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. Serum Chemistry: Hyperglycemia, hypoglycemia, hypoalbuminemia, hypoproteinemia, hyperkalemia, and hyponatremia. Time to peak concentration was not significantly different between fed and fasted subjects. Rx only NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Equilibrium was achieved between plasma and tonsil tissue within 4 hours of dosing. The toxic symptoms following an overdose of beta-lactam antibiotics may include nausea, vomiting, epigastric distress, and diarrhea. Clinical Trials Adverse events thought possibly or probably related to cefpodoxime in single-dose clinical trials conducted in the United States were: Rx only Absorption was somewhat diminished and elimination unchanged in patients with cirrhosis. When a 200 mg dose of the suspension was taken with food, the extent of absorption (mean AUC) and mean peak plasma concentration in fed subjects were not significantly different from fasted subjects, but the rate of absorption was slower with food (48% increase in Tmax). Following multiple-dose administration every 12 hours for 5 days of 200 mg or 400 mg cefpodoxime proxetil, the mean maximum cefpodoxime concentration in skin blister fluid averaged 1.6 and 2.8 mcg/mL, respectively. Cefpodoxime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Our Kundl site in Austria will also manufacture antibiotics for . Cefpodoxime Proxetil has not been studied for use during labor and delivery. Available for Android and iOS devices. IF CEFPODOXIME IS TO BE ADMINISTERED TO PENICILLIN SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. Proxetil for Oral Each patient received a single, oral, 5 mg/kg dose of cefpodoxime oral suspension. There are, however, no adequate and well-controlled studies of cefpodoxime proxetil use in pregnant women. If superinfection occurs during therapy, appropriate measures should be taken. NOTE: The efficacy of cefpodoxime in treating male patients with rectal infections caused by N. gonorrhoeae has not been established. There were no deaths or permanent disabilities in any of the patients in these studies. (See CLINICAL STUDIES section.) Cefpodoxime Plasma Levels (mcg/mL) in Fasted Adults After Film-coated Tablet Administration (Single Dose), Distribution Protein binding of cefpodoxime ranges from 22 to 33% in serum and from 21 to 29% in plasma. constituted Rx only, Rising NDC 64980-403-50 Cefpodoxime is a prescription drug used to treat a wide variety of bacterial infections. :RX164517/B, Item No. Cystitis These results demonstrated that concentrations of cefpodoxime exceeded the MIC90 of S. pyogenes for at least 7 hours after dosing of 100 mg of cefpodoxime proxetil. In acute rodent toxicity studies, a single 5 g/kg oral dose produced no adverse effects. Anticonvulsant therapy can be given if clinically indicated. <p>Cefpodoxime Sandoz is used for the treatment of patients infected with susceptible strains of micro-organisms which include a wide range of gram-positive & gram-negative bacteria. Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. In subjects with mild impairment of renal function (50 to 80 mL/min creatinine clearance), the average plasma half-life of cefpodoxime was 3.5 hours. The following serious adverse experiences have been reported: allergic reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and serum sickness-like reactions, pseudomembranous colitis, bloody diarrhea with abdominal pain, ulcerative colitis, rectorrhagia with hypotension, anaphylactic shock, acute liver injury, in utero exposure with miscarriage, purpuric nephritis, pulmonary infiltrate with eosinophilia, and eyelid dermatitis. Mechanism of Resistance When a 200 mg dose of the suspension was taken with food, the extent of absorption (mean AUC) and mean peak plasma concentration in fed subjects were not significantly different from fasted subjects, but the rate of absorption was slower with food (48% increase in Tmax). These results demonstrated that concentrations of cefpodoxime exceeded the MIC90 of S. pyogenes for at least 7 hours after dosing of 100 mg of Cefpodoxime Proxetil. IF AN ALLERGIC REACTION TO Cefpodoxime Proxetil OCCURS, DISCONTINUE THE DRUG. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. Carboxymethyl cellulose calcium, colloidal silicon dioxide, crospovidone, FD&C Yellow No. Other pharmacokinetic parameters (Cmax, AUC, and Tmax) were unchanged relative to those observed in healthy young subjects. If superinfection occurs during therapy, appropriate measures should be taken. Time to peak concentration was not significantly different between fed and fasted subjects. The effective therapeutic dose for skin infections was higher than those used in other recommended indications. Elderly subjects do not require dosage adjustments unless they have diminished renal function. Skin: Skin moniliasis, urticaria, fungal dermatitis, acne, exfoliative dermatitis, maculopapular rash. No detection of cefpodoxime in tonsillar tissue was reported 12 hours after dosing. In these studies, the following bacterial eradication rates were obtained at 5 to 9 days after therapy: In these studies, clinical cure rates and bacterial eradication rates for Cefpodoxime Proxetil were comparable to the comparator agents; however, the clinical cure rates and bacteriologic eradication rates were lower than those observed with some other classes of approved agents for cystitis. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. In subjects with mild impairment of renal function (50 to 80 mL/min creatinine clearance), the average plasma half-life of cefpodoxime was 3.5 hours. Most of these abnormalities were transient and not clinically significant. Rx only Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. Protein binding of cefpodoxime ranges from 22 to 33% in serum and from 21 to 29% in plasma. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. (See PRECAUTIONS.) In patients with normal renal function, neither accumulation nor significant changes in other pharmacokinetic parameters were noted following multiple oral doses of up to 400 mg Q 12 hours. Skin urticaria, rash, pruritus non-application site, diaphoresis, maculopapular rash, fungal dermatitis, desquamation, dry skin non-application site, hair loss, vesiculobullous rash, sunburn. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Long-term animal carcinogenesis studies of cefpodoxime proxetil have not been performed. Please see, Acute bacterial exacerbation of chronic bronchitis, Acute, uncomplicated urethral and cervical gonorrhea, Acute, uncomplicated ano-rectal infections in women, Uncomplicated skin and skin structure infections, Uncomplicated urinary tract infections (cystitis), Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis. There is minimal metabolism of cefpodoxime in vivo. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. 100 mg, (Orange colored, oval shaped, film coated tablets debossed with "A55" on one side and plain on other side) BEFORE THERAPY WITH Cefpodoxime Proxetil IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFPODOXIME, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. The percentage of Cefpodoxime Proxetil-treated patients who discontinued study drug because of adverse events was significantly greater at a dose of 800 mg daily than at a dose of 400 mg daily or at a dose of 200 mg daily. It will not work for viral infections (such as. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. 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 in vivo micronucleus test, were all negative. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefpodoxime Proxetil tablets, and may range in severity from mild diarrhea to fatal colitis. Following oral administration of 100 mg of cefpodoxime proxetil to fasting subjects, approximately 50% of the administered cefpodoxime dose was absorbed systemically. Cefpodoxime Sandoz Components: Cefpodoxime Method of action: Bactericidal Treatment option: Bronchitis, Acute Bronchitis, Pneumonia, Tonsillitis, Pharyngitis Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Metabolic and Nutritional dehydration, gout, peripheral edema, weight increase. Lung Tissue Cystitis In two double-blind, 2:1 randomized, comparative trials performed in adults in the United States, Cefpodoxime Proxetil was compared to other beta-lactam antibiotics. Drug class: third generation cephalosporins, Acute bacterial exacerbations of chronic bronchitis, ANALYSIS(67877-878, 67877-879), MANUFACTURE(67877-878, 67877-879), PACK(67877-878, 67877-879). Cefpodoxime proxetil is a prodrug that is absorbed from the gastrointestinal tract and de-esterified to its active metabolite, cefpodoxime. 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. Therapy may be instituted while awaiting the results of these studies. Urogenital hematuria, urinary tract infections, metrorrhagia, dysuria, urinary frequency, nocturia, penile infection, proteinuria, vaginal pain. Following a single, oral 100 mg cefpodoxime proxetil film-coated tablet, the mean maximum cefpodoxime concentration in tonsil tissue averaged 0.24 mcg/g at 4 hours post-dosing and 0.09 mcg/g at 7 hours post-dosing. 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. Last updated on Apr 1, 2023. Bottles of 100 NDC 67877-879-01 Genital: Vaginitis. Sandoz Inc: 2008-05 . Body fungal infections, abdominal distention, malaise, fatigue, asthenia, fever, chest pain, back pain, chills, generalized pain, abnormal microbiological tests, moniliasis, abscess, allergic reaction, facial edema, bacterial infections, parasitic infections, localized edema, localized pain. Anticonvulsant therapy can be given if clinically indicated. In these studies, using very strict evaluability criteria and microbiologic and clinical response criteria at the 4 to 21 day post-therapy follow-up, the following presumptive bacterial eradication/clinical success outcomes (cured and improved) were obtained. Its molecular formula is C21H27N5O9S2 and its structural formula is represented below: The molecular weight of cefpodoxime proxetil is 557.6. NOTE: In considering the use of Cefpodoxime Proxetil in the treatment of cystitis, Cefpodoxime Proxetils lower bacterial eradication rates should be weighed against the increased eradication rates and different safety profiles of some other classes of approved agents. C. difficile produces toxins A and B which contribute to the development of CDAD. The mean cefpodoxime T1/2 and renal clearance in cirrhotic patients were similar to those derived in studies of healthy subjects. Revised: October, 2022, NDC 67877-878-20 Dosage form: tablet, film coated Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiellapneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus. Before reconstitution, remove the desiccant capsule by pulling out two small rings, then discard. 