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PubMed1989

[Controlled multicentric study comparing cefixime and amoxicillin in the treatment of lower respiratory tract infections in adults].

This multicentre, randomized, double-blind study evaluated the effectiveness and safety of cefixime versus amoxicillin. Patients were admitted if they had lower respiratory tract infection with a bacterial pathogen susceptible to both study drugs. Diagnoses included acute respiratory tract infections with no underlying pulmonary pathology (cefixime 21, amoxicillin 27), acute exacerbation of chronic obstructive lung disease (cefixime 32, amoxicillin 42), superinfection of viral bronchitis or lung cancer, and pleuritis (cefixime 10, amoxicillin 6). Patients were treated for at least 10 days with either cefixime 200 mg b.d. or amoxicillin 1 g b.d. A clinical success rate of 80.7 per cent (50/62) in the cefixime group and 82.2 per cent (60/73) in the amoxicillin group was achieved in infections due to susceptible organisms. In acute infections with no underlying pathology, the clinical success rate was 90.5 per cent with cefixime and 81.5 per cent with amoxicillin. Twenty-three cefixime patients and 20 amoxicillin patients were seen 2 to 6 weeks after treatment: there were 2 and 1 clinical recurrences, respectively. All 3 patients were suffering from chronic obstructive lung disease. The bacteriological eradication rate at the end of treatment in assessable patients was 94.7 per cent (17/18) with cefixime and 80 per cent (16/20) with amoxicillin. Six and 11 new organisms appeared, responsible for 2 superinfections under cefixime and 7 under amoxicillin. Treatment was well tolerated by 96.4 per cent of cefixime patients and 90 per cent of amoxicillin patients. This study confirms the value of cefixime as a new oral antibiotic in the treatment of lower respiratory tract infections in adults.

Adolescent↗

PubMed1986

In vitro evaluation of cefixime (FK027, FR17027, CL284635): spectrum against recent clinical isolates, comparative antimicrobial activity, beta-lactamase stability, and preliminary susceptibility testing criteria.

Cefixime, a new orally absorbed cephalosporin, was compared by in vitro testing with other oral beta-lactams, including cephalexin, cefaclor, cefuroxime, amoxicillin, and amoxicillin + clavulanate. Enterobacteriaceae were inhibited by lower concentrations of cefixime than any of the reference drugs; 90% and 95% were inhibited by less than or equal to 1.0 and less than or equal to 8.0 micrograms/ml, respectively. Cefixime was the least active among these drugs against staphylococci, with only 31% of 1106 strains inhibited by less than or equal to 8.0 micrograms/ml and less than 1% by less than or equal to 1.0 microgram/ml. Enterococci and pseudomonads were not susceptible to any of the drugs tested. Penicillin-resistant pneumococci were relatively resistant to cefixime, but penicillin-susceptible pneumococci were very susceptible to cefixime. Other streptococci were generally susceptible to all compounds tested, with relative activities of amoxicillin greater than cefaclor and cefuroxime greater than cefixime greater than cephalexin. Cefixime was inactive against Bacteroides species. A slight inoculum effect occurred with cefixime with inocolum concentrations varying from 10(5) to 10(6) colony forming units per milliliter, but this was more marked at 10(7) colony forming units per milliliter. Cefixime was resistant to hydrolysis by seven common beta-lactamases. It inhibited the hydrolysis of nitrocefin only by type 1 cephalosporinases. The disk diffusion zone diameter breakpoints for the 30-micrograms cefixime disk were determined by regression analysis to be greater than or equal to 27 mm (susceptible) and less than or equal to 23 mm (resistant), respectively corresponding to minimal inhibitory concentration breakpoints of less than or equal to 1.0 and greater than or equal to 4.0 micrograms/ml. Because of the high interpretive error rate (13.8%) and the occurrence of these breakpoints on the parabolic portion of the regression curve, we recommend further evaluation of cefixime disks with lower potencies.

Amoxicillin↗

PubMed1989

Influence of an antacid containing aluminum and magnesium on the pharmacokinetics of cefixime.

