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WARNING: NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling.
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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.
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
Clinical Trials Related to Bicillin CR (Penicillin G)
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.
Antibiotic Treatment and Intravenous Immunoglobulin Trial for PANDAS [Not yet recruiting]
An increasing body of evidence indicates that an immune basis might underline a number of
pediatric neuropsychiatric disorders. Research studies found a subgroup of children who had
Obsessive compulsive (OCD) and/or tic disorders following a Group A beta-hemolytic
streptococcal (GAS) infection. The subgroup is identified by the acronym, PANDAS (pediatric
autoimmune neuropsychiatric disorders associated with streptococcal infections. More
recently, several PANDAS variants have been described, including adult-onset variant. There
are many evidences that OCD/tic symptoms could be due to an immunologic reaction against
brain tissues following a streptococcal infection.
The purpose of this study is to know if sertraline (one of the SSRI approved by FDA to
improve OCD/tic symptoms in these patients) plus antibiotic (benzathine penicillin G or
azithromycin in case of penicillin allergy) is more effective than SSRI only.
Patients who will not respond to antibiotic will be treated with intravenous immunoglobulin
(IVIG) in order to inactivate the immune reaction versus brain tissues.(No treatment
response is based on the lack of a Y-BOCS score improvement of at least 35%).
Objectives:
- To determine the safety and efficacy of SSRI+AB compared to SSRI only.
- To test the safety and additional beneficial effects of high dose of IVIG on antibiotic
prophylaxis for the treatment of OCD symptoms in non-responders patients with PANDAS.
Study methodology:
- Participants will be screened to obtain medical history and other information at
Neurologic and Psychiatric Sciences Department of Florence University Hospital and at
Paris-est University.
- Participants will receive a treatment of either SSRI+AB or SSRI+placebo for 12 weeks
(double-blind randomized trial)
- Patients who will not respond to AB will be admitted to the hospital to receive IVIG
for 5 days, for 5 consecutive months.
- Follow-up visits will take place 3 and 6 months after the first evaluation, followed by
6 months follow-ups for 3 additional years.
Blood samples (including blood cytokine determination), ECG, Doppler and 2-dimensional
echocardiogram EEG, imaging studies (2 tesla MRI), and other tests will be performed both
before and after the treatment with SSRI+AB or SSRI+placebo and in case also after IVIG
treatment.
The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients [Not yet recruiting]
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Page last updated: 2013-02-10
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