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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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Amoxicillin

Paul A. Pham Pharm.D. and John G. Bartlett M.D.
09-23-2010

Zambia Specific Information

  • Available formulation in Zambia:  Capsule or tablet: 250 mg; 500 mg (anhydrous). Powder for oral liquid: 125 mg (anhydrous)/5 ml.
  • Hydroxylated derivative of ampicillin with similar antibacterial activity and improved oral bioavailability.
  • Increased resistance observed with H.influenzae, N.gonorrhoeae, E.coli, Salmonella, and Shigella.
  • Pneumonia (mild to moderate severity in HIV-negative pts): 1000 mg PO q8h.
  • High failure rates in HIV+ children with severe pneumonia treated with amoxicillin.
  • Otitis media: amoxicillin 90 mg/kg/d divided q8h (children); 1000 mg PO q8h x 5 d (adults).
  • Acute bacterial sinusitis: amoxicillin 1 gm q8h x 10d
  • Dental abscess and/or severe gingivitis: amoxicillin 500 mg PO q8h (if PCN allergic: erythromycin plus metronidazole).
  • Impetigo: amoxicillin 500 mg q8h x 5 d (erythromycin if PCN allergic).
  • Chlamydia: amoxicillin 500 mg PO three times a day x 7d (alternative to doxycycline and erythromycin).

REFERENCES

Zambia Information Author: Paul A. Pham Pharm.D.

INDICATIONS

FDA

  • Bronchopulmonary infections
  • Urinary tract infections (cystitis, pyelonephritis)
  • Duodenal ulcer caused by H. pylori (in combination with clarithromycin and a PPI)
  • Acute bacterial sinusitis
  • Uncomplicated gonorrhea (currently not the drug of choice)
  • Otitis media (, nonbeta-lactamase producer)
  • Proteus mirabilis infections
  • Lower respiratory infection (PCN-sensitive community-acquired pneumonia: CAP)
  • Skin and skin structure infections (would only routinely recommend for streptococcal cellulitis), and nose and throat infections, tonsillitis and/or pharyngitis secondary to S. pyogenes (amoxicillin ER).
NON-FDA APPROVED USES

  • Lyme disease
  • Enterococcus

FORMS

brand 
name
 
generic 
Mfg 
brand 
forms
 
cost* 
AmoxilAmoxicillin trihydrate~GlaxoSmithKlinePO
cap
250mg
0.27
      PO
cap
500mg
0.14
      PO
cap
875mg
0.87
      PO
chew tab
200mg
0.45
      PO
chew tab
400mg
0.55
      PO
susp
125mg/5mL
0.11 per 5mL
      PO
susp
250mg/5mL
0.24 per 5mL
      PO
susp
400mg/5mL
0.54 per 5mL
      IV
vial
250mg; 500mg; 1000 mg
Not available in the U.S.
Moxatag Amoxicillin Middle Brook Pharmaceutical PO
ER tablet
775 mg
$9.00

*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

  • Community-acquired pneumonia: 500mgPO q8h (for sensitive S. pneumoniae); 1000 mg PO q8h (for pts at risk for drug resistant S. pneumoniae) PLUS a macrolide.
  • Higher doses (3-4 gm/day) recommended for some intermediately-resistant pneumococcal infections.
  • UTI (uncomplicated): 250-500mg PO q8h (consider 875mg q12h).
  • Tonsillitis and/or pharyngitis: amoxicillin 250-500 mg PO q8h OR amoxicillin ER 775 mg once-daily with food x 10 days.
  • Skin and soft tissue infections: 250mg-500mg PO q8h (consider 875mg q12h), this is adequate for streptococcal cellulitis but if concern for MSSA would use amoxicillin/clavulanate.

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

250 - 500 mg q8h.

DOSING FOR GLOMERULAR FILTRATION OF 10-50

CrCL >30 ml/min: 250-500 mg. CrCL 10-30 ml/min: 250 - 500 mg q12h.

DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN

500 mg 24h.

DOSING IN HEMODIALYSIS

500 mg q24h. On days of HD, dose post-HD or supplement 250 - 500 mg post-HD.

