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Cefpodoxime proxetil (CP) is a prodrug with poor oral bioavailability because of its metabolism to Cefpodoxime acid (CA) in luminal contents and intestinal epithelial cells. In the present investigation, regional variability in different segments of the gastrointestinal tract vis-à-vis solubility and metabolism were investigated, and the results indicated potential for a gastro retentive (GR) dosage form. Suitability of a GR dosage from for CP and finally in vivo efficacy were investigated. Thereafter, an effervescent floating GR dosage form was developed for CP and evaluated in rats. The GR dosage form improved the oral bioavailability of CP significantly by about 75%, hence providing a proof-of-concept. The Tmax value increased to 1.43+/-0.24 h from 0.91+/-0.23 h of pure drug, while Cmax values of 4735+/-802 ng/ml and 3094+/-567 ng/ml were obtained for the GR dosage form and pure drug respectively.
In a crossover study design, 25 mg of cephalexin/kg or 9.6 mg of cefpodoxime/kg was administered orally. Blood samples were collected before (time 0) and 0.33, 0.66, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after treatment. An ultrafiltration device was used in vivo to collect ISF at 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours. Plasma and ISF concentrations were analyzed with high-pressure liquid chromatography. Plasma protein binding was measured by use of a microcentrifugation technique.
Carboxylesterases (CE) are ubiquitous enzymes responsible for the detoxification of xenobiotics. Many therapeutically useful drugs are metabolized by these proteins which impacts upon the efficiency of drug treatment. In some instances, CEs convert inactive prodrugs to active metabolites, a process that is essential for biological activity. Such compounds include the anticancer agents CPT-11 (3) and capecitabine (4), the antibiotics Ceftin (9) and Vantin, as well as the illicit street drug heroin (6). However, more commonly, CEs hydrolyze many esterified drugs to inactive products that are then excreted. Agents such as flestolol (11), meperidine (5), lidocaine (8) and cocaine (7), are all hydrolyzed and inactivated by these enzymes. Therefore the efficacy of esterified drugs will be dependent upon the distribution and catalytic activity of different CEs. In this review, we examine the structural aspects of CEs and their roles in drug detoxification and propose that modulation of CE activity may allow for improvements in, and potentiation of, drug efficacy.
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We conducted a blinded taste test evaluating 12 antimicrobial suspensions by smell, texture, taste, aftertaste and overall acceptance. Drugs received cumulative scores in each category as well as a total score ranking. Overall Lorabid scored highest but not significantly higher than Keflex, Suprax and Ceclor, all of which score higher than the other test drugs. Cefzil and Augmentin scored just below this group of drugs and higher than all other test drugs. Vantin was inferior to these drugs primarily because of its low score in aftertaste. It was ranked along with V-Cillin-K, Veetids, Sulfatrim and Pediazole, the lowest scoring group of drugs other than Dynapen which scored lower than all other test drugs. No difference overall was detected between the two penicillin VK suspensions evaluated, V-Cillin-K and Veetids.
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In Japan, oral antimicrobial agents are prophylactically used with oxytocics after normal delivery to prevent puerperal infections. The present study was designed to investigate bacterial floras in the endometrial cavity immediately after normal delivery and the effect of prophylactic use of anti-microbial agents on those floras. Sixty-six puerperae who underwent uneventful courses of pregnancy and delivery were subjected for this study. Intrauterine contents were collected on the first day and the fifth day of the puerperium and submitted to microbiological examinations. Cefpodoxime proxetil (CPDX-PR) was orally given to the puerperae for prophylaxis for 5 days after the initial sampling. On the puerperal first day, a total of 98 strains (71 strains of aerobic bacteria, 27 strains of anaerobic bacteria) was detected in the uteri of the 66 subjects. The incidences of aerobic Gram-positive cocci, aerobic Gram-negative bacilli and anaerobic bacteria were 59.2%, 12.2%, 27.6% of the 98 strains, respectively. On the puerperal fifth day, a total of 82 strains (51 strains of aerobic bacteria and 31 strains of anaerobic bacteria) were detected in the uteri of the 66 subjects. The incidences of aerobic Gram-positive cocci, aerobic Gram-negative bacilli and anaerobic bacteria were 52.5%, 8.6% and 37.7% of 82 strains, respectively.
