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Antimicrobial Agents and Chemotherapy Feb 2019Amoxicillin is widely used to treat bacterial infections in neonates. However, considerable intercenter variability in dosage regimens of antibiotics exists in clinical...
Amoxicillin is widely used to treat bacterial infections in neonates. However, considerable intercenter variability in dosage regimens of antibiotics exists in clinical practice. The pharmacokinetics of amoxicillin has been described in only a few preterm neonates. Thus, we aimed to evaluate the population pharmacokinetics of amoxicillin through a large sample size covering the entire age range of neonates and young infants and to establish evidence-based dosage regimens based on developmental pharmacokinetics-pharmacodynamics. This is a prospective, multicenter, pharmacokinetic study using an opportunistic sampling design. Amoxicillin plasma concentrations were determined using high-performance liquid chromatography. Population pharmacokinetic analysis was performed using NONMEM. A total of 224 pharmacokinetic samples from 187 newborns (postmenstrual age range, 28.4 to 46.3 weeks) were available for analysis. A two-compartment model with first-order elimination was used to describe population pharmacokinetics. Covariate analysis showed that current weight, postnatal age, and gestational age were significant covariates. The final model was further validated for predictive performance in an independent cohort of patients. Monte Carlo simulation demonstrated that for early-onset sepsis, the currently used dosage regimen (25 mg/kg twice daily [BID]) resulted in 99.0% of premature neonates and 87.3% of term neonates achieving the pharmacodynamic target (percent time above MIC), using a MIC breakpoint of 1 mg/liter. For late-onset sepsis, 86.1% of premature neonates treated with 25 mg/kg three times a day (TID) and 79.0% of term neonates receiving 25 mg/kg four times a day (QID) reached the pharmacodynamic target, using a MIC breakpoint of 2 mg/liter. The population pharmacokinetics of amoxicillin was assessed in neonates and young infants. A dosage regimen was established based on developmental pharmacokinetics-pharmacodynamics.
Topics: Amoxicillin; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Female; Humans; Infant; Infant, Newborn; Male; Microbial Sensitivity Tests; Models, Theoretical; Prospective Studies
PubMed: 30509939
DOI: 10.1128/AAC.02336-18 -
Clinical and Experimental Allergy :... Aug 2019Amoxicillin is the most common antibiotic prescribed in children with increasing use over time. While up to 10% of children are labelled as amoxicillin allergic, most... (Review)
Review
Amoxicillin is the most common antibiotic prescribed in children with increasing use over time. While up to 10% of children are labelled as amoxicillin allergic, most children can tolerate amoxicillin after allergy evaluation. It is well documented that the label of amoxicillin allergy in children is associated with adverse health outcomes such as antibiotic-resistant infections. However, it remains controversial how best to assess children for amoxicillin allergy. While in general it is recommended that skin testing be done prior to drug provocation test in the evaluation of amoxicillin allergy, there is increasing evidence that drug provocation testing could be done in lower risk children without skin testing prior. The goal of this article as a narrative review is to review the strengths and limitations of skin testing prior to drug provocation test in children who have a history of either immediate or non-immediate, reactions to amoxicillin.
