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CEFPODOXIME PRODUCT MONOGRAPH PDF

Drug monographs for CEFPODOXIME PROXETIL provide an overview of the drug product, therapeutic uses, key development issues, regulatory information. Cefpodoxime Proxetil reference guide for safe and effective use from the For empiric outpatient treatment of CAP when risk factors for drug-resistant S. Cefpodoxime is indicated for the treatment of the following infections when caused by susceptible pathogens (see sections and ) in adults.

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Cefpodoxime mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains Pharmaceutical form Film-coated cdfpodoxime Coral red, elliptical, film-coated tablets debossed with ‘C’ on one side and ’62’ on the other side. Consideration should be given to the official guidance on the appropriate use of antibacterial agents. The tablets should produdt taken with food for monograpu absorption. Adults and adolescents with normal renal function: Upper respiratory tract infections: Acute exacerbation of chronic bronchitis: It is not necessary to modify the dose in elderly patients with normal renal function.

Pediatric formulation of cefpodoxime is available for infants and children. 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.

Cefpodoxime Proxetil Tablets Dosage & Rx Info | Uses, Side Effects – MPR

Haemodialysis Patients Single dose 1 administered after each dialysis session. Cefpodoxime is not recommended for the treatment of pneumonia due to S. 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 monoggaph, 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 section 4.

Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported monoograph 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 section 4. Cepodoxime of 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.

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This can produce a positive Coomb’s test and very rarely, haemolytic anaemia.

Cefpodoxime mg tablets – Summary of Product Characteristics (SmPC) – (eMC)

Cross-reactivity may occur with penicillin for this reaction. 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 difficilewhich may require interruption of treatment.

Interaction with laboratory tests: 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 tests based on enzymatic glucose oxidase reactions. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase cepfodoxime or glucose-galactose malabsorption should not take this medicine. Sunset yellow E may cause allergic reactions. Histamine H 2 -antagonists and antacids reduce the bioavailability of cefpodoxime.

Probenecid reduces the excretion of cephalosporins.

Cephalosporins potentially enhance the anticoagulant effect of coumarins and reduce the contraceptive effect of oestrogens. Simultaneous administration of cefpodoxime with warfarin may augment its anti-coagulant effects. There have been many reports of increases in oral anti-coagulant activity in patients receiving antibacterial agents, including cephalosporins.

The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the cephalosporins to the increase in INR international normalised ratio is difficult to assess.

It is recommended that the INR should be monitored frequently during and shortly after co-administration of cefpodoxime with an oral anti-coagulant agent. Therefore, such drugs as antacids of the mineral cefpodoxxime and H 2 blockers such as ranitidine, which can cause an increase in gastric pH, should be taken 2 to 3 hours after Cefpodoxime administration.

There are no or limited amount of data from the use of cefpodoxime in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see monograoh 5. Due to the benefit of antibiotic treatment, the use of cefpodoxime may be considered during pregnancy if necessary.

Caution should be exercised when prescribing to pregnant women. Cefpodoxime is excreted in breast milk in small amounts. Cefpodoxime may be used during breast-feeding. Continuation of breast-feeding should be questioned in case of diarrhoea or mucosal fungus infection in the breastfed infant.

The possibility of sensitisation should be borne in mind. Frequencies priduct defined as: Haematological disorders mlnograph as reduction in haemoglobin, thrombocytosis, thrombocytopenia, leucopenia and eosinophilia Very rare: Nervous system disorders Uncommon: Headache, paraesthesia, dizziness Ear and labyrinth disorders Uncommon: Tinnitus Gastrointestinal disorders Common: Gastric pressure, nausea, vomiting, pfoduct pain, flatulence, diarrhoea.

Bloody diarrhoea can occur as a symptom of enterocolitis. The possibility of pseudomembranous enterocolitis should be considered if severe or persistent diarrhoea occurs during or after treatment see section 4. Metabolism and nutrition disorders Common: Loss of appetite Immune system disorders Hypersensitivity reactions of all degrees of severity have been observed see section 4.

Renal monogrqph urinary disorders Very rare: Slight increases in blood urea and creatinine Hepato-biliary disorders Rare: 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. Hypersensitivity mucocutaneous reactions, rash, urticaria, pruritus Very rare: Stevens- Johnson syndrome, toxic epidermal necrolysis and erythema multiforme Infections and infestations There can be multiplication of non-sensitive micro-organisms see section 4.

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Asthenia or malaise 4. In cases of overdosage, particularly in patients with renal insufficiency, encephalopathy may occur.

Cefpodoxime 200mg tablets

The encephalopathy is usually reversible once cefpodoxime plasma levels have fallen. Beta-lactam antibacterial, a 3 rd generation cephalosporin. J01DD13 Mode of Action: For cephalosporins, 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 cefpodoxlme minimum inhibitory concentration MIC of cefpodoxime for individual target species i.

Mechanism s of resistance: Resistance to cephalosporins results from a variety of mechanisms: The identification and antimicrobial susceptibility tests on any such cefpodoxi,e must be repeated and if the result is oroduct the isolate must be sent to a reference laboratory.

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. Antibacterial spectrum Commonly Susceptible species Aerobic Gram positive organisms: Staphylococcus aureus Methicillin-susceptible Streptococcus pyogenes Aerobic Gram negative organisms: Staphylococcus aureus methicillin resistant Aerobic Gram negative organisms Morganella morganii Pseudomonas aeruginosa.

Legionella pneumophila Mycoplasma spp. When cefpodoxime proxetil is administered orally to fasting subjects as a tablet corresponding to mg of cefpodoxime, The volume of distribution prdouct The maximum plasma concentration is 1. Following administration of mg and mg twice daily over 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, hr fractions after a single dose exceed MIC 90 of common urinary pathogens. Good diffusion of cefpodoxime is also seen into renal tissue, with concentrations above MIC 90 of the common urinary pathogens, hrs after an administration of a single mg dose 1. Concentrations of cefpodoxime in the medullary and cortical tissues is similar.

Studies in healthy volunteers show median concentrations of cefpodoxime in the total ejaculate hrs following administration of a single mg dose to be above the MIC 90 of N. Not all pack sizes may be marketed. This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies.

Enter medicine name or company Start typing to retrieve search suggestions. Continue typing to refine. Back to top Aurobindo Pharma – Milpharm Ltd. Active ingredient cefpodoxime proxetil. Last updated on eMC: