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

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

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*

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

BACKGROUND: The purpose of this research was to compare one hospital family practise residents' diagnostic and therapeutic behavior with a Dupont et al described Guidelines on acute infectious diarrhea in adults and HARRISON'S PRINCIPLES OF INTERNAL MEDICINE 15th edition's algorithm for the management of acute diarrheal patients. METHODS: From March 1, 2003 to April 30, 2003, we reviewed 82 acute diarrheal patients (3.19% of the total patients) who had visited one hospital's emergency room which was located in Jeonju district. Doctor's diagnostic and therapeutic approaches were reviewed on the basis of history and physical exam. Then we compared with the standard algorithm referred above. RESULTS: Inpatients were 36.6% (30 patients) among the total of 82 and 63.4% (52 patients) returned home after symptomatic treatment. Among the 52 return home patients, doctors did not entirely conduct stool exam. Among the 30 hospitalized patients, doctors conducted stool exam in 25% among 4 of 16 high fever patients, in 25% among 2 of 8 moderately dehydrated who had diarrhea more than 10 times per day, and in 60% among 6 of 10 patients whose symptom duration was more than 48 hours. Doctors did not use antibiotics in 76.9% (40 patients) of 52 return home patients. Quinolone and Augmentin tablets were administered to each 6 patients of 12 return home patients. Among the 30 inpatients, Augmentin injection were given to 80% (24 patients) and second-generation cephalosporin with aminoglycoside combination injection to 13.3% (4 patients) and quinolone injection to 6.7% (2 patients). CONCLUSION: Compared with standard algorithm, doctors neglected testing stool examination that may be the most important way to diagnose the specific etiology of acute diarrhea. If we actively utilize the stool exam, it may help in providing the correct diagnosis and suitable treatment.
Adult ; Amoxicillin-Potassium Clavulanate Combination ; Anti-Bacterial Agents ; Diagnosis ; Diarrhea ; Emergency Service, Hospital ; Fever ; Humans ; Inpatients ; Internal Medicine ; Jeollabuk-do ; Tablets

A 77-year-old woman presented with a trauma to the scalp caused from the blade of a windmill. The condition was persistent from the past 50 years. At the initial examination, a deep, foul-smelling and well-circumscribed ulcer was apparent on the head region, involving the majority of the cranium. Skin biopsy specimens of the lesion were nonspecific. The bone biopsy showed extensive necrotic areas of bone and soft tissues, with lymphocytic exudate foci. A computed tomography scan of the head revealed bone destruction principally involving both the parietal bones, and parts of the frontal and occipital bones. Streptococcus parasanguis was isolated from the skin culture, and Proteus mirabilis and Peptostreptococcus sp. were identified in the cultures from the bone. A long-term treatment with amoxicillin-clavulanic acid (1 g/12 h) and levofloxacin (500 mg/day) was prescribed, but even after 6 months, the lesion remained unchanged. The frequency of occurrence of scalp ulcers in dermatological patients is less, principally because of the rich blood supply to this area. We have not found any similar case report of a scalp ulcer secondary to chronic osteomyelitis discovered more than 50 years after the causal trauma. We want to highlight the importance of complete cutaneous evaluation including skin and bone biopsies, when scalp osteomyelitis is suspected.
Aged ; Amoxicillin-Potassium Clavulanate Combination ; Biopsy ; Exudates and Transudates ; Female ; Head ; Humans ; Occipital Bone ; Ofloxacin ; Osteomyelitis ; Parietal Bone ; Peptostreptococcus ; Proteus mirabilis ; Scalp ; Skin ; Skull ; Streptococcus ; Ulcer

BACKGROUND: Antibiotics are used prophylactically in surgery to prevent postoperative infection. However, antibiotics administered in large doses can cause a bleeding diathesis as a result of platelet dysfunction. We wondered whether these antibiotics might impair platelet function by interfering with the initial step of platelet activation: the binding of agonists to their specific receptors on the platelet surface. METHODS: In 30 patients (male 18, women 12) undergoing primary elective knee arthroscopic surgery, the whole blood coagulation system was prospectively evaluated before, and 10 and 40 minutes after administration of 1 g of augmentin. All patients who had abnormal preoperative coagulation profiles or who received anticoagulant or antiplatelet, antibiotics therapy within 7 days prior to surgery were precluded. RESULTS: At 10 minutes after augmentin administration 25 of 30 patients had a significant impairment in all phases of whole blood coagulation as monitored by thromboelastography. In contrast, three of 30 patients had a significantly decreased coagulation time. Two of 30 patients had no significant changes of TEG variables. TEG variables were restored toward baseline in fourty minutes after augmentin administration. CONCLUSIONS: Augmentin can cause a significant but transient change in the viscoelastic properties of blood. Coagulation parameters of the TEG should be measured prior to augmentin administration to prevent and prospect a bleeding diathesis as a result of platelet dysfunction.
Amoxicillin-Potassium Clavulanate Combination ; Anti-Bacterial Agents ; Arthroscopy ; Blood Coagulation ; Blood Platelets ; Disease Susceptibility ; Female ; Hemorrhage ; Humans ; Knee ; Platelet Activation ; Prospective Studies ; Thrombelastography*