eMedExpert Home > Compare Drugs > Amoxicillin Clavulanate (Augmentin)

• Recurrent Otitis media (infection of the middle ear)
  For recurrent ear infection treatment with amoxicillin/clavulanate for 7 days is comparable to the treatment with amoxicillin for 10 days.
  
  A double-blind study1 with parallel groups, compared treatment with amoxicillin/clavulanate suspension (Spektramox) for 7 days with amoxicillin suspension (Imacillin) for 10 days. Amoxicillin/clavulanate and amoxicillin showed equally high, satisfactory treatment results, i.e. more than a 90% response. Similarly, there was no statistically significant difference between the treatment groups at the second follow-up visit (about 30 days after start of treatment). Elimination of the initially occurring pathogens was equal in the two study groups with the exception of Branhamella catarrhalis which was eliminated to a significantly higher extent with amoxicillin/clavulanate. Both drugs were well tolerated.
• Secretory Otitis media (fluid in the middle ear, or "Glue ear")
  Amoxicillin/clavulanate may have some advantages over amoxicillin in the treatment of otitis media with effusion.
  
  A double-blind randomized clinical trial2 compared amoxicillin/clavulanate potassium and amoxicillin trihydrate for the treatment of otitis media with effusion. At ten days following entry, 29 (51.8%) of 56 patients in the amoxicillin/clavulanate group were effusion free compared with 16 (32.0%) of 50 patients in the amoxicillin group. At four weeks following entry, 26 (50%) of 50 patients in the amoxicillin/clavulanate group were effusion free compared with 23 (51.1%) of 45 patients in the amoxicillin group. By the 16-week visit, 8 (36.4%) of 22 patients in the amoxicillin/clavulanate group who were effusion free at four weeks had recurrence of effusion, compared with 12 (63.2%) of 19 patients in the amoxicillin group.
• Respiratory tract infections (pneumonia, bronchitis, bronchiectasis)
  Amoxicillin plus clavulanic acid is more effective than amoxicillin in the treatment of respiratory infections. Amoxicillin/clavulanic acid is superior to amoxicillin against strains of Branhamella catarrhalis, E. coli, coagulase-negative staphylococci and K. pneumoniae.
  
  A Croatian study3 compared amoxicillin/clavulanic acid and amoxicillin in the treatment of respiratory tract infections. Leucocytosis and macroscopic purulence of sputum significantly improved with amoxicillin/clavulanate therapy while with amoxicillin there was no significant improvement. With respect to the presence of fever, there was no significant difference between two antibiotics. The overall symptoms improvement and bacteriological response (eradication of bacteria) were very good and good in 88.5% of patients treated with amoxicillin/clavulanate compared to 75% of those receiving amoxicillin.
• Sinusitis (sinus infection)
  Both amoxicillin/clavulanate and amoxicillin are equally effective in the treatment of acute sinusitis.
  
  A double-blind, placebo-controlled study4 compared the relative effectiveness of amoxicillin and amoxicillin/clavulanate potassium, in the treatment of acute maxillary sinusitis in children 2 to 16 years of age. 93 children were evaluated: 30 received amoxicillin, 28 received amoxicillin/clavulanate potassium, and 35 received placebo. Clinical assessment was performed at three and ten days. On each occasion, children treated with an antibiotic were more likely to be cured than children receiving placebo. The overall cure rate was 67% for amoxicillin, 64% for amoxicillin/clavulanate potassium, and 43% for placebo.

• Dental Abscess
  A dentoalveolar abscess is an acute lesion characterized by localization of pus in the structures that surround the teeth.
  Amoxicillin/clavulanic acid is as effective as penicillin in the treatment of acute dentoalveolar abscess.
  
  In a randomised, operator-blind, comparative clinical trial21, the efficacy of co-amoxiclav (250 mg amoxicillin plus 125 mg clavulanic acid, eight-hourly) was compared to that of penicillin V (250 mg phenoxymethylpenicillin, six-hourly) in the treatment of acute dentoalveolar abscess. Symptoms improved in all patients, however those receiving amoxicillin/clavulanic acid recorded a significantly greater decrease in pain during the second and third days of the treatment. Only one patient reported a significant adverse effect associated with drug therapy, and this was in the penicillin group.
• Streptococcal pharyngitis (Strep throat)
  Amoxicillin/clavulanic acid and penicillin V are similarly effective for the first treatment of strep throat. There is no evidence that amoxicillin/clavulanic acid is better than penicillin V22.
  
