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 adverse reactions are discussed in other sections of the labeling: Hypersensitivity reactions [see Warnings and Precautions (5.1) ] Neurotoxicity [see Warnings and Precautions (5.2) ] Clostridioides difficile -associated diarrhea [see Warnings and Precautions (5.3) ] The most common adverse reactions (incidence ≥1%) were local reactions, positive Coombs’ test, decreased phosphorous, increased ALT and AST, increased PT and PTT and rash.
( 6.1 ) At the highest dose (2 g every 8 hours), incidence of adverse reactions was ≥1% for rash, diarrhea, nausea, vomiting, pruritis, fever, and headache.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact B.
Braun Medical Inc.
at 1-833-425-1464 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.
In clinical trials using multiple doses of cefepime, 4137 patients were treated with the recommended dosages of cefepime (500 mg to 2 g intravenously every 12 hours).
There were no deaths or permanent disabilities thought related to drug toxicity.
Sixty-four (1.5%) patients discontinued medication due to adverse reactions thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity.
Thirty-three (51%) of these sixty-four patients who discontinued therapy did so because of rash.
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions : Cross-hypersensitivity may occur in up to 10% of patients with a history of penicillin allergy.
If an allergic reaction occurs, discontinue the drug.
( 5.1 ) Neurotoxicity : May occur especially in patients with renal impairment administered unadjusted doses.
If neurotoxicity associated with Cefepime for Injection and Dextrose Injection occurs, discontinue the drug.
( 5.2 ) Clostridio ides difficile- associated diarrhea (CDAD): Evaluate if diarrhea occurs.
Like all medications, Cefepime Hydrochloride And Dextrose 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: