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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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Penicillin

Paul A. Pham, Pharm.D. and John G. Bartlett, M.D.
10-20-2010

Zambia Specific Information

  • Available formulation in Zambia (benzathine penicillin): 1.44 g benzylpenicillin (=2.4 million IU) in 5ml vial
  • Syphilis: benzathine penicillin 2.4 million units IM q week x 3 doses
  • Bacterial tonsillitis: 1.2 million units IM x1
  • Available formulation in Zambia (benzyl penicillin) (PCN G): 600 mg (= 1 million IU); 3 g (= 5 million IU) (sodium or potassium salt) vial.
  • Aspiration pneumonia: Benzylpenicillin 2 million units IV q6h (plus metronidazole 400 mg PO q8h).
  • Pyogenic liver abscess: Benzylpenicillin 2 million units IV q6h (plus metronidazole and gentamicin).
  • PID: Benzylpenicillin 2 million units IV q6h (plus metronidazole, gentamicin, and doxycycline).
  • Neurosyphilis: Benzylpenicillin 20 million units per day in 4-6 divided doses x 10 days.
  • Peritonsillar abscess: Benzylpenicillin 2 million units IV q6h
  • Available formulation in Zambia (Phenoxymethyl penicillin) (PCN V): Powder for oral liquid: 250 mg (as potassium salt)/5 ml. Tablet: 250 mg (as potassium salt).
  • Bacterial tonsillitis and/or peritonsillar abscess: phenoxymethylpenicillin 1000 mg PO q12h x 10 days
Zambia Information Author: Paul A. Pham Pharm.D.

INDICATIONS

FDA

  • Endocarditis
  • Skin and soft tissue infection (erysipelas, erysipeloid)
  • Rat-bite fever
  • Syphilis
  • Vincent's infection fusospirochetosis (Vincent's gingivitis and pharyngitis)
  • PCN procaine: anthrax due to Bacillus anthracis, including inhalation anthrax (post-exposure). However, CDC does not recommend as first line agent due to beta-lactamase production (see "biodefense-anthrax").
  • Actinomycosis
  • Empyema
  • Pasteurella infections
  • Pneumonia, upper respiratory tract infection, Otitis media, venereal infections (penicillin G benzathine suspension), rheumatic fever prophylaxis, chorea prophylaxis, upper bacterial respiratory infection, syphilis and neurosyphilis, glomerulonephritis prophylaxis, prophylaxis for rheumatic fever, rheumatic heart disease, rheumatic chorea.
NON-FDA APPROVED USES

  • Brain Abscess
  • Lung Abscess
  • Endocarditis (S. viridans)
  • Necrotizing Fasciitis (S. pyogenes)
  • Gas Gangrene
  • Lyme Arthritis
  • Neisseria meningitidis
  • Neurosyphilis (Treponema pallidum)

FORMS

brand 
name
 
generic 
Mfg 
brand 
forms
 
cost* 
Penicillin V PotassiumPCN G Potassium~VariousPO
tab
250mg
$0.22
      PO
tab
500mg
$0.40
      PO
susp
125mg/5mL
$0.38 per 5 mL
      PO
susp
250mg/5mL
$0.22 per 5 mL
Penicillin G potassiumPCN G Potassium~Sandoz and various generic manufacturers

      IV
minibag
3MU
$13.69
      IV
minibag
2MU
$13.19
      IV
vial
5MU
$7.99
Bicillin L-APCN G BenzathineMonarch IM
syringe
0.6MU/mL
$33.26 per mL
      IM
syringe
1.2MMU/2mL
$57.60 per 2mL
      IM
syringe
2.4MMU/4mL
$118.04 per 4mL
Bicillin C-RPCN G Benzathine and PCN G Procaine co-formulation.Monarch IM
syringe
1.2mm/mL
$45.92
Bicillin C-R 900/300PCN G Benzathine and PCN G Procaine co-formulation.Monarch IM
syringe
900-300/2mL  Ped
$47.80
      IM
syringe
1.2MMU/2mL Adult
$45.92
Penicillin G sodium PCN G sodium Sandoz and various generic manufacturers IV
vial
5 million units
$47.91

*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

  • Parenteral: Aqueous PCN G:2-4 million units IV q4h.
  • Infective endocarditis (IE): 4 million units IV q4h (see resistance section for duration of treatment).
  • Skin and soft tissue infections, due to susceptible streptococci (rarely used): PCN benzathine/procaine (Bicillin C-R) 2.4 million units IM x 1.
  • Oral: PCN VK:250-500mg PO q6h (amoxicillin generally preferred due to better bioavailability). Twice daily administration may be considered for streptococcal tonsillopharyngitis.
  • Syphilis, including primary, secondary, and latent syphilis: PCN benzathine (Bicillin L-A) 2.4 million units x 1 dose. Note: notbe be confused with Bicillin C-R.
  • Late (latent) syphilis: PCN benzathine (Bicillin L-A) 2.4 million units x 3 doses at 7-day intervals. Note: not be be confused with Bicillin C-R.
  • Neurosyphilis or ocular syphilis: Aqueous PCN G 3-4 million units IV q4h x 14 days. Alternative: Procaine PCN 2.4 million units q24h plus probenecid 500 mg PO q6h x 14 days.
  • Note: Benzathine PCN (Bicillin L-A, use for syphilis) and benzathine/procaine PCN (Bicillin C-R use for skin/soft tissue infection) are NOT interchangeable.

