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Mond Furadon Nasofrin Azestine SAlbuVent CortiVent OtiClean The STudy The Result Comparative bioavailability study of cefuroxime axetil (equivalent to 500 mg cefuroxime/tablet) tablets (Zednad® versus Zinnat®) in healthy male volunteers. Only ZEDNAD & Zennat have the same : ZEDNAD is the only generic Cefuroxime axetil equivalent to Ceftin What is Acute Cystitis Patient Pregnant episode Recurrence disease 1 st E.Coli E. Coli Staph.
Saprophyticus E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli E. Coli Staph.
Saprophyticus E. Coli E. Coli 95 % 5 % Pathogens E. Coli Staph.
Saprophyticus Acute Cystitis Causes Results Complications Low clinical success rates Persistence of UTI Reinfection The same bacteria not being eradicated in the urine 2 weeks after sensitivity-adjusted treatment Is a recurrence with a different organism, the same organism in more than 2 weeks UTI Complications UTI Complications UTIs in pregnant women pose serious health risks for both mother and child. Miscarriage Premature
labour A colony count of > 10X10X10 cfu/mL of uropathogens is microbiologically diagnostic in women who present with symptoms of acute uncomplicated cystitis You Need You have Low clinical success rates Persistence of UTI Reinfection The same bacteria not being eradicated in the urine 2 weeks after sensitivity-adjusted treatment Is a recurrence with a different organism, the same organism in more than 2 weeks UTI Complications High clinical success rates No Persistence of UTI No Reinfection Antibiotic with Acute Cystitis Pregnants Superior Hyper production of
beta-lactamase Production of IRT enzymes E.coli with no enzyme activity The hyperproduction of TEM-1 ß-lactamase
due to the presence of highly efficient promoters or to the presence of the corresponding bla gene in different copies may result in
The loss of susceptibility to amoxicillin–clavulanate and other ß-lactam–ß-lactamase inhibitor combinations. IRT enzymes represent an adaptive resistance
mechanism specifically developed by bacteria to overcome the activity of beta-lactamase inhibitors. a What is the effective Antibiotic? Cefuroxime Axetil (ZEDNAD) Amoxicillin / Clavulanate Amoxicillin What is the effective Antibiotic? Cefuroxime Axetil Amoxicillin / Clavulanate Amoxicillin What is the non-effective Antibiotic? What is the effective Antibiotic? Cefuroxime Axetil Amoxicillin / Clavulanate Amoxicillin What is the in-effective Antibiotic? Amoxicillin / Clavulanate Amoxicillin / Clavulanate Zendad has beter clinical cure rate than Amox/Clav Zendad has less persistence of UTI than Amox/Clav Zendad has less reinfection rate of UTI than Amox/Clav three two one b c Introduction Clinical cure rate Required antibiotic activity
against all strains of E.Coli What is the Different between :
Zednad and Amox/Clav The Antibiotic activity against all E.coli strains four Persistence of UTI The same bacteria not being eradicated in the urine 2 weeks after sensitivity-adjusted treatment Low Eradication Rate Low Urinary excretion rate Low Urine Concentration What is the best bioavailabity Antibiotic? ZEDNAD Amox/Clav Cefixime 100% 50-80% 50% Urinary Excretion Rate % Cefuroxime Axetil (ZEDNAD) has the best excretion rate
100% of the dose excretion unchanged in the urine.
While the half of both Amox/Clav and Cefixime dose will be exerted in urine What is the best Antibiotic Concentration? Urinary Concentration
& MIC Cefixime ZEDNAD Amox/Clav 1000 2000 4000 6000 3000 7000 5000 1000 500 167 1000 500 167 1000 2000 1300 1000 2000 1300 1000 2000 4000 6000 3000 7000 5000 8 mcg/ml E.Coli MIC Cefuroxime Axetil 8 mcg/ml E.Coli MIC Amox/Clav 1 mcg/ml E.Coli MIC Cefixime Zednad Urine Concentration is 875 fold the Target MIC for all E.Coli type What is the best Antibiotic Eradication Rate? The Eradication Rate Cefuroxime Axetil (ZEDNAD) has the best E.Coli Eradication Rate which is 98.3%.
While Cefixime has the lowest Eradication Rate 74%. ZEDNAD 98.3% Amox/Clav 84% Zednad Has the best eradication rate 98.3% Reinfection Reinfection caused by introduction of a new microorganism from the fecal/perineal flora into the urinary tract However, the original strain may remain as a part of the intestinal flora and may even cause a reinfection of the urinary tract months after the index episode Some Antibiotics will eradicate gram negative bacteria in the
gastrointestinal tract but they are replaced by enterobactereacea or psuedomonas species Amox/Clav Causes overgrowth of enterobacteriacea leads to Facilitates early reinfection Superior Cefixime 74% 1st Trimester Amoxicillin
Increased the risk of Cleft lip 2nd Trimester 3rd Trimester Amoxicillin
Can affect on
Pregnant and Neonate Decreases The plasma and urinary concentration of estrogens during the first days of therapy necrotizing enterocolitis to Neonates Pregnancy Trimester What is the Safest Antibiotic
during Pregnancy? What is
the latest recommendations? 2011 The Society of Obstetricians AND
Gynaecologists OF CANADA Amox/Clav shouldn’t be used in pregnancy in case of pPROM 2012 Amox/Clav
should be avoided in pregnancy unless considered essential by physicians 2012 Pregnancy Category B No evidence of risk in humans-Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities Cefuroxime Axetil (ZEDNAD) The United States Food and Drug Administration (FDA) has defined bioequivalence as "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study" 2011 Investigate the bioequivalence of cefuroxime axetil tablets between a generic test product (A) Zednad® Tablet (500 mg cefuroxime/ tablet, Diamond Pharma, Syria), and the Reference Product (B) Zinnat® Tablet (500 mg cefuroxime/tablet, GlaxoSmithKline, Saudi Arabia) Pharmacokinetic parameters, determined by standard non-compartmental methods, and ANOVA statistics were calculated using SAS Statistical Software. The study demonstrated that the test product (A) was found bioequivalent to the reference product (B) following an oral dose of 500 mg tablet. Therefore, the two formulations were considered to be bioequivalent. AUC 0∞∞ Cmax AUC 0 t Area under the plasma concentration-time (bioavailabibity) curve from time zero to the last measurable concentration Area under the plasma concentration-time curve from time zero extrapolated to the infinite time Maximum observed plasma concentration AUC 0∞∞ Cmax AUC 0 t Area under the plasma concentration-time (bioavailabibity) curve from time zero to the last measurable concentration Area under the plasma concentration-time curve from time zero extrapolated to the infinite time Maximum observed plasma concentration Thanks For Your Listening ZEDNAD Choose The Best