Lipid based drug delivery systems have gained prominence in last decade for drugs with dissolution rate limited oral bioavailability.
Twenty-seven randomized clinical trials (6463 patients), 6 systematic reviews, and 11 observational studies (252,934 patients) were included in our review. Acute uncomplicated cystitis in women can be diagnosed without an office visit or urine culture. Trimethoprim-sulfamethoxazole (160/800 mg twice daily for 3 days), nitrofurantoin monohydrate/macrocrystals (100 mg twice daily for 5-7 days), and fosfomycin trometamol (3 g in a single dose) are all appropriate first-line therapies for uncomplicated cystitis. Fluoroquinolones are effective for clinical outcomes but should be reserved for more invasive infections. β-Lactam agents (amoxicillin-clavulanate and cefpodoxime-proxetil) are not as effective as empirical first-line therapies. Immediate antimicrobial therapy is recommended rather than delayed treatment or symptom management with ibuprofen alone. Limited observational studies support 7 to 14 days of therapy for acute urinary tract infection in men. Based on 1 observational study and our expert opinion, women with diabetes without voiding abnormalities presenting with acute cystitis should be treated similarly to women without diabetes.
According to recently issued treatment guidelines, appropriate empiric choices for ambulatory patients with community-acquired pneumonia (CAP) are a macrolide, doxycycline (for patients aged > or = 8 years), or an oral beta-lactam agent with good activity against pneumococci.
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In a multicenter, randomized, investigator-blinded trial, patients were randomly selected to receive either cefpodoxime proxetil or amoxicillin-clavulanate potassium orally for the treatment of acute suppurative otitis media. Patients were seen before, during, and at the end of therapy, and 2 to 3 weeks after completion of therapy. A total of 229 patients, 153 receiving cefpodoxime and 76 receiving amoxicillin-clavulanate were entered into the study; all patients were examined to determine drug safety. A total of 146 patients, 98 in the cefpodoxime group and 48 in the amoxicillin-clavulanate group, completed the study and were examined to determine drug efficacy. End-of-therapy microbiologic eradication rates in assessable patients were 92% for cefpodoxime and 86% for amoxicillin-clavulanate (p = 0.14; 95% confidence interval (CI) on difference: -4.4%, 19.2%). End-of-therapy clinical response rates for assessable patients were as follows: cured, 68% for cefpodoxime and 65% for amoxicillin-clavulanate; improved, 24% for cefpodoxime and 23% for amoxicillin-clavulanate; and failed, 8% for cefpodoxime and 13% for amoxicillin-clavulanate (p = 0.57; 95% CI: -8.4%, 16.5%). Recurrence rates at long-term follow-up were 24% for cefpodoxime-treated patients and 25% for those given amoxicillin-clavulanate. Both drugs were well tolerated; 20.9% of those given cefpodoxime and 31.6% of amoxicillin-clavulanate-treated patients had drug-related adverse medical events (p = 0.102; 95% CI: -23.9%, 2.6%). Gastrointestinal complaints were the most frequently reported drug-related side effect in both groups: 11.8% of cefpodoxime-treated patients and 21.1% of those given amoxicillin-clavulanate (p = 0.076; 95% CI: -20.8%, 2.2%). Drug-related dermatologic side effects (e.g., diaper rash, pruritus, urticaria) were reported in 7.8% of cefpodoxime-treated patients and 14.5% of those who received amoxicillin-clavulanate (p = 0.160; 95% CI: -16.6%, 3.3%). Our findings suggest that clinical efficacy for cefpodoxime administered twice daily is equivalent to that of amoxicillin-clavulanate administered three times a day.
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The administration of oral CPDX-PR (100 mg, twice daily, for 3 days) appears to be a safe, cost-saving, convenient prophylaxis which reduces overall expense.
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The linear regression analysis data for the calibration plots showed good linear relationship, with r(2) = 0.998 ± 0.0015 with respect to peak area in the concentration range of 100-600 ng per spot. The mean value±SD of slope and intercept were 3.38 ± 1.47 and 986.9 ± 108.78 with respect to peak area. The method was validated for precision, recovery, and robustness. The limits of detection and quantification were 3.99 and 12.39 ng per spot, respectively. Cefpodoxime proxetil was subjected to acid and alkali hydrolysis, oxidation, and thermal degradation. The drug undergoes degradation under acidic and basic conditions, indicating that the drug is susceptible to both acid and base. The degraded product was well resolved from the pure drug, with significantly different R(f) value. Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of the investigated drug.