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Upper respiratory tract infections in children are common and usually self-limiting conditions, which include acute otitis media (AOM), acute rhinosinusitis (ARS), and acute pharyngitis (AP). Management of pediatric AOM considers observation strategy for selected and uncomplicated cases, older than 2 years of age, only when adequate follow-up can be ensured. Otherwise, an antibiotic treatment should be prescribed. Amoxicillin should be preferred as the first-choice therapy. Switch therapy to ceftriaxone is suggested if amoxicillin regimen failure occurs within 48-72 hours. The diagnosis of ARS is established by the persistence of purulent nasal of post-nasal draining lasting at least 10 days especially if accompanied by supporting symptoms and signs. Amoxicillin is the first choice drug for mild ARS in children. When symptoms persist or worsen, amoxicillin/clavulanate or cefpodoxime proxetil, or ceftriaxone are recommended. Clinical criteria alone are not sufficiently accurate in children with AP to distinguish bacterial and viral etiology. Thus microbiological evaluation is needed and positive throat culture or rapid antigen detection test are required to establish the diagnosis of streptococcal pharyngitis and consequently to prescribe antibiotic treatment. The first choice treatment in European countries still remains amoxicillin or amoxicillin/clavulanate.
Prospective, randomized, observer-blind, multicenter study.
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Self-nanoemulsifying drug delivery systems (SNEDDS) were developed with the objective to overcome problems associated with the delivery of cefpodoxime proxetil (CFP), a poorly bioavailable high dose antibiotic having pH dependant solubility. Solubility of CFP in oily phases and surfactants was determined to identify components of SNEDDS. Various surfactants and co-surfactants were screened for their ability to emulsify selected oily phases. Ternary phase diagrams were constructed to identify area of nanoemulsification for the selected systems. The influence of CFP and the pH of dilution medium on the phase behavior of selected system were assessed. The globule size of optimized CFP SNEDDS in various dissolution media was determined to check the effect of pH on its behavior. The optimized CFP SNEDDS needed surfactant content less than 40% and yielded nanoemulsion of mean globule size 170 nm, which was not affected by the pH of dilution medium. The optimized SNEDDS released CFP completely within 20 min irrespective of the pH of dissolution medium.
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Antimicrobial resistance among organisms that cause acute otitis media (AOM) and new approaches in the prevention and treatment of AOM are discussed. Organisms commonly responsible for causing AOM include Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. The evolution of pneumococcal resistance to penicillins, erythromycin, trimethoprim-sulfamethoxazole, and oral cephalosporins may require treatment with agents such as vancomycin or rifampin in certain patients. H. influenzae and M. catarrhalis are becoming increasingly resistant to penicillins, trimethoprim-sulfamethoxazole, oral cephalosporins, and macrolides. Mechanisms of resistance include changes in penicillin-binding proteins, production of beta-lactamase, alterations in target enzymes, and inhibition of drug access to the site of action. Because of changing resistance patterns and the limited spectra of activity of many currently available antimicrobials, new antimicrobials have been developed in the hope of improving therapy. While amoxicillin and trimethoprim-sulfamethoxazole are appropriate first-line agents, children at risk for resistant infections may be treated initially with cefuroxime axetil, cefpodoxime proxetil, cefprozil, or amoxicillin-clavulanate. After local resistance patterns, patient adherence to therapy, in vitro data, and cost factors have been weighed, other agents to consider include loracarbef, clarithromycin, azithromycin, and ceftriaxone. Along with the efforts to improve treatment, research is focusing on the prevention of otitis media with bacterial and viral vaccines. The emergence of resistant strains of organisms causing AOM has complicated its treatment.
