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Research Article| Volume 17, ISSUE 4, P701-707, July 1995

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An open-label, noncomparative study to evaluate the efficacy, safety, and tolerability of azithromycin in the treatment of patients with acute sinusitis

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      Abstract

      The efficacy, safety, and tolerability of a 5-day, once-daily course of azithromycin were assessed in patients with acute sinusitis. Patients received two 250-mg capsules of azithromycin on day 1 and once 250-mg capsule on days 2 through 5. Of 102 clinically assessable patients, 27 (26.5%) were cured and 69 (67.5%) were improved on days 5 to 7. At days 12 to 16, 88 (86.3%) had a favorable clinical response. A total of 64 patients experienced adverse events; in all but two patients, adverse events were of mild or moderate severity. Thus azithromycin given once daily for 5 days was an effective treatment for patients with acute sinusitis.
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      References

        • Fiese EF
        • Steffen SH
        Comparison of acid stability of azithromycin and erythromycin A.
        J Antimicrob Chemother. 1990; 25 (Suppl A): 39-47
        • Bright GM
        • Nagel AA
        • Bordner J
        • et al.
        Synthesis, in vitro and in vivo activity of novel 9-deoxo-9a-aza-9a-homerythromycin A derivatives: A new class of macrolide antibiotics, the azalides.
        J Antibiot. 1988; 41: 1029-1047
        • Retsema J
        • Girard A
        • Schelkly W
        • et al.
        Spectrum and mode of action of azithromycin (CP-62,993), a new 15-membered-ring macrolide with improved potency against gram-negative organisms.
        Antimicrob Agents Chemother. 1987; 31: 1939-1947
        • Goldstein FW
        • Emirian MF
        • Coutrot A
        • Acar JF
        Bacteriostatic and bactericidal activity of azithromycin against Haemophilus influenzae.
        J Antimicrob Chemother. 1990; 25 (Suppl A): 25-28
        • Hardy DJ
        • Hensey DM
        • Beyer JM
        • et al.
        Comparative in vitro activities of 14-, 15- and 16-membered macrolides.
        Antimicrob Agents Chemother. 1988; 32: 1710-1719
        • Foulds G
        • Shepard RM
        • Johnson RB
        The pharmacokinetics of azithromycin in human serum and tissues.
        J Antimicrob Chemother. 1990; 25 (Suppl A): 73-82
        • Karma P
        • Pukander J
        • Penttil M
        Azithromycin concentrations in sinus fluid and mucosa after oral administration.
        Eur J Clin Microbiol Infect Dis. 1991; 10: 856-859
        • Coates P
        • Daniel R
        • Houston AC
        • et al.
        An open study to compare the pharmacokinetics, safety and tolerability of a multiple-dose regimen of azithromycin in young and elderly volunteers.
        Eur J Clin Microbiol Infect Dis. 1991; 10: 850-852
        • Gladue RP
        • Bright GM
        • Isaacson RE
        • et al.
        In vitro and in vivo uptake of azithromycin (CP-62,993) by phagocytic cells: Possible mechanism of delivery and release at sites of infection.
        Antimicrob Agents Chemother. 1989; 33: 277-282
        • Panteix G
        • Guillaumond B
        • Harf R
        • et al.
        In-vitro concentration of azithromycin in human phagocytic cells.
        J Antimicrob Chemother. 1993; 31 (Suppl E): 1-4
        • Retsema JA
        • Bergeron JM
        • Girard D
        • et al.
        Preferential concentration of azithromycin in an infected mouse thigh model.
        J Antimicrob Chemother. 1993; 31 (Suppl E): 5-16
      1. 49th ed. Physicians' Desk Reference®. Medical Economics Data Production Company, Montvale, NJ1995
        • Felstead SJ
        • Daniel R
        • European Azithromycin Study Group
        Short-course treatment of sinusitis and other upper respiratory tract infections with azithromycin: A comparison with erythromycin and amoxicillin.
        J Int Med Res. 1991; 19: 363-372
        • Casiano RR
        Azithromycin and amoxicillin in the treatment of acute maxillary sinusitis.
        Am J Med. 1991; 91 (Suppl 3A): 27S-30S
        • Honig PK
        • Wortham DC
        • Zamani K
        • Cantilena LR
        Comparison of the effect of erythromycin clarithromycin and azithromycin on terfenadine steady-state pharmacokinetics and electrocardiographic parameters.
        Drug Invest. 1994; 7: 148-156
        • Amacher DE
        • Schomaker SJ
        • Retsema JA
        Comparison of the effects of the new azalide antibiotic, azithromycin, and erythromycin estolate on rat liver cytochrome P-450.
        Antimicrob Agents Chemother. 1991; 35: 1186-1190
        • Harris S
        • Morse I
        • Hilligoss DM
        • et al.
        Azithromycin and terfenadine: Lack of drug interaction, a double-blind, placebo-controlled study.
        Program and Abstracts of the 33rd Interscience Conference on Antimicrobial Agents and Chemotherapy. 1993; (New Orleans, La Abstract #597)