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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
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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.