Cefixime

Cefixime
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

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Overview

Cefixime is a 3rd generation cephalosporin that is FDA approved for the treatment of uncomplicated urinary tract infections, otitis media, pharyngitis and tonsillitis, acute exacerbations of chronic bronchitis and uncomplicated gonorrhea.. Common adverse reactions include diarrhea, nausea, loose stools, abdominal pain, dyspepsia and vomiting..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• The recommended dose of cefixime is 400 mg daily.

• May be given as a 400 mg tablet or capsule daily or
• 400 mg tablet may be split and given as one half tablet every 12 hours

Uncomplicated Urinary Tract Infections

• Caused by Escherichia coli and Proteus mirabilis.

Otitis Media

• Caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes.

Pharyngitis and Tonsillitis

• Pharyngitis and Tonsillitis caused by Streptococcus pyogenes.
• Dosage: A therapeutic dosage of cefixime for at least 10 days

Acute Exacerbations of Chronic Bronchitis

• Caused by Streptococcus pneumoniae and Haemophilus influenzae.

Uncomplicated Gonorrhea (cervical/urethral)

• Caused by Neisseria gonorrhoeae.
• Dosage: a single oral dose of 400 mg

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cefixime in adult patients.

Non–Guideline-Supported Use

• Salmonella infection

• Prophylaxis of sexually transmitted infectious disease for victim of sexual aggression

• Cefixime 400 mg orally in a single dose PLUS metronidazole or azithromycin

• Sinusitis

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Pediatric patients six months of age or older
• The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.

• Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. cefixime chewable tablets must be chewed or crushed before swallowing.

Uncomplicated Urinary Tract Infections

• Caused by Escherichia coli and Proteus mirabilis.

Otitis Media

• Caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes.

Pharyngitis and Tonsillitis

• Pharyngitis and Tonsillitis caused by Streptococcus pyogenes.
• A therapeutic dosage of cefixime for at least 10 days

Acute Exacerbations of Chronic Bronchitis

• Caused by Streptococcus pneumoniae and Haemophilus influenzae.

Uncomplicated Gonorrhea (cervical/urethral)

• Caused by Neisseria gonorrhoeae.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cefixime in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cefixime in pediatric patients.

Contraindications

Cefixime is contraindicated in patients with known allergy to cefixime or other cephalosporins.

Warnings

Hypersensitivity Reactions

• Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime.

• Before therapy with Suprax is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. If this product is to be given to penicillin-sensitive patients, caution should be exercised because cross hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Suprax occurs, discontinue the drug.

Clostridium difficile-Associated Diarrhea

• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Suprax, 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 isolates 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 two 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.

Dose Adjustment in Renal Impairment

• The dose of Suprax should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully

Coagulation Effects

• Cephalosporins, including Suprax, may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

Development of Drug-Resistant Bacteria

• Prescribing cefixime in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

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.

The most commonly seen adverse reactions in U.S. trials of the tablet formulation were gastrointestinal events, which were reported in 30% of adult patients on either the twice daily or the once daily regimen. Five percent (5%) of patients in the U.S. clinical trials discontinued therapy because of drug-related adverse reactions. Individual adverse reactions included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7%, dyspepsia 3%, and flatulence 4%. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in pediatric patients receiving the suspension was comparable to the incidence seen in adult patients receiving tablets.

Postmarketing Experience

The following adverse reactions have been reported following the use of cefixime. Incidence rates were less than 1 in 50 (less than 2%).

Gastrointestinal

• Several cases of documented pseudomembranous colitis were identified in clinical trials. The onset of pseudomembranous colitis symptoms may occur during or after therapy.

Hypersensitivity Reactions

• Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, drug fever, pruritus, angioedema, and facial edema. Erythema multiforme, Stevens-Johnson syndrome, and serum sickness-like reactions have been reported.

Hepatic

• Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, jaundice.

Renal

• Transient elevations in BUN or creatinine, acute renal failure.

Central Nervous System

• Headaches, dizziness, seizures.

Hemic and Lymphatic System

• Transient thrombocytopenia, leukopenia, neutropenia, prolongation in prothrombin time, elevated LDH, pancytopenia, agranulocytosis, and eosinophilia.

Abnormal Laboratory Tests

• Hyperbilirubinemia

Other Adverse Reactions

• Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis.

Adverse Reactions Reported for Cephalosporin-class Drugs

• Allergic reactions, superinfection, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and colitis.
• Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Drug Interactions

Carbamazepine

• Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.

Warfarin and Anticoagulants

• Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.

Drug/Laboratory Test Interactions

• A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide.

• The administration of cefixime may result in a false-positive reaction for glucose in the urine using Clinitest®**, Benedict's solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix®** or TesTape®**) be used. A false-positive direct Coombs test has been reported during treatment with other cephalosporins; therefore, it should be recognized that a positive Coombs test may be due to the drug.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cefixime in women who are pregnant.

Labor and Delivery

Cefixime has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.

Nursing Mothers

It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

Pediatric Use

Safety and effectiveness of cefixime in children aged less than six months old have not been established. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets.

Geriatic Use

Clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. A pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters. These differences were small and do not indicate a need for dosage adjustment of the drug in the elderly.

Gender

There is no FDA guidance on the use of Cefixime with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cefixime with respect to specific racial populations.

Renal Impairment

The dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully.

Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Refer to Table 2 for dose adjustments for adults with renal impairment. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.

Hepatic Impairment

There is no FDA guidance on the use of Cefixime in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cefixime in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cefixime in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Monitoring

Patients on dialysis should be monitored carefully.

IV Compatibility

There is limited information regarding the compatibility of Cefixime and IV administrations.

Overdosage

Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of cefixime did not differ from the profile seen in patients treated at the recommended doses.

Pharmacology

There is limited information regarding Cefixime Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Cefixime Mechanism of Action in the drug label.

Structure

There is limited information regarding Cefixime Structure in the drug label.

Pharmacodynamics

There is limited information regarding Cefixime Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Cefixime Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Cefixime Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Cefixime Clinical Studies in the drug label.

How Supplied

There is limited information regarding Cefixime How Supplied in the drug label.

Storage

There is limited information regarding Cefixime Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Cefixime Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Cefixime interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Cefixime Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Cefixime Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Cefixime
Suprax® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [4]

Overview

Cefixime (Suprax in the USA )is a cephalosporin antibiotic used to treat bacterial infections. The bactericidal action of cephalosporin due to the inhibition of cell wall synthesis. It binds to one of the penicillin binding proteins (PBPs) which inhibits the final transpeptidation step of the peptidoglycan synthesis in the bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death.

Category

Antibacterial

US Brand Names

Suprax^®

FDA Package Insert

Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Overdosage | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages