875 mg

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

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

MICs

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

In comparative studies, 904 patients received

AUGMENTIN

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

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 Institute, 940 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA,

2012

Counsel patients to

take

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

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

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.

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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

rates

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

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.