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All about: Cefepime

Big Image Pronouncation: (SEFF-eh-pim)
Class: Antibiotic, Cephalosporin

Trade Names:
Maxipime
- Powder for Injection 500 mg
- Powder for Injection 1 g
- Powder for Injection 2 g

Mechanism of Action

Pharmacology

Inhibits mucopeptide synthesis in bacterial cell wall.

Pharmacokinetics

Absorption

IV (500 mg to 2 g doses)

C max is 39.1 to 163.9 mcg/mL. AUC is about 70.8 to 284.8 h•mcg/mL.

IM (500 mg to 2 g doses)

C max is about 13.9 to 57.5 mcg/mL. AUC is about 60 to 262 h•mcg/mL. T max is about 1.4 to 1.6 h.

Distribution

Vd is about 18 L (at steady state). About 20% protein bound. Excreted in human milk; crosses the inflamed blood-brain barrier.

Metabolism

Metabolized to N-methylpyrrolidine, which is then converted to the N-oxide.

Elimination

About 85% is excreted unchanged in the urine; t ½ is 102 to 138 min.

Special Populations

Renal Function Impairment

Total body Cl is decreased proportionally with Ccr. Dosage adjustment is recommended.

Elderly

Total body Cl is decreased. Adjust dose if Ccr is less than or equal to 60 mL/min.

Indications and Usage

Treatment of pneumonia and infections of the skin and skin structures and urinary tract caused by susceptible strains of specific microorganisms. Treatment of empiric therapy for febrile neutropenic patients as monotherapy. Treatment for complicated intra-abdominal infections in combination with metronidazole.

Contraindications

Hypersensitivity to cephalosporins, penicillins, or other beta-lactam antibiotics.

Dosage and Administration

Mild to Moderate Uncomplicated or Complicated UTIs
Adults

IV/IM 0.5 to 1 g every 12 h for 7 to 10 days.

Severe Uncomplicated or Complicated UTIs
Adults

IV 2 g every 12 h for 10 days.

Moderate to Severe Pneumonia
Adults

IV 1 to 2 g every 12 h for 10 days.

Moderate to Severe Uncomplicated Skin and Skin Structure Infections
Adults

IV 2 g every 12 h for 10 days

Children under 40 kg

50 mg/kg/dose every 12 h (every 8 h for febrile neutropenic patients) for 7 to 10 days. Do not exceed the recommended adult dose.

Renal Function Impairment (Children)

Data not available; however, changes in dosing regimen similar to those in adults are recommended.

General Advice

  • Inject IM preparations deep into large muscle groups.
  • Dilute IV preparations with 50 to 100 mL of compatible IV fluid and administer over 30 min.
  • Do not administer if particulate matter or discoloration is noted in reconstituted solution.

Storage/Stability

Store unopened vials at room temperature (68° to 77°F). Store reconstituted solutions at room temperature (68° to 77°F) for up to 24 h or refrigerated (36° to 46°F) for up to 7 days. Protect from light.

Drug Interactions

Aminoglycosides

Increased risk of nephrotoxicity and ototoxicity.

Incompatibility

Metronidazole, vancomycin, gentamicin, tobramycin, netilmicin, aminophylline, and ampicillin (greater than 40 mg/mL).

Laboratory Test Interactions

May cause false-positive reaction for glucose in the urine when using Clinitest tablets but not with tests based on enzymatic glucose oxidase reactions (eg, Clinistix ).

Adverse Reactions

CNS

Headache.

GI

Nausea; vomiting; diarrhea; colitis; including pseudomembranous colitis; oral moniliasis.

Dermatologic

Rash; pruritus; urticaria.

Miscellaneous

Hypersensitivity, including Stevens-Johnson syndrome; erythema multiforme; toxic epidermal necrolysis; candidal overgrowth; serum sickness–like reactions (eg, skin rashes, polyarthritis, arthralgia, fever); phlebitis; pain or inflammation at injection site; fever.

Precautions

Monitor

Response to therapy

Monitor patient's response to therapy. Notify health care provider if infection does not appear to improve or worsens.

Side effects

Monitor patient for GI, DERM, and general body side effects, and signs of superinfection. Inform health care provider if noted and significant. Immediately report severe diarrhea, diarrhea containing blood or pus, or severe abdominal cramping.


Pregnancy

Category B .

Lactation

Excreted in breast milk.

Children

Safety and efficacy in children younger than 12 yr of age have not been established.

Hypersensitivity

Reactions range from mild to life-threatening. Administer drug with caution to penicillin-sensitive patients because of possible cross-sensitivity.

Renal Function

Dosage adjustment is necessary in patients with Ccr less than  60 mL/min.

Superinfection

Drug may cause bacterial or fungal overgrowth of nonsusceptible microorganisms.

Pseudomembranous colitis

Consider in patients in whom diarrhea develops.

Overdosage

Symptoms

Seizures, encephalopathy, neuromuscular excitability.

Patient Information

  • Instruct patient to check body temperature daily. If fever persists for more than a few days or if high fever (above 102°F) or shaking chills are noted, notify health care provider immediately.
  • Advise patient to maintain normal fluid intake while using this medication.
  • Advise patient to report signs of superinfection: black “furry” tongue, white patches in mouth, foul-smelling stools, vaginal itching or discharge.
  • Instruct patient in good personal hygiene (especially mouth and perineal care).
  • Advise patient to report any increase in ecchymoses, petechiae, or nose bleeds.
  • Advise patient to eat/drink 4 oz of yogurt or buttermilk a day as a prophylaxis against intestinal superinfection.
  • Advise diabetic patient to use enzyme-based tests (eg, Clinistix , Testape ) for monitoring urine glucose because drug may give false results with other tests.
  • Instruct patient to report these symptoms to health care provider: nausea, vomiting, diarrhea, skin rash, hives, sore throat, bruising, bleeding, muscle or joint pain.
  • Warn patient that diarrhea containing blood or pus may be a sign of serious disorders.
  • Tell patient to seek medical care for symptoms and not to treat at home. Instruct patient to seek emergency care if wheezing or difficulty in breathing occurs.

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