Tradename
Invanz
Generic Name
Ertapenem
Category
Antimicrobials
Form
Vial
Composition
Ertapenem sodium.........1 g
Description
Properties/Actions
Indications
Invanz is indicated for the treatment of adult patients and pediatric patients (3 months of age and
older) with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms:
  1. Complicated intra-abdominal infections: Invanz is indicated for the treatment of complicated intra-abdominal infections due to Escherichia coli, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus species, Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, or Bacteroides uniformis.
  2. Complicated skin and skin structure infections, including diabetic food infections without osteomyelitis: Invanz is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis due to Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae, Streptococcus pyogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Bacteroides fragilis, Peptostreptococcus species, Porphyromonas asaccharolytica, or Prevotella bivia. Invanz has not been studied in diabetic foot infections with concomitant osteomyelitis
  3. Community acquired penumonia: Invanz is indicated for the treatment of community acquired pneumonia due to Streptococcus pneumoniae (penicillin susceptible isolates only) including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates only), or Moraxella catarrhalis.
  4. Complicated urinary tract infections including pyelonephritis: Invanz is indicated for the treatment of complicated urinary tract infections including pyelonephritis due to Escherichia coli, including cases with concurrent bacteremia, or Klebsiella pneumoniae.
  5. Acute pelvic infections including post-partum endomyometritis, septic aborion and post-surgical gynecological infections: Invanz is indicated for the treatment of acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecological infections due to Streptococcus agalactiae, Escherichia coli, Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus species, or Prevotella bivia.
  6. Prophylaxis of surgical site infection following elective colorectal surgery: Invanz is indicated for the prevention of surgical site infection following elective colorectal surgery.
Contraindications
Invanz is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.
Due to the use of lidocaine HCl as diluent, Invanz administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type.
Drug Interactions
The following interactions have been reported:
  • Probenecid: Probenecid intereferes with the active tubular secretion of ertapenem, resulting in increased plasma concentrations of ertapenem. Co-administration of probenecid with ertapenem is not recommended.
  • Valproic acid: Case reports in the literature have shown that co-administration of carbapenems, including ertapenem, to patients receiving valproic acid or divalproex sodium results in a reduction of valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Although the mechanism of this interaction is unknown, data from in vitro and animal studies suggest that carbapenems may inhibit the hydrolysis of valproic acid's glucuronide metabolite (VPA-g) back to valproic acid, thus decreasing the serum concentrations of valproic acid. 
Side Effects/Adverse Effects
Pregnancy & Lactation
Dosage & Administration
Invanz is intended for intramusuclar or intravenous use only. It should not be mixed or confused with other medications. Diluents containing dextrose (α-D-glucose) should not be used.
Invanz may be administered by intravenous infusion for up to 14 days or intramuscular injection for up to 7 days. When administered intravenously, Invanz should be infused over a period of 30 minutes. Intramuscular administration of Invanz may be used as an alternative to intravenous administration in the treatment of those infections for which intramuscular therapy is appropriate.

1. Patients 3 years of age and older:
The recommended dose is 1 gram given once a day.

2. Patients 3 months to 12 years of age:
15 mg/kg twice daily (not to exceed 1g/day).
Table 1 presents the appropriate treatment guidelines for Invanz.

Table 2 presents prophylaxis guidlines for Invanz in adults.


3. Patients with Renal Impairment:
Invanz
may be used for the treatment of infections in adult patients with renal impairment.
In patients whose creatinine clearance is >30 mL/min/1.73 m2, no dosage adjustment is necessary.
Adult patients with severe renal impairment (creatinine clearance ≤30 mL/min/1.73 m2) and end-stage renal disease (creatinine clearance ≤10 mL/min/1.73 m2) should receive 500 mg daily.
A supplementary dose of 150 mg is recommended if ertapenem is administered within 6 hours prior to hemodialysis.
There are no data to support the use of ertapenem in pediatric patients with renal impairment.

4. Patients on Hemodialysis:
When adult patients on hemodialysis are given the recommended daily dose of 500 mg of Invanz within 6 hours prior to hemodialysis, a supplementary dose of 150 mg is recommended following the hemodialysis session. If Invanz is given at least 6 hours prior to hemodialysis, no supplementary dose is needed.
There are no data in patients undergoing peritoneal dialysis or hemofiltration. There are no data in pediatric patients on hemodialysis.
When only the serum creatinine is available, the following formula may be used to estimate creatinine
clearance. The serum creatinine should represent a steady state of renal function.


5. Patients with Hepatic Impairment:

No dose adjustment recommendations can be made in patients with hepatic impairment.

6. Preparation and Reconstitution for Administration
Adults and pediatric patients 13 years of age and older:
Do not mix or co-infuse Invanz with other medications. Do not use diluents containing dextrose (α-D-Glucose).
a) In case of IV administration, Invanz must be reconstituted and then diluted prior to administration:
  • Reconstitute the contents of a 1 g vial of Invanz with 10 ml of one of the following: Water for injection, 0.9% sodium chloride injection, Bacteriostatic water for injection.
  • Shake well to dissolve and immediately tranfer contents of the reconstituted vial to 50 ml of 0.9% sodium chloride injection.
  • Complete the infusion within 6 hours of reconsititution.
b) In case of IM administration, Invanz must only be reconstituted prior to administraiton:
  • Reconstitute the contents of a 1 g vial of Invanz with 3.2 ml of 1.0% lidocaine HCl injeciton (without epinephrine). Shake vial thoroughly to form a solution.
  • Immediately withdraw the contents of the vial and administer by deep intramuscular injection into a large muscle mass (gluteal muscle or laterla part of the thigh).
  • The reconstituted IM solution should be used within 1 hour after preparation.
  • Note: The reconstituted solution should NOT be administered intravenously.

Pediatric patients 3 months to 12 years of age:
Do not mix or co-infuse Invanz with other medications. Do not use diluents containing dextrose (α-D-Glucose).
a) In case of IV administration, Invanz must be reconstituted and then diluted prior to administration:

  • Reconstitute the contents of a 1 g vial of Invanz with 10 ml of one of the following: Water for injection, 0.9% sodium chloride injection, Bacteriostatic water for injection.
  • Shake well to dissolve and immediately withdraw a volume equal to 15 mg/kg body weight (not to exceed 1g/day) and dilute in 0.9% sodium chloride injection to a final concentration of 20 mg/ml or less.
  • Complete the infusion within 6 hours of reconstitution.
b) In case of IM administration, Invanz must only be reconstituted prior to administraiton:
  • Reconstitute the contents of a 1 g vial of Invanz with 3.2 ml of 1.0% lidocaine HCl injeciton (without epinephrine). Shake vial thoroughly to form a solution.
  • Immediately withdraw a volume equal to 15 mg/kg body weight (not to exceed 1g/day) and administer by deep intramuscular injection into a large muscle mass (gluteal muscles or lateral part of the thigh).
  • The reconstituted IM solution should be used within 1 hour after preparation.
  • Note: The reconstituted solution should NOT be administered intravenously.
Overdosage
Warnings
Notes
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Invanz and other antibacterial drugs, Invanz 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.
Storage
Packaging
Manufacturer
Abott
Price
Date Added/Updated
3rd June 2012 11:46 pm

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