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

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

Warnings

There is limited information regarding Cefixime Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

There is limited information regarding Cefixime Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Cefixime Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Cefixime in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cefixime in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cefixime during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cefixime in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Cefixime in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Cefixime in geriatric settings.

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

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

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

Monitoring

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

IV Compatibility

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

Overdosage

There is limited information regarding Cefixime overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

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