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 discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)] Rhabdomyolysis [see Warnings and Precautions (5.3) ] Seizure Potential [see Warnings and Precautions (5.4) ] Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid [see Warnings and Precautions (5.5) ] Clostridioides difficile – Associated Diarrhea [see Warnings and Precautions (5.6) ] Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.7) ] Overgrowth of Nonsusceptible Organisms [see Warnings and Precautions (5.8) ] Thrombocytopenia [see Warnings and Precautions (5.9) ] Potential for Neuromotor Impairment [see Warnings and Precautions (5.10) ] High Sodium Load [see Warnings and Precautions (5.11) ] Most common adverse reactions (greater than or equal to 2%) are: headache, nausea, constipation, diarrhea, anemia, vomiting, and rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact B.
Braun Medical Inc.
at 1-800-854-6851 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Adverse Reactions from Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reactions 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.
Adult Patients: During clinical investigations, 2904 immunocompetent adult patients were treated for non-CNS infections with meropenem for injection (500 mg or 1000 mg every 8 hours).
Deaths in 5 patients were assessed as possibly related to meropenem;
36 (1.2%) patients had meropenem discontinued because of adverse events.
Many patients in these trials were severely ill and had multiple background diseases, physiological impairments and were receiving multiple other drug therapies.
In the seriously ill patient population, it was not possible to determine the relationship between observed adverse events and therapy with meropenem for injection.
The following adverse reaction frequencies were derived from the clinical trials in the 2904 patients treated with meropenem for injection.
5 WARNINGS AND PRECAUTIONS Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactams.
( 5.1 ) Severe cutaneous adverse reactions have been reported in patients receiving meropenem intravenous.
Discontinue meropenem immediately if patients experience these signs and symptoms and consider alternative treatment.
( 5.2 ) Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue Meropenem for Injection and Sodium Chloride Injection and initiate appropriate therapy.
( 5.3 ) Seizures and other adverse CNS experiences have been reported during treatment.
Like all medications, Meropenem And Sodium Chloride 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: