Ertapenem - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams.

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

Co-administration of ertapenem for injection with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures.

Clostridioides difficile -associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs.

Caution should be taken when administering ertapenem for injection intramuscularly to avoid inadvertent injection into a blood vessel.

5.1 Hypersensitivity Reactions 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 who have experienced severe hypersensitivity reactions when treated with another beta-lactam.

Before initiating therapy with ertapenem for injection, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens.

If an allergic reaction to ertapenem for injection occurs, discontinue the drug immediately.

Serious anaphylactic reactions require immediate emergency treatment as clinically indicated.

5.2 Seizure Potential Seizures and other central nervous system (CNS) adverse experiences have been reported during treatment with ertapenem for injection [see Adverse Reactions ] .

During clinical investigations in adult patients treated with ertapenem for injection (1 gram once a day), seizures, irrespective of drug relationship, occurred in 0.5% of patients during study therapy plus 14-day follow-up period [see Adverse Reactions ] .

These experiences have occurred most commonly in patients with CNS disorders (e.g., brain lesions or history of seizures) and/or compromised renal function.

Close adherence to the recommended dosage regimen is urged, especially in patients with known factors that predispose to convulsive activity.

Anticonvulsant therapy should be continued in patients with known seizure disorders.

If focal tremors, myoclonus, or seizures occur, patients should be evaluated neurologically, placed on anticonvulsant therapy if not already instituted, and the dosage of ertapenem for injection re-examined to determine whether it should be decreased or discontinued.

5.3 Interaction with Valproic Acid Case reports in the literature have shown that co-administration of carbapenems, including ertapenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations.

The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures.

Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction.

The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended.

Anti-bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium.

If administration of ertapenem for injection is necessary, supplemental anti-convulsant therapy should be considered [see Drug Interactions ].

5.4 Clostridioides difficile -Associated Diarrhea (CDAD) CDAD has been reported with use of nearly all antibacterial agents, including ertapenem, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridioides difficile .