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Medication Safety Issues
Sound-alike/look-alike issues:
Vantin® may be confused with Ventolin®
Pronunciation
(sef pode OKS eem)
U.S. Brand Names
Index Terms
Generic Available
Yes
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of susceptible acute, community-acquired pneumonia caused by S. pneumoniae or nonbeta-lactamase producing H. influenzae; acute uncomplicated gonorrhea caused by N. gonorrhoeae; uncomplicated skin and skin structure infections caused by S. aureus or S. pyogenes; acute otitis media caused by S. pneumoniae, H. influenzae, or M. catarrhalis; pharyngitis or tonsillitis; and uncomplicated urinary tract infections caused by E. coli, Klebsiella, and Proteus
Pregnancy Risk Factor
B
Pregnancy Considerations
Teratogenic events were not observed in animal studies; therefore, cefpodoxime is classified as pregnancy category B. It is not known if cefpodoxime crosses the human placenta. Other cephalosporins cross the placenta and are considered safe in pregnancy.
Lactation
Enters breast milk (small amounts)/not recommended
Breast-Feeding Considerations
Very small amounts of cefpodoxime are excreted in breast milk. Breast-feeding is not recommended by the manufacturer. Other cephalosporins are considered safe during breast-feeding. Nondose-related effects could include modification of bowel flora.
Contraindications
Hypersensitivity to cefpodoxime, any component of the formulation, or other cephalosporins
Warnings/Precautions
Concerns related to adverse effects:
• Penicillin allergy: Use with caution in patients with a history of penicillin 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.
Adverse Reactions
>10%:
Dermatologic: Diaper rash (12%)
Gastrointestinal: Diarrhea in infants and toddlers (15%)
1% to 10%:
Central nervous system: Headache (1%)
Dermatologic: Rash (1%)
Gastrointestinal: Diarrhea (7%), nausea (4%), abdominal pain (2%), vomiting (1% to 2%)
Genitourinary: Vaginal infection (3%)
<1%: Anaphylaxis, chest pain, hypotension, fungal skin infection, pseudomembranous colitis, vaginal candidiasis, pruritus, flatulence, decreased salivation, malaise, fever, decreased appetite, cough, epistaxis, dizziness, fatigue, anxiety, insomnia, flushing, weakness, nightmares, taste alteration, eye itching, tinnitus, purpuric nephritis
Reactions reported with other cephalosporins: Seizure, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, urticaria, serum-sickness reactions, renal dysfunction, interstitial nephritis toxic nephropathy, cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, pancytopenia, agranulocytosis, colitis, vaginitis, superinfection
Drug Interactions
Antacids: May decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy
H2-Antagonists: May decrease the absorption of Cefpodoxime. Separate oral doses by at least 2 hours. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Risk D: Consider therapy modification
Uricosuric Agents: May decrease the excretion of Cephalosporins. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Food: Food delays absorption; cefpodoxime serum levels may be increased if taken with food.
Reconstitution
Shake well before using. After mixing, keep suspension in refrigerator. Discard unused portion after 14 days.
Mechanism of Action
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.
Pharmacodynamics/Kinetics
Absorption: Rapid and well absorbed (50%), acid stable; enhanced in the presence of food or low gastric pH
Distribution: Good tissue penetration, including lung and tonsils; penetrates into pleural fluid
Protein binding: 18% to 23%
Metabolism: De-esterified in GI tract to active metabolite, cefpodoxime
Half-life elimination: 2.2 hours; prolonged with renal impairment
Time to peak: Within 1 hour
Excretion: Urine (80% as unchanged drug) in 24 hours
Dosage
Usual dosage range:
Children 2 months to 12 years: Oral: 10 mg/kg/day divided every 12 hours (maximum dose: 400 mg/day)
Children ?12 years and Adults: Oral: 100-400 mg every 12 hours
Indication-specific dosing:
Children 2 months to 12 years: Oral:
Acute maxillary sinusitis: 10 mg/kg/day divided every 12 hours for 10 days (maximum: 200 mg/dose)
Acute otitis media: 10 mg/kg/day divided every 12 hours (400 mg/day) for 5 days (maximum: 200 mg/dose)
Pharyngitis/tonsillitis: 10 mg/kg/day in 2 divided doses for 5-10 days (maximum: 100 mg/dose)
Children ?12 years and Adults: Oral:
Acute community-acquired pneumonia and bacterial exacerbations of chronic bronchitis: 200 mg every 12 hours for 14 days and 10 days, respectively
Acute maxillary sinusitis: 200 mg every 12 hours for 10 days
Pharyngitis/tonsillitis: 100 mg every 12 hours for 5-10 days
Skin and skin structure: 400 mg every 12 hours for 7-14 days
Uncomplicated gonorrhea (male and female) and rectal gonococcal infections (female): 200 mg as a single dose
Uncomplicated urinary tract infection: 100 mg every 12 hours for 7 days
Dosing adjustment in renal impairment: Clcr <30 mL/minute: Administer every 24 hours
Hemodialysis: Administer dose 3 times/week following hemodialysis
Administration: Oral
Administer around-the-clock to promote less variation in peak and trough serum levels.
