Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following are described in greater detail in the Warnings and Precautions section.
Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Seizure Potential [see Warnings and Precautions ( 5.2 )] Interaction with Valproic Acid [see Warnings and Precautions ( 5.3 )] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.4 )] Caution with Intramuscular Administration [see Warnings and Precautions ( 5.5 )] Development of Drug-Resistant Bacteria [see Warnings and Precautions ( 5.6 )] Laboratory Tests [see Warnings and Precautions ( 5.7 )] Adults: The most common adverse reactions (≥5%) in patients treated with ertapenem for injection, including those who were switched to therapy with an oral antimicrobial, were diarrhea, nausea, headache and infused vein complication.
( 6.1 ) In the prophylaxis indication the overall adverse experience profile was generally comparable to that observed for ertapenem in other clinical trials.
( 6.1 ) Pediatrics: Adverse reactions in this population were comparable to adults.
The most common adverse reactions (≥5%) in pediatric patients treated with ertapenem for injection, including those who were switched to therapy with an oral antimicrobial, were diarrhea, vomiting and infusion site pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults Receiving Ertapenem for Injection as a Treatment Regimen Clinical trials enrolled 1954 patients treated with ertapenem for injection;
in some of the clinical trials, parenteral therapy was followed by a switch to an appropriate oral antimicrobial [see Clinical Studies ( 14 )].
Most adverse experiences reported in these clinical trials were described as mild to moderate in severity.
5 WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams.
( 5.1 ) Seizures and other central nervous system adverse experiences have been reported during treatment.
( 5.2 ) 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.
( 5.3 ) Clostridioides difficile -associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs.
( 5.4 ) Caution should be taken when administering ertapenem for injection intramuscularly to avoid inadvertent injection into a blood vessel.
Like all medications, Ertapenem can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: