DOSAGE AND ADMINISTRATION
The dose of INVANZ in patients 13 years of age and older is 1 gram (g) given once a day. The dose of INVANZ in patients 3 months to 12 years of age is 15 mg/kg twice daily (not to exceed 1 g/day). 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.
DO NOT MIX OR CO-INFUSE INVANZ WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).
Table 11 presents treatment guidelines for INVANZ.
Table 11: Treatment Guidelines for Adults and Pediatric Patients With Normal Renal Function
and Body Weight | Infection
| Daily Dose
(IV or IM)
Adults and Pediatric Patients 13 years of age and older | Daily Dose
(IV or IM)
Pediatric Patients 3 months to 12 years of age | Recommended Duration of Total Antimicrobial Treatment |
| Complicated intra-abdominal infections | 1 g | 15 mg/kg
twice daily
| 5 to 14 days |
| Complicated skin and skin structure infections, including diabetic foot infections
| 1 g | 15 mg/kg
twice daily | 7 to 14 days
|
| Community acquired pneumonia | 1 g | 15 mg/kg
twice daily | 10 to 14 days
|
| Complicated urinary tract infections, including pyelonephritis | 1 g | 15 mg/kg
twice daily | 10 to 14 days |
| Acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections | 1 g | 15 mg/kg
twice daily | 3 to 10 days |
Table 12 presents prophylaxis guidelines for INVANZ.
Table 12: Prophylaxis Guidelines for Adults | Indication |
Daily Dose
(IV)
Adults
|
Recommended Duration of Total Antimicrobial Treatment
|
| Prophylaxis of surgical site infection following elective colorectal surgery | 1 g |
Single intravenous dose given 1 hour prior to surgical incision
|
Patients with Renal Insufficiency: INVANZ may be used for the treatment of infections in adult patients with renal insufficiency. In patients whose creatinine clearance is >30 mL/min/1.73 m2, no dosage adjustment is necessary. Adult patients with advanced renal insufficiency (creatinine clearance ≤30 mL/min/1.73 m2) and end-stage renal insufficiency (creatinine clearance ≤10 mL/min/1.73 m2) should receive 500 mg daily. There are no data in pediatric patients with renal insufficiency.
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.
Males: (weight in kg) x (140-age in years)
(72) x serum creatinine (mg/100 mL)
Females: (0.85) x (value calculated for males)
Patients with Hepatic Insufficiency: No dose adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency and PRECAUTIONS.)
No dosage adjustment is recommended based on age (13 years of age and older) or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
PREPARATION OF SOLUTION
Vials
Adults and pediatric patients 13 years of age and older
Preparation for intravenous administration:
DO NOT MIX OR CO-INFUSE INVANZ WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).
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 or Bacteriostatic Water for Injection.
- Shake well to dissolve and immediately transfer contents of the reconstituted vial to 50 mL of 0.9% Sodium Chloride Injection.
- Complete the infusion within 6 hours of reconstitution.
Preparation for intramuscular administration:
INVANZ MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION.
- Reconstitute the contents of a 1 g vial of INVANZ with 3.2 mL of 1.0% lidocaine HCl injection (without epinephrine ). Shake vial thoroughly to form solution.
- Immediately withdraw the contents of the vial and administer by deep intramuscular injection into a large muscle mass (such as the 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.
Pediatric patients 3 months to 12 years of age:
Preparation for intravenous administration:
DO NOT MIX OR CO-INFUSE INVANZ WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).
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 or Bacteriostatic Water for Injection.
- Shake well to dissolve and immediately withdraw a volume equal to 15 mg/kg of body weight (not to exceed 1 g/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.
Preparation for intramuscular administration:
INVANZ MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION.
- Reconstitute the contents of a 1 g vial of INVANZ with 3.2 mL of 1.0% lidocaine HCl injection (without epinephrine ). Shake vial thoroughly to form solution.
- Immediately withdraw a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) and administer by deep intramuscular injection into a large muscle mass (such as the 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.
ADD-Vantage® Vials
See separate INSTRUCTIONS FOR USE OF INVANZ (Ertapenem for Injection) IN ADD-Vantage® VIALS. INVANZ in ADD-Vantage® vials should be reconstituted with ADD-Vantage® diluent containers containing 50 mL or 100 mL of 0.9% Sodium Chloride Injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit. Solutions of INVANZ range from colorless to pale yellow. Variations of color within this range do not affect the potency of the product.
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