Interaction studies in dogs have indicated that antacids significantly decrease the oral bioavailability of cefixime. Twelve healthy adult male volunteers participated in a randomized, four-way crossover trial to evaluate the influence of an aluminum-magnesium antacid (Maalox; 20 ml) on the pharmacokinetics of cefixime (400 mg). Regimens were (i) cefixime alone; (ii) cefixime simultaneous with antacid; (iii) cefixime 2 h before antacid; and (iv) cefixime 2 h after antacid. Serial blood and urine samples were collected over a 24-h period following each dose of cefixime. There was a 1-week washout interval between regimens. Cefixime concentrations in serum and urine were analyzed by high-performance liquid chromatography. Maximum cefixime concentrations in serum for regimens i through iv were (mean +/- standard deviation) 4.9 +/- 1.4, 5.7 +/- 1.3, 5.1 +/- 1.0, and 5.5 +/- 1.5 micrograms/ml, respectively. Corresponding values for area under the serum concentration-time curve extrapolated to infinity were 38.3 +/- 14.5, 42.8 +/- 13.9, 38.5 +/- 9.8, and 41.6 +/- 16.7 micrograms.h/ml. There was a trend toward increased concentrations in serum and area under the curve of cefixime when it was administered concomitantly with antacid; however, these differences were not statistically significant (P greater than 0.05; analysis of variance). We conclude that single-dose administration of an aluminum-magnesium antacid does not significantly decrease the oral bioavailability of cefixime.

Adult↗

PubMed1992

[Biliary excretion and hepatic disposal of cefixime: experimental and clinical study].

Cefixime is a new oral cephalosporin with in vitro activity similar to that of third-generation cephalosporins. Renal excretion accounts for only 40% of systemic clearance of cefixime, suggesting that biliary excretion of the drug may be significant. This study was designed to determine to what extent nonrenal clearance of cefixime is due to biliary excretion of the parent compound. In an isolated perfused rabbit liver model, biliary excretion of cefixime was very low, with only 0.28 +/- 0.15% of a single 10 mg dose injected in the system being recovered in the bile after three hours perfusion. The liver biotransformation rate for cefixime was found to be 16.2%. These results are in striking contrast with those obtained in human studies. Cefixime levels in duodenal juice aspirates collected over four hours following an intravenous injection of 200 mg cefixime in six healthy volunteers were at least fivefold concomitant serum levels. Studies of bile collected by external biliary drainage during 24 hours following an oral dose of 200 mg cefixime in ten cholecystectomized patients showed that the Cmax was 56.9 +/- 70 mg/l, i.e., 25-fold the serum Cmax (2.3 +/- 0.85 mg/l). The bile AUC/serum AUC ratio was 20.4 +/- 20.3. Mean bile level of cefixime was still as high as 4.3 +/- 3.7 mg/l 20 hours after dosing. The amount of cefixime excreted in the bile over 24 hours was 10.0 +/- 12.3 mg i.e., 5% of the dose administered. Twenty-four hour renal excretion of cefixime was 53.3 +/- 26.2 mg.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗

PubMed1988

A double-blind, multicenter, comparative study of the safety and efficacy of cefixime versus amoxicillin in the treatment of acute urinary tract infections in adult patients.

In this 31-site multicenter trial, 565 adult patients with urinary tract infections were randomly assigned to receive either a 10-day course of cefixime 400 mg once daily (n = 279) or amoxicillin 250 mg three times daily (n = 286). Although all patients were included in the safety analysis, only 93 (33 percent) cefixime-treated and 99 (35 percent) amoxicillin-treated patients were fully evaluable for the efficacy analysis. One week after therapy, the evaluable patients treated with cefixime demonstrated a 90 percent clinical cure rate and a 92 percent eradication rate of the baseline pathogen. This compared with an 83 percent clinical cure rate and an 84 percent bacterial eradication rate in the amoxicillin-treated group. The most frequently isolated pathogen was Escherichia coli (80 percent) followed by Proteus mirabilis (10 percent). One hundred thirty-seven (49 percent) of the 279 cefixime-treated and 126 (44 percent) of the 286 amoxicillin-treated patients reported at least one adverse experience during the study. Adverse reactions associated with cefixime were similar to those reported for other beta-lactam antibiotics. The most frequent adverse experiences reported by cefixime-treated patients were diarrhea (15 percent) and stool changes (12 percent). Headaches (11 percent) and diarrhea (9 percent) were the most frequently reported adverse reactions by the amoxicillin-treated patients. Eleven cefixime-treated patients (3.9 percent) and 10 amoxicillin-treated patients (3.5 percent) discontinued therapy because of adverse experiences. Results of this study demonstrate that a once-daily regimen of cefixime is as safe and effective as a three-times-daily regimen of amoxicillin in the treatment of acute urinary tract infections. Although the incidence of bowel changes was somewhat higher in the cefixime treatment group, these events usually resolved when therapy was discontinued.

