A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
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 (77°F).
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 (25°C) and used within 6 hours or stored for 24
hours under refrigeration (5°C) 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. 3843—1 g ertapenem equivalent
NDC 0006-3843-71 in trays of 10 vials
No. 3843—1 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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