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Cefpodoxime proxetil is an orally absorbed broad spectrum third generation cephalosporin antibacterial. It is a prodrug that is de-esterified in vivo to its active metabolite, cefpodoxime. After single- and multiple-dose (12-hourly) administration of cefpodoxime proxetil in the therapeutic dose range of 100 to 400mg of cefpodoxime equivalents, average peak plasma concentrations of cefpodoxime range from 1.0 to 4.5 mg/L and occur between 1.9 and 3.1 hours after administration. The half-life of cefpodoxime ranges from 1.9 to 2.8 hours. The absolute bio-availability of cefpodoxime proxetil tablets is 50%, and absorption is enhanced by concomitant administration of food. Raising gastric pH by pretreatment with antacids or H2-receptor antagonists results in reduced absorption. Binding of cefpodoxime to human plasma or serum protein is low (18 to 23%), suggesting that cefpodoxime should readily transfer across the capillary lining into tissues. Cefpodoxime undergoes minimal metabolism in humans. Drug not absorbed is degraded in the gastrointestinal tract and excreted in the faeces. As expected for a drug eliminated primarily by renal excretion, the disposition of cefpodoxime is altered in patients with impaired renal function; the half-life increases, while apparent plasma clearance and renal clearance decrease. The pharmacokinetics of cefpodoxime after oral administration of cefpodoxime proxetil are not affected by age.
A multicenter study was conducted in which the in vitro activity of cefpodoxime (the active metabolite of the prodrug ester cefpodoxime proxetil) was compared with those of cefixime, cefuroxime, cefaclor, cefadroxil, and clarithromycin against 5556 recent clinical isolates. Cefpodoxime demonstrated potent activity against members of the Enterobacteriaceae, in particular against species generally resistant to the established oral cephalosporins such as Proteus vulgaris [minimum inhibitory concentration (MIC)50, 0.12 microgram/ml], Providencia rettgeri (MIC50, 0.015 microgram/ml), and Serratia marcescens (MIC50, 2 micrograms/ml). Cefpodoxime was very effective against the fastidious organisms most frequently associated with respiratory infections, such as Streptococcus pneumoniae (MIC90, 0.12 microgram/ml), Haemophilus influenzae (MIC90, 0.12 microgram/ml), and Moraxella catarrhalis (MIC90, 1 microgram/ml). In contrast to other orally administrated third-generation cephalosporins (cefixime or ceftibuten), cefpodoxime demonstrated reasonable activity against oxacillin-susceptible staphylococci, with MIC50 ranging from 1 to 2 micrograms/ml. All cephalosporins tested demonstrated poor activity against Pseudomonas spp., Xanthomonas spp., Enterococcus spp., and oxacillin-resistant staphylococci. Cefpodoxime had the widest spectrum of activity of all tested oral cephalosporins.
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Urinary tract infection is among the most common reasons for an outpatient visit and antibiotic use in adult populations. The increasing prevalence of antibacterial resistance among community uropathogens affects the diagnosis and management of this clinical syndrome.
MEDLINE (1966-1997), EMBASE (1974-1997), Current Contents, and Science Citation Index searches were conducted to identify randomized controlled trials of the treatment of acute otitis media in children with antibiotics of different durations.