Acute Disease↗

PubMed1992

Evaluation of cefixime biliary disposition in the isolated perfused rabbit liver model and in humans.

Cefixime is a new orally effective third-generation cephalosporin. It inhibits a wide variety of Gram-positive and Gram-negative bacteria, especially most of the Enterobacteriaceae. Since extrarenal excretion processes have been reported to account for 60% of cefixime systemic clearance we have endeavoured to determine the place taken up by biliary excretion of unchanged cefixime in this pattern. We initially used the isolated perfused rabbit liver technique. Six perfusions were performed. Cefixime concentrations were measured by HPLC chromatography. After addition of a single 10-mg dose of cefixime to the circulating blood, biliary elimination of the drug proved to be very low, since only 0.28 +/- 0.15% of the dose was recovered during the 3-h perfusion period. The rate of cefixime biotransformation in the liver was found to be 16.2%. In contrast, the data obtained in humans highlight substantial biliary excretion of the drug. In six healthy volunteers submitted to duodenal aspiration and receiving a single 200-mg i.v. dose of cefixime, drug levels in duodenal fluid were at least fivefold greater than the simultaneous concentrations in serum. Biliary excretion of cefixime was further investigated in ten cholecystectomized patients provided with T-tube drainage: following a single 200 mg oral dose of cefixime, Cmax in bile reached 56.9 +/- 70 mg/l, that is about 25 times as high as Cmax in serum, 2.3 +/- 0.85 mg/l. Drug levels in choledochal bile proved to be sustained, since a concentration of 4.3 +/- 3.7 mg/ml was still observed 20 h after dosing.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

PubMed1990

[Cefixime in urinary tract infections. (Specific studies and literature review)].

Cefixime, a new oral cephalosporin, is more active against enterobacteriaceae than the conventional oral cephalosporins. About 20% of the drug is excreted by the kidneys as active drug. Therefore, the treatment of urinary tract infection (UTI) by cefixime may be a good alternative. In two smaller uncontrolled and four larger, controlled (amoxicillin, co-trimoxazole) "western" studies as well as in eight Japanese studies the good efficacy of cefixime in uncomplicated UTI could be demonstrated. Because of its antibacterial spectrum in this kind of infection the therapy with cefixime can be initiated already prior to sensitivity testing. Concerning the treatment of acute pyelonephritis only few cases are reported. Good results, except in the case of Proteus mirabilis infection, could be achieved. In the treatment of complicated UTI our own controlled (norfloxacin) and 13 uncontrolled Japanese studies showed cefixime to be an effective antibiotic if infections are caused by sensitive strains. Since in complicated UTI also gram-positive and nonfermenting pathogens resistant to cefixime can be found, treatment should not be initiated without sensitivity testing. Concerning treatment of UTI in children only few, but promising, results are reported. The tolerance of cefixime was similar to that of the comparative drugs. The once daily dose (400 mg), however, showed a higher incidence of gastrointestinal adverse effects than a twice daily dose (200 mg). Therefore, the daily dose should be administered in two divided doses. In summary, cefixime proved to be a good alternative in the treatment of UTI.

Anti-Infective Agents, Urinary↗

PubMed1991

Cefixime compared with amoxicillin for treatment of acute otitis media.

