CEFUROXIME AXETIL Drug Interactions: What You Need to Know

INTERACTIONS

• Oral Contraceptives: Effects on gut flora may lower estrogen reabsorption and reduce efficacy of oral contraceptives. ( 7.1 )
• Drugs that reduce gastric acidity may lower the bioavailability of cefuroxime axetil. ( 7.2 )
• Co-administration with probenecid increases systemic exposure to cefuroxime axetil and is therefore not recommended. ( 7.3 )

7.1 Oral Contraceptives Cefuroxime axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. Counsel patients to consider alternate supplementary (non-hormonal) contraceptive measures during treatment.

7.2 Drugs that Reduce Gastric Acidity Drugs that reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with administration in the fasting state. Administration of drugs that reduce gastric acidity may negate the food effect of increased absorption of cefuroxime axetil when administered in the postprandial state. Administer cefuroxime axetil at least 1 hour before or 2 hours after administration of short-acting antacids. Histamine-2 (H2) antagonists and proton pump inhibitors should be avoided.

7.3 Probenecid Concomitant administration of probenecid with cefuroxime axetil tablets increases serum concentrations of cefuroxime <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3)]</span>. Co-administration of probenecid with cefuroxime axetil is not recommended.

7.4 Drug/Laboratory Test Interactions A false-positive reaction for glucose in the urine may occur with copper reduction tests (e.g., Benedict&apos;s or Fehling&apos;s solution), but not with enzyme-based tests for glycosuria. As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil. The presence of cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.

Cefuroxime axetil tablets are contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil tablets or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil tablets or to other β-lactams (e.g., penicillins and cephalosporins). ( 4 )

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 <span class="opacity-50 text-xs">[see Adverse Reactions (6.2) ]</span> . 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. Cefuroxime axetil is contraindicated in patients with a known hypersensitivity to cefuroxime axetil or other β-lactam antibacterial drugs <span class="opacity-50 text-xs">[see Contraindications (4) ]</span> . Before initiating therapy with cefuroxime axetil, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, discontinue cefuroxime axetil and institute appropriate therapy.

5.2 Clostridioides difficile -Associated Diarrhea Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefuroxime axetil, 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 C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

5.3 Potential for Microbial Overgrowth The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.

5.4 Development of Drug-Resistant Bacteria Prescribing cefuroxime axetil either in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

5.6 Interference with Glucose Tests A false-positive result for glucose in the urine may occur with copper reduction tests, and a false-negative result for blood/plasma glucose may occur with ferricyanide tests in subjects receiving cefuroxime axetil <span class="opacity-50 text-xs">[see Drug Interactions (7.3) ]</span> .