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:
- Lower respiratory tract infections, including pneumonia and bronchitis as an exacerbation of COPD, caused by
Streptococcus pneumoniae
and
Haemophilus influenzae.
- 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.
- 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 * .
- 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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