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Pharmaceutical approval update.

Manufacturer: Merck and Co. Inc., Whitehouse Station, NJ Indications: For the treatment of moderate-tosevere infections in adults caused by many common gram-positive and gram-negative aerobic and anaerobic bacteria. Ertapenem is used in the treatment of the following community-acquired infections caused by susceptible strains of the designated bacteria: complicated intraabdominal infections; complicated skin and skin structure infections; community-acquired pneumonia; complicated urinary tract infections, including pyelonephritis (kidney infection); and acute pelvic infections, including postpartum endomyometritis, septic abortion, and post-surgical gynecologic infections. Drug Class: Structurally unique 1-(beta) methyl-carbapenem related to the class of antibiotics known as beta-lactam Uniqueness of Drug: Ertapenem has a spectrum of bacterial activity distinct from other carbapenems in that ertapenem does not cover Pseudomonas and Acinetobacter species— pathogens typically associated with hospital-acquired infections. Like other beta-lactams, ertapenem works by blocking the formation of bacterial cell wall, thereby causing cell death. Warnings: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity that have experienced severe hypersensitivity reactions when treated with another beta-lactam. Before initiating therapy with ertapenem, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens. If an allergic reaction to ertapenem occurs, discontinue the drug immediately. Ertapenem should not be used in patients with known hypersensitivity to any component of the product, or to other drugs in the same class, or in patients who have demonstrated anaphylactic reactions to beta-lactams. Ertapenem administered intramuscularly should not be used in patients with a known hypersensitivity to local anesthetics of the amide type. 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. Other therapy may also be administered as indicated. Seizures and other central nervous system (CNS) adverse experiences have been reported during treatment with ertapenem. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ertapenem, and can range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and might permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis.” After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate-to-severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis. Dosage: The dose of ertapenem in adults is 1 gram (g) given once per day. Ertapenem may be administered by intravenous infusion for up to 14 days or by intramuscular injection for up to seven days. When administered intravenously, ertapenem should be infused over a period of 30 minutes. Ertapenem will be supplied in single-dose vials for administration either intravenously or intramuscularly following reconstitution or dilution. Intramuscular administration of ertapenem may be used as an alternative to intravenous administration in the treatment of those infections for which intramuscular therapy is appropriate. In patients with renal insufficiency, ertapenem may be used for the treatment of infections. In preparation of ertapenem for intravenous administration, do not mix or co-infuse ertapenem with other medications. Do not use diluents containing dextrose [(alpha)-D-glucose]. Ertapenem must be reconstituted prior to administration. P&T Committee Considerations: Imipenem was the first carbapenem approved for use in hospital patients against community-acquired infections produced by virtually all bacterial pathogens with few exceptions. Imipenem often is held Pharmaceutical-Approval Update