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Primaxin I.M. (Imipenem / Cilastatin Sodium) - Summary

 
 



PRIMAXIN I.M. SUMMARY

PRIMAXIN I.M. (Imipenem and Cilastatin for Injectable Suspension) is a formulation of imipenem (a thienamycin antibiotic) and cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase I). PRIMAXIN I.M. is a potent broad spectrum antibacterial agent for intramuscular administration.

PRIMAXIN I.M. is indicated for the treatment of serious infections (listed below) of mild to moderate severity for which intramuscular therapy is appropriate. PRIMAXIN I.M. is not intended for the therapy of severe or life-threatening infections, including bacterial sepsis or endocarditis, or in instances of major physiological impairments such as shock.

PRIMAXIN I.M. is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

  1. Lower respiratory tract infections, including pneumonia and bronchitis as an exacerbation of COPD, caused by Streptococcus pneumoniae and Haemophilus influenzae.
  2. Intra-abdominal infections, including acute gangrenous or perforated appendicitis and appendicitis with peritonitis, caused by Group D streptococcus including Enterococcus faecalis * ; Streptococcus viridans group * ; Escherichia coli; Klebsiella pneumoniae * ; Pseudomonas aeruginosa * ; Bacteroides species including B. fragilis, B. distasonis * , B. intermedius * and B. thetaiotaomicron * ; Fusobacterium species and Peptostreptococcus * species.
  3. Skin and skin structure infections, including abscesses, cellulitis, infected skin ulcers and wound infections caused by Staphylococcus aureus including penicillinase-producing strains; Streptococcus pyogenes * ; Group D streptococcus including Enterococcus faecalis; Acinetobacter species * including A. calcoaceticus, * ; Citrobacter species * ; Escherichia coli; Enterobacter cloacae; Klebsiella pneumoniae * ; Pseudomonas aeruginosa * and Bacteroides species * including B. fragilis * .
  4. Gynecologic infections, including postpartum endomyometritis, caused by Group D streptococcus including Enterococcus faecalis * ; Escherichia coli; Klebsiella pneumoniae * ; Bacteroides intermedius * ; and Peptostreptococcus species * .

As with other beta-lactam antibiotics, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with PRIMAXIN I.M. During therapy of Pseudomonas aeruginosa infections, periodic susceptibility testing should be done when clinically appropriate.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRIMAXIN I.M. and other antibacterial drugs, PRIMAXIN I.M. 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.


*Efficacy for this organism in this organ system was studied in fewer than 10 infections.


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NEWS HIGHLIGHTS

Published Studies Related to Primaxin I.M. (Imipenem / Cilastatin)

Comparison of 30-min and 3-h infusion regimens for imipenem/cilastatin and for meropenem evaluated by Monte Carlo simulation. [2010.11]
Imipenem/cilastatin and meropenem are carbapenem antibiotics that are infused intravenously (IV) over 30 to 45 min...

Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial. [2010.07.21]
BACKGROUND: Tigecycline, a first-in-class broad-spectrum glycylcycline antibiotic, has broad-spectrum in vitro activity against bacteria commonly encountered in complicated intra-abdominal infections (cIAIs), including aerobic and facultative Gram-positive and Gram-negative bacteria and anaerobic bacteria. In the current trial, tigecycline was evaluated for safety and efficacy vs. imipenem/cilastatin in hospitalized Chinese patients with cIAIs... CONCLUSIONS: Clinical cure rates for tigecycline were consistent with those found in global cIAI studies. The overall safety profile was also consistent with that observed in global studies of tigecycline for treatment of cIAI, as well as that observed in analyses of Chinese patients in those studies; no novel trends were observed. TRIAL REGISTRATION: ClinicalTrials.gov NCT00136201.

Population Pharmacokinetics and Pharmacodynamics of Continuous vs. Short-Term Infusion of Imipenem/Cilastatin in Critically Ill Patients: A Randomized, Controlled Trial. [2007.07.09]
Beta-lactams are regularly administered as intermittent short-term infusions. The time that free drug concentrations exceed the minimal inhibitory concentration (fT>MIC) is the measure of drug exposure that best correlates with clinical outcome for beta-lactams... Larger clinical trials are warranted for evaluation of continuous infusions at a reduced dose of imipenem in critically ill patients.

Clinical comparative study of sulbactam/ampicillin and imipenem/cilastatin in elderly patients with community-acquired pneumonia. [2006]
CONCLUSION: These results suggest that sulbactam/ampicillin therapy has excellent efficacy and tolerability and that it may be highly effective, even in severe cases of pneumonia. This regimen may thus serve as first-line treatment for the treatment of community-acquired pneumonia in elderly patients.

Meropenem versus imipenem-cilastatin for the treatment of hospitalized patients with complicated skin and skin structure infections: results of a multicenter, randomized, double-blind comparative study. [2005.09]
BACKGROUND: Meropenem, a broad-spectrum carbapenem with potent in vitro activity, is postulated to be an effective monotherapy for the treatment of complicated skin and skin structure infections (cSSSI)... CONCLUSION: In one of the largest studies conducted to date of hospitalized patients with cSSSI, meropenem, 500 mg IV q8h had comparable safety and efficacy to imipenem-cilastatin, 500 mg IV q8h.

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Clinical Trials Related to Primaxin I.M. (Imipenem / Cilastatin)

Complicated Skin and Skin Structure Infections [Completed]
The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.

GSK2251052 in Complicated Urinary Tract Infection [Recruiting]
This study is being conducted to evaluate the safety, efficacy (clinical and microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it would be a suitable antibiotic for the treatment for febrile lower cUTI and pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to imipenem-cilastatin, which is an antibiotic commonly used to treat serious cUTI infections. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cUTI.

A Study of the Safety and Effectiveness of Doripenem in the Treatment of Patients With Ventilator-associated Pneumonia [Recruiting]
The purpose of the study is to show that doripenem is as effective as imipenem-cilastatin in the treatment of patients with ventilator-associated pneumonia. The study population will include hospitalized patients who have a diagnosis of ventilator-associated pneumonia.

A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005 AM1) [Recruiting]
Part I of this study will compare the pharmacokinetics of MK-7655, dosed in combination with PRIMAXIN® (imipenem + cilastatin), in participants with impaired renal function and matched control participants. In Part II of the study, the potential for renal insufficiency to affect non-renal clearance mechanisms will be investigated.

Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With FUO [Not yet recruiting]
A multicenter open-label non-inferiority randomized clinical trial comparing the safety (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal carbapenem with regard to treatment failure in comparison with extended treatment (at least 9 days) of high-risk febrile neutropenia in hematology patients receiving standard antimicrobial prophylaxis.

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Page last updated: 2011-12-09

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