  One hundred and sixty-five consecutive patients ( > 2 years of age) with acute group A streptococcal (GAS) pharyngitis randomly received amoxicillin/clavulanic acid (79 patients) or penicillin V (86 patients). After 7 days, tonsillar cultures from seven patients (9.6%) in the penicillin V group grew group A streptococcus; three of these patients had tonsillitis symptoms. In the amoxicillin/clavulanic acid group these figures were three (3.8%) and two respectively. Within the 12 month follow up period, there were 4 clinical recurrences (6.1%) in the penicillin V group and 7 (9.3%) in the co-amoxiclav group. There is no evidence that amoxicillin/clavulanic acid is better than oral penicillin V for the first treatment of acute GAS pharyngitis, but bacteriological failure and clinical recurrence are strongly associated with the presence of beta-lactamase activity in commensal flora.
• Recurrent Streptococcal tonsillitis
  Amoxicillin/clavulanic acid may be more effective than penicillin V for prevention of recurrent infection.
  
  The failure of penicillin to eradicate Group A beta-haemolytic streptococcal tonsillitis may be caused by beta-lactamase producing bacteria in the tonsillar tissue. A prospective randomized clinical study23 comparing the efficacy of penicillin-V potassium with amoxicillin/ clavulanate potassium in the treatment of acute episodes of recurrent streptococcal tonsillitis was conducted. Twenty children were included in each group. Surface tonsillar cultures were obtained before therapy, 10 days after termination of therapy, and then once every two months for up to one year. beta-Lactamase producing aerobic and anaerobic bacteria were present in 34 of the 40 (85%) tonsillar cultures prior to treatment. Group A beta-haemolytic streptococci were eradicated in 14 of 20 (70%) patients treated with penicillin and in all those treated with amoxicillin/clavulanate potassium. In a one-year follow-up, 11 of the 19 patients treated with penicillin and two of the 18 treated with amoxicillin/clavulanate potassium had recurrent streptococcal tonsillitis (P less than 0.005). This study demonstrates the efficacy of amoxicillin/clavulanate potassium in the therapy of acute episodes of recurrent tonsillitis and prevention of recurrent infection.
• Otitis media
  Amoxicillin/clavulanate is superior to penicillin V in the treatment of otitis media.
  
  Prospective, double-blind, randomized study24 compared the effect of 2 different antimicrobial agents in the treatment of secretory otitis media. 360 children (aged 1-10 years) with secretory otitis media of at least 3 months' duration were evenly distributed among 4 treatment groups: penicillin V for 14 and 28 days, and amoxicillin and clavulanate potassium in combination for 14 and 28 days. Criteria for improvement was a change in tympanometric findings to type C1 or type A. The success rates were in favor of amoxicillin/clavulanate treatment for 28 days (rates for respective 14- and 28-day groups: penicillin V, 23% and 19%; amoxicillin/clavulanate, 31% and 44%). Antimicrobial therapy was more efficient in unilateral vs bilateral disease. Amoxicillin/clavulanate provides superior improvement to penicillin V.