The care strategy of pharyngitis has been changed dramatically these last years. Because of evolution of antibiotic resistance, the attitude which prevailed of the systematic treatment of pharyngitis in order to prevent a hypothetical acute rheumatic fever, could not persist. Discrimination between pharyngitis due to group A streptococcus (GAS) and nonstreptococcal pharyngitis (usually of viral causes) cannot be made in a reliable way by the clinical signs and symptoms, even if clinical scores are used. The free availability to practitioners of GAS rapid diagnostic tests, sensitive (>90%) and specific (>95%), changes the rule by simplifying it: pharyngitis with positive test must be treated with antibiotics, those with negative test should not be received such treatment. A reduction of two thirds of antibiotics consumption for pharyngitis can be expected, while maintaining the benefit (improvement of the clinical signs, reduction of contagiousness and the complications) for the patients for whom it is necessary. Because of GAS resistance to macrolides and the absence of resistance to beta-lactam antibiotics, a compound belonging of this last family should be prescribed and for a short treatment duration: amoxicillin (50 mg/kg/j, b.i.d for 6 days), cefpodoxime proxetil (8 mg/kg/j b.i.d for 5 days), cefuroxime axetil (30 mg/kg/j b.i.d for 4 days).
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Patients received either cefpodoxime proxetil oral suspension (10 mg/kg/day, once daily for 10 days) or cefixime oral suspension (8 mg/kg/day, once daily for 10 days).
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Cefpodoxime proxetil (CS-807) is an orally active prodrug of an oxime-type cephem antibiotic. The MIC60 values of cefpodoxime (R-3746) the active form of CS-807, were 3.13, 6.25, 0.05, 0.38, 0.2, 0.1, 3.13, 3.13, 6.25, 6.25, 0.1 and 12.5 micrograms/ml against S. aureus, coagulase-negative staphylococci, S. pneumoniae, E. coli carrying R plasmids, P. vulgaris, P. rettgeri, C. freundii, S. marcescens, A. calcoaceticus, P. cepacia, ampicillin-resistant H. influenzae and B. fragilis, respectively. Its activity was stronger than that of cefaclor and ampicillin. R-3746 manifested little activity against P. aeruginosa, methicillin-resistant S. aureus, and Enterococcus spp. R-3746 showed stronger binding affinity than cefaclor with the PBP2 of S. aureus, PBPs 1a, 1bs, 2 and 3 of E. coli, PBPs 1b, 1c and 3 of P. rettgeri, and the PBP3 of P. aeruginosa than cefaclor. Synergy of the bactericidal effect between R-3746 and serum complement was moderate, although the cells of E. coli NIHJ-JC2 and S. aureus 209P were well engulfed and rapidly digested by mouse-cultured macrophages in the presence of greater than 1/8 MIC of R-3746. Good clinical efficacy can be expected of CS-807 provided its pharmacokinetics prove to be good.
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Pathogenic bacteria were isolated from 90% of patients with acute otitis media. This higher-than-expected rate of positive cultures was probably related to the meticulous bacteriologic techniques used.
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In-vitro killing curves, a protection model in immunocompetent mice and an ex-vivo model in volunteers were used to evaluate the efficacy of amoxycillin, cefuroxime axetil and cefpodoxime proxetil against a penicillin-intermediate-resistant Streptococcus pneumoniae (MIC = 1 mg/L) (PRP) and a penicillin-susceptible S. pneumoniae (MIC = 0.01 mg/L) (PSP). In vitro, the maximal bactericidal activity was obtained with amoxycillin (1 x MIC versus 2 x MIC cefpodoxime and 4 x MIC cefuroxime). Mice were challenged by intraperitoneal inoculation and treated orally every 8 h for 48 h with 2.5, 5, 7.5 and 10 mg/kg doses of these three beta-lactams. The rate of survival for the PSP strain was 100% with any dose of the three tested antibiotics. For the PRP strain only amoxycillin showed 100% survival with 5, 7.5 or 10 mg/kg doses. Twelve healthy volunteers were randomized in three groups and each received two doses of the oral antibiotic. Blood samples were collected from each subject 0.5 h and 2 h after drug administration and serum inhibitory and bactericidal titres were measured. Similar values were obtained with the three beta-lactams against PSP but against PRP only the serum of volunteers that had taken amoxycillin exhibited serum bactericidal titres of > or = 8. This study suggests a more predictable therapeutic efficacy against pneumococcal infection with amoxycillin than with available oral cephalosporins.