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Here’s what to ask a doctor about hereditary angioedema

Cefpodoxime

Pronunciation

Pronunciation

(sef pode OKS eem)

Index Terms

  • Cefpodoxime Proxetil
  • Vantin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension Reconstituted, Oral:

Generic: 50 mg/5 mL (50 mL, 100 mL); 100 mg/5 mL (50 mL, 100 mL)

Tablet, Oral:

Generic: 100 mg, 200 mg

Pharmacologic Category

  • Antibiotic, Cephalosporin (Third Generation)

Pharmacology

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Absorption

Rapid and well absorbed (50%); tablet AUC increased 21% to 33% with food

Distribution

Good tissue penetration, including lung and tonsils; penetrates into pleural fluid

Metabolism

De-esterified in GI tract to active metabolite, cefpodoxime

Excretion

Urine (~29% to 33% as unchanged drug) in 12 hours

Time to Peak

Tablets: Within 2 to 3 hours; Oral suspension: Slower in presence of food, 48% increase in Tmax

Half-Life Elimination

~2 to 3 hours; prolonged with renal impairment (~10 hours for CrCl <30 mL/minute)

Protein Binding

Serum: 22% to 33%; Plasma: 21% to 29%

Special Populations: Renal Function Impairment

Elimination is reduced in those with CrCl less than 50 mL/minute.

Special Populations: Elderly

The half-life is increased to about 4.2 hours.

Use: Labeled Indications

Chronic bronchitis, acute bacterial exacerbation: Treatment of acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (non-beta-lactamase-producing strains only), or Moraxella catarrhalis.

Gonorrhea:

Acute, uncomplicated anorectal infections in women: Treatment of acute, uncomplicated anorectal infections in women due to N. gonorrhoeae (including penicillinase-producing strains). Note: Due to issues of resistance, cefpodoxime is no longer recommended for the treatment of acute, uncomplicated anorectal infections in women.

Acute, uncomplicated urethral and cervical: Treatment of acute, uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains). Note: Due to issues of resistance, cefpodoxime is no longer recommended for the treatment of acute, uncomplicated urethral and cervical gonorrhea.

Otitis media, acute: Treatment of acute otitis media caused by S. pneumoniae, (excluding penicillin-resistant strains), Streptococcus pyogenes, H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase producing strains).

Pharyngitis or tonsillitis: Treatment of pharyngitis or tonsillitis caused by S. pyogenes.

Pneumonia, community-acquired: Treatment of community-acquired pneumonia caused by S. pneumoniae or H. influenzae (including beta-lactamase-producing strains).

Sinusitis, acute maxillary: Treatment of acute maxillary sinusitis caused by H. influenzae (including beta-lactamase producing strains), S. pneumoniae, and M. catarrhalis. Note: According to the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis, cefpodoxime is no longer recommended as monotherapy for initial empiric treatment.

Skin and skin structure infections, uncomplicated: Treatment of uncomplicated skin and skin structure infections caused by S. aureus (including penicillinase-producing strains) or S. pyogenes.

Urinary tract infections (cystitis), uncomplicated: Treatment of cystitis caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.

Use: Unlabeled

Acute bacterial rhinosinusitis (ABRS) (pediatric) in combination with clindamycin

Contraindications

Hypersensitivity to cefpodoxime, any component of the formulation, or other cephalosporins

Dosing: Adult

Bronchitis (chronic), bacterial exacerbation: Oral: 200 mg every 12 hours for 10 days

Pharyngitis/tonsillitis: Oral: 100 mg every 12 hours for 5 to 10 days

Pneumonia, acute community acquired: Oral: 200 mg every 12 hours for 14 days

Rhinosinusitis, acute maxillary: Oral: 200 mg every 12 hours for 10 days

Skin and skin structure: Oral: 400 mg every 12 hours for 7 to 14 days

Urinary tract infection, uncomplicated: Oral: 100 mg every 12 hours for 7 days

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Usual dosage range:

Infants ≥2 months and Children <12 years: Oral: 10 mg/kg/day divided every 12 hours (maximum: 200 mg/dose).

Children ≥12 years and Adolescents: Oral: 100 to 400 mg every 12 hours.

