To study the bioequivalence of Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets, a randomized cross-over study was conducted in 18 healthy volunteers. A single oral dose of 1,000 mg Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets (Tested formulation, T) or Augmentin syrup (Reference formulation, R). Concentrations in plasma were determined with high-performance liquid chromatography. The main parameters of T were: for Clavulanate Potassium and Amoxicillin, Cmax: 2.46 +/- 1.11 micrograms/ml and 18.81 +/- 7.26 micrograms/ml, Tmax: 1.12 +/- 0.23 h and 1.30 +/- 0.34 h, AUC(0-6 h): 5.18 +/- 2.24 micrograms.h/ml and 45.09 +/- 14.53 micrograms.h/ml, t1/2: 1.43 +/- 0.44 h and 1.09 +/- 0.22 h., respectively. The relative bioavailability of T to R were 96.5 +/- 19.2% and 98.4 +/- 26.1%, respectively. Statistical analysis showed that the two formulations were bioequivalent.
Adult ; Amoxicillin-Potassium Clavulanate Combination ; pharmacokinetics ; Drug Therapy, Combination ; pharmacokinetics ; Humans ; Male ; Tablets ; Therapeutic Equivalency

To study the bioequivalence of Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets, a randomized cross-over study was conducted in 18 healthy volunteers. A single oral dose of 1,000 mg Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets (Tested formulation, T) or Augmentin syrup (Reference formulation, R). Concentrations in plasma were determined with high-performance liquid chromatography. The main parameters of T were: for Clavulanate Potassium and Amoxicillin, Cmax: 2.46 +/- 1.11 micrograms/ml and 18.81 +/- 7.26 micrograms/ml, Tmax: 1.12 +/- 0.23 h and 1.30 +/- 0.34 h, AUC(0-6 h): 5.18 +/- 2.24 micrograms.h/ml and 45.09 +/- 14.53 micrograms.h/ml, t1/2: 1.43 +/- 0.44 h and 1.09 +/- 0.22 h., respectively. The relative bioavailability of T to R were 96.5 +/- 19.2% and 98.4 +/- 26.1%, respectively. Statistical analysis showed that the two formulations were bioequivalent.
Amoxicillin-Potassium Clavulanate Combination/*pharmacokinetics ; Drug Therapy, Combination/*pharmacokinetics ; Tablets ; Therapeutic Equivalency

The Stevens-Johnson syndrome is a severe form of erythema multiforme associated with multiple organ involvement that can result in severe mortality. Various etiologic factors have been reported to include drugs, bacteria, virus, etc. We experienced a case of amoxicillin clavulanic acid induced Stevens-Johnson syndrome with the involvement of oral mucosa, skin, and conjunctiva. This patient was treated with steroid and supportive care.
Amoxicillin* ; Amoxicillin-Potassium Clavulanate Combination* ; Bacteria ; Conjunctiva ; Erythema Multiforme ; Humans ; Mortality ; Mouth Mucosa ; Skin ; Stevens-Johnson Syndrome*

Amoxicillin-Clavulanic acid continues to be one of the most commonly used antibiotic combinations. Hepatic injury due to this antibiotic is rare. We report a case of amoxicillin-clavulanic acid induced hepatitis causing painless jaundice to bring to attention this rare side effect of this commonly used antibiotic. This is a case of a 62-year-old Caucasian female, who presented with acute onset severe painless jaundice, nausea, vomiting, and pruritus of less than 1-week duration. She had completed a course of amoxicillin-clavulanic acid 3 weeks prior to presentation. A careful history pointed to this simple diagnosis. It may be easily missed without an in-depth history and the patient may be subjected to unnecessary expensive tests. This case is reported to highlight cost conscious care by keeping in mind a rare side effect of the commonly used antibiotic.
Amoxicillin-Potassium Clavulanate Combination* ; Diagnosis ; Female ; Gastroenterology ; Hepatitis* ; Humans ; Jaundice ; Middle Aged ; Nausea ; Pruritus ; Vomiting