Topics: Amoxicillin; Anti-Bacterial Agents; Child; Child, Preschool; Drug Hypersensitivity; Female; Humans; Male; Skin Tests
PubMed: 31141238
DOI: 10.1111/cea.13443 -
Nihon Rinsho. Japanese Journal of... Feb 2002
Review
Topics: Amoxicillin; Animals; Drug Resistance, Bacterial; Drug Therapy, Combination; Enzyme Inhibitors; Helicobacter Infections; Helicobacter pylori; Humans; Omeprazole; Proton Pump Inhibitors
PubMed: 11979866
DOI: No ID Found -
Clinical Pharmacy 1984The chemistry, microbiology, pharmacokinetics, therapeutic use, adverse effects, and dosage of amoxicillin-potassium clavulanate, a beta-lactamase-resistant antibiotic... (Review)
Review
The chemistry, microbiology, pharmacokinetics, therapeutic use, adverse effects, and dosage of amoxicillin-potassium clavulanate, a beta-lactamase-resistant antibiotic combination, are reviewed. Clavulanic acid is a "suicide" inhibitor of bacterial beta-lactamase enzymes and has been effective in preventing destruction of penicillins by these enzymes. Clavulanic acid alone has weak antibacterial activity against most organisms. After oral administration, clavulanic acid is rapidly absorbed; amoxicillin appears to increase its absorption. Absorption of amoxicillin-clavulanic acid is not affected by food. Amoxicillin-clavulanic acid is effective in treating both acute uncomplicated and complicated urinary-tract infections and exacerbations of chronic bronchitis caused by amoxicillin-resistant organisms in adults. It appears to be comparable in efficacy to cefaclor for treating uncomplicated urinary-tract infections in adults and children, acute bronchitis and bronchopneumonia, and acute sinusitis, otitis media, and skin and soft-tissue infections in children. Other infections for which the combination has been effective include cellulitis and intra-abdominal and pelvic sepsis caused by mixed aerobic/anaerobic organisms. Amoxicillin-clavulanic acid has also successfully cured urethritis in men caused by penicillinase-producing Neisseria gonorrhoeae and is superior to amoxicillin alone for beta-lactamase-positive Haemophilus ducreyi infections (chancroid). Diarrhea or loose stools is the most common side effect seen with amoxicillin-clavulanic acid; nausea, vomiting, and skin rash may also occur. Nausea, vomiting, and diarrhea may be lessened by taking the combination with food.(ABSTRACT TRUNCATED AT 250 WORDS)
Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Chemical Phenomena; Chemistry; Clavulanic Acids; Costs and Cost Analysis; Drug Combinations; Humans; Kinetics; Otitis Media; Penicillin Resistance; Respiratory Tract Infections; Skin Diseases, Infectious; Urinary Tract Infections; beta-Lactamases
PubMed: 6391783
DOI: No ID Found -
Progres En Urologie : Journal de... Jun 2016This is a review article aiming to bring the place and manner of use of amoxicillin-clavulanic acid in urology. (Review)
Review
OBJECTIVE
This is a review article aiming to bring the place and manner of use of amoxicillin-clavulanic acid in urology.
METHOD
Data collection on the conditions of use of amoxicillin-clavulanic acid in urology has been performed from the Medline database. The following keywords were used: amoxicillin; clavulanic acid; urine; diffusion; pharmacokinetics. The selection was based on the methodology, language of publication (English/French), relevance to the topic and date of publication of the articles collected.
RESULTS
Overall, it is clear from the literature and the national and international guidelines that amoxicillin-clavulanic acid in urinary infections can not be used in probabilistic. However, this association remains valid excepted in the treatment of male urinary tract infections due to a probable fault prostatic diffusion. Note that changing the critical concentrations by the CA-SFM/EUCAST for cystitis of this association should allow an extension of its indication in this situation. Serious adverse effects of amoxicillin-clavulanic acid remain rare.
CONCLUSION
If long, the amoxicillin-clavulanic acid played a role of first order in the field of urology, the association has given way to other molecules because of the emergence of resistance. However, A-AC keeps indications in the field of antibiotic therapy in urinary tract infections, surgical antimicrobial prophylaxis and postoperative infections in urology.
Topics: Amoxicillin-Potassium Clavulanate Combination; Humans; Practice Guidelines as Topic; Urinary Tract Infections; beta-Lactamase Inhibitors
PubMed: 27344075
DOI: 10.1016/j.purol.2016.05.002 -
Saudi Journal of Gastroenterology :... 2023Vonoprazan-amoxicillin (VA) dual therapy has recently been proposed to eradicate Helicobacter pylori (H. pylori) with controversial results. We, therefore, conducted a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vonoprazan-amoxicillin (VA) dual therapy has recently been proposed to eradicate Helicobacter pylori (H. pylori) with controversial results. We, therefore, conducted a meta-analysis to assess the effect of this therapy for H. pylori eradication.
