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Pfizerpen (Penicillin G Potassium) - Summary

 
 



PFIZERPEN SUMMARY

Buffered
PFIZERPEN
(penicillin G potassium)
for Injection

Buffered Pfizerpen (penicillin G potassium) for Injection is a sterile, pyrogen-free powder for reconstitution. Buffered Pfizerpen for Injection is an antibacterial agent for intramuscular, continuous intravenous drip, intrapleural or other local infusion, and intrathecal administration. Each million units contains approximately 6.8 milligrams of sodium (0.3 mEq) and 65.6 milligrams of potassium (1.68 mEq).

Aqueous penicillin G (parenteral) is indicated in the therapy of severe infections caused by penicillin G-susceptible microorganisms when rapid and high penicillin levels are required in the conditions listed below. Therapy should be guided by bacteriological studies (including susceptibility tests) and by clinical response.

The following infections will usually respond to adequate dosage of aqueous penicillin G (parenteral):

  • Streptococcal infections.

NOTE: Streptococci in groups A, C, H, G, L, and M are very sensitive to penicillin G. Some group D organisms are sensitive to the high serum levels obtained with aqueous penicillin G.

Aqueous penicillin G (parenteral) is the penicillin dosage form of choice for bacteremia, empyema, severe pneumonia, pericarditis, endocarditis, meningitis, and other severe infections caused by sensitive strains of the gram-positive species listed above.

  • Pneumococcal infections.
  • Staphylococcal infections –penicillin G sensitive.
  • Other infections: Anthrax.
  • Actinomycosis.
  • Clostridial infections (including tetanus).
  • Diphtheria (to prevent carrier state).
  • Erysipeloid (Erysipelothrix insidiosa) endocarditis.
  • Fusospirochetal infections–severe infections of the oropharynx (Vincent's), lower respiratory tract and genital area due to Fusobacterium fusiformisans spirochetes.
  • Gram-negative bacillary infections (bacteremias)– (E. coli, A. aerogenes, A. faecalis, Salmonella, Shigella and P. mirabilis).
  • Listeria infections (Listeria monocytogenes).
  • Meningitis and endocarditis.
  • Pasteurella infections (Pasteurella multocida).
  • Bacteremia and meningitis.
  • Rat-bite fever (Spirillum minus or Streptobacillus moniliformis).
  • Gonorrheal endocarditis and arthritis (N. gonorrhoeae).
  • Syphilis (T. pallidum) including congenital syphilis.
  • Meningococcic meningitis.

Although no controlled clinical efficacy studies have been conducted, aqueous crystalline penicillin G for injection and penicillin G procaine suspension have been suggested by the American Heart Association and the American Dental Association for use as part of a combined parenteral-oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic, or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen.

NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1

To reduce the development of drug-resistant bacteria and maintain effectiveness of Pfizerpen and other antibacterial drugs, Pfizerpen should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.


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NEWS HIGHLIGHTS

Published Studies Related to Pfizerpen (Penicillin G)

Treatment of streptococcal pharyngitis with once-daily amoxicillin versus intramuscular benzathine penicillin G in low-resource settings: a randomized controlled trial. [2011.06]
BACKGROUND: Primary prevention of acute rheumatic fever is achieved by proper antibiotic treatment of group A beta -hemolytic streptococcal (GAS) pharyngitis... CONCLUSION: If compliance is a major issue, a single dose of IM BPG may be preferable for treatment of GAS pharyngitis.

Administration of perioperative penicillin reduces postoperative serum amyloid a response in horses being castrated standing. [2010.07]
OBJECTIVES: To compare postoperative inflammatory responses in horses administered perioperative procaine penicillin and those not administered penicillin using acute phase protein serum amyloid A (SAA) as a marker of inflammation. STUDY DESIGN: Randomized clinical trial. ANIMALS: Stallions (n=50) castrated under field conditions... CONCLUSIONS: Perioperative antimicrobial therapy reduced the postoperative SAA response, suggesting that bacteria were present in the surgical wound and contributed to inflammation after castration. Horses with elevated preoperative SAA concentrations developed infectious complications more often than horses with normal preoperative SAA concentrations. CLINICAL RELEVANCE: Administration of antimicrobials may be important in horses being castrated standing under field conditions. Increased SAA concentrations seem to be an indicator of increased surgical risk in horses and may be useful before elective surgery for planning.

A phase III equivalence trial of azithromycin versus benzathine penicillin for treatment of early syphilis. [2010.06.01]
BACKGROUND: Syphilis remains an important source of morbidity worldwide. Long-acting penicillin is the only therapy currently recommended for syphilis in much of the world. Because of hesitation to use penicillin for fear of anaphylaxis, there is a need for an effective, well-tolerated alternative to penicillin for syphilis therapy... CONCLUSIONS: In this trial, the efficacy of azithromycin at a dosage of 2.0 g administered orally was equivalent to that of benzathine penicillin G for the treatment of early syphilis in persons without HIV infection.

Comparison of ampicillin plus gentamicin vs. penicillin plus gentamicin in empiric treatment of neonates at risk of early onset sepsis. [2010.05]
AIM: We aimed to compare the clinical efficacy of ampicillin (AMP) vs. penicillin (PEN) both combined with gentamicin in the empirical treatment of neonates at risk of early onset neonatal sepsis (EOS)... CONCLUSIONS: AMP and PEN combined with gentamicin have similar effectiveness in the empiric treatment of suspected neonatal EOS.

Evaluation of penicillin G potassium troches in the treatment of minor recurrent aphthous ulceration in a Chinese cohort: a randomized, double-blinded, placebo and no-treatment-controlled, multicenter clinical trial. [2010.04]
CONCLUSIONS: Penicillin G potassium troches are effective in reducing ulcer size and alleviating ulcer pain of the patients in the treatment of a single episode of MiRAU in this Chinese cohort. Few adverse effects were observed with this therapeutic approach. Copyright 2010 Mosby, Inc. All rights reserved.

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Clinical Trials Related to Pfizerpen (Penicillin G)

Bicillin L-A vs Placebo for the Treatment of Chronic, Plaque-Type Psoriasis Unresponsive to Topical Medications [Recruiting]
The purpose of this study is to determine the efficacy for Bicillin L-A, administered intramuscularly in a dose of 2. 4 million units every three (3) weeks, for the treatment of chronic, plaque-type psoriasis unresponsive to topical medications or when other systemic therapies are contraindicated.

Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia [Recruiting]
This study seeks to determine whether clinical outcome following initial treatment of severe pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin. The study will also provide an estimate of the proportion of Kenyan children with severe pneumonia who fail treatment with a single antibiotic.

Simplified Antibiotic Therapy for Sepsis in Young Infants [Recruiting]
This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families.

A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals [Completed]
To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization.

Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.

Azithromycin/Bicillin Syphilis [Active, not recruiting]
The purpose of this study is to determine if Azithromycin, a drug approved for treatment of other infections, is as affective for syphilis therapy is as the usual treatment. Approximately 600 healthy adults, who are HIV-negative, age 18 to 55 years of age with primary, secondary or early latent syphilis, will be participating in this research study. Volunteers will be enrolled in 4 cities of the United States and in Madagascar. Participants will be chosen randomly (by chance) to receive one of 2 study drugs: Benzathine Penicillin given as one dose (2 shots in the buttocks) or 4 tablets of Azithromycin. Over 2 years, 10 visits are required. Procedures will include blood samples, physical exam, and swabs of sores. For subjects who report history of Penicillin allergy will be given either 2. 0 g of oral Azithromycin or 100 mg Doxycycline taken orally, twice a day for 14 days.

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Page last updated: 2011-12-09

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