• Otitis media
  Azithromycin and amoxicillin/clavulanate have similar efficacy in the treatment of acute otitis media in children. However, azithromycin is significantly better tolerated than amoxicillin/clavulanate.
  Randomized, double-blind study5 compared azithromycin and amoxicillin/ clavulanate for the treatment of acute otitis media in children. One hundred and eighty-eight children (mean age 3.5 years) were randomized to azithromycin and 185 to co-amoxiclav. At day 10, the clinical success rate was 153/185 (83%) in children treated with azithromycin and 159/181 (88%) in children treated with co-amoxiclav. At day 28, 134/182 (74%) of the children were cured on azithromycin compared with 124/180 (69%) on co-amoxiclav. Also at day 28, signs of acute otitis media, such as abnormal reflectometry (45% versus 59%), bulging of the eardrum (10% versus 16%) and loss of tympanic membrane landmarks (11% versus 22%) were seen less frequently in azithromycin- than co-amoxiclav-treated children, respectively. Treatment-related side effects were seen in 11% of azithromycin patients compared with 20% on co-amoxiclav.
• Sinusitis
  Azithromycin and amoxicillin/clavulanate have similar efficacy in the treatment of sinusitis. However, azithromycin is better tolerated than amoxicillin/clavulanate.
  Randomized double-blind study6 compared 3- and 6-day regimens of azithromycin with a 10-day amoxicillin-clavulanate regimen for treatment of acute bacterial sinusitis. Clinical success (based on direct observation of the patient) rates were equivalent among patients at the end of therapy (azithromycin 3 days, 88.8%; azithromycin 6 days, 89.3%; amoxicillin/clavulanate, 84.9%) and at the end of the study (azithromycin 3 days, 71.7%; azithromycin 6 days, 73.4%; amoxicillin/clavulanate, 71.3%). Patients treated with amoxicillin/clavulanate reported a higher incidence of treatment-related side effects (51.1%) than azithromycin-3 (31.1%) or azithromycin-6 (37.6%). More amoxicillin/clavulanate patients discontinued the study (n = 28) than azithromycin-3 (n = 7) and azithromycin-6 (n = 11). Diarrhea was the most frequent treatment-related side effect.
• Lower respiratory tract infections
  Azithromycin and amoxicillin/clavulanate have similar efficacy in the treatment of lower respiratory tract infections, but azithromycin is better tolerated than amoxicillin/clavulanate. An additional advantage of the azithromycin is the easy administration and short duration of therapy.
  Multicentre randomized double-blind, double-dummy study7 compared the efficacy, safety and tolerability of a 3 day course of azithromycin with a 10 day course of co-amoxiclav in the treatment of children with acute lower respiratory tract infection. Of 110 patients, 56 and 54 patients, respectively, were treated with azithromycin or co-amoxiclav. The percentage of patients cured or clinically improved at days 10-13 (primary endpoint) was 91% for azithromycin and 87% for co-amoxiclav. This difference of 4% was not statistically significant. Significantly more treatment-related side effects were found in the co-amoxiclav group. This was largely due to a higher percentage (43% versus 19%) of gastrointestinal complaints.

• Rhinosinusitis
  Clarithromycin and amoxicillin/clavulanate are first line antibiotics used to treat acute rhinosinusitis. Both antibiotics are equally effective in treatment of acute rhinosinusitis. Clarithromycin produces more rapid improvement in symptoms.
  
  The study25 examined the efficacy of clarithromycin and amoxicillin/clavulanate for the treatment of acute rhinosinusitis relative to the patient's quality of life. Twenty patients completed the study. The six-item Symptom Severity Survey and the Rhinoconjunctivitis quality of life Questionnaire demonstrated significant improvement for all patients at week 4. The six-item Symptom Severity Survey demonstrated significant improvement for clarithromycin at 14 days and at 28 days, whereas amoxicillin/clavulanate patients demonstrated significant improvement in symptoms only at 28 days. The Rhinoconjunctivitis quality of life Questionnaire, which reflects the previous 2 weeks, demonstrated significant improvement for the amoxicillin/clavulanate patients at 28 days.
• Sinusitis
  Clarithromycin ER is comparable, and for selected measures superior, to amoxicillin/clavulanate in the treatment of acute bacterial sinusitis.
  
  The controlled, multicenter, investigator-blinded study26, compared the efficacy and tolerability of clarithromycin extended-release (ER) to amoxicillin/ clavulanate in patients diagnosed with acute bacterial sinusitis. The clinical cure rate in clinically evaluable patients was 98% (184/188) in the clarithromycin ER group and 97% (179/185) in the amoxicillin/clavulanate group. Clinical cure was sustained at the follow-up visit (96% for each treatment group). The pathogen eradication rates were 94% (61/65) in the clarithromycin ER group and 98% (61/62) in the amoxicillin/clavulanate group. The radiological success rate was 94% (172/183) in both the clarithromycin ER and amoxicillin/clavulanate groups. Symptomatic improvement or relief was observed as early as 2 days-5 days after the initiation of study drug, with a statistically significantly higher resolution rate of sinus pressure and improvement/resolution rate of nasal congestion during treatment with clarithromycin ER. The resolution/improvement rate at the test-of-cure visit for each treatment group was > or = 94% for the primary acute sinusitis signs/symptoms, with a statistically significantly higher resolution/improvement rate of purulent nasal discharge with clarithromycin ER. Both study drugs had a positive and rapid impact on quality of life. Patients reported a high level of satisfaction and probability of using either study antibiotic again, and health care resource use was low, with slightly fewer sinusitis-related physician and outpatient visits required by patients in the clarithromycin ER group. The treatment groups were comparable with respect to incidence of drug-related side effects.
• Chronic bronchitis
  Both clarithromycin extended-release and amoxicillin/clavulanate are effective in the treatment of acute exacerbation of chronic bronchitis. However, clarithromycin extended-release is better tolerated.
  