Monitoring Parameters
Observe for signs and symptoms of anaphylaxis during first dose
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
Dietary Considerations
May be taken with food.
Patient Education
Do not take any new medication during therapy unless approved by prescriber. Take as directed, at regular intervals around-the-clock (with or without food). Chilling oral suspension improves flavor (do not freeze); shake well before using. Maintain adequate hydration unless instructed to restrict fluid intake. Complete full course of medication, even if you feel better. May cause false test results with Clinitest®; use of another type of glucose testing is preferable. May cause nausea or vomiting (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); or diarrhea (yogurt, Bifidobacterium bifidum, Lactobacillus acidophilus, Saccharomyces boulardii may help). Report rash; breathing or swallowing difficulty; persistent diarrhea, nausea, vomiting, or abdominal pain; changes in urinary pattern or pain on urination; opportunistic infection (eg, vaginal itching or drainage, sores in mouth, blood in stool or urine, unusual fever or chills); CNS changes (eg, irritability, agitation, nervousness, insomnia, hallucinations); or other adverse reactions. Breast-feeding precaution: Consult prescriber if breast-feeding.
Geriatric Considerations
Considered one of the drugs of choice for outpatient treatment of community-acquired pneumonia in the elderly. Adjust dosage with renal impairment.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause nervousness; case reports of euphoria, delusion, illusions, and depersonalization with cephalosporins
Mental Health: Effects on Psychiatric Treatment
May rarely cause neutropenia; use caution with clozapine and carbamazepine
Nursing: Physical Assessment/Monitoring
Assess results of culture/sensitivity tests and patient's allergy history prior to therapy. Assess other pharmacological or herbal products patient may be taking for potential interactions. Assess results of laboratory tests (prothrombin time), therapeutic response, and adverse effects (eg, hemolytic anemia, hypoprothrombinemia, and bleeding) regularly during therapy. Advise patients with diabetes about use of Clinitest® (may cause false-positive test). Teach patient possible side effects/appropriate interventions and adverse symptoms to report (eg, nephrotoxicity, opportunistic infection, hypersensitivity reaction).
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Granules for suspension, oral: 50 mg/5 mL (50 mL, 75 mL, 100 mL); 100 mg/5 mL (50 mL, 75 mL, 100 mL)
Tablet: 100 mg, 200 mg
Vantin®: 100 mg [DSC], 200 mg
Pricing: U.S. (www.drugstore.com)
Suspension (reconstituted) (Vantin)
50 mg/5 mL (50): $33.99
50 mg/5 mL (100): $61.99
100 mg/5 mL (50): $56.99
100 mg/5 mL (100): $113.99
Tablets (Cefpodoxime Proxetil)
200 mg (20): $114.03
Tablets (Vantin)
100 mg (20): $127.59
200 mg (20): $185.13
References
Adam D, Bergogne-Berezin E, and Jones RN, “Symposium on Cefpodoxime Proxetil: A New Third Generation Oral Cephalosporin,” Drugs, 1991, 42(Suppl 3):1-66.
American Thoracic Society, “Guidelines for the Initial Management of Adults With Community-Acquired Pneumonia: Diagnosis, Assessment of Severity, and Initial Antimicrobial Therapy,” Am Rev Respir Dis, 1993, 148(5):1418-26.
Backhouse C, Wade A, Williamson P, et al, “Multiple Dose Pharmacokinetics of Cefpodoxime in Young Adult and Elderly Patients,” J Antimicrob Chemother, 1990, 26(Supp E):29-34.
Borin MT, “A Review of the Pharmacokinetics of Cefpodoxime Proxetil,” Drugs, 1991, 42(Suppl 3):13-21.
Cohen R, “Clinical Experience With Cefpodoxime Proxetil in Acute Otitis Media,” Pediatr Infect Dis J, 1995, 14(Suppl 4):12-8.
Fujii R, “Clinical Trials of Cefpodoxime Proxetil Suspension in Pediatrics,” Drugs, 1991, 42(Suppl 3):57-60.
Marshall WF and Blair JE, “The Cephalosporins,” Mayo Clin Proc, 1999, 74(2):187-95.
Mendelman PM, Del-Beccaro MA, McLinn SE, et al, “Cefpodoxime Proxetil Compared With Amoxicillin-Clavulanate for the Treatment of Otitis Media,” J Pediatr, 1992, 121(3):459-65.
Schatz BS, Karavokiros KT, Taeubel MA, et al, “Comparison of Cefprozil, Cefpodoxime Proxetil, Loracarbef, Cefixime, and Ceftibuten,” Ann Pharmacother, 1996, 30(3):258-68.
International Brand Names
Lexi-Comp.com
Last full review/revision July 2009
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