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

Usual dose.

DOSING FOR GLOMERULAR FILTRATION OF 10-50

Neurosyphilis, endocarditis or serious infections: 2-3 million units IV q4h. Mild-moderate infections: 1-1.5 million units IV q4h.

DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN

Neurosyphilis, endocarditis or serious infections: 2 million units IV q4-6h. Mild-moderate infections: 1 million units IV q6h. No dose adjustment needed for oral PCN.

DOSING IN HEMODIALYSIS

Neurosyphilis, endocarditis or serious infections: 2 million units IV q4-6h, dose post-HD on days of dialysis or supplement with 500,000 units post-dialysis. Mild-moderate infections: 1 million units IV q6h.

DOSING IN PERITONEAL DIALYSIS

Neurosyphilis, endocarditis or serious infections: 2 million units IV q4-6h. Mild-moderate infections: 1million units IV q6h.

DOSING IN HEMOFILTRATION

No data. CVVH: consider 2-3 million units q6h for serious infections. CVVHD: consider 3 million units IV q4h for serious infections. 1.5 million units IV q6h for mild-moderate infections.

ADVERSE DRUG REACTIONS

OCCASIONAL

  • Hypersensitivity reaction without anaphylaxis.The most common reaction is idiopathic with a maculopapular or morbilliform rash that occurs in 1-4% of penicillin recipients and 5.2-9.5% of ampicillinrecipients (Lancet 1969;2:969; JAMA 1976;235:918).
  • GI intolerance (with oral administration)
  • Drug fever
  • Coombs' test positive without hemolytic anemia
  • Phlebitis at infusion sites and sterile abscesses at IM sites
  • Jarisch-Herxheimer reaction (with treatment of syphilis or other spirochetal infections)
  • C. difficile-associated colitis
RARE

  • Anaphylaxis: the frequency of anaphylaxis reaction is reported at 0.004 - 0.015% of PCN courses.
  • Hemolytic anemia
  • Thrombocytopenia
  • Leukopenia
  • Interstitial nephritis
  • Hepatitis
  • Seizure (higher doses in pts with renal failure)

DRUG INTERACTIONS

  • Probenecid: increased PCN serum concentration (beneficial if high serum level needed). Avoid co-administration in renal failure.
  • Tetracyclines: antagonism, avoid co-administration. Bactericidal effect of penicillins may be diminished in vivo. 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]. However there was not a difference in mortality between penicillin monotherapy and penicillin plus tetracyclinein the treatment of pneumococcal pneumonia [Arch Intern Med 1953; 91:197].

SPECTRUM

Detailed Spectrum of Activity

RESISTANCE

  • S. pneumoniae: PCN resistance rate was 10.3 % (using resistance 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 ).
  • 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. pneumoniaebreak points (non-meningeal, parenteral therapy PCN): < 2 mcg/mL (sensitive); 4 mcg/mL (intermediate); > 8 mcg/mL (resistant).
  • S. pneumoniaebreak points (meningeal isolates, PCN): < 0.06 mcg/mL (sensitive); > 0.12 mcg/mL (resistant).
  • IE caused by Viridans Group Streptococci and S. bovis with MIC < 0.12 mcg/mL: PCN monotherapy x 4 weeks OR PCN + gentamicin x 2 weeks (short course in uncomplicated cases only).
  • IE caused by Viridans Group Streptococci and S. bovis with MIC >0.12 mcg/mL to 0.5 mcg/mL: PCN x 4 weeks + gentamicin x 2 weeks.
  • IE caused by Viridans Group Streptococci and S. bovis with MIC >0.5 mcg/mL: PCN + gentamicin x 4-6 weeks.

PHARMACOLOGY

Pharmacology

COMMENTS

PCN is the gold standard for treating Group A strep infections and syphilis. Generic substitution of PCN G benzathine injection is not recommended. With continuous infusion, change bag every q12h or use cold packs with infusion pumps to increase stability (JAC 2004; 53: 675).

  • Penicillin skin test: This is useful only for Type I penicillin allergy. The testing requires both major determinants (commercially available as PrePen) and minor determinants (not commercially available in the US). The use of major determinants alone will detect 75-95% of potentially positive reactions; testing with both major and minor determinants will identify 99% (NEJM 1971;285:22). A previous study showed that 80-90% of persons reporting penicillin allergy will have negative tests. The patients who need beta-lactams with a history of penicillin allergy with Type I reactions should have skin testing, and negative results when using both major and minor determinants will assure tolerance without sequelae in over 98%. Frequency of allergic reactions with cephalosporin administration to patients with a positive skin test was 5.6% and for those with a history of penicillin allergy plus a negative test, it was 1.7% (Allergy Clin N Am 1991;11:611).

REFERENCES

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