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

Film Coated Tablets

Granules for oral suspension

Patients with Renal Dysfunction

• For patients with severe renal impairment (<30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on hemodialysis, the dose frequency should be 3 times/week after hemodialysis.
• When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to estimate creatinine clearance (mL/min). For this estimate to be valid, the serum creatinine level should represent a steady state of renal function.
• Males: Weight (kg) x (140 - age)

(mL/min) 72 x serum creatinine (mg/100 mL)

• Females: 0.85 x above value

(mL/min)

Patients with Cirrhosis

• Cefpodoxime pharmacokinetics in cirrhotic patients (with or without ascites) are similar to those in healthy subjects. Dose adjustment is not necessary in this population

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cefpodoxime proxetil 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

• Antacids: Concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels by 24% to 42% and the extent of absorption by 27% to 32%, respectively. The rate of absorption is not altered by these concomitant medications. Oral anti-cholinergics (e.g., propantheline) delay peak plasma levels (47% increase in Tmax), but do not affect the extent of absorption (AUC).
• Probenecid: As with other beta-lactam antibiotics, renal excretion of cefpodoxime was inhibited by probenecid and resulted in an approximately 31% increase in AUC and 20% increase in peak cefpodoxime plasma levels.
• Nephrotoxic drugs: Although nephrotoxicity has not been noted when cefpodoxime proxetil was given alone, close monitoring of renal function is advised when cefpodoxime proxetil is administered concomitantly with compounds of known nephrotoxic potential.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B

Pregnancy

Teratogenic Effects

Cefpodoxime proxetil was neither teratogenic nor embryocidal when administered to rats during organogenesis at doses up to 100 mg/kg/day (2 times the human dose based on mg/m2) or to rabbits at doses up to 30 mg/kg/day (1 to 2 times the human dose based on mg/m2). There are, however, no adequate and well-controlled studies of cefpodoxime proxetil use 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 Cefpodoxime proxetil in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

Cefpodoxime is excreted in human milk. In a study of 3 lactating women, levels of cefpodoxime in human milk were 0%, 2% and 6% of concomitant serum levels at 4 hours following a 200 mg oral dose of cefpodoxime proxetil. At 6 hours post-dosing, levels were 0%, 9% and 16% of concomitant serum levels. Because of the potential for serious reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and efficacy in infants less than 2 months of age have not been established.

Geriatic Use

Of the 3338 patients in multiple-dose clinical studies of cefpodoxime proxetil film-coated tablets, 521 (16%) were 65 and over, while 214 (6%) were 75 and over. No overall differences in effectiveness or safety were observed between the elderly and younger patients. In healthy geriatric subjects with normal renal function, cefpodoxime half-life in plasma averaged 4.2 hours and urinary recovery averaged 21% after a 400 mg dose was given every 12 hours for 15 days. Other pharmacokinetic parameters were unchanged relative to those observed in healthy younger subjects. Dose adjustment in elderly patients with normal renal function is not necessary.

Gender

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

Race

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

Renal Impairment

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.

Hepatic Impairment

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

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cefpodoxime proxetil 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 Tablets : administer tablets orally with food to enhance absorption
• Oral Suspension : give without regard to food

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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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

• Vantin

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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