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Penicillin G Procaine (Penicillin g) - Summary

 
 



Prior to administration of the drug, carefully read the WARNINGS, ADVERSE REACTIONS, and DOSAGE and ADMINISTRATION sections of the labeling.

 

SUMMARY

Penicillin G Procaine Injectable Suspension
TUBEX® 1 mL and 2 mL
for deep IM injection only

This product is designed to provide a stable aqueous suspension of penicillin G procaine, ready for immediate use. This eliminates the necessity for addition of any diluent, required for the usual dry formulation of injectable penicillin.

Penicillin G procaine is indicated in the treatment of moderately severe infections in both adults and pediatric patients due to penicillin-G-susceptible microorganisms that are susceptible to the low and persistent serum levels common to this particular dosage form in the indications listed below. Therapy should be guided by bacteriological studies (including susceptibility tests) and by clinical response.

NOTE: When high, sustained serum levels are required, aqueous penicillin G, either IM or IV, should be used.

The following infections will usually respond to adequate dosages of intramuscular penicillin G procaine: Moderately severe to severe infections of the upper respiratory tract, skin and soft-tissue infections, scarlet fever, and erysipelas due to susceptible streptococci (Group A-without bacteremia).

NOTE: Streptococci in Groups A, C, G, H, L, and M are very sensitive to penicillin G. Other groups, including Group D (enterococcus), are resistant. Aqueous penicillin is recommended for streptococcal infections with bacteremia.

Moderately severe infections of the respiratory tract due to susceptible pneumococci.

NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, peritonitis, and arthritis of pneumococcal etiology are better treated with aqueous penicillin G during the acute stage.

Moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible).

NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Indicated surgical procedures should be performed.

Fusospirochetosis (Vincent's gingivitis and pharyngitis). Moderately severe infections of the oropharynx due to susceptible fusiform bacilli and spirochetes.

NOTE: Necessary dental care should be accomplished in infections involving the gum tissue.

Syphilis (all stages) due to susceptible Treponema pallidum.

NOTE: This drug should not be used in the treatment of beta-lactamase producing organisms which include most strains of Neisseria gonorrhea.

Yaws, Bejel, Pinta due to susceptible organisms.

Penicillin G procaine is an adjunct to antitoxin for prevention of the carrier stage of diphtheria due to susceptible C. diphtheriae.

Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of the disease following exposure to aerosolized Bacillus anthracis.

Rat-bite fever due to susceptible Streptobacillus moniliformis and Spirillum minus organisms.

Erysipeloid due to susceptible Erysipelothrix rhusiopathiae.

Subacute bacterial endocarditis, only in extremely sensitive infections, due to susceptible Group A streptococci.


See all Penicillin G Procaine indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Penicillin G Procaine (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.

more studies >>

Clinical Trials Related to Penicillin G Procaine (Penicillin g)

Penicillin and Metronidazole in Treatment of Peritonsillar Abscess [Completed]
Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are required in addition to abscess drainage we perform a prospective, double blind, placebo-controlled, randomised study on 200 adult patients with peritonsillar abscess. 100 patients are given penicillin and metronidazole and 100 patients get penicillin and placebo. Recovery and recurrence and analyzed.

Penicillin Skin Testing in Patients With History of Allergic Reactions to Betalactams [Completed]
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.

Evaluation of Skin Testing Reagents for Penicillin Allergy [Completed]
A self- or parent-reported history of penicillin allergy excludes approximately 10% of the US population from receiving penicillin (Kerr 1994, Kagy, Blaiss 1998, Solensky et al. 2000, Neugut et al. 2001). Yet approximately 80% of patients labeled as allergic to the penicillins can safely take these antibiotics without fear of a life-threatening reaction (Gadde et al. 1993, Macy et al. 1997). The outcomes of this erroneous classification of patients include unnecessary denial of an effective and well-tolerated class of antibiotics, which are often the treatment of choice. The primary aim of skin testing with the Penicillin Skin Test Kit is to identify subjects at very low risk of developing acute IgE-dependent reactions when given a penicillin or cross-reacting drug. The negative predictive value (NPV) of skin testing is assessed by oral challenge with a penicillin.

Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood [Recruiting]
Pregnant,laboring women will receive 2 grams of oral penicillin V before delivery. At the time of delivery of the infant, umbilical vein cord blood will be obtained from the umbilical cord. These cord blood samples will be sent for bioassay of penicillin levels.

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

more trials >>

Reports of Suspected Penicillin G Procaine (Penicillin g) Side Effects

Drug Hypersensitivity (60)Hypersensitivity (13)NO Adverse Event (7)Nausea (4)Headache (3)Malaise (3)Rash (2)Urticaria (1)Food Allergy (1)Vomiting (1)


Page last updated: 2011-12-09

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