NEODOSE

INDICATIONS

• Anthrax:

FDA APPROVED INDICATION

Not indicated in patients with meningitis because safety and efficacy have not beenestablished.Not recommended in pediatric patients with CNS infections because of the risk of seizures.

• Intravenous: Lower respiratory tract infections caused by Staphylococcus aureus (penicillinase-producing strains), Acinetobacter species, Enterobacter species, Escherichia coli, Haemophilus influenzae, H parainfluenzae, Klebsiella species, and Serratia marcescens. Urinary tract infections (complicated and uncomplicated) caused by E faecalis, S aureus (penicillinase-producing strains), Enterobacter species, E coli, Klebsiella species, Morganella morganii, P vulgaris, P rettgeri, and Pseudomonas aeruginosa. Intra-abdominal infections caused by E faecalis, S aureus (penicillinase-producing strains), S epidermidis, Citrobacter species, Enterobacter species, E coli, Klebsiella species, M morganii, Proteus species, P aeruginosa, Bifidobacterium species, Clostridium species, Eubacterium species, Peptococcus species, Peptostreptococcus species, Propionibacterium species, Bacteroides species including B fragilis and Fusobacterium species. Imipenem-cilastatin is considered an appropriate single agent for pediatric patients with a complicated extra-biliary intra-abdominal infection. Bacterial septicemia caused by E faecalis, S aureus (penicillinase-producing strains), Enterobacter species, E coli, Klebsiella species, P aeruginosa, Serratia species, Bacteroides species including B fragilis. Bone and joint infections caused by E faecalis, S aureus (penicillinase-producing strains), S epidermidis, Enterobacter species, P aeruginosa. Skin and skin structure infections caused by E faecalis, S aureus (penicillinase-producing strains), S epidermidis, Acinetobacter species, Citrobacter species, Enterobacter species, E coli, Klebsiella species, M morganii, P vulgaris, Providencia rettgeri, P aeruginosa, Serratia species, Peptococcus species, Peptostreptococcus species, Bacteroides species including B fragilis, Fusobacterium species. Endocarditis caused by S aureus (penicillinase-producing strains)

CONTRAINDICATIONS

Contraindicated in patients with hypersensitivity to imipenem or cilastatin, or any component of the product. Intramuscular dosage form contraindicated in patients with hypersensitivity to local anesthetics of the amide type and in patients with severe shock or heart block, as the IM product is to be diluted with lidocaine.

PRECAUTIONS

Concomitant Use: Concomitant use with valproic acid/divalproex sodium is not generally recommended; however, if Primaxin® is necessary, supplemental anticonvulsant therapy is recommended as increasing the dose of valproic acid or divalproex sodium may not be sufficient. Concomitant use with probenecid is not recommended. Avoid use with concomitant ganciclovir unless the benefits outweigh the risks. Neurological: Imipenem is not recommended for the treatment of central nervous system (CNS) infections in pediatric patients due to the risk for seizures. Seizures occur most often in patients with meningitis, preexisting CNS pathology, renal dysfunction, and in patients receiving excessive doses.

ADVERSE EFFECTS

Seizures occur frequently in patients with meningitis, preexisting CNS pathology, and severe renal dysfunction. Local reactions at the injection site and increased platelet counts are the most frequent adverse effects. Other reactions, including eosinophilia, elevated hepatic transaminases, and diarrhea, also occur in more than 5% of patients.

ADMINISTRATION

Administer by IV infusion over 20 to 30 minutes at a concentration of 5 mg/mL or less.

MONITORING

Periodic CBC and hepatic transaminases. Assess IV site for signs of phlebitis.