DOSING IN PERITONEAL DIALYSIS

250 mg q12h.

DOSING IN HEMOFILTRATION

No data. Consider 500 mg q12h.

ADVERSE DRUG REACTIONS

GENERAL

  • Generally well tolerated
COMMON

  • Rash (especially in setting of either infectious mononucleosis or chronic lymphocytic leukemia)
OCCASIONAL

  • Diarrhea  
  • C. difficile colitis
  • Hypersensitivity reactions
  • Jarisch-Herxheimer reaction with spirochetal infections 
  • Drug fever
RARE

  • Coombs' test positive, hemolytic anemia
  • Leukopenia
  • Thrombocytopenia
  • CNS: seizures and twitching (especially seen with high doses in patients with renal failure) 
  • Interstitial nephritis
  • LFT elevations

DRUG INTERACTIONS

  • Allopurinol: may increase the risk of rash with amoxicillin co-administration.
  • Oral contraceptives: may decrease the efficacy. 
  • Tetracyclines: in vitro antagonism when co-administered. In two studies involving a total of 79 patients with pneumococcal meningitis treated with either penicillin plus tetracyclines or penicillin monotherapy resulted in a higher mortality rate (79-85%) in the combination therapy compared to penicillin monotherapy (30-33%) [Arch Intern Med 1951:88:489, Ann Intern Med 1961; 55:545]. Interaction resulted in higher treatment failure for meningitis but not pneumonia (Arch Intern Med 1953; 91:197). Do not co-administer PCN with tetracycline.

SPECTRUM

Detailed Spectrum of Activity

RESISTANCE

  • S. pneumoniae: PCN resistance rate was 10.3 % (using resistant break point MIC of 2 mcg/mL), but only 1.2 % (using an MICs of 8 mcg/mL for IV PCN for non-meningeal involvement, (MMWR 2008; 57: 1353). Without meningeal involvement, S. pneumoniae with MIC of 2 mcg/mL or lower can be treated with high dose PCN or amoxicillin (3-4 gm/day; CID 2005; 41: 139-48 ).
  • Risk factors for drug resistant S. pneumoniae (DRSP): chronic heart, lung, liver, or renal disease; diabetes mellitus; alcoholism; malignancies; asplenia; immunosuppressing conditions or use of immunosuppressing drugs; use of antimicrobials within the previous 3 months.
  • S. pneumoniae break points (non-meningeal, oral therapy PCN): < 0.06 mcg/mL (sensitive); 0.12-1.0 mcg/mL (intermediate); > 2 mcg/mL (resistant).
  • S. pneumoniae break points (non-meningeal, parenteral therapy PCN): < 2 mcg/mL (sensitive); 4 mcg/mL (intermediate); > 8 mcg/mL (resistant).
  • S. pneumoniae break points (meningeal isolates, PCN): < 0.06 mcg/mL (sensitive); > 0.12 mcg/mL (resistant).

PHARMACOLOGY

Pharmacology

COMMENTS

Aminopenicillin derivative with comparable gram-positive & gram-negative coverage to ampicillin, but better absorption and GI tolerance with oral administration. This is the preferred oral penicillin for all infections w/ possible exception of Group A strep pharyngitis (PCN preferred) & shigellosis (ampicillin preferred). When rash occurs with amoxicillin in setting of infectious mononucleosis, this is not a true allergy and does not preclude future use of drug.

Basis for Recommendations

  • Mandell LA, Wunderink RG, Anzueto A, et al. ; Community-Acquired Pneumonia in Adults: Guidelines for Management ; Clinical Infectious Diseases ; 2007 ; Vol. 44 ; pp. S27-72;
    ISSN: 1537-6591;
    PUBMED: 17278083
    Rating: Basis for recommendation
    Comments:Amoxicillin 1 g q8h OR amoxicillin-clavulanate 2 g q12h plus a macrolide is the preferred outpatient treatment regimen in pts at risk for drug resistant S. pneumoniae (DRSP). Pts with chronic illness, alcoholism, and abx within the last 3 months are at risk for DRSP.

REFERENCES

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