Cefpodoxime Proxetil (Granule, For Suspension)

Cefpodoxime Proxetil (Granule, For Suspension)

Absorption and Excretion:<br/>Effects of Food:<br/>Pharmacokinetics of Cefpodoxime Proxetil Suspension:<br/>Distribution:<br/>Skin Blister:<br/>Tonsil Tissue:<br/>Lung Tissue:<br/>CSF:<br/>Effects of Decreased Renal Function:<br/>Effect of Hepatic Impairment (cirrhosis):<br/>Pharmacokinetics in Elderly Subjects:<br/>Microbiology: NOTE: Cefpodoxime is inactive against methicillin-resistant staphylococci. Staphylococcus saprophyticus Streptococcus pneumoniae (excluding penicillin-resistant strains) Streptococcus pyogenes Klebsiella pneumoniae Proteus mirabilis Haemophilus influenzae (including beta-lactamase producing strains) Moraxella (Branhamella) catarrhalis Neisseria gonorrhoeae (including penicillinase-producing strains) The following in vitro data are available, but their clinical significance is unknown. Cefpodoxime exhibits in vitro minimum inhibitory concentrations (MICs) of���2 mcg/mL against most (���90%) of isolates of the following microorganisms. However, the safety and efficacy of cefpodoxime in treating clinical infections due to these microorganisms have not been established in adequate and well controlled clinical trials. Aerobic Gram-positive microorganisms: Streptococcus agalactiae Streptococcus spp. (Groups C, F, G) NOTE: Cefpodoxime is inactive against enterococci. Aerobic Gram-negative microorganisms: Citrobacter diversus Klebsiella oxytoca Proteus vulgaris Providencia rettgeri Haemophilus parainfluenzae NOTE: Cefpodoxime is inactive against most strains of Pseudomonas and Enterobacter. Anaerobic Gram-positive microorganisms:<br/>Susceptibility Testing: The interpretive criteria for Haemophilus spp. is applicable only to broth microdilution susceptibility testing done with Haemophilus Test Medium(HTM) broth. ���Intermediate���and���Resistant���categories have not been determined. For Susceptibility Testing of Neisseria gonorrhoeae. The interpretive value for N. gonorroheae is applicable only to agar dilution susceptibility testing done with Neisseria gonorrhoeae susceptibilitytest medium. ���Intermediate���and���Resistant���categories have not been determined. The interpretive value for S. pneumoniae is applicable only to broth microdilution susceptibility testing done with cation-adjusted Mueller-Hintonbroth with lysed horse blood (LHB) (2 to 5% v/v). The interpretive value for Streptococcus spp. is applicable only to broth microdilution susceptibility testing done with cation-adjustedMueller-Hinton broth with lysed horse blood (LHB) (2 to 5% v/v).<br/>Quality Control: Microorganism (ATCC#) MIC Range (mcg/mL) Staphylococcus aureus (29213) 1 - 8 Haemophilus influenzae (49247) 0.25 - 1 Neisseria gonorrhoeae(49226) 0.03 - 0.12 Streptococcus pneumoniae (49619)0.03 - 0.12 These quality control ranges are applicable to tests performed by a broth microdilution procedure using Haemophilus Test Medium (HTM). These quality control ranges are applicable to tests performed by agar dilution only using GC agar base with 1% defined growth supplement.<br/>Quality Control: Microorganism (ATCC#) Zone Diameter Range (mm) Staphylococcus aureus(25923) 19-25 Haemophilus influenzae (49247) 25-31 Neisseria gonorrhoeae (49226) 35-43 Streptococcus pneumoniae (49619)28-34 This zone diameter range is only applicable to tests performed on Haemophilus Test Medium (HTM) agar incubated in 5% CO. This zone diameter range is only applicable to tests performed on GC agar base and 1% defined growth supplement incubated in 5% CO. This organism is to be used for quality control testing for both S. pneumoniae and Streptococcus spp.

Cefpodoxime proxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.

dailymed-ingredient:Citric_Acid_Anhydrous, dailymed-ingredient:Citron, dailymed-ingredient:Colloidal_Silicon_Dioxide, dailymed-ingredient:Corn_Starch, dailymed-ingredient:Croscarmellose_Sodium, dailymed-ingredient:Ferric_Oxide_Yellow, dailymed-ingredient:Hydroxypropyl_Cellulose, dailymed-ingredient:Lactose_Monohydrate, dailymed-ingredient:Microcrystalline_Cellulose_and_Carboxymethyl_Cellulose_Sodium, dailymed-ingredient:Sodium_Benzoate, dailymed-ingredient:Sodium_Citrate, dailymed-ingredient:Sucrose, dailymed-ingredient:Vanille

Cefpodoxime Proxetil

Clinical Trials: The incidence of diarrhea in infants and toddlers (age 1 month to 2 years) was 12.8%. Diaper rash/Fungal skin rash 2.0% (includes moniliasis) The incidence of diaper rash in infants and toddlers was 8.5%. Other skin rashes 1.8% Digestive: Nausea, monilia, anorexia, dry mouth, stomatitis, pseudomembranous colitis. Hemic&Lymphatic: Thrombocythemia, positive direct Coombs' test, eosinophilia, leukocytosis, leukopenia, prolonged partial thromboplastin time, thrombocytopenic purpura. Metabolic&Nutritional: Increased SGPT. Musculo-Skeletal: Myalgia. Nervous: Hallucination, hyperkinesia, nervousness, somnolence. Respiratory: Epistaxis, rhinitis. Skin: Skin moniliasis, urticaria, fungal dermatitis, acne, exfoliative dermatitis, maculopapular rash.<br/>Laboratory Changes:<br/>Post-marketing Experience:<br/>Cephalosporin Class Labeling:

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