Penicillin G (Penicillin G Potassium) - Summary

PENICILLIN G SUMMARY

Penicillin G Potassium, USP is a natural penicillin.

Therapy

Penicillin G Potassium Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Penicillin G Potassium Injection, USP may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below; however, once these results become available, appropriate therapy should be continued.

CLINICAL INDICATION	INFECTING ORGANISM
Septicemia, empyema, pneumonia, pericarditis, endocarditis, meningitis	Streptococcus pyogenes (group A β-hemolytic streptococcus), other β-hemolytic streptococci including groups C, H, G, L and M, Streptococcus pneumoniae and Staphylococcus species (non-penicillinase producing strains)
Anthrax	Bacillus anthracis
Actinomycosis (cervico-facial disease and thoracic and abdominal disease)	Actinomyces israelii
Botulism (adjunctive therapy to antitoxin), gas gangrene, and tetanus (adjunctive therapy to human tetanus immune globulin)	Clostridium species
Diphtheria (adjunctive therapy to antitoxin and prevention of the carrier state)	Corynebacterium diphtheriae
Erysipelothrix endocarditis	Erysipelothrix rhusiopathiae
Fusospirochetosis (severe infections of the oropharynx [Vincent’s], lower respiratory tract and genital area)	Fusobacterium species and spirochetes
Listeria infections including meningitis and endocarditis	Listeria monocytogenes
Pasteurella infections including bacteremia and meningitis	Pasteurella multocida
Haverhill fever	Streptobacillus moniliformis
Rat bite fever	Spirillum minus or Streptobacillus moniliformis
Disseminated gonococcal infections	Neisseria gonorrhoeae (penicillin-susceptible)
Syphilis (congenital and neurosyphilis)	Treponema pallidum
Meningococcal meningitis and/or septicemia	Neisseria meningitides
Gram-negative bacillary infections (bacteremias)	Escherichia coli, Enterobacter aerogenes, Alcaligenes faecalis, salmonella , shigella and Proteus mirabilis, Penicillin G is not the drug of choice in the treatment of gram-negative bacillary infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin G Potassium Injection, USP and other antibacterial drugs, Penicillin G Potassium Injection, USP 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 Penicillin G

Periparturient use of parenteral micronised procaine penicillin to reduce the risk of clinical mastitis in heifers after calving. [2009.02.16]
Mastitis in primiparous heifers immediately postpartum can be both a significant welfare concern and a heavy economic loss... Preventative treatment of heifers immediately following calving with 15 million iu micronised procaine penicillin parenterally could be of benefit as part of a control programme aimed at reducing the incidence of clinical mastitis in heifers in their first lactation.

Antibiotic prophylaxis for orthognathic surgery: a prospective, comparative, randomized study between amoxicillin-clavulanic acid and penicillin. [2008.11]
CONCLUSION: There were no differences in infection between the two groups of antibiotics. Based on the present study, short-term penicillin is still the most appropriate choice for prophylactic antibiotic in orthognathic surgery.

Influence of an intramammary infusion at drying-off of combined penethamate hydriodide, benethamine penicillin, and framycetin sulfate on intramammary infections and somatic cell counts in dairy sheep. [2008.09]
The dynamics of intramammary infection (IMI) during the dry period were studied in 435 half-udders of 229 Assaf ewes, belonging to 2 flocks with high and medium IMI prevalences. Ewes were randomly assigned to 2 lots: 1) treated lot (TL) with 223 half-udders (118 ewes), which received complete dry therapy (1 syringe/teat) of an antibiotic combination containing 100 mg of penethamate hydriodide, 280 mg of benethamine penicillin, and 100 mg of framycetin sulfate, and 2) control lot (CL) with 212 nontreated half-udders (111 ewes).

Pharmacodynamic analysis and clinical trial of amoxicillin sprinkle administered once daily for 7 days compared to penicillin V potassium administered four times daily for 10 days in the treatment of tonsillopharyngitis due to Streptococcus pyogenes in children. [2008.07]
An a priori pharmacokinetic/pharmacodynamic (PK/PD) target of 40% daily time above the MIC (T >MIC; based on the MIC(90) of 0.06 microg/ml for Streptococcus pyogenes reported in the literature) was shown to be achievable in a phase 1 study of 23 children with a once-daily (QD) modified-release, multiparticulate formulation of amoxicillin (amoxicillin sprinkle)...

Once-daily amoxicillin versus twice-daily penicillin V in group A beta-haemolytic streptococcal pharyngitis. [2008.06]
BACKGROUND: Rheumatic fever is a preventable chronic disease preceded by group A beta-haemolytic streptococcal (GABHS) pharyngitis. OBJECTIVE: To test the non-inferiority of once-daily (QD) oral amoxicillin to the recommended twice-daily (BID) oral penicillin V in GABHS pharyngitis... CONCLUSION: In this adequately powered study, once-daily oral amoxicillin is not inferior to twice-daily penicillin V for the treatment and eradication of GABHS in children with pharyngitis.

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Clinical Trials Related to Penicillin G

Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin [Terminated]
The purpose of this study is to examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results

TELI TON - Telithromycin in Tonsillitis [Terminated]
This is a multinational, randomized (1: 1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13. 3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.

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.

TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults [Terminated]
This is a multinational, randomized (1: 1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.

Penicillin Skin Testing in Patients With History of Allergic Reactions to Betalactams [Recruiting]
This study aims to compare the readings of skin testing results in patients with suspected penicillin allergy between in-house penicillin test preparation and commercial available penicillin testing kit.

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