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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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One hundred and fifty female patients with acute uncomplicated cystitis were given 200 mg of CPDX-PR twice daily for 3-7 days to evaluate both its overall clinical efficacy and its adverse effects. In 82 cases (Group I) in which it was administered for 3 days, the overall clinical efficacy, evaluated by the criteria proposed by the Japanese UTI committee, was excellent in 64 cases, moderate in 17 and poor in one, with the effective rate being 98.8%. In 35 cases (Group II) in which it was administered for 4-7 days, the overall clinical efficacy was excellent in 18 cases, moderate in 15 and poor in 2, with the effective rate being 94.3%. The overall clinical evaluation was not performed in another 33 cases because they were given CPDX-PR for more than 8 days or 300 mg/day. Subjective adverse effects such as hoarseness and lingual inflammation were observed in only one of the 150 cases, but they disappeared spontaneously after the cessation of administration of CPDX-PR. These findings suggest that CPDX-PR is one of the most effective and safe antibiotic in the treatment of acute uncomplicated cystitis.
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AOM accounted for 5.8% of the 43 433 visits or 6.2 cases/week per pediatrician. Among 3141 evaluable AOM cases (mean age 16.7±8 months, peak incidence at 10 months), 99% had been vaccinated with PCV7 and 42.1% attended day care (DCC). Recurrent AOM comprised 24.5% of cases and 51% of children had received ATB in the last 3 months. At the time of diagnosis, 47.1% had fever≥38,5°C, 74.5% otalgia and 4.7% otorrhea. Febrile and painful AOM accounted for 29.5% of cases and cunjunctivitis-otitis syndrome for 18.2%. ATB was prescribed in 98.7% of cases (cefpodoxime proxetil, 59% and amoxicillin/clavulanate, 37%). The failure rate was 6.4% and failure risk was greater in children in DCC (OR=1.50, [1.10;2.05]), young age<18 months (OR=1.47, [1.06;2.04]) and history of recurrent AOM (OR=1.45, [1.02;2.06]).
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In a cross-over study on twelve healthy volunteers cefpodoxime proxetil (CAS 87239-81-4) and acetylcysteine (CAS 616-91-1) were evaluated for possible pharmacokinetic interactions. After a standardized breakfast, the subjects received p.o. either 200 mg cefpodoxime administered as cefpodoxime proxetil (reference) or 200 mg cefpodoxime and 200 mg acetylcysteine (test). To determine the pharmacokinetic profile of cefpodoxime the plasma concentrations were determined by HPLC. The plasma concentration-time curve of cefpodoxime was very similar after both regimens, and with respect to cefpodoxime bioequivalence has been proven. The narrow range of 90% confidence intervals for the quotient test/reference for Cmax and AUC indicate reliable bioavailability of cefpodoxime proxetil independent of co-administered acetylcysteine.
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The disposition of cefpodoxime after single, oral 200-mg doses of cefpodoxime proxetil (cefpodoxime equivalents) was investigated in an open-label study of six patients with end-stage renal disease currently maintained on hemodialysis. Subjects were randomly assigned to one of two treatment groups, which differed in the sequence of the interdialytic and intradialytic periods. Doses were separated by at least 2 weeks. Blood samples were serially collected for 48 hours after each treatment; if obtainable, urine was also collected over this same period. During the intradialytic period, hemodialysis was scheduled to begin approximately 3 hours after dosing, and dialysate was collected before and until the end of dialysis. Average cefpodoxime elimination half-life for the interdialytic period was 18.0 +/- 6.5 hours; apparent total body clearance was 28.6 +/- 13 mL/minute. The half-life during hemodialysis, 2.66 +/- 0.74 hours, was considerably shorter than that after hemodialysis, 19.2 +/- 3.5 hours, in the intradialytic period of the study. Hemodialysis clearance of cefpodoxime was 120 +/- 31 mL/minute, which was 57.1 +/- 13% and 71.7 +/- 25% of the hemodialysis clearance for urea nitrogen and creatinine, respectively. The 2.86 +/- 0.25 hour hemodialysis session removed 22.4 +/- 2.9% of the administered dose, as assessed by cefpodoxime recovery in dialysate. A maximum rebound in cefpodoxime plasma concentration of 0.41 +/- 0.33 mcg/mL was observed, at about one-half hour after the end of hemodialysis. Based on these results, dosage adjustment is not required, but extension of the dosing interval is warranted.(ABSTRACT TRUNCATED AT 250 WORDS)
