Cefixime (cefixime)

Cefixime is commercially available as the trihydrate; potency of the drug is expressed in terms of cefixime (the free acid), calculated on the anhydrous basis.

Cefixime is administered orally as capsules, conventional tablets, chewable tablets, or an oral suspension.

Capsules containing 400 mg of cefixime are bioequivalent to conventional tablets containing 400 mg of the drug when administered under fasting conditions.

Cefixime chewable tablets are bioequivalent to cefixime oral suspension.

Cefixime conventional tablets and oral suspension are not bioequivalent.

Store cefixime capsules, conventional tablets, or chewable tablets at 20-25degreesC.

Store cefixime powder for oral suspension in tight containers at 20-25degreesC. After reconstitution, store the oral suspension in a tight container. The reconstituted suspension is stable for 14 days at room temperature or when refrigerated; discard any unused suspension after 14 days.

Cefixime may be administered once or twice daily. Once- and twice-daily regimens reportedly are similarly effective for the treatment of otitis media, tonsillitis, or uncomplicated urinary tract infections. Relative efficacy of the 2 regimens has not been evaluated in other infections, and some clinicians suggest that twice-daily dosing may be preferable for the treatment of some lower respiratory tract infections or for complicated urinary tract infections+. Results of most studies indicate that the incidence of GI effects is similar with once- and twice-daily regimens.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Antibiotics/Fecal Microbiota

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Fecal microbiota is a suspension of live bacteria, which may be compromised by concurrent use of antibiotics.(1)

CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota. Antibacterial treatment should be completed for 24 to 72 hours before initiating treatment with fecal microbiota. Do not use antibiotics for up to 8 weeks after fecal microbiota.(1)

DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota.

Antibiotics/Fecal Microbiota Spores

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1)

CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1)

DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores.

Antimicrobials/Live Typhoid Vaccine

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1)

CLINICAL EFFECTS: Vaccination may be ineffective.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3)

DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3)

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to cefixime or other cephalosporins.

There are no contraindication contraindications for this drug.

• Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
• Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Chronic kidney disease stage 5 (failure) GFr<15 ml/min
• Clostridioides difficile infection
• Hemolytic anemia

• Kidney disease with likely reduction in glomerular filtration rate (GFr)
• Lower seizure threshold
• Myoclonus
• Seizure disorder

The most common adverse reactions in patients receiving cefixime are diarrhea (16%), nausea (7%), loose stools (6%), abdominal pain (3%), dyspepsia (3%), and vomiting.

Rare or Very Rare

• Abnormal hepatic function tests
• Acute generalized exanthematous pustulosis
• Agranulocytosis
• Anaphylaxis
• Angioedema
• Clostridioides difficile infection
• DRESS syndrome
• Drug fever
• Eosinophilia
• Erythema multiforme
• Hemolytic anemia
• Hepatitis
• Hyperbilirubinemia
• Hypoprothrombinemia
• Jaundice
• Kidney disease with reduction in glomerular filtration rate (GFr)
• Leukopenia
• Neutropenic disorder
• Pancytopenia
• Pruritus of skin
• Renal failure
• Seizure disorder
• Serum sickness
• Skin rash
• Stevens-johnson syndrome
• Thrombocytopenic disorder
• Thrombocytosis
• Toxic epidermal necrolysis

More Frequent

• Acute abdominal pain
• Diarrhea
• Dyspepsia
• Loose stools
• Nausea
• Vomiting

Less Frequent

• Candidiasis
• Dizziness
• Flatulence
• Headache disorder
• Vaginitis

Rare or Very Rare

• Facial edema
• Genital organ pruritus
• Urticaria

No enhanced messaging available.

Safety and efficacy of cefixime in children <6 months of age have not been established.

The frequency of adverse GI effects (e.g., diarrhea, loose stools) reported in pediatric patients receiving cefixime oral suspension is similar to that reported in adults receiving cefixime tablets. Diarrhea or loose stools has been reported in up to 15% of children 6 months to 13 years of age receiving oral cefixime. CDAD has been reported rarely in children receiving cefixime. In 3 reported cases, the onset of symptoms (abdominal pain, diarrhea) occurred 4-14 days after the first dose of cefixime.

Reproduction studies in mice and rats using oral cefixime dosages up to 40 times the usual human dosage have not revealed evidence of harm to the fetus. Cefixime has been reported to cross the placenta. There are no adequate and controlled studies to date using cefixime in pregnant women, and the drug should be used during pregnancy only when clearly needed. Use of cefixime during labor and delivery has not been studied to date, and the drug should be used in these circumstances only when clearly needed.

Cefixime is distributed into milk in rats. Although the drug reportedly was not detected in milk following a single dose in lactating women in one study, it is not known whether cefixime is distributed into milk in humans. Therefore, consideration should be given to temporarily discontinuing nursing during therapy with the drug.

Modification of the usual dosage of cefixime is not necessary in geriatric adults based on age, but may be required because of age-related decreases in renal function.

Clinical studies did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger adults. Other reported clinical experience has not identified differences in responses between geriatric and younger patients.

Some evidence indicates that oral bioavailability of the drug may be increased in geriatric patients, but such increases are not considered clinically important.

Because renal function decreases with age and may be impaired in geriatric patients, the possibility that adjustment of cefixime dosage may be necessary in this age group should be considered.

Although the difference was not considered clinically important, one study in geriatric patients >64 years of age receiving 400-mg doses of cefixime once daily for 5 days indicated that peak serum concentrations of cefixime were 20-26% higher and AUCs were approximately 40-42% higher in these geriatric adults than in healthy adults 18-35 years of age.