tonsils, interstitial fluid and prostate tissue.
As the majority of cefpodoxime is eliminated in the urine, the concentration is high (concentrations in 0-4, 4-8, 8-12 hr fractions after a single dose exceed MIC90 of common urinary pathogens). Good diffusion of cefpodoxime is also seen into renal tissue, with concentrations above MIC90 of the common urinary pathogens, 3-12 hrs after an administration of a single 200 mg dose (1.6-3.1 μg/g). Concentrations of cefpodoxime in the medullary and cortical tissues is similar.
Studies in healthy volunteers show median concentrations of cefpodoxime in the total ejaculate 6-12 hrs following administration of a single 200 mg dose to be above the MIC90 of N. gonorrhoeae.
The main route of excretion is renal, 80% is excreted unchanged in the urine, with an elimination half-life of approx. 2.4 hours.
MedsGo Class
Cephalosporins
Features
Brand
Swich
Full Details
Dosage Strength
200mg
Drug Ingredients
- Cefpodoxime
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Cefpodoxime Proxetil
Dosage Form
Film-Coated Tablet
Registration Number
DRP-10069-02
Drug Classification
Prescription Drug (RX)
Please sign in so that we can notify you about a reply