  The study27 examined the efficacy and safety of extended-release formulation of clarithromycin compared with amoxicillin/clavulanate in the treatment of acute exacerbation of chronic bronchitis. Of 287 patients randomized and treated, 270 were clinically evaluable (137 clarithromycin, 133 amoxicillin/clavulanate). Among clinically evaluable patients at test of cure, 85% and 87% of clarithromycin- and amoxicillin/clavulanate-treated patients, respectively, demonstrated clinical cure; among clinically and bacteriologically evaluable patients, 92% versus 89%, respectively, demonstrated bacteriologic cure. Overall pathogen eradication rates were similar in the 2 groups (88% clarithromycin, 89% amoxicillin/clavulanate). Rates of premature discontinuation of study drug for any reason differed between treatments: 3% (4/142) of clarithromycin-treated patients versus 12% (17/145) of amoxicillin/clavulanate-treated patients. One percent (2/142) and 6% (8/145) of the respective treatment groups discontinued study drug because of adverse effects. Adverse events generally occurred with a similar frequency in the 2 groups; however, taste alteration was more common with clarithromycin (9/142) than with amoxicillin/clavulanate (1/145). Mean severity scores for gastrointestinal adverse events showed a significant difference between groups (1.16 for clarithromycin-treated patients and 1.58 for amoxicillin/clavulanate-treated patients).
• Otitis media
  The efficacy of clarithromycin is comparable with amoxicillin/clavulanate in the treatment of acute otitis media in children. Clarithromycin is better tolerated than amoxicillin/clavulanate with a lower incidence of gastrointestinal side effects.
  
  The randomized, investigator-blinded, multicenter trial28 compared the safety and efficacy of clarithromycin and amoxicillin/clavulanate in the treatment of acute otitis media in patients ages 6 months to 12 years. A successful clinical response was seen in 90% (121 of 135) of evaluable clarithromycin patients vs. 92% (133 of 145) of evaluable amoxicillin/clavulanate patients. Clinical failure or relapse (Posttreatment Days 0 to 4) occurred in 10% (14 of 135) of clarithromycin-treated patients vs. 8% (12 of 145) of amoxicillin/clavulanate-treated patients. Gastrointestinal adverse effects were the most commonly reported in both groups. Of these side effects diarrhea was the most frequent, occurring in 12% (19 of 161) of clarithromycin and 32% (57 of 177) of amoxicillin/clavulanate-treated patients.
  

• Acute Otitis Media
  There is evidence from a randomized study in children 6–36 months of age with acute otitis media that a 5-day regimen of cefuroxime axetil is as effective as and may be better tolerated than an 8- or 10-day regimen of amoxicillin/clavulanate8.
• Acute Otitis Media with Effusion
  Cefuroxime axetil suspension 15 mg/kg twice daily is as effective as amoxicillin/clavulanate suspension 13.3 mg/kg three times daily in the treatment of children with acute otitis media with effusion, but produces fewer gastrointestinal side effects, particularly diarrhea9.
• Bronchitis
  Cefuroxime axetil 250 mg twice daily is as effective as amoxicillin/clavulanate 500 mg three times daily in the treatment of acute bronchitis. Cefuroxime axetil produces fewer gastrointestinal adverse events, particularly diarrhea and nausea.
  
  Two independent, investigator-blinded, multicenter, randomized clinical trials10 compared the clinical and bacteriologic efficacy and safety of cefuroxime axetil and amoxicillin/clavulanate, in the treatment of patients with secondary bacterial infections of acute bronchitis. Three hundred sixty patients with signs and symptoms of acute bronchitis were enrolled at 22 centers and were randomly assigned to receive 10 days of treatment with either cefuroxime axetil 250 mg twice daily (BID) (n= 177) or amoxicillin/clavulanate 500 mg three times daily (TID) (n = 183).
  A satisfactory clinical outcome (cure or improvement) was achieved in 86% (117 of 136) and 83% (130 of 157) of the patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively. With respect to the eradication of bacterial pathogens, a satisfactory outcome (cure, presumed care, or cure with colonization) was obtained in 91% (53 of 58) and 86% (60 of 70) of patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively. Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related side effects than was treatment with cefuroxime axetil (39% vs 23%), primarily reflecting a higher incidence of drug-related gastrointestinal adverse effects (37% vs 15%), particularly diarrhea and nausea. Four patients in the cefuroxime axetil group and eight patients in the amoxicillin/clavulanate group withdrew from the study because of drug-related adverse effects.
• Community-acquired pneumonia
  Cefuroxime axetil twice a day is as effective as amoxicillin/clavulanate three times a day in the treatment of outpatients with mild to moderate community-acquired pneumonia.
  
