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.

Selected Important Safety Information

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 (CNS) adverse experiences have been reported during treatment with INVANZ.

Co-administration of carbapenems, including INVANZ, to patients receiving valproic acid or divalproex sodium results in a reduction of valproic acid concentrations, which may drop below the therapeutic range and increase the risk of breakthrough seizures. Increasing the dose of valproic acid or divalproex sodium may not be sufficient. Concomitant use of INVANZ and valproic acid/divalproex sodium is generally not recommended. Consider other anti-bacterials in patients whose seizures are well controlled on valproic acid or divalproex sodium. If INVANZ is necessary, consider supplemental anticonvulsant therapy.

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.

Lidocaine HCl is the diluent for intramuscular administration of INVANZ. Refer to the prescribing information for lidocaine HCl.

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%).

INVANZ is not recommended in infants younger than 3 months, as no data are available.

INVANZ is not recommended in the treatment of meningitis in the pediatric population due to lack of sufficient cerebrospinal fluid penetration.

The overall adverse experience profile in pediatric patients is comparable to that in adult patients.

The most common drug-related adverse experiences in pediatric patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, were diarrhea (6.5%), infusion-site pain (5.5%), infusion-site erythema (2.6%), and vomiting (2.1%).

Before prescribing INVANZ, please read the Prescribing Information.

This site is intended only for health care professionals of the United States, its territories, and Puerto Rico.

INVANZ and MerckSource are registered trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Other brands mentioned are trademarks of their respective owners.

20950585(4)-11/09-INV

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