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Cefpodoxime + Clavulanic Acid

Cephalosporin · Antibiotic

Also known as Macpod CV, Cepodem CV, Swich CV, Monocef O CV, Zedocef CV

CephalosporinAntibioticATC J01DD13 (for Cefpodoxime, as a combined ATC code for FDCs is not always assigned and its efficacy is extended by Clavulanic Acid)
CDSCO approvedSchedule HATC J01DD13 (for Cefpodoxime, as a combined ATC code for FDCs is not always assigned and its efficacy is extended by Clavulanic Acid)
Pharmacokineticsplasma · t hours
1.5hONSET2.5hPEAK2.5h12hDURATION
ONSET
1.5h · Relatively rapid, typically within 1-2 hours of oral administration.
PEAK
2.5h · Cefpodoxime: Approximately 2-3 hours after oral dose; Clavulanic Acid: Approximately 1 hour after oral dose.
2.5h · Cefpodoxime: Approximately 2-3 hours; Clavulanic Acid: Approximately 1 hour.
DURATION
12h · Effective concentrations typically maintained for 12 hours with twice-daily dosing.
EXCRETION
not curated
INTERACTIONS
none in our sources
PREGNANCY
B (Based on individual component data, indicating no evidence of harm in animal studies, but human data are limited.)
FDA category + note

Mechanism

Cefpodoxime, a third-generation cephalosporin, exerts bactericidal action by inhibiting bacterial cell wall synthesis through binding to penicillin-binding proteins (PBPs). Clavulanic acid, a beta-lactamase inhibitor, protects cefpodoxime from degradation by a wide range of beta-lactamase enzymes produced by many Gram-positive and Gram-negative bacteria. This combination synergistically extends the antimicrobial spectrum of cefpodoxime against resistant bacterial strains. Combination rationale: This FDC is rational because clavulanic acid protects cefpodoxime from enzymatic degradation by beta-lactamase-producing bacteria. This extends cefpodoxime's spectrum of activity to include many organisms that would otherwise be resistant, thereby improving its clinical utility in treating a broader range of bacterial infections.

Indications

Community-acquired pneumonia (CAP)Acute exacerbation of chronic bronchitis (AECB)Acute bacterial sinusitisPharyngitis/TonsillitisUncomplicated urinary tract infections (UTIs)Skin and soft tissue infectionsAcute otitis media

Dosing

Adult
Typically 200 mg Cefpodoxime + 125 mg Clavulanic Acid orally twice daily for 5-10 days, depending on the severity and type of infection. Available strengths commonly include 200 mg + 125 mg and 100 mg + 62.5 mg tablets.
Pediatric
For children (typically > 3 months of age), dosing is based on the cefpodoxime component: 10 mg/kg/day in two divided doses every 12 hours, for 5-10 days. Common strengths include oral suspensions of 50 mg + 31.25 mg per 5 mL.
Renal adjustment
For creatinine clearance (CrCl) 30-80 mL/min: typically 200 mg Cefpodoxime + 125 mg Clavulanic Acid every 12 hours. For CrCl < 30 mL/min: administer every 24 hours. Hemodialysis patients: administer after dialysis.
Hepatic adjustment
No specific dose adjustment is generally required for patients with hepatic impairment, as cefpodoxime is primarily excreted renally and clavulanic acid is also predominantly eliminated by the kidneys.
Geriatric
No specific dose adjustment required based solely on age, but renal function should be assessed and dose adjusted if creatinine clearance is below 30 mL/min.
Max dose
The usual maximum daily dose for cefpodoxime is 400 mg/day, and for clavulanic acid, it is typically limited by the fixed combination to avoid adverse effects.

Pharmacokinetics

Onset
Relatively rapid, typically within 1-2 hours of oral administration.
Peak effect
Cefpodoxime: Approximately 2-3 hours after oral dose; Clavulanic Acid: Approximately 1 hour after oral dose.
Duration
Effective concentrations typically maintained for 12 hours with twice-daily dosing.
Half-life
Cefpodoxime: Approximately 2-3 hours; Clavulanic Acid: Approximately 1 hour.
Bioavailability
Cefpodoxime proxetil: Approximately 50% (oral); Clavulanic Acid: Approximately 60-70% (oral)
Protein binding
Cefpodoxime: Approximately 20-30%; Clavulanic Acid: Approximately 25%.
Metabolism
Cefpodoxime proxetil is a prodrug that is de-esterified in the gastrointestinal tract to its active metabolite, cefpodoxime. Clavulanic acid is extensively metabolized in the liver.
Excretion
Cefpodoxime: Primarily renal (approximately 29-39% of dose excreted unchanged in urine within 12 hours). Clavulanic Acid: Primarily renal, with approximately 30-40% excreted unchanged in urine.

Contraindications

  • Known hypersensitivity to cefpodoxime, clavulanic acid, or any other cephalosporin antibiotics
  • History of severe hypersensitivity reactions to any other beta-lactam antibiotics (e.g., penicillins)

Side effects

Common
DiarrheaNauseaVomitingAbdominal painHeadacheRashVaginal candidiasis (in females)
Serious
  • Clostridioides difficile-associated diarrhea (CDAD)
  • Anaphylaxis and other severe hypersensitivity reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
  • Hepatotoxicity
  • Renal dysfunction (e.g., interstitial nephritis)
  • Seizures (especially with high doses or renal impairment)

Pregnancy & lactation

Pregnancy

B (Based on individual component data, indicating no evidence of harm in animal studies, but human data are limited.)

Lactation

Both cefpodoxime and clavulanic acid are excreted in breast milk in small amounts. Generally considered compatible with breastfeeding, but caution is advised, and the infant should be monitored for potential adverse effects such as diarrhea, candidiasis, or allergic reactions.

Related guidelines

Other Cephalosporin drugs

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