  In a multicentre, investigator-blinded clinical trial11, 162 patients with community-acquired pneumonia were randomly assigned to receive orally either cefuroxime axetil 500 mg twice a day (n = 84) or amoxicillin/clavulanate 500 mg/125 mg three times a day (n = 78) for 10 days. Cure or improvement were achieved in 100% (55 of 55) and 96% (49 of 51) of patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively. With respect to eradication of bacterial pathogens, a satisfactory outcome (cure, presumed cure or cure with colonization) was obtained in 94% (32 of 34) and 93% (37 of 40) of patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively. Both treatment regimens used in this study were well tolerated. The most common drug-related side effects were gastrointestinal, reported by 8% and 4%, respectively, of the patients in the amoxicillin/clavulanate and cefuroxime axetil groups.
• Sinusitis
  Cefuroxime axetil is as effective as amoxicillin/clavulanate in the treatment of acute bacterial sinusitis but produces fewer side effects.
  
  Multicenter study12 compared the clinical and bacteriologic efficacy of cefuroxime axetil and amoxicillin/clavulanate, in the treatment of acute bacterial maxillary sinusitis. A satisfactory clinical outcome (cure or improvement) was achieved in 85% (98 of 115) and 82% (102 of 124) of patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively. With respect to the eradication of the bacterial pathogens, a satisfactory outcome (cure or presumed cure) was obtained in 84% (31 of 37) and 87% (34 of 39) of patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively. Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse effects (13% versus 3%), particularly diarrhea (8% versus 1%). Two patients in the cefuroxime axetil group and three patients in the amoxicillin/clavulanate group withdrew from the study due to adverse effects.

• Chronic suppurative otitis media
  Ciprofloxacin seems to be an effective treatment for chronic otitis media, and superior to amoxicillin/clavulanic acid.
  
  Ciprofloxacin (500 mg twice daily) was compared13 with amoxicillin/clavulanic acid (500 mg three times daily) in 76 persons with chronic suppurative otitis media. At the end of treatment, otorrhoea disappeared in 57.5% of the ciprofloxacin group and 37.1% of the amoxicillin/clavulanic acid group. Bacterial eradication rate was also significantly greater with ciprofloxacin (69.7%) than with amoxicillin/clavulanic acid (27.3%).
• Sinusitis
  Ciprofloxacin is at least as effective as amoxicillin/clavulanic acid in the treatment of chronic sinusitis.
  
  Adults with chronic sinusitis were enrolled into prospective double-blind, double-placebo comparison14 of ciprofloxacin (500 mg twice daily) with amoxicillin/clavulanic acid (500 mg three times daily). Treatment lasted 9 days, at the end of which nasal discharge disappeared in 71/118 (60.2%) patients of the ciprofloxacin group and 69/123 (56.1%) of those in the amoxicillin/clavulanic acid group. The clinical cure and bacteriological eradication rates were 58.6% versus 51.2% and 88.9% versus 90.5% for ciprofloxacin and amoxicillin/clavulanic acid, respectively. These differences were not significant, however, among patients who had a positive initial culture and who were evaluated 40 days after treatment. Ciprofloxacin recipients had a significantly higher cure rate than those treated with amoxicillin/clavulanic acid (83.3% vs. 67.6%). Tolerance was significantly better with ciprofloxacin, essentially due to a large number of gastro-intestinal side-effects in the amoxicillin/clavulanic acid group.
• Urinary tract infections
  Ciprofloxacin is significantly more effective than amoxicillin/clavulanic acid in the treatment of urinary tract infections15.
• Cystitis in women
  Amoxicillin/clavulanate is not as effective as ciprofloxacin for the treatment of cystitis, even in women infected with susceptible bacteria.
  