Indication-specific dosing:

Bronchitis (chronic), bacterial exacerbation: Children ≥12 years and Adolescents: Oral: Refer to adult dosing.

Otitis media, acute: Infants ≥2 months and Children <12 years: Oral: 5 mg/kg/dose (maximum: 200 mg/dose) every 12 hours for 5 days. Note: AAP guidelines recommend duration based on patient age: If <2 years of age or severe symptoms (any age): 10-day course; if 2 to 5 years of age with mild to moderate symptoms: 7-day course; if ≥6 years of age with mild to moderate symptoms: 5- to 7-day course (AAP [Lieberthal 2013]).

Pharyngitis/tonsillitis:

Infants ≥2 months and Children <12 years: Oral: 5mg/kg/dose every 12 hours (maximum: 100 mg/dose) for 5 to 10 days.

Children ≥12 years and Adolescents: Oral: Refer to adult dosing.

Pneumonia, acute community acquired: Children ≥12 years and Adolescents: Oral: Refer to adult dosing.

Rhinosinusitis, acute maxillary:

Infants ≥2 months and Children <12 years: Oral: 5 mg/kg/dose (maximum: 200 mg/dose) every 12 hours for 10 days. Note: IDSA recommends use in combination with clindamycin for 10 to 14 days in patients with non-type 1 penicillin allergy, after failure of initial therapy or in patients at risk for antibiotic resistance (eg, daycare attendance, age <2 years, recent hospitalization, antibiotic use within the past month) (Chow 2012).

Children ≥12 years and Adolescents: Oral: Refer to adult dosing.

Skin and skin structure: Children ≥12 years and Adolescents: Oral: Refer to adult dosing.

Urinary tract infection, uncomplicated: Children ≥12 years and Adolescents: Oral: Refer to adult dosing.

Dosing: Renal Impairment

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Administer every 24 hours.

Hemodialysis: Dose 3 times/week following dialysis.

Dosing: Hepatic Impairment

Cirrhosis (with or without ascites): No dosage adjustment necessary.

Reconstitution

Suspension: Refer to manufacturer’s product labeling for reconstitution instructions.

Administration

Oral: Administer around-the-clock to promote less variation in peak and trough serum levels. Administer tablets with food; suspension may be administered without regard to food. Shake suspension well before using.

Dietary Considerations

Take tablets with food.

Storage

Suspension: Store at 20°C to 25°C (68°F to 77°F); after reconstitution, suspension may be stored in refrigerator for 14 days.

Tablet: Store at 20°C to 25°C (68°F to 77°F); protect from light.

Drug Interactions

Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Antacids: May decrease the serum concentration of Cefpodoxime. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination

H2-Antagonists: May decrease the absorption of Cefpodoxime. Separate oral doses by at least 2 hours. Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Probenecid: May increase the serum concentration of Cephalosporins. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Test Interactions

Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction

Adverse Reactions

>10%:

Dermatologic: Diaper rash (12%)

Gastrointestinal: Diarrhea (infants and toddlers 15%)

1% to 10%:

Central nervous system: Headache (1%)

Dermatologic: Skin rash (1%)

Gastrointestinal: Diarrhea (7%), nausea (4%), abdominal pain (2%), vomiting (1% to 2%)

Genitourinary: Vaginal infection (3%)

<1% (Limited to important or life-threatening): Anaphylaxis, anxiety, chest pain, cough, decreased appetite, dizziness, dysgeusia, epistaxis, eye pruritus, fatigue, fever, flatulence, flushing, fungal skin infection, hypotension, insomnia, malaise, nightmares, pruritus, pseudomembranous colitis, purpuric nephritis, tinnitus, vulvovaginal candidiasis, weakness, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• Beta-lactam allergy: Use with caution in patients with a history of beta-lactam allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

Monitoring Parameters

Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.

Pregnancy Risk Factor

B

Pregnancy Considerations

Teratogenic events were not observed in animal reproduction studies. An increase in most types of birth defects was not found following first trimester exposure to cephalosporins.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea. Have patient report immediately to prescriber bruising, bleeding, severe loss of strength and energy, urinary retention, change in amount of urine passed, chills, pharyngitis, seizures, vaginitis, or signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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