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 Guide Editors
 Editor In Chief
    Joel E. Gallant, MD, MPH

Pharmacology Editor
    Paul Pham, PharmD, BCPS

Zambia Guideline Team
   Peter Mwaba MMed PhD FRCP
   Alywn Mwinga MMed
   Isaac Zulu MMed MPH
   Velepie Mtonga MMed
   Albert Mwango MBChB
   Jabbin Mulwanda MMed FCS
 

 

 

Drugs>Antimicrobial Agents>
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Azithromycin

Paul A. Pham, Pharm.D. and John G. Bartlett, M.D.
12-01-2010

Zambia Specific Information

  • Available formulation in Zambia: tablets: 250 mg, 500 mg, and 600 mg.
  • MAC prophylaxis: 1200 mg once weekly.
  • MAC treatment: 600 mg once daily + ethambutol 15 mg/kg/d.
  • No drug-drug interactions with PIs, NNRTIs, and rifamycins.
Zambia Information Author: Paul A. Pham, Pharm.D.

INDICATIONS

FDA

  • Treatment and prophylaxis of disseminated M. avium infection (treatment requires co-administration with ethambutol).
  • Community-acquired pneumonia of mild severity (20%-30% of S. pneumonia strains resistant to azithromycin).
  • Pharyngitis/tonsillitis; acute bacterial sinusitis.
  • Acute bacterial exacerbations of chronic obstructive pulmonary disease (Z-pack and Tri-pack).
  • Uncomplicated skin and skin structure infections.
  • Urethritis and cervicitis (caused by GC and C. trachomatis).
  • Genital ulcer disease.
NON-FDA APPROVED USES

FORMS

brand 
name
 
generic 
Mfg 
brand 
forms
 
cost* 
Zithromax and generic azithromycinAzithromycin Pfizer and generic manufacturersPO
Z-Pak
250 mg x 6 tabs
$33.36 per pack
      PO
T ri-pack
6-250 mg tabs (500 mg x 3 days)
$33.36
      PO
tablet
250 mg
$11.12
      PO
tablet
500, 600 mg
$15.57;$18.68
      IV
vial
500 mg
$22.24
      PO
powder packet
1g
$37.89
      PO
suspension
100 mg/5 mL; 200 mg/5 mL (15mL)
$47.08
      PO
Zmax (SR suspension)
2gm/60ml
$67.04

*Prices represent cost per unit specified and are representative of "Average Wholesale Price" (AWP). AWP Prices were obtained and gathered by Lakshmi Vasist Pharm D using the Red Book, manufacturer's information, and the McKesson database.

^Dosage is indicated in mg unless otherwise noted.

USUAL ADULT DOSING

  • CAP: Z-pack 500 mg 1st d, then 250 mg once-daily x 4 days; 500 mg IV once-daily . or Zmax 2 gm x 1
  • Acute bacterial sinusitis; acute exacerbations of chronic bronchitis: Tri-pak 500 mg PO daily x 3d or Z-pack 500mg 1st day, then 250 mg once-daily x 4 days or Zmax 2gm x1
  • MAC prophylaxis: 1200 mg (two 600 mg tabs or suspension) every week.
  • MAC treatment: 600 mg once-daily + ethambutol 15mg/kg/d.
  • Toxoplasmosis: 900-1200 mg po once-daily + pyrimethamine 200 mg PO x 1, then 50-75 mg PO once-daily + leucovorin 10-20 mg once-daily x 6 wks, then half dose of each
  • Gonococcal urethritis or cervicitis: 2 g PO x 1 (poor GI tolerability).
  • Genital ulcer disease (chancroid) or non-gonococcal urethritis (C. trachomatis) or cervicitis: 1 g PO x 1.
  • Early syphilis: 2g PO x 1 (poor GI tolerability). High rates of macrolide resistance reported in San Francisco (CID 2006; 42:337).

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

Usual dose.

DOSING FOR GLOMERULAR FILTRATION OF 10-50

No data, but probably usual dose likely due to high biliary excretion.

DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN

No data, but probably usual dose likely due to high biliary excretion.

DOSING IN HEMODIALYSIS

HD: no data, but usual dose likely.

DOSING IN PERITONEAL DIALYSIS

Usual regimen.

DOSING IN HEMOFILTRATION

No data.

ADVERSE DRUG REACTIONS

COMMON

  • GI intolerance: diarrhea, nausea, and abdominal pain in up to 14% of pts.
OCCASIONAL

  • Reversible dose-dependent hearing loss in 5% with mean exposure of 59 gm.
RARE

  • Erythema multiforme
  • Vaginitis
  • Transaminase elevation
  • Taste/smell perversion and/or loss
  • Exacerbations of myasthenia gravis

DRUG INTERACTIONS

Unlike other macrolides, azithromycin does not significantly inhibit CYP3A4.

  • Pimozide: avoid concurrent administration due to potential for QTc prolongation and cardiac arrhythmia.
  • Theophylline: serum levels of theophylline may be increased. Monitor theophylline levels with co-administration.
  • Warfarin: INR may be increased with co-administration. Monitor INR closely.
  • Cyclosporin: close monitoring of cyclosporine levels is indicated. Azithromycin did not affect cyclosporine in report of 6 pts (Nephron 1996:73:724).
  • No significant interactions with PIs, NNRTIs, RAL, MVC, and ENF.

SPECTRUM

Detailed Spectrum of Activity

RESISTANCE

  • S. pneumoniae  resistance increasing (~25%). Resistance may not correlate with clinical failure when macrolides are used to treat ambulatory respiratory tract infections.
  • Group A strep resistance increasing. Up to 35%of pharyngeal isolates in children were resistant ( Green et al. AAC 2004; 48: 473 )
  • Breakpoint for Streptococcus spp.: < 0.5 mcg/mL (sensitive); 1 mcg/mL (intermediate); > 2 mcg/mL (resistant).
  • Breakpoint for Haemophilus spp.: < 4 mcg/mL.

PHARMACOLOGY

Pharmacology

COMMENTS

Indicated for MAC prophylaxis and treatment in HIV-infected pts. Clarithromycin may have a slight advantage over azithromycin in terms of MAC Cx clearance. Unlike other macrolides, not likely to interact with PIs and NNRTIs. Significance of rising macrolide-resistance in S. pneumoniae (~25% U.S. isolates) of uncertain clinical significance for the treatment of ambulatory respiratory tract infections.

REFERENCES

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