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)

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 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.

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.

Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants [Active, not recruiting]
Approximately one-third of neonatal deaths in developing countries are due to infections acquired through the birth canal and/or exposure to an unclean environment soon after birth. Current World Health Organization recommendations for the management of infants younger than 2 months of age who have serious bacterial infections involve hospitalization and parenteral therapy for at least 10 days with antibiotic regimens containing penicillin or ampicillin combined with an aminoglycoside. However, in many settings throughout the developing world, this is not currently possible, nor is this standard of care likely to be feasible in the near future. Several studies have reported that for a variety of sociocultural reasons many families are unable or unwilling to access hospital-based care and their sick young infants do not get hospitalized, and instead, receive a variety of home-based antibiotic therapies, or none at all. In our community field sites, approximately 70% of families refuse hospital referral for a sick newborn, despite provision of transport.

Thus, there is an urgent need to define the role of community/first-level facility-based care versus hospitalization for the management of young infants with serious bacterial infections, and the potential for community-based parenteral antibiotics as an alternative strategy in resource poor areas with high neonatal mortality rates. Bang and colleagues have demonstrated significant reductions in neonatal mortality from infections in an underdeveloped rural district in Maharashtra, India by a field-based case management approach which used oral cotrimoxazole and intramuscular gentamicin given for 7 days as treatment for neonates with sepsis.

This study is an equivalence randomized controlled trial (RCT) comparing once daily IM ceftriaxone injection to once daily IM procaine penicillin and gentamicin injection, to once daily intramuscular gentamicin injection and twice daily oral cotrimoxazole, given for 7 days in babies with clinically-diagnosed possible serious bacterial infection (pneumonia, or sepsis with or without local infections such as skin or umbilical infections) whose families refused referral to a hospital. After supplementary informed consent, patients meeting specific inclusion and exclusion criteria are randomly allocated to one of the three regimens being tested. The study hypothesis is that all 3 regimens will perform equally well in the treatment of sepsis in a first-level facility setting.

Management of Early Onset Neonatal Septicaemia: Selection of Optimal Antibacterial Regimen for Empiric Treatment [Completed]
A prospective two-center antibiotic regimen switch study will be conducted to compare the

clinical efficacy of two antibiotic regimens - penicillin/gentamicin versus

ampicillin/gentamicin - in the empirical treatment of early onset neonatal sepsis. The

influence of either regimen on bowel colonization pattern and on the development of antibiotic resistance of gut microflora will also be assessed. The primary endpoint is the need for a change in antibacterial treatment within 72 hours of therapy, based on pre-defined criteria. Secondary endpoints will be the incidence rate and etiology of early and late onset neonatal sepsis and susceptibility pattern of causative microorganisms; mortality rate within 60 days; duration of hospitalization in NICU; duration of artificial ventilation; colonization pattern and susceptibility of colonizing bacteria (including resistance to empiric antibiotic regimen).

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