Trade.Information

Product Name: INVANZ® (Medicines)

Product Description

INVANZ is a broad-spectrum, injectable, carbapenem antibiotic with activity against gram-positive, gram-negative, and anaerobic bacteria.
Indicated for the following moderate to
severe infections: 
Diabetic foot infections without osteomyelitis
Complicated intra-abdominal infections
Complicated skin/skin structure infections
Community-acquired pneumonia
Acute pelvic infections
Complicated urinary tract infections
Demonstrated efficacy and coverage 
Excellent clinical efficacy in moderate to severe complicated intra-abdominal infections and complicated skin/skin structure infections1,2
Demonstrated gram-positive, gram-negative, and anaerobic coverage
Demonstrated overall safety profile
Convenient once-daily monotherapy 
Convenient for inpatient and outpatient parenteral antimicrobial therapy3
Flexible IV/IM administration
For pediatric (3 months and older) and adult patients 
In patients aged 3 months to 12 years: 15 mg/kg twice daily
In patients aged 13 years and older with normal renal function and body weight: 1 gram once daily
For full dosing information, click here.
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Selected important safety information

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

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.

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 a diluent, INVANZ administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. (Refer to the prescribing information for lidocaine HCl.)

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING THERAPY WITH BETA-LACTAMS. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE, OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION.

Seizures and other central nervous system adverse experiences have been reported during treatment with INVANZ.

Clostridium difficile–associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including INVANZ, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. CDAD has been reported to occur over 2 months after administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued. 

As with other antibiotics, prolonged use of INVANZ may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.

During clinical trials, the most common drug-related adverse experiences in adult patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, were diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), vaginitis in females (2.1%), phlebitis/thrombophlebitis (1.3%), and vomiting (1.1%).

Before prescribing INVANZ, please read the Prescribing Information available on this website.
References:
1.
Solomkin JS, Yellin AE, Rotstein OD, et al, and the Protocol 017 Study Group. Ertapenem versus piperacillin/tazobactam in the treatment of complicated intra-abdominal infections: results of a double-blind, randomized comparative phase III trial. Ann Surg. 2003;237:235–245. 
2.
Graham DR, Lucasti C, Malafaia O, et al, and the Ertapenem Complicated Skin and Skin Structure Infections Study Group. Ertapenem once daily versus piperacillin-tazobactam 4 times per day for treatment of complicated skin and skin-structure infections in adults: results of a prospective, randomized, double-blind multicenter study. Clin Infect Dis.
2002;34:1460–1468. 
3.
Tice AD, Rehm SJ, Dalovisio JR, et al. Practice guidelines for outpatient parenteral antimicrobial therapy. Clin Infect Dis. 2004;38:1651–1672.

Company Details

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The company... more