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Invanz Indications, Dosage, Storage, Stability - Ertapenem

Invanz Indications, Dosage, Storage, Stability - Ertapenem

INDICATIONS AND USAGE

INVANZ is indicated for the treatment of adult patients with the following moderate to severe infections caused by susceptible strains of the designated microorganisms. (See DOSAGE AND ADMINISTRATION):

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.

Complicated Skin and Skin Structure Infections due to Staphylococcus aureus (methicillin susceptible strains only), Streptococcus pyogenes, Escherichia coli, or Peptostreptococcus species.

Community Acquired Pneumonia due to Streptococcus pneumoniae (penicillin susceptible strains only) including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative strains only), or Moraxella catarrhalis.

Complicated Urinary Tract Infections including pyelonephritis due to Escherichia coli, including cases with concurrent bacteremia, or Klebsiella pneumoniae.

Acute Pelvic Infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections due to Streptococcus agalactiae, Escherichia coli, Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus species, or Prevotella bivia.

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ertapenem. Therapy with INVANZ (ertapenem) may be initiated empirically before results of these tests are known; once results become available, antimicrobial therapy should be adjusted accordingly.

DOSAGE AND ADMINISTRATION

The dose of INVANZ in adults is 1 gram (g) given once a 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 (a-D-GLUCOSE).

Table 5 presents dosage guidelines for INVANZ.

Table 5 Dosage Guidelines for Adults With Normal Renal Function* and Body Weight

Infection

Daily Dose (IV or IM)

Recommended Duration of Total Antimicrobial Treatment

Complicated intra-abdominal infections

1 g

5 to 14 days

Complicated skin and skin structure infections

1 g

7 to 14 days

Community acquired pneumonia

1 g

10 to 14 days

Complicated urinary tract infections, including pyelonephritis

1 g

10 to 14 days

Acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections

1 g

3 to 10 days

*defined as creatinine clearance >90 mL/min/1.73 m2

due to the designated pathogens (see INDICATIONS AND USAGE)

duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated.

Patients with Renal Insufficiency: INVANZ may be used for the treatment of infections in patients with renal insufficiency. In patients whose creatinine clearance is >30 mL/min/1.73 m2, no dosage adjustment is necessary. 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. Patients on Hemodialysis: When 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. 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 or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)

PREPARATION OF SOLUTION

Preparation for intravenous administration:

DO NOT MIX OR CO-INFUSE INVANZ WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (-D-GLUCOSE).

INVANZ MUST BE RECONSTITUTED AND THEN DILUTED PRIOR TO ADMINISTRATION.

1. 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.

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:

INVANZ MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION.

1. 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.

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 IM solution should be used within 1 hour after preparation. NOTE: THE RECONSTITUTED SOLUTION SHOULD NOT BE ADMINISTERED INTRAVENOUSLY.

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.

STORAGE AND STABILITY

Before reconstitution

Do not store lyophilized powder above 25 C (77F).

Reconstituted and infusion solutions

The reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection (see DOSAGE AND ADMINISTRATION, PREPARATION OF SOLUTION), may be stored at room temperature (25C) and used within 6 hours or stored for 24 hours under refrigeration (5C) and used within 4 hours after removal from refrigeration. Solutions of INVANZ should not be frozen.

HOW SUPPLIED

INVANZ is supplied as a sterile lyophilized powder in single dose vials containing ertapenem for intravenous infusion or for intramuscular injection as follows:

No. 38431 g ertapenem equivalent

NDC 0006-3843-71 in trays of 10 vials

No. 38431 g ertapenem equivalent NDC 0006-3843-45 in trays of 25 vials.

CLINICAL STUDIES

Complicated Intra-Abdominal Infections

Ertapenem was evaluated in adults for the treatment of complicated intra-abdominal infections in a clinical trial. This study compared ertapenem (1 g intravenously once a day) with piperacillin/tazobactam (3.375 g intravenously every 6 hours) for 5 to 14 days and enrolled 665 patients with localized complicated appendicitis, and any other complicated intra-abdominal infection including colonic, small intestinal, and biliary infections and generalized peritonitis. The combined clinical and microbiologic success rates in the microbiologically evaluable population at 4 to 6 weeks posttherapy (test of cure) were 83.6% (163/195) for ertapenem and 80.4% (152/189) for piperacillin/tazobactam.

Complicated Skin and Skin Structure Infections

Ertapenem was evaluated in adults for the treatment of complicated skin and skin structure infections in a clinical trial. This study compared ertapenem (1 g intravenously once a day) with piperacillin/tazobactam (3.375 g intravenously every 6 hours) for 7 to 14 days and enrolled 540 patients including patients with deep soft tissue abscess, posttraumatic wound infection and cellulitis with purulent drainage. The clinical success rates at 10 to 21 days posttherapy (test of cure) were 83.9% (141/168) for ertapenem and 85.3% (145/170) for piperacillin/tazobactam.

Community Acquired Pneumonia

Ertapenem was evaluated in adults for the treatment of community acquired pneumonia in two clinical trials. Both studies compared ertapenem (1 g parenterally once a day) with ceftriaxone (1 g parenterally once a day) and enrolled a total of 866 patients. Both regimens allowed the option to switch to oral amoxicillin/clavulanate for a total of 10 to 14 days of treatment (parenteral and oral). In the first study the primary efficacy parameter was the clinical success rate in the clinically evaluable population and success rates were 92.3% (168/182) for ertapenem and 91.0% (183/201) for ceftriaxone at 7 to 14 days posttherapy (test of cure). In the second study the primary efficacy parameter was the clinical success rate in the microbiologically evaluable population and success rates were 91% (91/100) for ertapenem and 91.8% (45/49) for ceftriaxone at 7 to 14 days posttherapy (test of cure).

Complicated Urinary Tract Infections Including Pyelonephritis

Ertapenem was evaluated in adults for the treatment of complicated urinary tract infections including pyelonephritis in two clinical trials. Both studies compared ertapenem (1 g parenterally once a day) with ceftriaxone (1 g parenterally once a day) and enrolled a total of 850 patients. Both regimens allowed the option to switch to oral ciprofloxacin (500 mg twice daily) for a total of 10 to 14 days of treatment (parenteral and oral). The microbiological success rates (combined studies) at 5 to 9 days posttherapy (test of cure) were 89.5% (229/256) for ertapenem and 91.1% (204/224) for ceftriaxone.

Acute Pelvic Infections Including Endomyometritis, Septic Abortion And Post-Surgical Gynecological Infections

Ertapenem was evaluated in adults for the treatment of acute pelvic infections in a clinical trial. This study compared ertapenem (1 g intravenously once a day) with piperacillin/tazobactam (3.375 g intravenously every 6 hours) for 3 to 10 days and enrolled 412 patients including 350 patients with obstetric/postpartum infections and 45 patients with septic abortion. The clinical success rates in the clinically evaluable population at 2 to 4 weeks posttherapy (test of cure) were 93.9% (153/163) for ertapenem and 91.5% (140/153) for piperacillin/tazobactam.

REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. Fifth Edition; Approved Standard, NCCLS Document M7-A5, Vol. 17, No. 2 NCCLS, Wayne, PA, December 2000.

2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests. Seventh Edition; Approved Standard, NCCLS Document M2-A7, Vol. 17, No. 1 NCCLS, Wayne, PA, January 2000.

3. National Committee for Clinical Laboratory Standards. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria - Fourth Edition; Approved Standard, NCCLS Document M11-A4, Vol. 17, No. 22. NCCLS, Wayne, PA, December 1997.

4. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing - Eleventh Informational Supplement. Approved Standard, NCCLS Document M100-S11, Vol. 21, No. 1. NCCLS, Wayne, PA, January 2001.

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