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cefepime

CEFEPIME HYDROCHLORIDE

Manufacturer: Sagent Pharmaceuticals

Score: 141.0

Quick Summary

Cefepime Hydrochloride and Dextrose is a cephalosporin antibacterial drug used for the treatment of various infections, including pneumonia, febrile neutropenia, urinary tract infections, skin and skin structure infections, and intra-abdominal infections. The drug is administered intravenously over 30 minutes and is available in 1g and 2g strengths. Key clinical findings and indications include its effectiveness against a range of Gram-positive and Gram-negative bacteria. Important safety information and contraindications include hypersensitivity reactions, potential nephrotoxicity and ototoxicity when used with aminoglycosides, and interactions with diuretics. Main dosing recommendations vary by condition and patient population, with adjustments needed for patients with renal impairment. Special population considerations include use during pregnancy, pediatric and geriatric use, and nursing mothers.

Key Clinical Findings and Indications

  • Treatment of pneumonia, febrile neutropenia, urinary tract infections, skin and skin structure infections, and intra-abdominal infections
  • Effective against a range of Gram-positive and Gram-negative bacteria
  • Administered intravenously over 30 minutes
  • Available in 1g and 2g strengths

Important Safety Information

Warning

Hypersensitivity reactions, potential nephrotoxicity and ototoxicity when used with aminoglycosides

Contraindications

  • Known immediate hypersensitivity reactions to cefepime or other cephalosporins, penicillins or other beta-lactam antibacterial drugs
  • Hypersensitivity to corn products

Adverse Reactions

  • Local reactions, positive Coombs' test, decreased phosphorus, increased ALT and AST, increased PT and PTT, and rash
  • Clostridioides difficile-associated diarrhea

Dosing Recommendations

General Guidance

Adjust dose in patients with creatinine clearance less than or equal to 60 mL/min

Pneumonia

Adult Dose

1-2g IV every 8-12 hours

Pediatric Dose

50mg/kg/dose every 12 hours

Febrile neutropenia

Adult Dose

2g IV every 8 hours

Pediatric Dose

50mg/kg/dose every 8 hours

Special Population Considerations

Pregnancy

  • No cases of cefepime exposure during pregnancy reported from postmarketing experience or clinical trials
  • Cefepime crosses the placenta

Nursing Mothers

  • No information available on the use of cefepime in nursing mothers

Pediatric Use

  • Safety and effectiveness established in pediatric patients 2 months to 16 years
  • Use in pediatric patients below 2 months not established

Geriatric Use

  • Of the more than 6400 adults treated with cefepime in clinical studies, 35% were 65 years or older
  • Care should be taken in dose selection, and renal function should be monitored

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