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Tablet: Red color, elongated, biconvex, film coated tablets having break line on one side and plain on other side.
Each film coated tablet contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 200 mg.
Suspension: White to off-white granular powder filled in HDPE bottle. After reconstitution with water: off-white color suspension is produced.
Each 5 mL (after reconstitution) suspension contains: Cefpodoxime proxetil USP eq. to Cefpodoxime 100 mg.

Pharmacotherapeutic Group: Beta-lactam antibacterial, 3rd generation cephalosphorin.
Pharmacology: Pharmacodynamics: Tablet: Mode of action: Cefpodoxime inhibits bacterial cell wall synthesis following attachment to penicillin binding 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 cephalosporins 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. β-lactamase production.
4. Bacterial efflux pumps.
See Table 1.

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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.)

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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.
Tablet: 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.
Suspension: Concentration of cefpodoxime is excess of the minimum inhibitory levels (MIC) for common pathogens can be achieved.

Tablet: Cefpodoxime is indicated for the treatment of the following infections when caused by susceptible pathogens (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Suspension: Used in the treatment of susceptible infections including gonorrhoea, otitis media, pharyngitis, lower respiratory tract infections, such as bronchitis, and urinary tract infections.

Tablet: 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.)

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Suspension: Infants and Pediatric Patients (age 2 months through 12 years): See Table 4.

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Adults: Adults with normal renal functions: Upper respiratory tract infections: For upper respiratory tract caused by organisms sensitive to Cefpodoxime, including sinusitis. In tonsillitis and pharyngitis, Cefpodoxime should be reserved for recurrent or chronic infections, or for infections where the causative organism is known or suspected to be resistant to commonly used antibiotics. Sinusitis: 200 mg twice daily. Other upper respiratory tract infections: 100 mg twice daily. Lower respiratory tract infections: For lower respiratory tract infections caused by organisms sensitive to Cefpodoxime, including acute bronchitis, relapses or exacerbations of chronic bronchitis and bacterial pneumonia: 100-200 mg twice daily, dependent on the severity of the infection.
Urinary tract infections: Uncomplicated lower urinary tract infections: 100 mg should be taken twice daily.
Uncomplicated lower urinary tract infections: 200 mg should be taken twice daily.
Uncomplicated gonococcal urethritis: 200 mg should be taken as a single dose.
Skin and soft tissue infections: 200 mg should be taken twice daily.
Cefpodoxime should be taken during meals for optimum absorption.
Elderly: It is not necessary to modify the dose in elderly patients with normal renal function.
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 5.)

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NOTE: The unit dose is either 100 mg or 200 mg, depending on the type of infection.
Directions for reconstitution: Shake bottle to loosen the powder. Slowly add boiled and cooled water up to the arrow mark on the label and shake well. Add more water, if necessary to adjust the volume up to the arrow mark, to make 60 mL.

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.

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.

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.
In cases of severe renal insufficiency it may be necessary to reduce the dosage regimen dependent on the creatinine clearance (see Dosage & Administration).
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. Cross reactivity 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.
Tablet: 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. 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 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.
Suspension: Preliminary enquiry about allergy to penicillin is necessary before prescribing cephalosporins since cross allergy to penicillins occurs in 5-10% of cases.
Particular care will be needed in patients sensitive to penicillin: strict medical surveillance is necessary from the very first administration. Where there is doubt, medical assistance should be available at the initial administration, in order to treat any anaphylactic episode. In patients who are allergic to other cephalosporins, the possibility of cross allergy to Cefpodoxime, should be borne in mind. Cefpodoxime should not be given to those patients with a previous history of immediate type hypersensitivity to cephalosporin.
Hypersensitivity reactions (anaphylaxis) observed with beta-lactam antibiotics can be serious and occasionally fatal.
The onset of any manifestation of hypersensitivity indicates that treatment should be stopped.
Possible side effects include gastrointestinal disorders such as nausea, vomiting and abdominal pain. Antibiotics should always be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis. Cefpodoxime may induce diarrhoea, antibiotic associated colitis and pseudomembranous colitis. These side-effects, which may occur more frequently in patients receiving higher doses for prolonged periods, should be considered as potentially serious. The presence of C. difficile should be investigated. In all potential cases of colitis, the treatment should be stopped immediately. The diagnosis should be confirmed by sigmoidoscopy and specific antibiotic therapy (vancomycin) substituted if considered clinically necessary. The administration of products which cause faecal stasis must be avoided. Although any antibiotic may cause pseudomembranous colitis, the risk may be higher with broad-spectrum drugs, such as the cephalosporin.

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.

Suspension: Possible side effects include gastrointestinal disorders such and rarely antibiotic-associated colitis, nausea, vomiting and abdominal pain and rash urticaria and itching. Changes in renal function have been observed with antibiotics from the same group as Cefpodoxime, particularly when co-prescribed with aminoglycosides and/or potent diuretics.
Occasional cases have been reported of headaches, dizziness, tinnitus, paresthesia, and malaise. Rare cases of allergic reactions include hypersensitivity mucocutaneous reactions, skin rashes and pruritus. Occasional cases of bullous reactions such as Stevens-Johnson, toxic epidermal necrolysis and erythema multiforme have also been received. Transient moderate elevations of ASAT, ALAT and alkaline phosphatases and/or bilirubin have been reported. These laboratory abnormalities which may be explained by the infection, may rarely exceed twice the upper limit of the named range and elicit a pattern of liver injury, usually cholestatic and most often asymptomatic. Slight increases in blood urea and creatinine have also been reported. Exceptionally rare are the occurrence of liver damage and of haematological disorders such as reduction in haemoglobin, thrombocytosis, thrombocytopenia, leucopenia and eosinophilia. Haemolytic anaemia has extremely rarely been reported.
As with other beta-lactam antibiotics, neutropenia and, more rarely, agranulocytosis may develop during treatment with Cefpodoxime, particularly if given over long periods.
As with other cephalosporins, there have been rare reports of anaphylactic reactions, bronchospasm, purpura and angioedema, serum-sickness like reactions with rashes, fever and arthralgia.

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.
Tablet: 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.
Suspension: As with other cephalosporins, isolated cases showing development of a positive Coombs' test have been reported.
Studies have shown that bioavailability is decreased by approximately 30% when Cefpodoxime is administered with drugs which neutralize gastric pH or inhibit acid secretions. Therefore, such drugs as antacids of the mineral type and H-blockers such as ranitidine, which can cause an increase in gastric pH, should be taken 2 to 3 hours after Cefpodoxime administration.
The bioavailability increases if the product is administered during meals.
A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets, but not with test based on enzymatic glucose oxidase reactions.

Store at temperatures not exceeding 30°C.
Suspension: And within 14 days if reconstituted and stored at refrigerated conditions (2-8°C).

Cephalosporins

J01DD13 - cefpodoxime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

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