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Cefpodoxime proxetil, a new oral cephalosporin, is the prodrug ester of cefpodoxime. Minimal inhibitory concentrations (MIC) of RU 51746 (sodium salt of cefpodoxime: CPD) were evaluated by agar dilution for 1 696 bacterial strains isolated in 5 hospitals. For Enterobacteriaceae, MIC 50 and 90% were respectively (micrograms/ml): (1) naturally non bêtalactamase producing species: E. coli, Shigella and Salmonella 0.25-0.5; P. mirabilis 0.06-0.12. (II) chromosomal penicillinase producing species: Klebsiella 0.12-1. (III) chromosomal cephalosporinase producing species: E. cloacae and C. freundii 2-greater than 128; S. marcescens 2-64; indole + Proteus 0.25-64; P. stuartii 0.25-16. Activity of CPD was not modified on plasmid mediated penicillinase producing strains, but CPD was inactive on cephalosporinase hyperproducing strains, and on broad spectrum bêtalactamases producing strains. CPD was inactive on P. aeruginosa (MIC greater than or equal to 64) and on A. baumannii (16-pi 128). Haemophilus, regardless on bêtalactamase production status, were very susceptible to CPD (MIC less than or equal to 0.25) and B. catarrhalis was generally inhibited by 0.12 to 1. CPD was poorly active on methicillin susceptible Staphylococci (MIC 50 and 90%: 2-4) and inactive on methicillin resistant strains. Enterococci and Listeria monocytogenes were generally resistant; Streptococci A, B, C, G and Pneumococci were inhibited by low concentration: 0.002 to 0.25 (MIC 50 and 90%: 0.016-0.032) whereas MIC for other Streptococci were 0.004 to 32 (MIC 50 and 90%: 0.25-4). These antibacterial properties placed CPD in excellent position among oral cephalosporins.
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OBJECTIVE: To compare the clinical and bacteriologic efficacy of a 5-day course of cefpodoxime proxetil (CPD) with that of a 10-day course of penicillin V (PNV) or amoxycillin---clavulanate (AMC) in recurrent pharyngitis in adults. A cost-effectiveness study (reported elsewhere) was carried out at the same time. METHODS: This multicenter, randomized, open label trial involved 580 adult patients consulting general practitioners for clinical recurrent pharyngitis (greater-than-or-equal3 episodes within the last 12 months) regardless of the bacterial etiology. Patients were treated for 5 days with CPD, 100 mg twice daily, or for 10 days with PNV, 1x106 IU three times a day, or for 10 days with AMC, 500 mg (amoxycillin) three times a day. Clinical and bacteriologic outcomes were noted at the end of treatment, and cases of clinical recurrence were recorded during a 6-month follow-up period. RESULTS: At the end of treatment, clinical response was satisfactory in 157 of 170 (92.3%) patients on CPD, 147 of 166 (88.5%) patients on PNV, and 168 of 177 (94.9%) patients on AMC. Group A beta-hemolytic streptococci (GABHS) were eradicated in 22 of 23 (95.65%) patients on CPD, 16 of 16 (100%) patients on PNV, and 19 of 20 (95%) patients on AMC. The rates of clinical success and GABHS eradication were not significantly different between the groups. Compliance (p<0.001) and tolerance (p<0.001) were significantly better in the CPD group than in the other two groups. Among the 389 patients evaluable 6 months after the end of treatment, the recurrence rate of acute pharyngitis (due to any bacterium) was significantly lower in the CPD group (p=0.01 versus PNV; p<0.01 versus AMC). A Kaplan---Meier analysis (469 patients over 6 months) of the rate of non-recurrence, with comparison by the log-rank test, also showed a significant difference in favor of CPD. CONCLUSIONS: A 5-day treatment of recurrent pharyngitis with CPD was as effective and better tolerated than a 10-day treatment with PNV or AMC. The risk of recurrence was lower with CPD.
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Studies were included if they met the following criteria: subjects aged 4 weeks to 18 years, clinical diagnosis of acute otitis media, no antimicrobial therapy at time of diagnosis, and randomization to less than 7 days of antibiotic treatment vs 7 days or more of antibiotic treatment.
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Fine particles of cefpodoxime proxetil (CPD) were prepared using an Aerosol Solvent Extraction System (ASES) with supercritical CO(2). The resulting primary particles were approximately 0.1-0.2microm in size and were almost spherical in shape. The secondary particles were approximately 0.2-0.6microm in size and had irregular shapes. The larger particle size and irregular shapes were due to the agglomeration of the primary particles. The effects of solvent type, CO(2)-to-CPD solution weight ratio, and CPD solution concentration on the extent of agglomeration were investigated. As a result, the use of ethyl acetate and acetone as solvents also reduced the degree of agglomeration. The degree of agglomeration was reduced with the use of a high CO(2)-to-solution weight ratio, and a low solution concentration. In particular, spherical particles, approximately 0.1-0.4microm in size, were obtained when a 10.0wt% CPD solution was used. As a result of dissolution study, almost 90% of the processed CPD had dissolved within 10min. The recovery yield of the CPD powder reached approximately 80% using a membrane filter.
