Cefpodoxime

Cefpodoxime
Black Box Warning
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: Rabin Bista, M.B.B.S. [2]

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Black Box Warning

ConditionName: See full prescribing information for complete Boxed Warning. BEFORE THERAPY WITH CEFPODOXIME PROXETIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFPODOXIME, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFPODOXIME IS TO BE ADMINISTERED 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 CEFPODOXIME PROXETIL OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINE, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Overview

Cefpodoxime is a orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class that is FDA approved for the treatment of acute otitis media,pharyngitis,tonsillitis,community-acquired pneumonia,acute bacterial exacerbation of chronic bronchitis,acute uncomplicated urethral and cervical gonorrhea,acute maxillary sinusitis,uncomplicated urinary tract infections and uncomplicated skin and skin structure infections.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Diarrhea,Nausea,Vaginal Fungal Infections,Vulvovaginal Infections,Abdominal pain, Headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Acute otitis media caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilus influenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains).
• Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes.
• Community-acquired pneumonia caused by S. pneumoniae or H. Influenzae (including beta-lactamase-producing strains).
• Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
• Acute, uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
• Acute, uncomplicated ano-rectal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).
• Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes. Abscesses should be surgically drained as clinically indicated.

• Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae, and Moraxella catarrhalis.
• Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.

Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Cefpodoxime in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Contraindications

Cefpodoxime proxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.

Warnings

ConditionName: See full prescribing information for complete Boxed Warning. BEFORE THERAPY WITH CEFPODOXIME PROXETIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFPODOXIME, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFPODOXIME IS TO BE ADMINISTERED 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 CEFPODOXIME PROXETIL OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINE, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

• Description

Precautions

• In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of cefpodoxime proxetil should be reduced because high and prolonged serum antibiotic concentrations can occur in such individuals following usual doses. Cefpodoxime, like other cephalosporins, should be administered with caution to patients receiving concurrent treatment with potent diuretics.
• As with other antibiotics, prolonged use of cefpodoxime proxetil may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
• Prescribing cefpodoxime proxetil 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.

Adverse Reactions

Clinical Trials Experience

Body as a Whole

• Diarrhea
• Nausea
• Vaginal Fungal Infections
• Vulvovaginal Infections
• Abdominal Pain
• Headache

Cardiovascular

• congestive heart failure
• migraine
• palpitations
• vasodilation
• hematoma
• hypertension
• hypotension

Digestive

• vomiting
• dyspepsia
• dry mouth
• flatulence
• decreased appetite
• constipation
• oral moniliasis
• anorexia
• eructation
• gastritis
• mouth ulcer
• gastrointestinal disorders
• rectal disorders
• tongue disorders
• tooth disorders
• increased thirst
• oral lesions
• tenesmus
• dry throat
• toothache

Hematologic and Lymphatic

• anemia

Metabolic and Nutritional

• dehydration
• gout
• peripheral edema
• weight increase

Musculoskeletal

• myalgia

Neurologic

• dizziness
• insomnia
• somnolence
• anxiety
• shakiness
• nervousness
• cerebral infarction
• change in dreams
• impaired concentration
• confusion
• nightmares
• paresthesia
• vertigo

Respiratory

• asthma
• cough
• epistaxis
• rhinitis
• wheezing
• bronchitis
• dyspnea
• pleural effusion
• pneumonia
• sinusitis

Skin and Hypersensitivy Reactions

• urticaria
• rash
• pruritus
• diaphoresis
• maculopapular rash
• fungal dermatitis
• desquamation
• dry skin non-application site
• hair loss
• vesiculobullous rash
• sunburn

Special Senses

• taste alterations
• eye irritation
• taste loss
• tinnitus

Urogenital

• hematuria
• urinary tract infections
• metrorrhagia
• dysuria
• urinary frequency
• nocturia
• penile infection
• proteinuria
• vaginal pain

Miscellaneous

• fungal infections
• abdominal distention
• malaise, fatigue
• asthenia
• fever
• chest pain
• back pain
• chills
• generalized pain
• abnormal microbiological test
• moniliasis
• abscess
• allergic reaction
• facial edema
• bacterial infections
• parasitic infections
• localized edema
• localized pain

Postmarketing Experience

• The following serious adverse experiences have been reported: allergic reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and serum sickness-like reactions, pseudomembranous colitis, bloody diarrhea with abdominal pain, ulcerative colitis, rectorrhagia with hypotension, anaphylactic shock, acute liver injury, in utero exposure with miscarriage, purpuric nephritis, pulmonary infiltrate with eosinophilia, and eyelid dermatitis.
• One death was attributed to pseudomembranous colitis and disseminated intravascular coagulation.

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cefpodoxime in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Cefpodoxime with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Cefpodoxime with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Cefpodoxime with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

There is no FDA guidance on the use of Cefpodoxime in patients with renal impairment.

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Cefpodoxime in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Cefpodoxime in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Cefpodoxime in the drug label.

Pharmacology

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

Mechanism of Action

Structure

File:Cefpodoxime01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Cefpodoxime in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Cefpodoxime in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Precautions with Alcohol

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

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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