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.

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NEWS HIGHLIGHTS

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

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.

Pharmacokinetics of imipenem-cilastatin following intravenous administration in healthy adult horses. [2005.08]
In two studies, six healthy adult horses were given imipenem-cilastatin by slow intravenous (i.v.) infusion at an imipenem dosage of 10 mg/kg (study 1) and 20 mg/kg (study 2). The same horses were used in each dosage schedule, with a 2-week washout period between studies...

Pharmacokinetic evaluation of meropenem and imipenem in critically ill patients with sepsis. [2005]
OBJECTIVE: To evaluate and compare the pharmacokinetic profiles of imipenem and meropenem in a population of critically ill patients with sepsis to find possible differences that may help in selecting the most appropriate drug and/or dosage in order to optimise empiric antimicrobial therapy... CONCLUSION: The more favourable pharmacokinetic profile of imipenem compared with meropenem in critically ill patients with sepsis might balance the possibly greater potency demonstrated in vitro for meropenem against Gram-negative strains. Hence, the clinical efficacy of the two carbapenems depends mostly on their correct dosage.

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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.

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