Cefixime was compared with amoxicillin for treatment of acute otitis media in a randomized trial. Results of tympanocentesis on day 3 to 5 of therapy were used as the major outcome. Total daily doses were 8 mg/kg of cefixime and 40 mg/kg of amoxicillin. One hundred twenty-six patients were randomly assigned to receive treatment; 64 cultures grew pathogens. Pathogens were eradicated from the middle ear after 3 to 5 days of therapy in 27 (79.4%) of 34 children given amoxicillin and 26 (86.7%) of 30 children given cefixime (p = 0.47). When Streptococcus pneumoniae cases were analyzed, bacteriologic cure occurred in 14 (93.3%) of 15 children given amoxicillin and 12 (75%) of 16 given cefixime (p = 0.333). When cases of Haemophilus influenzae infection were analyzed, significantly more cures occurred with cefixime (10/10, 100%) than amoxicillin (8/13, 62%) (p = 0.046). Pathogens associated with failure of amoxicillin therapy were H. influenzae (five cases, two beta-lactamase-positive), S. pneumoniae (one case), and Moraxella catarrhalis (one case, beta-lactamase-positive). The four failures with cefixime therapy were all in patients infected with S. pneumoniae. Rates of rash, diarrhea, and vomiting were the same in both groups and did not necessitate stopping therapy. We conclude the following: (1) Cefixime and amoxicillin were equivalent in overall clinical and bacteriologic efficacy for otitis media. (2) Cefixime was more efficacious than amoxicillin in treating H. influenzae otitis media and should be preferred when H. influenzae is the suspected etiologic agent. (3) Side effects of both drugs were mild and equivalent.

Acute Disease↗

PubMed1991

Double-blind comparison of cefixime and cefaclor in the treatment of acute otitis media in children.

In a double-blind study cefixime, an oral cephalosporin of the third generation, was compared to cefaclor in the treatment of acute otitis media in 397 children aged 6 months to 12 years. Clinical evaluation was carried out at the beginning, at day 10-12 and day 28-35 after the start of the treatment. Specimens for bacterial culture and sensitivity testings were taken from the nasopharynx at the initial visit. Patients were randomized either to cefixime in a dose of 8 mg/kg/day or cefaclor in a dose 40 mg/kg/day in the proportion of 2 cefixime patients to 1 cefaclor patient. Two daily doses were administered for 7 days. At day 10-12, 93.5% in the cefixime group and 90.5% in the cefaclor group (p = 0.08) were clinically cured or improved. At day 28-35 the rate of cured or improved patients had decreased, mostly due to reinfections, to 90.1% in the cefixime group and to 86.6% in the cefaclor group (p = 0.12), respectively. 375 patients (69.9%) had positive bacterial culture in the nasopharynx of at least one strain of Haemophilus influenzae, Streptococcus pneumoniae, Branhamella (Moraxella) catarrhalis or combinations of these 3.73.6% of the B. catarrhalis strains were beta-lactamase producing and 11.4% of the H. influenzae strains, respectively. All isolated bacteria were sensitive to cefixime. Adverse events were reported in 17.9% in the cefixime and 10.6% in the cefaclor group. Most reactions were of moderate or mild nature and mostly affected skin or the gastrointestinal region. No serious adverse experiences occurred. In view of the good clinical results obtained cefixime seems to be at least as effective as cefaclor in the treatment of acute otitis media in children.

Acute Disease↗

PubMed1989

[Effect of sub-inhibitory concentrations of cefixime on the morphology, hemagglutination and adhesiveness of urinary strains of Escherichia coli].

The treatment of urinary tract infections is one of the indications of cefixime, a new oral cephem. The aim of the present work was to study the in vitro effect of cefixime sub- and infra-MICs on the morphology, haemagglutination and adhesiveness to epithelial cells of three uropathogenic Escherichia coli strains pretreated with sub-MICs (1/2 to 1/64 the MIC) of cefixime during growth phase (37 degrees C for 18 h). This treatment led to morphological alterations of the bacteria with filament formation. The E. coli strains showed different haemagglutination profiles (MS; MS-MR; MR). In the presence of cefixime sub-MICs (1/2 to 1/32 the MIC), MR E. coli showed a markedly altered capacity for haemagglutination (using guinea pig, human P1 and p erythrocytes). Adhesiveness was studied with human buccal cells for MS adhesins and human urothelial cells for MR adhesins. A significant decrease of adherence (70-90 per cent) was observed after pretreatment of E. coli strains with cefixime (up to 1/32 the MIC). Compared with other antibiotics active against E. coli, such as nalidixic acid, norfloxacin and ampicillin, the effect of 1/8 the MIC of cefixime on adhesiveness, was more pronounced. These results demonstrate that sub-MICs of cefixime induce a marked reduction in adhesiveness of E. coli. This property might potentiate the effectiveness of cefixime in the treatment of urinary tract infections due to E. coli.

