Bioequivalence assessment of Azomycin (Julphar, UAE) as compared to Zithromax (Pfizer, USA)--two brands of azithromycin--in healthy human volunteers. [Susceptibility to macrolide antibiotics of Bordetella pertussis and Bordetella parapertussis strains isolated from whooping cough patients in 1968 and in 1997-99] Rx drugs

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This study was designed to investigate the effect of an increased inoculum on the MIC of azithromycin for Salmonella typhi. Growth curves of nine strains were obtained in cation-adjusted Mueller-Hinton broth containing azithromycin at concentrations of 0-32 mg/L, and comparisons made between inoculation with large inocula, estimated as 10(7) cfu/mL, and with small inocula of c. 10(3) cfu/mL. Turbidity developed only with large inocula after 4-8 h in the presence of 8 or 16 mg/L of azithromycin, thus correlating with microscopic appearance of elongated, curved and widened bacteria. Bacteria that had survived exposure to 16 mg/L for 48 h showed low-grade resistance in comparison with those not exposed to antibiotic. Thus, the mechanism of the inoculum effect was expressed as an enlarging bacterial mass during bacteriostasis, with survival of bacterial populations with low-grade resistance of about two-fold increase in MIC.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11733476&dopt=Abstract

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Biopharm Drug Dispos. 2001 Jan;22(1):15-21.
Bioequivalence assessment of Azomycin (Julphar, UAE) as compared to Zithromax (Pfizer, USA)--two brands of azithromycin--in healthy human volunteers.

Najib NM, Idkaidek N, Ghanem IE, Admour I, Mahmood Alam S, Zaman Q, Dham R.

International Pharmaceutical Research Center (IPRC), Amman, Jordan.

Two studies have been performed to assess the relative bioavailability of Azomycin (Julphar, UAE) as compared with Zithromax (Pfizer, USA) at the International Pharmaceutical Research Center (IPRC), Amman, Jordan. One study involved Azomycin capsules and the other Azomycin suspension. Each study enrolled 24 volunteers and in both studies, after an overnight fasting, the two brands of azithromycin were administered as single dose on two treatment days separated by a 2 weeks washout period. After dosing, serial blood samples were collected for a period of 192 h. Plasma harvested from blood, was analysed for azithromycin by HPLC coupled with electrochemical detection. Various pharmacokinetic parameters including AUC(0-t,) AUC(0-infinity,) C(max), T(max), T(1/2) and K(elm) were determined from plasma concentrations for both formulations and found to be in good agreement with the reported values. AUC(0-t), AUC(0-infinity) and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence intervals for the test/reference ratios of these parameters were found within the bioequivalence acceptance range of 80-125%. Based on these statistical inferences it was concluded that Azomycin capsule is bioequivalent to Zithromax capsule and Azomycin suspension is bioequivalent to Zithromax suspension. Copyright 2001 John Wiley & Sons, Ltd.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11745903&dopt=Abstract

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Med Dosw Mikrobiol. 2001;53(1):39-43.
[Susceptibility to macrolide antibiotics of Bordetella pertussis and Bordetella parapertussis strains isolated from whooping cough patients in 1968 and in 1997-99]

[Article in Polish]

Chodorowska M, Kuklinska D, Tyski S.

Zaklad Bakteriologii PZH w Warszawie.

The activity of erythromycin, azithromycin, clarithromycin, dirithromycin, oleandomycin, roxithromycin, spiramycin and josamycin against 21 and 34 B. pertussis strains and against 6 and 8 B. parapertussis strains isolated respectively in the years 1968 and 1997-99 was examined. The antibiotic agar dilution method was used. The minimum concentration of macrolides which inhibited growth of B. pertussis and B. parapertussis was calculated for 50% (MIC50) and 90% (MIC90) of isolates. The susceptibility to macrolides of B. pertussis and B. parapertussis strains isolated in the years 1968 and 1997-99 did not differ significantly. The MIC90 values of erythromycin were the same for B. pertussis (MIC90 = 0.125 mg/l) and B. parapertussis strains (MIC90 = 0.25 mg/l) recovered in 1968 as for those recovered in the years 1997-99. The most active antibiotic against all strains was azithromycin (MIC90 = 0.06 mg/l). The least active antibiotics were oleandomycin (MIC90 = 2-4 mg/l) and spiramycin (MIC90 = 8 mg/l). The study showed that erythromycin remains the antibiotic of choice for treatment of whooping cough and in case of emergence of B. pertussis and/or B. parapertussis strains erythromycin resistant, can be replaced by azithromycin.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11757403&dopt=Abstract

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