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An effective procedure for decontamination of beta-lactam antibiotic residues or contaminants in the pharmaceutical manufacturing environment was investigated. Decontamination with solutions of hydrochloric acid, sodium hydroxide, hydrogen peroxide and hydroxylamine as agents for degradation was assessed. According to the results, the beta-lactam antibiotics were significantly degraded with sodium hydroxide and hydroxylamine. From the structural analysis of the degradation products of a cephem antibiotic, cefpodoxime proxetil, it was found that hydroxylamine degraded the beta-lactam structure under mild conditions, while sodium hydroxide did not. Therefore, hydroxylamine was considered an appropriate decontamination agent for beta-lactam antibiotics.
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Deciding whether an antibiotic is necessary, when to begin therapy and selecting an optimal drug is an everyday challenge in clinical practice. In vitro susceptibility testing which determines the minimum concentration necessary for a particular antibiotic to inhibit or kill most strains of a bacterial species and pharmacodynamic modeling are useful but have limitations. The need for antibiotic therapy for acute otitis media (AOM) has been recently questioned. However, explanations for uniformly positive results with many antibiotic and placebo comparative trials include overdiagnosis of AOM at study entry, inclusion of patients with mild or uncomplicated AOM and broad criteria for the definition of clinical success. Recurrent and persistent AOM does not have as favorable a natural history as uncomplicated AOM; children below 2 years of age benefit most from antibiotic therapy. Selecting the best choice among the many antibiotics that can be used to treat AOM has become more complex over the last decade due to escalating antibiotic resistance among the pathogens that cause this infection. Broader spectrum antibiotics such as cefdinir, the newly introduced third generation cephalosporin, have their most prominent use in the treatment of persistent and recurrent AOM. In the early 1950s and 1960s penicillin clearly was the best available agent for the treatment of group A streptococcal (GAS) infections. In the 1970s the situation began to change as cephalosporin antibiotics became available. Superior eradication rates with cephalosporins such as cefdinir have now been well-documented. The leading hypothesis to explain the widening gap in efficacy between penicillin and cephalosporins relates to two major concepts: the presence of copathogens and differential alteration of the normal microbial ecology in the throat as a consequence of the selected therapy. There are positive and negative consequences to early initiation of antibiotic therapy for GAS tonsillopharyngitis. Penicillin has persisting good efficacy in patients older than the age of 12 years and in those who have been ill for >2 days. Shortening therapy for GAS tonsillopharyngitis offers a therapeutic advantage. Cefpodoxime proxetil and cefdinir have a 5-day indication for the treatment of GAS tonsillopharyngitis. Antibiotics with lower side effect profile, infrequent dosing, good palatability in suspension formulation and efficacy with short duration of treatment may lead to better outcomes because noncompliance often results in failed therapy, persistence of infection and morbidity.
Analysis of restriction fragment-length polymorphism of ribosomal DNA regions (ribotypes) was used as an epidemiologic tool to compare 25 pre- and posttreatment strains obtained from 12 patients treated with either cefpodoxime proxetil or amoxicillin-clavulanic acid. Ribotyping is a promising method to differentiate relapse from reinfection in the treatment failures of Escherichia coli urinary tract infections.
The antibacterial activity of cefpodoxime proxetil was studied in an in-vitro model simulating doses of 100, 200 and 400 mg. Strains of Klebsiella spp. Proteus mirabilis, Escherichia coli, Streptococcus pyogenes, and Haemophilus influenzae were effectively reduced by a dose of 200 mg. While for Esch. coli no dose-activity relationship was observed--the maximal effect was achieved with a simulated dose of 100 mg--Staphylococcus aureus could be reduced effectively only by a simulated dose of 400 mg. The lower doses showed stepwise lower activities. Apart from broad spectrum beta-lactamases like SHV 2 or TEM 5 the presence of plasmid coded beta-lactamases in Esch. coli and H. influenzae did not affect the antibacterial activity of cefpodoxime proxetil. The results show that cefpodoxime was more active against Gram-negative bacteria than amoxycillin, and comparable activity to intramuscular cefotiam in the in-vitro model.
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The present work is the maiden drug utilization study conducted in ENT department at our university hospital. It highlighted some rational prescription patterns including less utilization of antibiotics in ENT infections, good adherence by patients and prescription by brand names. The data presented here will be useful in future, long-term and more extensive drug utilization studies in the hospital and in promotion of rational prescribing and drug use in hospitals.