Animals↗

PubMed1987

H+ gradient-dependent and carrier-mediated transport of cefixime, a new cephalosporin antibiotic, across brush-border membrane vesicles from rat small intestine.

The characteristics of the transport of cefixime, a new p.o. cephalosporin, antibiotic, were studied by using brush-border membrane vesicles from the rat small intestine. The initial rate of uptake of cefixime was not affected by the presence of an inward gradient of either Na+ or other monovalent cations. With an intravesicular pHi of 7.5, optimal cefixime uptake occurred at an extravesicular pHo of 5.0, with about 6-fold acceleration compared with that in the absence of an inward proton gradient (pHi = pHo = 7.5). A protonophore, carbonyl-cyanide-4-trifluoromethoxy-phenylhydrazone, abolished the stimulating effect of low pHo. In the presence of a sufficient inward proton gradient (pHi = 7.5, pHo = 5.0), cefixime uptake showed an overshoot phenomenon and apparent saturation kinetics expressed by the Michaelis-Menten equation with the maximum rate of 2.67 +/- 0.06 nmol/30 sec/mg of protein and a Michaelis constant of 0.83 +/- 0.04 mM. Cefixime uptake was inhibited competitively by glycyl-L-proline and stimulated by the countertransport effect of this dipeptide. The other peptides also inhibited cefixime uptake significantly. A valinomycin-induced inside-negative K+-diffusion potential had a dramatic reducing effect on the uptake of dianionic cefixime. All the data obtained in this study demonstrate that cefixime transport across the brush-border membrane vesicles is carrier-mediated, independent of Na+ and dependent on a H+ gradient via the peptide transport systems.

Amino Acids↗

PubMed1990

[Cefixime treatment in different bacterial infections in the ENT region].

The clinical efficacy and tolerance of cefixime were evaluated in an open uncontrolled clinical trial including 37 patients suffering from ENT-infections. The MIC90 values of this new oral cephalosporin against gram-negative pathogens are less than 1 mg/l. The antibacterial activity of cefixime against gram-negative pathogens is stronger than that of other oral cephalosporins. Cefixime was administered for five to twelve days twice daily in a dose of 200 mg. In one patient the treatment with cefixime was discontinued after five days due to perioral dermatitis. In 33 of 36 patients cure or distinct improvement was observed after cefixime treatment, showing a clinical success rate of 91.7%. Causative organisms were isolated in 17 of 37 patients (47.2%). After the cefixime therapy the causative organisms were eradicated in 13 of 17 patients (76.5%). The tolerance of cefixime is comparable with that of other oral cephalosporins.

Adolescent↗

PubMed1987

Randomized, open label, multicenter trial of cefixime compared with amoxicillin for treatment of acute otitis media with effusion.

Cefixime, a new third generation cephalosporin antibiotic for oral use, was evaluated for safety and efficacy in the treatment of children with acute otitis media with effusion. Fifteen United States clinical investigators participated in the multicenter clinical trial. One hundred twenty children were randomly assigned to a 10-day course of either cefixime, 8 mg/kg, given daily (qd) (60 patients) or amoxicillin, 40 mg/kg/day, administered in three divided doses (60 patients). Tympanocentesis was performed on each patient before therapy was initiated. Pathogens were isolated from a middle ear aspirate in 88% of the cases. Of the specimens from which pathogens were cultured, 33% yielded Haemophilus sp., 41% Streptococcus pneumoniae and 6% Branhamella catarrhalis. Of the 120 patients, 64 (30 cefixime and 34 amoxicillin) were evaluable for assessment of efficacy. Favorable clinical responses (cure or improvement) were obtained in 93% of cefixime-treated patients and in 94% of amoxicillin-treated patients. Overall, bacteriologic eradication rates (as determined by clinical criteria) were 94 and 95%, respectively. Clinical failure or relapse was documented in 2 of 30 (7%) patients treated with cefixime and in 2 of 34 (6%) patients treated with amoxicillin. Gastrointestinal disturbance and rash were significantly more common in children treated with cefixime (22 and 15%, respectively) than in those taking amoxicillin (8 and 2%, respectively), but in only one case was it necessary to discontinue medication because of these adverse effects (rash). Results of this study demonstrate that cefixime given once daily is as safe and effective as amoxicillin in the treatment of acute otitis media with effusion in children and has the possible advantage of less frequent dosing.

