Bicillin CR (Penicillin G Benzathine / Penicillin G Procaine) - Summary

BICILLIN CR SUMMARY

Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) contains equal amounts of the benzathine and procaine salts of penicillin G. It is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin C-R and other antibacterial drugs, Bicillin C-R should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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.

This drug is indicated in the treatment of moderately severe infections due to penicillin-G-susceptible microorganisms that are susceptible to serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including susceptibility testing) and by clinical response.

Bicillin C-R is indicated in the treatment of the following in adults and pediatric patients:

Moderately severe to severe infections of the upper-respiratory tract, scarlet fever, erysipelas, and skin and soft-tissue infections due to susceptible streptococci.

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

Moderately severe pneumonia and otitis media due to susceptible pneumococci.

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

When high, sustained serum levels are required, penicillin G sodium or potassium, either IM or IV, should be used. This drug should not be used in the treatment of venereal diseases, including syphilis, gonorrhea, yaws, bejel, and pinta.

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NEWS HIGHLIGHTS

Published Studies Related to Bicillin CR (Penicillin G)

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]
CONCLUSIONS: Penicillin G potassium troches are effective in reducing ulcer size

Antibiotic prophylaxis for orthognathic surgery: a prospective, comparative, randomized study between amoxicillin-clavulanic acid and penicillin. [2008]
CONCLUSION: There were no differences in infection between the two groups of

Flucloxacillin alone or combined with benzylpenicillin to treat lower limb cellulitis: a randomised controlled trial. [2005]
patients with lower limb cellulitis... CONCLUSIONS: This study provides no evidence to support the addition of

Efficacy of a new pharmacokinetically enhanced formulation of amoxicillin/clavulanate (2000/125 mg) in adults with community-acquired pneumonia caused by Streptococcus pneumoniae, including penicillin-resistant strains. [2005]
Community-acquired pneumonia (CAP) is a common respiratory illness, frequently caused by Streptococcus pneumoniae... pneumoniae infection was 92.3% (274/297) for amoxicillin/clavulanate, 2000/125 mg and 85.2% (46/54) for comparators (P=0.11).

The efficacy and safety of 50 mg penicillin G potassium troches for recurrent aphthous ulcers. [2003]
recurrent aphthous stomatitis (RAS)... CONCLUSIONS: Topical penicillin G, by mechanisms which remain unclear, reduces

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Clinical Trials Related to Bicillin CR (Penicillin G)

Bicillin L-A vs Placebo for the Treatment of Chronic, Plaque-Type Psoriasis Unresponsive to Topical Medications [Terminated]
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.

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.

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.

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.

Azithromycin/Bicillin Syphilis [Completed]
The purpose of this study is to determine if azithromycin, a drug approved for treatment of other infections, is as effective for syphilis (a sexually transmitted disease) as the standard treatment. Approximately 600 healthy adults, who are HIV-negative, ages 18 to 55 years of age, with primary, secondary or early latent syphilis, will participate in this research study. Volunteers will be enrolled in 5 U. S. cities and in Madagascar. Participants will be chosen randomly (by chance) to receive 1 of 2 study drugs: benzathine penicillin given (2 shots in the buttocks) or 4 tablets of azithromycin. Subjects who report a history of a penicillin allergy will be given either 2. 0 g of oral azithromycin or 100 mg doxycycline taken orally, twice a day for 14 days. Over 2 years, 10 visits will be required. Procedures will include blood samples, physical exams, and swabs of sores.

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