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 serious and otherwise important adverse reaction is described in greater detail in the Warnings and Precautions section of the label: Anaphylactic Reactions [see Warnings and Precautions (5.1)] .
The most common adverse reactions (≥3%) for cefuroxime axetil tablets are diarrhea, nausea/vomiting, Jarisch-Herxheimer reaction, and vaginitis (early Lyme disease).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.
at 1-866-850-2876 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Tablets Multiple-Dose Dosing Regimens with 7 to 10 Days’ Duration : In multiple-dose clinical trials, 912 subjects were treated with cefuroxime axetil (125 to 500 mg twice daily).
It is noted that 125 mg twice daily is not an approved dosage.
Twenty (2.2%) subjects discontinued medication due to adverse reactions.
Seventeen (85%) of the 20 subjects who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain.
The percentage of subjects treated with cefuroxime axetil who discontinued study drug because of adverse reactions was similar at daily doses of 1,000, 500, and 250 mg (2.3%, 2.1%, and 2.2%, respectively).
5 WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) reactions: In the event of a serious reaction, discontinue cefuroxime axetil and institute appropriate therapy.
( 5.1 ) Clostridioides difficile- associated diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD.
( 5.2 ) 5.1 Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on β-lactam antibacterials, including cefuroxime axetil [see Adverse Reactions (6.2) ] .
These reactions are more likely to occur in individuals with a history of β-lactam hypersensitivity and/or a history of sensitivity to multiple allergens.
There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins.
Like all medications, Cefuroxime Axetil 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: