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CEFPODOXIME PROXETIL
Overview
What is CEFPODOXIME PROXETIL?
Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl)-2-{(Z)methoxyimino}acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene- 2-carboxylate.
Its molecular formula is CHNOSand its structural formula is represented below:
The molecular weight of cefpodoxime proxetil is 557.6.
Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of cefpodoxime proxetil in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied as film-coated tablets.
Cefpodoxime proxetil tablets USP contain cefpodoxime proxetil USP equivalent to 100 mg or 200 mg of cefpodoxime activity and the following inactive ingredients: carboxy methyl cellulose calcium, lactose monohydrate, hydroxy propyl cellulose, sodium lauryl sulfate, crospovidone, corn starch, magnesium stearate, hypromellose, titanium dioxide, propylene glycol and FD&C yellow #6 aluminum lake. In addition, the 100 mg film-coated tablets contain iron oxide yellow and the 200 mg film-coated tablets contain FD&C red #40 aluminum lake.
What does CEFPODOXIME PROXETIL look like?
What are the available doses of CEFPODOXIME PROXETIL?
Sorry No records found.
What should I talk to my health care provider before I take CEFPODOXIME PROXETIL?
Sorry No records found
How should I use CEFPODOXIME PROXETIL?
(See for indicated pathogens.)
FILM-COATED TABLETS:
GRANULES FOR ORAL SUSPENSION:
Patients with Renal Dysfunction:
Weight (kg) x (140 - age)
Patients with Cirrhosis:
What interacts with CEFPODOXIME PROXETIL?
Cefpodoxime proxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.
What are the warnings of CEFPODOXIME PROXETIL?
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What are the precautions of CEFPODOXIME PROXETIL?
General:
In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of cefpodoxime proxetil should be reduced because high and prolonged serum antibiotic concentrations can occur in such individuals following usual doses. Cefpodoxime, like other cephalosporins, should be administered with caution to patients receiving concurrent treatment with potent diuretics. (See .)
As with other antibiotics, prolonged use of cefpodoxime proxetil may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Prescribing cefpodoxime proxetil in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Information for Patients:
Patients should be counseled that antibacterial drugs including cefpodoxime proxetil should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefpodoxime proxetil is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefpodoxime proxetil or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Drug Interactions:
Antacids:
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Drug/Laboratory Test Interactions:
Cephalosporins, including cefpodoxime proxetil, are known to occasionally induce a positive direct Coombs’ test.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long-term animal carcinogenesis studies of cefpodoxime proxetil have not been performed. Mutagenesis studies of cefpodoxime, including the Ames test both with and without metabolic activation, the chromosome aberration test, the unscheduled DNA synthesis assay, mitotic recombination and gene conversion, the forward gene mutation assay and the micronucleus test, were all negative. No untoward effects on fertility or reproduction were noted when 100 mg/kg/day or less (2 times the human dose based on mg/m) was administered orally to rats.
Pregnancy
Pregnancy Category B
Cefpodoxime proxetil was neither teratogenic nor embryocidal when administered to rats during organogenesis at doses up to 100 mg/kg/day (2 times the human dose based on mg/m) or to rabbits at doses up to 30 mg/kg/day (1 to 2 times the human dose based on mg/m).
There are, however, no adequate and well-controlled studies of cefpodoxime proxetil use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery:
Cefpodoxime proxetil has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.
Nursing Mothers:
Cefpodoxime is excreted in human milk. In a study of 3 lactating women, levels of cefpodoxime in human milk were 0%, 2% and 6% of concomitant serum levels at 4 hours following a 200 mg oral dose of cefpodoxime proxetil. At 6 hours post-dosing, levels were 0%, 9% and 16% of concomitant serum levels. Because of the potential for serious reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use:
Safety and efficacy in infants less than 2 months of age have not been established.
Geriatric Use:
Of the 3338 patients in multiple-dose clinical studies of cefpodoxime proxetil film-coated tablets, 521 (16%) were 65 and over, while 214 (6%) were 75 and over. No overall differences in effectiveness or safety were observed between the elderly and younger patients. In healthy geriatric subjects with normal renal function, cefpodoxime half-life in plasma averaged 4.2 hours and urinary recovery averaged 21% after a 400 mg dose was given every 12 hours for 15 days. Other pharmacokinetic parameters were unchanged relative to those observed in healthy younger subjects.
Dose adjustment in elderly patients with normal renal function is not necessary.
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What are the side effects of CEFPODOXIME PROXETIL?
Clinical Trials:
Film-coated Tablets (Multiple dose):
multiple doses
Incidence Greater Than 1%:
C. difficile
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Clinical Studies
Adverse events thought possibly or probably related to cefpodoxime proxetil that occurred in 1% of patients (N=4696)
Body
Cardiovascular
Digestive
Hemic and Lymphatic
Metabolic and Nutritional
Musculo-skeletal
Nervous
Respiratory
Skin
Special Senses
Urogenital
Granules for Oral Suspension (Multiple dose):
Incidence Greater Than 1%
Incidence Less Than 1%
Body:
Digestive:
Hemic & Lymphatic:
Metabolic & Nutritional:
Musculo-Skeletal:
Nervous:
Respiratory:
Skin:
Special Senses:
Film-coated Tablets (Single dose)
a
single dose
Incidence Greater Than 1%
Incidence Less Than 1%
Central Nervous System
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Genital
Gastrointestinal
Psychiatric
Laboratory Changes
Hepatic
:
Hematologic
:
Serum Chemistry
:
Renal
:
Post-marketing Experience:
in utero
Cephalosporin Class Labeling:
Adverse Reactions and Abnormal Laboratory Tests
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What should I look out for while using CEFPODOXIME PROXETIL?
Sorry No records found
What might happen if I take too much CEFPODOXIME PROXETIL?
In acute rodent toxicity studies, a single 5 g/kg oral dose produced no adverse effects.
In the event of serious toxic reaction from overdosage, hemodialysis or peritoneal dialysis may aid in the removal of cefpodoxime from the body, particularly if renal function is compromised.
The toxic symptoms following an overdose of beta-lactam antibiotics may include nausea, vomiting, epigastric distress, and diarrhea.
How should I store and handle CEFPODOXIME PROXETIL?
TALTZ is sterile and preservative-free. Discard any unused portion. Cefpodoxime Proxetil Tablets, USP 100 mg
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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