  In randomized trial16 clinical cure was achieved in 93 (58%) of 160 women treated with amoxicillin/clavulanate compared with 124 (77%) of 162 women treated with ciprofloxacin. Amoxicillin/clavulanate was not as effective as ciprofloxacin even among women infected with strains susceptible to amoxicillin/clavulanate (65 [60%] of 109 women in the amoxicillin/clavulanate group vs 114 [77%] of 149 women in the ciprofloxacin group). The difference in clinical cure rates occurred almost entirely within the first 2 weeks after therapy. Microbiological cure at 2 weeks was observed in 118 (76%) of 156 women treated with amoxicillin/clavulanate compared with 153 (95%) of 161 women treated with ciprofloxacin. At this visit, 45% of women in the amoxicillin/clavulanate group compared with 10% in the ciprofloxacin group had vaginal colonization with E coli.

• Otitis media
  Levofloxacin and amoxicillin/clavulanate are similarly effective for the treatment of recurrent acute otitis media.
  
  In an evaluator-blinded, active-comparator, noninferiority, multicenter study18, children (6 months to <5 years) were randomized to receive levofloxacin (10 mg/kg twice daily) or amoxicillin/clavulanate (14:1; amoxicillin 45 mg/kg twice daily) for 10 days, with evaluations 4-6 days of therapy (visit 2), 2-5 days after completing therapy (visit 3), and 10-17 days after last dose (visit 4). A total of 1650 children were randomized and 1305 were clinically evaluable at visit 3 (630 levofloxacin, 675 comparator). Clinical cure (resolution of signs and symptoms) rates were 72.4% (456 of 630) in levofloxacin-treated and 69.9% (472 of 675) in amoxicillin/clavulanate-treated children. Cure rates were also similar for levofloxacin and comparator for each age group (< or =24 months: 68.9% versus 66.2%; >24 months: 76.9% versus 75.1%; respectively). Cure rates at visit 4 were 74.9% and 73.8% in levofloxacin and amoxicillin/clavulanate groups, respectively. Levofloxacin treatment is non-inferior to amoxicillin/clavulanate treatment overall and in both infants (6 months to 2 years) and children 2-5 years. No differences between treatment groups regarding the frequency or type of adverse events were apparent.
• Sinusitis
  Levofloxacin is as effective and safe as amoxicillin/clavulanic acid in the treatment of maxillary sinusitis. Levofloxacin is more effective in the bacteriological eradication of the infection.
  
  The objective of the study19 was to compare the clinical efficacy and bacteriological response of levofloxacin and amoxicillin/clavulanic acid (co-amoxiclav) in the treatment of purulent maxillary sinusitis. Sixty patients randomly received either levofloxacin 300 mg orally once daily (LEV group) or co-amoxiclav 625 mg three times a day (COA group) for 14 days. Thirty four patients were in the LEV group and 26 patients were in the COA group. Radiological improvement was 61.8% in the LEV group (41.2% resolution, 20.6% improvement) and 61.5% in the COA group (26.9% resolution, 34.6% improvement). Pretreatment maxillary antral aspiration cultures were positive in 28 patients (82.4%) in the LEV group and 20 patients (76.9%) in the COA group. Bacteriological eradication was 78.5% in the LEV group and 70.0% in the COA group, which was not significantly different. In the LEV group, the eradication rate for major pathogens of acute sinusitis was 100% for H. influenzae (both betalactamase +ve and -ve), 100% for S. pneumoniae and S. aureus, 100% for Neisseria species, and 66.7% for P. aeruginosa. The eradication rate in the COA group was 75% for H. influenzae (both betalactamase +ve and -ve), 100% for S. pnumoniae and S. aureus, 50% for Neisseria species, and 0% for P. aeruginosa. There were no significant changes in vital sign measurements or hemato-biochemical parameters at the end of treatment as compared to baseline values, in both groups. Adverse events were found in 8.8% of patient in the LEV group and in 7.7% of patients in the COA group. Adverse events included nausea, abdominal pain, and diarrhea. All the adverse events in both groups were mild and resolved spontaneously.
• Chronic bronchitis
  Levofloxacin appears to be slightly more effective than amoxicillin/clavulanate for treatment of acute bacterial exacerbation of chronic bronchitis.
  