Acute Disease↗

PubMed1991

[Effects of cefixime and cefaclor on pharyngeal flora in children].

Influences of cefixime and cefaclor, oral antibiotics, were studied in 50 children (age range, 11 months to 13 years) with pharyngitis. Daily doses of cefixime were 6 to 10 mg/kg in 25 children and those of cefaclor were 40 to 50 mg/kg in 25 children. Pharyngeal swabs were taken before and after 3 to 7 days of the antibiotic treatment. Pathogenic organisms, such as Streptococcus pyogenes, Haemophilus influenzae and Streptococcus pneumoniae, were isolated in 14 children before and in 1 child after cefixime use. But these bacteria were isolated in 15 children before and in 9 children, and 3 strains of H. influenzae and 3 strains of S. pneumoniae were newly isolated after cefaclor use. An isolation rate of Gram-negative bacilli, such as Acinetobacter spp., were increased after use of cefixime. In both antibiotics, isolation rates of yeasts were slightly increased. An isolation rate of alpha-hemolytic streptococci was increased from 16% to 48% by cefixime treatment and from 24% to 52% by cefaclor treatment. The MIC50 of cefixime and cefaclor against alpha-hemolytic streptococci isolated after treatment was higher than that isolated before. Effects of cefixime and cefaclor was less extensive than that of ampicillin in previous reports.

Adolescent↗

PubMed1988

In vitro activity of cefixime (CL284635) and other antimicrobial agents against Haemophilus isolates from pediatric patients.

In vitro activity of cefixime, an experimental oral third-generation cephalosporin and 7 other antimicrobials (ampicillin, augmentin, trimethoprim/sulfamethaxazole, cefamandole, cefotaxime, cefuroxime, and cefaclor) were determined for 150 isolates of Haemophilus obtained from pediatric patients. All (109) non-typeable H. influenzae isolates were sensitive to cefixime and cefotaxime. All (18) isolates of H. parainfluenzae were sensitive to cefotaxime, cefuroxime, cefamandole, cefaclor, and augmentin; 17/18 isolates were sensitive to cefixime. All (23) isolates of H. influenzae-b were sensitive to cefixime, cefotaxime, cefamandole, cefuroxime, cefaclor, and augmentin. Only 10/23 were sensitive to tri/sulfa. 137 of 150 (91.3%) isolates had MBCs equivalent to their MICs for cefixime, compared to 149/150 (99.3%) isolates for cefotaxime. Approximately 95% (143/150) of isolates tested had MICs of less than or equal to 0.06 microgram/ml for cefixime. These data demonstrate that in vitro cefixime has good activity against Haemophilus isolates and it is very similar to the activity of cefotaxime.

Anti-Bacterial Agents↗

PubMed1989

Cefixime. A review of its antibacterial activity. Pharmacokinetic properties and therapeutic potential.

