NEODOSE

INDICATIONS

• Anthrax: 
• Intra-abdominal infections, suspected or complicated or other serious infections caused by susceptible Gram-negative organisms resistant to other antibiotics.
• Treatment of Neonatal Meningitis: Data are lacking.

FDA APPROVED INDICATION

Complicated skin/skin structure infections due to Staphylococcus aureus (methicillinsusceptible isolates only), Streptococcus pyogenes, S agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species in pediatric patients 3 months and older. Intra-abdominal infections including complicated appendicitis and peritonitis caused by viridans group streptococci, E coli, Klebsiella pneumoniae, P aeruginosa, B fragilis, B thetaiotaomicron, and Peptostreptococcus species in pediatric patients 3 months and older. Meropenem is considered an appropriate single agent for pediatric patients with a complicated extra-biliary intra-abdominal infection. Bacterial meningitis caused by S pneumoniae (penicillin-susceptible isolates), Haemophilus influenzae , and Neisseria meningitidis in pediatric patients 3 months and older.

CONTRAINDICATIONS

Contraindicated in patients with known hypersensitivity to carbapenems or previous anaphylactic reactions to beta-lactams. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams; these reactions are more likely to occur in those with a history of hypersensitivity to other beta-lactams or to multiple allergens. Before initiating therapy, obtain a detailed history of previous hypersensitivity reactions.

PRECAUTIONS

• Concomitant Use:
  • Coadministration with valproic acid or divalproex sodium is generally not recommended due to a reduction in valproic acid concentrations that may not respond to a dose increase. In patients with well-controlled seizures on valproic acid or divalproex sodium, antibiotics other than carbapenems are recommended, and if coadministration of meropenem is necessary, supplemental anticonvulsant therapy is recommended.
• dermatologic:
  • Severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, and acute generalized exanthematous pustulosis have been reported; if signs and symptoms appear, immediately withdraw therapy and consider an alternative.
• Neurological:
  • Seizures and other CNS adverse events have been reported with meropenem therapy; these occurred mainly in patients with CNS disorders (eg, brain lesions or history of seizures) or patients with bacterial meningitis and/or compromised renal function.

ADVERSE EFFECTS

Diarrhea (4%), nausea/vomiting (1%) and rash (2%). May cause inflammation at the injection site. The use of carbapenem antibiotics can result in the development of cephalosporin resistance in Enterobacter, Pseudomonas, Serratia, Proteus, Citrobacter, and Acinetobacter species. The risks of pseudomembranous colitis and fungal infections are also increased.

ADMINISTRATION

Administer as an IV infusion over 30 minutes at a concentration of 1 to 20 mg/mL. Recommended standard concentrations are 20 and 50 mg/mL. Prolonged Infusion: There are some data that promote prolonged infusions (e.g. over 4 hours) particularly for resistant organisms in neonates . In contrast, infusions of 20 mg/kg over 30 minutes were demonstrated pharmacokinetically to be adequate for very low birth weight infants . Stability of meropenem needs to be considered as it is dependent on diluent, concentration, and temperature. Some studies demonstrated longer stability times.

MONITORING

Periodic CBC (for thrombocytosis and eosinophilia) and hepatic transaminases. Assess IV site for signs of inflammation.