  Post hoc analysis20 of data from a previous randomized, blinded, multicenter, parallel, noninferiority study assessed the bacterial etiology, symptom resolution, and tolerability of severe acute bacterial exacerbation of chronic bronchitis (ABECB) patients treated with either levofloxacin for 5 days or amoxicillin/clavulanate for 10 days. A total of 369 patients were included in the intent-to-treat population (187 treated with levofloxacin and 182 treated with amoxicillin/clavulanate), and 175 patients were microbiologically assessable (86 treated with levofloxacin and 89 treated with amoxicillin/clavulanate). At the on-treatment visit, a significantly higher proportion of microbiologically assessable patients in the levofloxacin group resolved purulent sputum production (57.5% vs 35.6%), sputum production (65.4% vs 45.3%), and cough (60.0% vs 44.0%), compared with the amoxicillin/clavulanate group. However, no significant between-group differences were observed at posttreatment. A total of 341 pathogens were isolated, of which 143 (41.9%) were traditional ABECB flora, 181 (53.1%) were other gram-negative organisms, and 17 (5.0%) were gram-positive organisms. Overall susceptibility of the pathogens was 97.1% for levofloxacin and 90.6% for amoxicillin/clavulanate. The prevalence of treatment-emergent adverse events was 42.1 % in patients who received levofloxacin and 48.6 % in those who received amoxicillin/clavulanate.

• Tracheobronchitis
  Doxycycline and amoxicillin/clavulanic acid are equally effective in the treatment of tracheobronchitis in adults. Gastrointestinal side effects occur more frequently with amoxicillin/clavulanic acid than with doxycycline.
  
  Doxycycline and amoxicillin/clavulanic acid (co-amoxiclav) were compared in a randomized clinical trial17 in patients with acute suppurative tracheobronchitis. Patients were treated for 5 to 10 days with either antibiotic following three schemes: co-amoxiclav 500 mg three times daily, or doxycycline 200 mg on day 1 followed by 100 mg daily, or 200 mg daily. Patients with inadequate response to the initial treatment were crossed over to the alternative antibiotic. Both antibiotic regimens proved equally efficacious, with rates of clinical response (cure or improvement) of 89% and 91% for doxycycline and co-amoxiclav, respectively. Patients who were crossed over to the alternative antibiotic had a significantly lower cure rate after their second course of antibiotics (22% compared with 70%). Adverse effects, most often of gastro-intestinal, were more common in the co-amoxiclav group than in the doxycycline-treated group, but rarely caused cessation of treatment.

• Amoxicillin Clavulanate (Augmentin) Medical Facts

• 1. Stenstrom C, Lundgren K, Ingvarsson L, Bertilson SO. Amoxycillin/clavulanate versus amoxycillin in recurrent otitis media and therapeutic failure in children. Acta Otolaryngol. 1991;111(1):120-9. PubMed
• 2. Chan KH, Mandel EM, Rockette HE, Bluestone CD, Bass LW, Blatter MM, Breck JM, Reisinger KS, Wolfson JH, Wucher FP, et al. A comparative study of amoxicillin-clavulanate and amoxicillin. Treatment of otitis media with effusion. Arch Otolaryngol Head Neck Surg. 1988 Feb;114(2):142-6. PubMed
• 3. Music E, Kumelj M, Prlja D, Paulin A, Potokar T. Comparison of amoxicillin and amoxiclav in the therapy of respiratory infections. Plucne Bolesti. 1989 Jul-Dec;41(3-4):187-92. PubMed
• 4. Wald ER, Chiponis D, Ledesma-Medina J. Comparative effectiveness of amoxicillin and amoxicillin-clavulanate potassium in acute paranasal sinus infections in children: a double-blind, placebo-controlled trial. Pediatrics. 1986 Jun;77(6):795-800. PubMed
• 5. Dunne MW, Latiolais T, Lewis B, Pistorius B, Bottenfield G, Moore WH, Garrett A, Stewart TD, Aoki J, Spiegel C, Boettger D, Shemer A. Randomized, double-blind study of the clinical efficacy of 3 days of azithromycin compared with co-amoxiclav for the treatment of acute otitis media. J Antimicrob Chemother. 2003 Sep;52(3):469-72. Epub 2003 Jul 29. PubMed
• 6. Henry DC, Riffer E, Sokol WN, Chaudry NI, Swanson RN. Randomized double-blind study comparing 3- and 6-day regimens of azithromycin with a 10-day amoxicillin-clavulanate regimen for treatment of acute bacterial sinusitis. Antimicrob Agents Chemother. 2003 Sep;47(9):2770-4. PubMed
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