Cefpodoxime Proxetil (Tablet, Film Coated)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3350

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Cefpodoxime Proxetil (Tablet, Film Coated)
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FILM-COATED TABLETS::<br/>GRANULES FOR ORAL SUSPENSION::<br/>Patients with Renal Dysfunction::<br/>Patients with Cirrhosis::
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Absorption and Excretion::<br/>Effects of Food::<br/>Pharmacokinetics of Cefpodoxime Proxetil Film-coated Tablets::<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) Klebsiella pneumoniae Proteus mirabilis Haemophilus influenzae (including beta-lactamase producing strains) Moraxella (Branhamella) catarrhalis Streptococcus agalactiae Streptococcus spp. (Groups C, F, G) Aerobic Gram-negative microorganisms: Citrobacter diversus Klebsiella oxytoca Proteus vulgaris Providencia rettgeri Haemophilus parainfluenzae<br/>Susceptibility Testing: The interpretive criteria for Haemophilus spp. is applicable only to broth microdilution susceptibility testing done with Haemophilus Test Medium (HTM) broth. For Susceptibility Testing of Neisseria gonorrhoeae. The interpretive value for N. gonorroheae is applicable only to agar dilution susceptibility testing done with Neisseria gonorrhoeae susceptibility test 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-Hinton broth with lysed horse blood (LHB) (2-5% v/v). The interpretive value for Streptococcus spp. is applicable only to broth microdilution susceptibility testing done with cation-adjusted Mueller-Hinton broth with lysed horse blood (LHB) (2-5% 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.
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Cefpodoxime proxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.
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Dispense in tight, light-resistant containe. Replace cap securely after each opening.
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General:<br/>Information for Patients:<br/>Drug Interactions:<br/>Drug/Laboratory Test Interactions:<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:<br/>Pregnancy:<br/>Teratogenic effects:<br/>Labor and Delivery:<br/>Nursing Mothers:<br/>Pediatric Use:<br/>Geriatric Use:
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Cefpodoxime Proxetil
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Cefpodoxime Proxetil (Tablet, Film Coated)
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Clinical Trials::<br/>Film-coated Tablets (Multiple dose)::<br/>Clinical Studies:<br/>Granules for Oral Suspension (Multiple dose)::<br/>Film-coated Tablets (Single dose)::<br/>Laboratory Changes:<br/>Post-marketing Experience::<br/>Cephalosporin Class Labeling::
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Cefpodoxime Proxetil