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In a study of pediatric patients with acute bacterial sinusitis, 7 to 15 years of age, and weighing at least 40 kg, the pharmacokinetics of amoxicillin and clavulanate were assessed following administration of AUGMENTIN XR 2000 mg/125 mg (as two 1000 mg/62.5 mg tablets) every 12 hours with food (Table 2).
Table 2: Mean (SD) Pharmacokinetic Parameters for Amoxicillin and Clavulanate Following Oral Administration of Two AUGMENTIN XR Tablets (2,000 mg/125 mg) Every 12 Hours With Food to Pediatric Patients (7 to 15 Years of
Age and Weighing ? 40kg) With Acute Bacterial Sinusitis Parameter (units) Amoxicillin (n=24) Clavulanate (n=23) AUC(0-?) (mcg•hr/mL) 57.8 (15.6) 3.18 (1.37) Cmax (mcg/mL) 11.0 (3.34) 1.17 (0.67) Tmax (hours) a 2.0 (1.0 -5.0) 2.0 (1.0-4.0) T?(hours) 3.32 (2.21) b 0.94 (0.13) c a Median (range) b n=18.
Amoxicillin binds to penicillin-binding proteins within the bacterial cell wall and inhibits bacterial cell wall amoxicillin 2 grams synthesis. Clavulanic acid is a ?-lactam, structurally related to penicillin, that may inactivate certain ?-lactamase enzymes. Resistance to penicillins may be mediated by destruction of the beta-lactam ring by a beta-lactamase,
altered affinity of penicillin for target, or decreased penetration of the antibiotic to reach the target site.
Amoxicillin alone is susceptible to degradation by ?lactamases, and therefore its spectrum of activity does not include bacteria that produce these enzymes. Amoxicillin/clavulanic acid has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.
Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae Moraxella catarrhalis.
The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit in vitro minimum inhibitory concentrations (MICs) less than or equal to the susceptible breakpoint for amoxicillin/clavulanic acid. 1 However, the safety and effectiveness of amoxicillin/clavulanic acid in treating clinical infections due to these bacteria have not been established in adequate and well-controlled clinical trials. When available, the clinical microbiology laboratory should provide cumulative results of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment.
Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds.
The MICs should be determined using a standardized test method 1,2 (broth and/or agar). The MIC values should be interpreted according to criteria provided in Table 3.
Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to
antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method. 1,3 This procedure uses paper disks impregnated with 30 mcg amoxicillin/clavulanate potassium (20 mcg amoxicillin plus 10 mcg clavulanate potassium) to test susceptibility of microorganisms to amoxicillin/clavulanate potassium.
Disk diffusion interpretive criteria should be interpreted according to criteria provided in Table 3. Table 3: Susceptibility Interpretive Criteria for Amoxicillin/ Clavulanate Potassium Pathogen Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion Zone Diameter (mm) S I R S I R Streptococcus pneumoniae (nonmeningitis isolates) ? 2/1 4/2 ? 8/4 - - - Haemophilus spp.
? 4/2 - ? 8/4 ? 20 - ? 19 Klebsiella children's amoxicillin price pneumonia ? 8/4 16/8 ? 32/16 ? 18 14 to 17 ? 13 S= Susceptible, I=Intermediate, R=Resistant. NOTE: Susceptibility of staphylococci to
amoxicillin/clavulanate may be deduced from testing only penicillin and either cefoxitin or oxacillin.
pneumoniae by disk
diffusion should be determined using a 1mcg oxacillin disk.
NOTE: For nonmeningitis isolates, a penicillin MIC of ? 0.06 mcg/ml (or oxacillin zone ? 20 mm) can predict susceptibility to amoxicillin/clavulanate. NOTE: Beta-lactamase–negative, ampicillin-resistant (BLNAR) H. influenzae isolates should be considered resistant to amoxicillin/clavulanic acid, despite apparent in vitro susceptibility of some BLNAR isolates to these agents.
A report of Susceptible indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound in the blood reaches the concentrations at the site of infection necessary to inhibit growth of the pathogen.
A report of Intermediate indicates that the result should be considered equivocal, and, if
the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated.
This category implies possible clinical applicability in body sites where the drug is physiologically concentrated.
This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected.
Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test. 1,2,3 Standard amoxicillin/clavulanate potassium powder should provide the following range of MIC noted in Table 4. For the disk diffusion technique using the 30 mcg amoxicillin/clavulanate potassium disk, the criteria in Table 4 should be achieved.
Table 4: Acceptable Quality Control Ranges for
Susceptibility Testing Quality Control Organism Minimum Inhibitory Concentration Range (mcg/mL) Disk Diffusion Zone Diameters (mm) Escherichia coli ATCC ®abc 35218 4/2 to 16/8 17 to 22 Escherichia coli ATCC 25922 2/1 to 8/4 18 to 24 Haemophilus influenzae ATCC 49247 2/1 to 16/8 15 to 23 Staphylococcus aureus ATCC 29213 0.12/0.06 to 0.5/0.25 - Staphylococcus aureus ATCC 25923 - 28 to 36 Streptococcus pneumoniae ATCC 49619 0.03/0.015 to 0.12/0.06 - a ATCC = American Type Culture Collection.
b QC strain recommended for testing beta-lactam/beta-lactamase inhibitor combinations.
c This strain may lose its plasmid and develop susceptibility to beta-lactam antimicrobial agents after repeated transfers onto media. Minimize by removing new culture from storage at least monthly, or whenever the strain begins to show increased zone diameters to ampicillin, piperacillin or ticarcillin.
Adults with a diagnosis of acute bacterial sinusitis (ABS) were evaluated in 3 clinical studies. In one study, 363 patients were randomized to receive either AUGMENTIN XR 2,000 mg/125 mg orally every 12 hours or levofloxacin 500 mg orally daily for 10 days in a double-blind, multicenter, prospective trial. These patients were clinically and radiologically evaluated at the test of cure (day 17-28) visit. The combined clinical and radiological responses were 84% for AUGMENTIN XR and 84% for levofloxacin at the test of cure visit in clinically evaluable patients (95% CI for the treatment difference = -9.4, 8.3).
The clinical response rates at the test of cure were 87% and 89%, respectively.
The other 2 trials were non-comparative, multicenter studies designed to
assess the bacteriological and clinical efficacy of AUGMENTIN XR (2,000 mg/125 mg orally every 12 hours for 10 days) in the treatment of 2288 patients with ABS.
Evaluation timepoints were the same as in the prior study. Patients underwent maxillary sinus puncture for culture prior to receiving study medication. pneumoniae with reduced susceptibility to penicillin were accrued through enrollment in these 2 open-label non-comparative clinical trials.
Microbiologic eradication rates for key pathogens in these studies are shown in Table 5.
Table 5: Clinical Outcome for ABS Penicillin MICs of S. pneumoniae Isolates Intent-To-Treat Clinically Evaluable n/N a % 95% CI b n/N a % 95% CI b All S.
pneumonia 344/370 93 — 318/326 98 — MIC ? 2.0 mcg/mL c 35/36 97 85.5, 99.9 30/31 96 83.3, 99.9 MIC = 2.0 mcg/mL 23/24 96 78.9, 99.9 19/20 95 75.1, 99.9 MIC ? 4.0 mcg/mL d 12/12 100 73.5, 100 11/11 100 71.5, 100 H. catarrhalis 94/105 90 — 86/90 96 — a n/N = patients with pathogen eradicated or presumed eradicated/total number of patients. b Confidence limits calculated using exact probabilities.
pneumoniae strains with penicillin MICs of ? 2 mcg/mL are considered resistant to penicillin. Community-Acquired Pneumonia: Four randomized, controlled, double-blind clinical studies and one non-comparative study were conducted in adults with community-acquired pneumonia (CAP).
In comparative studies, 904 patients received AUGMENTIN XR at a dose of 2,000 mg/125 mg orally every 12 hours for 7 or 10 days. In the non-comparative study to assess both clinical and bacteriological efficacy, 1,122 patients received AUGMENTIN XR 2,000 mg/125 mg orally every 12 hours for 7 days.
In the 4 comparative studies, the combined clinical success rate at test of cure ranged from 86% to 95% in clinically evaluable patients who amoxicillin bubble gum received AUGMENTIN XR. Data on the efficacy of AUGMENTIN XR in the treatment of community-acquired pneumonia due to S.
pneumoniae with reduced susceptibility to penicillin were accrued from the 4 controlled clinical studies and the 1 non-comparative study.
The majority of these cases were accrued from the non-comparative study.
pneumonia Penicillin MICs of S.pneumonia Isolates Intent-To-Treat Clinically Evaluable n/N a % 95% CI b n/N a % 95% CI b All S. pneumoniae 318/367 87 — 275/297 93 — MIC ? 2.0 mcg/mL c 30/35 86 69.7, 95.2 24/25 96 79.6, 99.9 MIC = 2.0 mcg/mL 22/24 92 73.0, 99.0 18/18 100 81.5, 100 MIC ? 4.0 mcg/mL d 8/11 73 39.0, 94.0 6/7 86 42.1, 99.6 a n/N = patients with pathogen eradicated or presumed eradicated/total number of patients.
b Confidence limits calculated using exact probabilities. pneumoniae strains with penicillin MICs of ? 2 mcg/mL are considered resistant to penicillin. pneumoniae penicillin MICs of 8 and 16 mcg/mL in the Intent-To-Treat group only. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational Supplement, CLSI document M100-S23. CLSI document M100-S23, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2013.
Clinical and Laboratory Standards Institute (CLSI).