METHODS
We searched PubMed, Embase, Cochrane Library, and Web of Science database from inception until November 2022, collecting randomized controlled trials (RCTs) comparing VA dual therapy with other regimens for H. pylori eradication. Pooled relative risks (RRs) were calculated using random effects model.
RESULTS
Five RCTs were ultimately included. Compared with the vonoprazan-amoxicillin-clarithromycin (VAC) triple therapy, the eradication rate of VA dual therapy was lower in intention-to-treat (ITT) analysis (n = 3 RCTs, RR = 0.94, 95% CI: 0.88-0.99, P = 0.03), but there was no significant difference between them in the per-protocol (PP) analysis (RR = 0.96, 95% CI: 0.91-1.01, P = 0.11). For clarithromycin-resistant H. pylori strains, the eradication rate of VA dual therapy was significantly higher than that of the VAC triple therapy (n = 2 RCTs, RR = 1.20, 95% CI: 1.03-1.39, P = 0.02). Compared with the PPI-based triple therapy (PAC), VA dual therapy had a superior eradication rate (n = 2 RCTs, ITT analysis: RR = 1.13, 95% CI: 1.04-1.23, P = 0.003; PP analysis: pooled RR = 1.14, 95% CI: 1.06-1.22, P = 0.0004). Compared with VAC or PAC triple therapy, VA dual therapy has a similar incidence of total adverse events and compliance.
CONCLUSIONS
VA dual therapy had a similar effect compared to VAC triple therapy and was superior to PAC triple therapy. Future RCTs are needed to ascertain the optimal dosage and duration of vonoprazan and amoxicillin, and the effect of VA dual therapy compared with the mainstream regimens recommended by current guidelines.
Topics: Humans; Amoxicillin; Clarithromycin; Anti-Bacterial Agents; Helicobacter pylori; Helicobacter Infections; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Drug Therapy, Combination; Treatment Outcome
PubMed: 37602635
DOI: 10.4103/sjg.sjg_153_23 -
Drugs Feb 1990Clavulanic acid enhances the antibacterial spectrum of amoxicillin by rendering most beta-lactamase-producing isolates susceptible to the drug. In clinical trials... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial Review
Clavulanic acid enhances the antibacterial spectrum of amoxicillin by rendering most beta-lactamase-producing isolates susceptible to the drug. In clinical trials amoxicillin/clavulanic acid is clinically and bacteriologically superior to amoxicillin alone and at least as effective as numerous other comparative agents, such as orally administered cephalosporins, cotrimoxazole, doxycycline and bacampicillin, in the treatment of adults and children with the most common forms of infection encountered in general practice, i.e. urinary tract infections, upper and lower respiratory tract infections, otorhinolaryngological infections, and skin and soft tissue infections. It may also provide effective treatment for uncomplicated gonorrhoea, chancroid and gynaecological infections as well as acting as a prophylactic agent against surgical infection. Thus, in general practice environments where beta-lactamase production has restricted the effectiveness of amoxicillin, the combination of clavulanic acid with amoxicillin has clearly extended the usefulness of a tried and proven first-line antibacterial agent.
Topics: Amoxicillin; Anti-Bacterial Agents; Clavulanic Acid; Clavulanic Acids; Female; Humans; Randomized Controlled Trials as Topic
PubMed: 2184003
DOI: 10.2165/00003495-199039020-00008 -
Expert Opinion on Drug Safety Jan 2009Despite the considerable number of newer antibacterials made available over the past decades, amoxicillin, alone or in combination with clavulanic acid, still accounts... (Comparative Study)
Comparative Study Review
Despite the considerable number of newer antibacterials made available over the past decades, amoxicillin, alone or in combination with clavulanic acid, still accounts among the most widely used antibacterial agents. Although they are often considered 'twin drugs', they are different both in terms of antibacterial activities and of safety profile. It is well documented that the clavulanate component may cause adverse reactions by itself, thus exposing patients to further, and sometimes undue, risks. Although amoxicillin/clavulanate should be considered as an alternative agent only for the treatment of resistant bacteria, evidence shows that it is often used also when a narrow-spectrum antibiotic would have been just as effective. This prescription habit may have serious consequences in terms of patients' safety, as well as in terms of the development of bacterial resistance.