100 mg/5 mL* 20 Tablets, NDC 67877-879-20 Hematologic: Eosinophilia, leukocytosis, lymphocytosis, granulocytosis, basophilia, monocytosis, thrombocytosis, decreased hemoglobin, decreased hematocrit, leukopenia, neutropenia, lymphocytopenia, thrombocytopenia, thrombocythemia, positive Coombs test, and prolonged PT, and PTT. Pharmacokinetics in Elderly Subjects: 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. Nephrotoxic drugs: Although nephrotoxicity has not been noted when cefpodoxime proxetil was given alone, close monitoring of renal function is advised when cefpodoxime proxetil is administered concomitantly with compounds of known nephrotoxic potential. In clinical trials using multiple doses of cefpodoxime proxetil granules for oral suspension, 2128 pediatric patients (93% of whom were less than 12 years of age) were treated with the recommended dosages of cefpodoxime (10 mg/kg/day Q 24 hours or divided Q 12 hours to a maximum equivalent adult dose). Suspension, USP 50 mg/5 mL* 50 mL when Dosage. Incidence Greater Than 1 %, Diarrhea or loose stools were dose-related: decreasing from 10.4% of patients receiving 800 mg per day to 5.7% for those receiving 200 mg per day. Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Other skin rashes 1.8% Was 21.99. Absorption and Excretion Cefpodoxime Proxetil is a prodrug that is absorbed from the gastrointestinal tract and de-esterified to its active metabolite, cefpodoxime. Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic cephalosporin antibiotic. Our global portfolio comprises approximately 1 000 . In clinical trials using a single dose of Cefpodoxime Proxetil film-coated tablets, 509 patients were treated with the recommended dosage of cefpodoxime (200 mg). Bottles of 20 NDC 67877-878-20 Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. No overall differences in effectiveness or safety were observed between the elderly and younger patients. Adverse Reactions and Abnormal Laboratory Tests: (See INDICATIONS AND USAGE for indicated pathogens.). Microbiology Mechanism of Action However, the efficacy of Cefpodoxime in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials. For patients with severe renal impairment (<30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. The results of this study indicated that cefpodoxime penetrated into lung tissue and produced sustained drug concentrations for at least 12 hours after dosing at levels that exceeded the MIC90 for S. pneumoniae and H. influenzae. Digestive vomiting, dyspepsia, dry mouth, flatulence, decreased appetite, constipation, oral moniliasis, anorexia, eructation, gastritis, mouth ulcers, gastrointestinal disorders, rectal disorders, tongue disorders, tooth disorders, increased thirst, oral lesions, tenesmus, dry throat, toothache. Twenty-four patients (1.1%) discontinued medication due to adverse events thought possibly or probably related to study drug. Psychiatric: Anxiety. Cefpodoxime, like other cephalosporins, should be administered with caution to patients receiving concurrent treatment with potent diuretics. (See INDICATIONS AND USAGE for indicated pathogens.) Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. Other pharmacokinetic parameters were unchanged relative to those observed in healthy younger subjects. There is minimal metabolism of cefpodoxime in vivo. Distributed by: Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. IF AN ALLERGIC REACTION TO CEFPODOXIME PROXETIL OCCURS, DISCONTINUE THE DRUG. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Pharmacokinetics in Elderly Subjects Elderly subjects do not require dosage adjustments unless they have diminished renal function. Effects of Decreased Renal Function Elimination of cefpodoxime is reduced in patients with moderate to severe renal impairment (<50 mL/min creatinine clearance). Cefpodoxime pharmacokinetics in cirrhotic patients (with or without ascites) are similar to those in healthy subjects. Method: ANALYSIS(64980-402, 64980-403), MANUFACTURE(64980-402, 64980-403). NOTE: In clinical trials, successful treatment of uncomplicated skin and skin structure infections was dose-related. Medically reviewed by Drugs.com. Over the recommended dosing range (100 to 400 mg), approximately 29 to 33% of the administered cefpodoxime dose was excreted unchanged in the urine in 12 hours. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefpodoxime proxetil, and may range in severity from mild diarrhea to fatal colitis. All doses of cefpodoxime proxetil in this insert are expressed in terms of the active cefpodoxime moiety. Staphylococcus saprophyticus Streptococcus pneumoniae (excluding penicillin-resistant isolates) Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes. Approximately 23% of the administered dose was cleared from the body during a standard 3-hour hemodialysis procedure. 10 mg/kg twice daily to a maximum of 125 mg twice daily. Mechanism of Action: Cephalosporins, including Cefpodoxime Proxetil, are known to occasionally induce a positive direct Coombs test. . Following multiple-dose administration every 12 hours for 5 days of 200 mg or 400 mg cefpodoxime proxetil, the mean maximum cefpodoxime concentration in skin blister fluid averaged 1.6 and 2.8 mcg/mL, respectively. Following a 200 mg tablet dose taken with food, the AUC was 21 to 33% higher than under fasting conditions, and the peak plasma concentration averaged 3.1 mcg/mL in fed subjects versus 2.6 mcg/mL in fasted subjects. The following serious adverse experiences have been reported: allergic reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and serum sickness-like reactions, pseudomembranous colitis, bloody diarrhea with abdominal pain, ulcerative colitis, rectorrhagia with hypotension, anaphylactic shock, acute liver injury, in utero exposure with miscarriage, purpuric nephritis, pulmonary infiltrate with eosinophilia, and eyelid dermatitis. Saddle Brook, NJ 07663 We comply with the HONcode standard for trustworthy health information. 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