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard -Ninth Edition. CLSI Document M7-A9 Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012. Clinical and Laboratory Standards Institute (CLSI).
Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard -Eleventh Edition. Clinical and Laboratory Standards amoxicillin and clavulanate potassium 625mg Institute, 940 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
Counsel patients to take AUGMENTIN XR every 12 hours with a low fat meal or snack to reduce the
possibility of gastrointestinal upset. If diarrhea develops and is severe or lasts more than 2 or 3 days, call your doctor. Patients should be counseled that antibacterial drugs, including AUGMENTIN XR, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
When AUGMENTIN XR is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by AUGMENTIN XR or other antibacterial drugs in the future. Counsel patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued.
Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial.
If diarrhea is severe or lasts more than 2 or 3 days, patients should contact their physician. Patients should be aware that AUGMENTIN
contains a penicillin class drug product that can cause allergic reactions in some individuals.
COVID-19 Impact & Recovery Analysis - Penicillin Market 2020-2024 | Comorbidities
Associated with Bacterial Infections to Boost Growth | Technavio.
Technavio has announced its latest market research report titled Global Penicillin Market 2020-2024 (Graphic: Business Wire) Technavio has announced its latest market research report titled Global Penicillin Market 2020-2024 (Graphic: Business Wire) LONDON--( BUSINESS WIRE )--Technavio has been monitoring the penicillin market and it is poised to grow by USD 1.65 billion during 2020-2024, progressing at a CAGR of over 4% during the forecast period. The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment. Technavio suggests three forecast scenarios (optimistic, probable, and pessimistic) considering the impact of COVID-19. Please Request Latest Free Sample Report on COVID-19 Impact. The market is fragmented, and the degree of fragmentation will accelerate during the forecast period. Astellas Pharma Inc., Biocon Ltd., Cadila Healthcare Ltd., GlaxoSmithKline Plc, Merck & Co. Inc., Mylan NV, Pfizer Inc., Sanofi, Sun Pharmaceutical Industries Ltd., and Teva Pharmaceutical Industries Ltd.
Although the comorbidities associated with bacterial infections will offer immense growth opportunities, use of alternative therapies will challenge the growth of the market participants. To make the most of the opportunities, market vendors should focus more on the growth prospects in the fast-growing segments, while maintaining their positions in the slow-growing segments.
Penicillin Market is segmented as below: Type Oral Parenteral Geographic Landscape North America Europe Asia ROW. To learn more about the global trends impacting the future of market research, download a free sample: https://www.technavio.com/talk-to-us?report=IRTNTR40093.
Technavio presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources.
Our penicillin market report covers the following areas: Penicillin Market size Penicillin Market trends Penicillin amoxicillin 875 mg potassium clavulanate 125 Market industry analysis. This study identifies the rising awareness about infectious diseases as one of the prime reasons driving the penicillin market growth during the next few years. We provide a detailed analysis of around 25 vendors operating in the penicillin market, including some of the vendors such as Astellas Pharma Inc., Biocon Ltd., Cadila Healthcare Ltd., GlaxoSmithKline Plc, Merck & Co. Inc., Mylan NV, Pfizer Inc., Sanofi, Sun Pharmaceutical Industries Ltd., and Teva Pharmaceutical Industries Ltd. Backed with competitive intelligence and benchmarking, our research reports on the Penicillin Market are designed to provide entry support, customer profile and M&As as well as go-to-market strategy support. Register for a free trial today and gain instant access to 17,000+ market research reports.
CAGR of the market during the forecast period 2020-2024 Detailed information on factors that will assist penicillin market growth during the next five years Estimation of the penicillin market size and its contribution to the parent market Predictions on upcoming trends and changes in consumer behavior The growth of the penicillin market Analysis of the market’s competitive landscape and detailed information on vendors Comprehensive details of factors that will challenge the growth of penicillin market vendors.
Preface Currency conversion rates for US$ PART 03: MARKET LANDSCAPE.
Market ecosystem Market characteristics Market segmentation analysis. Market definition Market sizing 2019 Market size and forecast 2019-2024.
Bargaining power of buyers Bargaining power of suppliers Threat of new entrants Threat of substitutes Threat of rivalry Market condition. Market segmentation by type Comparison by type Oral - Market size and forecast 2019-2024 Parenteral - Market size and forecast 2019-2024 Market opportunity by type.
Geographic segmentation Geographic comparison North America - Market size and forecast 2019-2024 Europe - Market size and forecast 2019-2024 Asia - Market size and forecast 2019-2024 ROW - Market size and forecast 2019-2024 Key leading countries Market opportunity.
Rising awareness about infectious diseases Growing risk of spreading infections via blood transfusions.
Overview Landscape disruption Competitive scenario. Vendors covered Vendor classification Market positioning of vendors Astellas Pharma Inc. Research methodology List of abbreviations Definition of market positioning of vendors. Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions.
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