Ertapenem Sodium (Page 2 of 8)

2.3 Prophylactic Regimen in Adults

Table 2 presents prophylaxis guidelines for Ertapenem for Injection.

Table 2: Prophylaxis Guidelines for Adults
Indication Daily Dose (I.V.) 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

2.4 Patients with Renal Impairment

Ertapenem for Injection 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 in pediatric patients with renal impairment.

2.5 Patients on Hemodialysis

When adult patients on hemodialysis are given the recommended daily dose of 500 mg of Ertapenem for Injection within 6 hours prior to hemodialysis, a supplementary dose of 150 mg is recommended following the hemodialysis session. If Ertapenem for Injection 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 1 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)


1
Cockcroft and Gault equation: Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976

2.6 Patients with Hepatic Impairment

No dose adjustment recommendations can be made in patients with hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

2.7 Preparation and Reconstitution for Administration

Vials

Adults and pediatric patients 13 years of age and older

Preparation for intravenous administration:

DO NOT MIX OR CO-INFUSE ERTAPENEM FOR INJECTION WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).

ERTAPENEM FOR INJECTION MUST BE RECONSTITUTED AND THEN DILUTED PRIOR TO ADMINISTRATION.

1. Reconstitute the contents of a 1 g vial of Ertapenem for Injection with 10 mL of one of the following: Water for Injection, 0.9% Sodium Chloride Injection or Bacteriostatic Water for Injection, using a syringe equipped with a 21-gauge or smaller diameter needle. NOTE: Use with a needleless IV system is not recommended

2. Shake well to dissolve and immediately transfer contents of the reconstituted vial to 50 mL of 0.9% Sodium Chloride Injection.

3. Complete the infusion within 6 hours of reconstitution.

Preparation for intramuscular administration:

ERTAPENEM FOR INJECTION MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION.

1. Reconstitute the contents of a 1 g vial of Ertapenem for Injection with 3.2 mL of 1% lidocaine HCl injection 2 (without epinephrine ). Shake vial thoroughly to form solution.

2. 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).

3. The reconstituted I.M. 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 ERTAPENEM FOR INJECTION WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).

ERTAPENEM FOR INJECTION MUST BE RECONSTITUTED AND THEN DILUTED PRIOR TO ADMINISTRATION.

1. Reconstitute the contents of a 1 g vial of Ertapenem for Injection with 10 mL of one of the following: Water for Injection, 0.9% Sodium Chloride Injection or Bacteriostatic Water for Injection, using a syringe equipped with a 21-gauge or smaller diameter needle. NOTE: Use with a needleless IV system is not recommended

2. 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. Discard vial with unused portion of Ertapenem for Injection reconstituted solution.

3. Complete the infusion within 6 hours of reconstitution.

Preparation for intramuscular administration:

ERTAPENEM FOR INJECTION MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION.

1. Reconstitute the contents of a 1 g vial of Ertapenem for Injection with 3.2 mL of 1% lidocaine HCl injection 2 (without epinephrine ). Shake vial thoroughly to form solution.

2. 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). Discard vial with unused portion of Ertapenem for Injection reconstituted solution.

3. The reconstituted I.M. solution should be used within 1 hour after preparation.

NOTE: THE RECONSTITUTED SOLUTION SHOULD NOT BE ADMINISTERED INTRAVENOUSLY .


2
Refer to the prescribing information for lidocaine HCl.

Storage

When prepared with the diluent, Ertapenem for Injection maintains satisfactory potency for 6 hours at room temperature (25°C) or for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of Ertapenem for Injection should not be frozen.

Before administering, see accompanying package circular for Ertapenem for Injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit. Solutions of Ertapenem for Injection range from colorless to pale yellow. Variations of color within this range do not affect the potency of the product.

3 DOSAGE FORMS AND STRENGTHS

For Injection: Vials

Ertapenem for Injection is a sterile lyophilized powder in a single-dose vial containing 1 g ertapenem equivalent to 1.046 g ertapenem sodium for intravenous infusion or for intramuscular injection.

4 CONTRAINDICATIONS

Ertapenem for Injection 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 a diluent, Ertapenem for Injection administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type.

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