riie snbjects werc 269 patients with uncomplicated gonococcal urethritis, who visited the Veiereal Disease Clinic of Choong-Ku Public Health Center in Fieoul from August to Decernber 1984. ()ni hundred and four of 108 patients treated with 1.anamycin, 2 gm, IM plus anipi illin,3.5 gm, p0 plus probenecid, 1 gm, PO regirrien recovered with 65(62. 5 post-gonococcal urethritis(PGlJ) and 4(3.7%) failed, One hundred and seven of III patients treated with kanamycin, 2 gm, IM plus talarnpicillin, 2 gm, PO plus probenecid, 1 gm, po regimen recovered with 71 (66. 4% ) post-goriococcal urethritis and 4(3. 6%) failed. It is suggeste,d that both these antibiotic comlbination regimens have similarly good effect in the treatment. of gonococcal urethritis.
Ampicillin* ; Humans ; Kanamycin* ; Probenecid* ; Public Health ; Talampicillin* ; Urethritis

BACKGROUND: Because extended-spectrum -lactamase (ESBL) producing strains can frequent-ly cause therapeutic failure and infectious outbreaks in hospitals, rapid and accurate detection of these strains are important. We compared the Vitek ESBL test with the NCCLS ESBL phenotypic confirmatory test by disk diffusion (NCCLS ESBL test) and double disk synergy test (DDST). METHODS: For a total of 316 clinical isolates composed of Escherichia coli (184), Klebsiella pneu-moniae (120) and Klebsiella oxytoca (12), we performed the Vitek ESBL test and the NCCLS ESBL test. For sixty-eight ESBL producing isolates, the Vitek ESBL test was compared with the NCCLS ESBL test and the DDST. The ESBL producer was defined as an organism showing an increase in the inhibited zone diameter of >or=5 mm for either cefotaxime or ceftazidime in combination with clavu-lanic acid versus its single test. The DDST was performed with 20 mm and 30 mm for interdisk diam-eter. For seven false negative isolates in the Vitek ESBL test, the DDST of cefepime was performed. RESULTS: Compared with the NCCLS ESBL test, the Vitek ESBL test showed one false positive (specificity, 99.6%), seven false negatives (sensitivity, 89.7%) and 97.5% agreement. Seven false negative isolates of the Vitek ESBL test were the cefoxitin-resistant ESBL producer. In positivity for the NCCLS ESBL test of 68 ESBL producing isolates, cefotaxime-clavulanic acid and ceftazidime-clavulanic acid were 94% and 91%. Cefotaxime, ceftazidime, aztreonam and ceftriaxone showed 95/90%, 100/55%, 100/85% and 95/80% positivity in double-disk synergy with amoxicillin-clavulanic acid (AMC) for 20/30 mm of the interdisk diameter respectively. For seven false negative isolates of the Vitek ESBL test, cefepime showed a distinct synergic effect with AMC. CONCLUSIONS: The Vitek ESBL test may be a useful method for clinical laboratories due to its easy, rapid and sensitive method but its method was less sensitive to cefoxitin-resistant ESBL. For these cases, if the NCCLS ESBL test or DDST with cefepime are added, the detection rate of the ESBL pro-ducer can be augmented.
Amoxicillin-Potassium Clavulanate Combination ; Aztreonam ; Cefotaxime ; Ceftazidime ; Ceftriaxone ; Diffusion ; Disease Outbreaks ; Escherichia coli* ; Escherichia* ; Klebsiella oxytoca ; Klebsiella*