Topics: Amoxicillin; Anti-Bacterial Agents; Clavulanic Acid; Drug Combinations; Drug Resistance, Bacterial; Humans
PubMed: 19236222
DOI: 10.1517/14740330802527984 -
Critical Reviews in Analytical Chemistry May 2017Bacterial infections are the second leading cause of global mortality. Considering this fact, it is extremely important studying the antimicrobial agents. Amoxicillin is... (Review)
Review
Bacterial infections are the second leading cause of global mortality. Considering this fact, it is extremely important studying the antimicrobial agents. Amoxicillin is an antimicrobial agent that belongs to the class of penicillins; it has bactericidal activity and is widely used in the Brazilian health system. In literature, some analytical methods are found for the identification and quantification of this penicillin, which are essential for its quality control, which ensures maintaining the product characteristics, therapeutic efficacy and patient's safety. Thus, this study presents a brief literature review on amoxicillin and the analytical methods developed for the analysis of this drug in official and scientific papers. The major analytical methods found were high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (U-HPLC), capillary electrophoresis and iodometry and diffuse reflectance infrared Fourier transform. It is essential to note that most of the developed methods used toxic and hazardous solvents, which makes necessary industries and researchers choose to develop environmental-friendly techniques to provide enhanced benefits to environment and staff.
Topics: Amoxicillin; Anti-Bacterial Agents; Bacterial Infections; Chromatography, High Pressure Liquid; Green Chemistry Technology; Humans; Streptococcus
PubMed: 28080135
DOI: 10.1080/10408347.2017.1281097 -
Paediatric Drugs 2009Pharmacokinetic/pharmacodynamic (PK/PD) modeling and Monte Carlo simulations suggest that amoxicillin should rarely fail as therapy for Streptococcus pneumoniae and... (Meta-Analysis)
Meta-Analysis Review
Pharmacokinetic/pharmacodynamic (PK/PD) modeling and Monte Carlo simulations suggest that amoxicillin should rarely fail as therapy for Streptococcus pneumoniae and Haemophilus influenzae acute otitis media (AOM) infections except when the S. pneumoniae are highly penicillin resistant or the H. influenzae are beta-lactamase producing. However, important and not infrequent exceptions to this expectation have been described. The objective of this review was to define the biologic variations in amoxicillin PK/PD parameters for the treatment of AOM in children and assess whether these variations could explain why the commonly employed amoxicillin PK/PD model is imperfect in predicting outcome for every patient in this clinical setting. To this end, a literature search of MEDLINE (1966-2006) and EMBASE (1974-2006) was conducted to identify studies that evaluated ampicillin or amoxicillin intestinal absorption, serum concentrations, and/or middle ear fluid (MEF) concentrations. Analysis of studies identified for review showed that the intestinal bioavailability of amoxicillin depends on passive diffusion and a saturable 'pump' mechanism that produces variable serum concentrations of the antibacterial agent. Indeed, substantial differences from patient to patient in serum (5- to 30-fold) and MEF (up to 20-fold) concentrations of amoxicillin occur following oral administration, and 15-35% of children have no detectable amoxicillin in MEF. These findings suggest that variability in PK/PD parameters may impact amoxicillin concentrations in serum and MEF, possibly explaining some AOM treatment failures.
Topics: Acute Disease; Amoxicillin; Anti-Infective Agents; Child; Humans; Otitis Media; Treatment Failure
PubMed: 19566108
DOI: 10.2165/00148581-200911040-00003