Cefixime, previously designated FK027, FR17027 and CL284635, is an orally active cephalosporin with a broad spectrum of antibacterial activity in vitro. It is particularly active against many Enterobacteriaceae, Haemophilus influenzae. Streptococcus pyogenes, Streptococcus pneumoniae and Branhamella catarrhalis, and is resistant to hydrolysis by many beta-lactamases. Cefixime has little activity against Staphylococcus aureus and is inactive against Pseudomonas aeruginosa. Cefixime is distinguished by its 3-hour elimination half-life which permits twice daily, or in many instances once daily, administration. Comparative trials, though few, indicate that the clinical and bacteriological efficacy of cefixime 200 to 400mg daily administered as a single dose or in 2 divided doses, is comparable with that of multiple daily doses of co-trimoxazole (trimethoprim + sulphamethoxazole) or amoxycillin in acute uncomplicated urinary tract infection, with that of amoxycillin, amoxycillin/clavulanic acid and cefaclor in acute lower respiratory tract infections, and with that of amoxycillin and cefroxidine in adult patients with acute tonsillitis or pharyngitis. Several comparative trials in children with acute otitis media demonstrate the similar effectiveness of cefixime 8 mg/kg daily (in 2 divided doses, or as a single daily dose), cefaclor 20 to 40 mg/kg daily and amoxycillin 40 mg/kg daily in 3 divided doses. The most frequently reported adverse effects, diarrhoea and stool changes, are usually mild to moderate in severity, transient, and mostly occur in the first few days of treatment with cefixime. Thus, cefixime is an effective orally active cephalosporin with a relatively long elimination half-life permitting a simplified treatment regimen. It is a suitable alternative to cefaclor or amoxycillin in acute otitis media and acute upper and lower respiratory tract infections, and to amoxycillin or co-trimoxazole in acute uncomplicated urinary tract infections.

Anti-Infective Agents↗

PubMed1989

[Pharmacokinetic interaction of cefixime and 2 antacids. Preliminary results].

A crossover study was undertaken in 8 healthy volunteers to evaluate the pharmacokinetics of cefixime administered orally alone or combined with an antacid. Each subject received successively: cefixime alone, Maalox followed 30 min later by cefixime, then Maalox followed 4 hours later by cefixime and finally Alka-Seltzer followed 30 min later by cefixime. Sixteen blood samples were drawn from 0 to 24 hours after oral administration, and plasma cefixime parameters were determined, using a HPLC assay. Four parameters were used to detect a possible interaction: Cmax, Tmax, AUCO-N and AUCO-alpha. No significant difference was observed between the four parameters. Thus, poor absorption of cefixime when combined with an antacid can be ruled out.

Adult↗

PubMed1989

[Comparative study of intravenous ceftriaxone followed by oral cefixime versus ceftriaxone alone in the treatment of severe upper urinary tract infections].

Cefixime is a new orally active cephalosporin. Its MICs and beta-lactamase stability are similar to those of the parenteral third generation cephalosporins. This trial was conducted to determine the effectiveness and safety of ceftriaxone as compared with a treatment where oral cefixime was given after a 4-day treatment with ceftriaxone in severe upper urinary tract infections usually requiring parenteral treatment during two weeks. In an open, controlled trial, 95 patients met the inclusion criteria; 48 received IV ceftriaxone 2 g daily during 4 days, followed by IM or IV ceftriaxone 1 g daily for 11 days; 47 patients were treated by IV ceftriaxone 2 g.o.d. during 4 days and then by oral cefixime 200 mg b.i.d. for 11 days. Clinical cure at the end of treatment was achieved in 44 patients in the cefixime group and 47 patients of the ceftriaxone group. Ten to 84 days after the end of treatment, the overall clinical cure and bacteriologic eradication rates for these patients were 74.3 per cent (29/39) for cefixime and 81 per cent (34/42) for ceftriaxone. Treatment failure occurred in two patients in the cefixime arm, one in a patient with renal atrophy and vascular stenosis and the other in an 86-year old diabetic and bed-ridden woman with an infection following the use of a urinary catheter. There were eight relapses or re-infections (about 20 per cent) in each group. Seven minor adverse events were seen in six patients treated with ceftriaxone: pain upon IM injection (3 cases), diarrhea (2 cases) associated in one case with a generalized rash for which treatment was discontinued, and nausea (one case). Laboratory changes in both groups were not noteworthy and without clinical relevance. These results suggest that it seems possible to propose new parenteral cephalosporins with conversion to the oral route on the 5th day using the same class of drugs in the treatment of severe upper urinary tract infections, excluding certain urological or vascular underlying conditions and provided that duration of treatment is adapted to the type of clinical setting. These data define more accurately the use of cefixime with respect to currently available drugs.

Administration, Oral↗