OBJECTIVES: Currently established first line therapy of acute (presumed bacterial) rhinosinusitis (ARS) consists of 10 to 14 days of oral amoxicillin or cephalosporins. This study compared the clinical efficacy and tolerance of cefcapene pivoxil (CP) and amoxicillin-clavulanate (AMC) in patients with ARS. METHODS: A randomized, open labeled, double-blinded trial of ARS patients over 15 years of age was performed. Patients diagnosed with ARS received paranasal sinus X-rays and nasal endoscopies and 2 weeks of either CP (150 mg, 3 times/ day) or AMC (625 mg, amoxicillin 500 mg, 3 times/day). All patients revisited the clinic on days 7, 14, and 28 for evaluation of changes in symptoms, endoscopy, and monitoring of any adverse reactions. Demographics, clinical characteristics and drug efficacy were also compared between the two groups. RESULTS: Among the 60 initially enrolled patients (CP 30, AMC 30), 5 patients in the CP group and 6 in the AMC group were excluded due to poor compliance. There were no significant differences in demographic data including age, sex, initial signs and symptoms, endoscopic and X-ray findings between the two groups. Rates of improvement after 2 weeks were 96% and 95.8% in the CP and AMC group, respectively. Sinus symptoms were changed significantly after 2 and 4 weeks, however, there was no difference between groups (P=0.41). The most common adverse reaction was gastrointestinal complication, diarrhea occurred in 1 patient in the CP group and 6 in the AMC group (P=0.04). CONCLUSION: CP and AMC were both effective in treating ARS. The difference of treatment outcome was not found between the two groups, however, gastrointestinal complications were less prevalent in the CP group.
Amoxicillin ; Amoxicillin-Potassium Clavulanate Combination ; Bacterial Infections ; Cephalosporins ; Clavulanic Acid ; Compliance ; Demography ; Diarrhea ; Double-Blind Method ; Endoscopy ; Humans ; Sinusitis ; Treatment Outcome

OBJECTIVES: The goal of the study was to investigate the clinical effects of amoxicillin-clavulanic acid (500+125 mg) with metronidazole 400 mg administered three times daily (Group I) versus azithromycin 500 mg administered once daily and with metronidazole 400 mg three times daily (Group II) for the prevention of postoperative infection following mandibular third molar surgical removal. MATERIALS AND METHODS: The study design was a single-center prospective study. Patients who reported to the Department of Oral and Maxillofacial Surgery between February 2015 and January 2017 for removal of mandibular third molar were screened, and 108 patients were chosen. One surgeon carried out all procedures. Patients were prescribed antibiotics until the two groups contained a similar number of cases. RESULTS: Our data showed that Group II had fewer incidences of surgical site infection, but with no statistical significance. CONCLUSION: Although both treatments are used routinely after removal of the mandibular third molar, neither is significantly better than the other.
Amoxicillin ; Amoxicillin-Potassium Clavulanate Combination* ; Anti-Bacterial Agents ; Antibiotic Prophylaxis ; Azithromycin* ; Humans ; Incidence ; Metronidazole* ; Molar, Third* ; Prospective Studies ; Surgery, Oral ; Surgical Wound Infection

During the course of infectious mononucleosis, intake of ampicillin and its analogues such as amoxicillin may cause hypersensitivity skin rashes. We report herein a case of ampicillin induced skin rash in a 41-year-old female patient with infectious mononucleosis. Infectious mononucleosis was confirrned by datetion of IgM antibody against Epstein-Barr(EB) viral capsid antigen(VCA) in her serum. During the icuteillness, she taked ampicillin for 3 days, and 1 week after the intake of ampicillin, a genertliz:d erythernatous and purpuric maculopapualr eruption developed. Physicians should be careful not to use ampicillin and its analogue if batients are suspected to be infected with EB virus as ampicillin induces severe skin rashes in patients with infectious mononucleosis.
Adult ; Amoxicillin ; Ampicillin* ; Capsid ; Exanthema* ; Female ; Humans ; Hypersensitivity ; Immunoglobulin M ; Infectious Mononucleosis* ; Skin*

Reference materials containing mixed degradation products of amoxicillin and ampicillin were developed after optimization of preparation processes. The target impurities were obtained by controlled stress testing, and each major component was identified with HPLC-MS and compared with single traceable reference standard each. The developed reference materials were applied to system suitability test for verifying HPLC system performed in accordance with set forth in China Pharmacopeia and identification of major impurities in samples based on retention and spectra information, which have advantages over the methods put forth in foreign pharmacopoeias. The development and application of the reference materials offer an effective way for rapid identification of impurities in chromatograms, and provide references for analyzing source of impurities and evaluation of drug quality.
Amoxicillin ; chemistry ; Ampicillin ; chemistry ; China ; Chromatography, High Pressure Liquid ; Drug Contamination ; Mass Spectrometry ; Reference Standards