cefepime

SEFF-e-peem

Therapeutic Classification: anti-infectives

Pharmacologic Classification: fourth.generation.cephalosporins

REMS

Treatment of the following infections caused by susceptible organisms:
- Uncomplicated skin and skin structure infections,
- Bone and joint infections,
- Uncomplicated and complicated urinary tract infections,
- Respiratory tract infections,
- Complicated intra-abdominal infections (with metronidazole),
- Septicemia.
Empiric treatment of febrile neutropenic patients.

Binds to the bacterial cell wall membrane, causing cell death.

Therapeutic effects:

Bactericidal action against susceptible bacteria.

Spectrum:

Similar to that of second- and third-generation cephalosporins, but activity against staphylococci is less, whereas activity against gram-negative pathogens is greater, even for organisms resistant to first-, second-, and third-generation agents.
Notable is increased action against:
- Enterobacter,
- Haemophilus influenzae (including β-lactamase-producing strains),
- Escherichia coli,
- Klebsiella pneumoniae,
- Neisseria,
- Proteus,
- Providencia,
- Pseudomonas aeruginosa,
- Serratia,
- Moraxella catarrhalis (including β-lactamase-producing strains).
Not active against methicillin-resistant staphylococci or enterococci.

Absorption: Well absorbed after IM administration; IV administration results in complete bioavailability.

Distribution: Widely distributed. Some CSF penetration.

Metabolism/Excretion: 85% excreted unchanged in urine.

Half-Life: Adults: 2 hr (↑ in renal impairment); Children 2 mo–6 yr: 1.7–1.9 hr.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IM	rapid	1–2 hr	12 hr
IV	rapid	end of infusion	12 hr

Contraindicated in:

Hypersensitivity to cephalosporins;
Serious hypersensitivity to penicillins.

Use Cautiously in:

Renal impairment (↓ dosing/↑ dosing interval recommended if CCr ≤60 mL/min);
History of GI disease, especially colitis;
Hepatic impairment or poor nutritional status (may be at ↑ risk of bleeding);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Geri: Dose adjustment due to age-related in renal function may be necessary in older adults.

Derm: rash, pruritus, urticaria

GI: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), diarrhea, nausea, vomiting

Hemat: bleeding, eosinophilia, hemolytic anemia, neutropenia, thrombocytopenia

Local: pain at IM site, phlebitis at IV site

Neuro: aphasia, ENCEPHALOPATHY, headache, SEIZURES ( RISK IN RENAL IMPAIRMENT)↑ risk in renal impairment)

Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), superinfection

Drug-drug:

Probenecid↓ excretion and ↑ levels.
Concurrent use of loop diuretics or aminoglycosides may ↑ risk of nephrotoxicity.

IM (Adults ): Mild to moderate uncomplicated or complicated urinary tract infections due to
Escherichia coli
: 0.5–1 g every 12 hr.
IV (Adults ): Moderate to severe pneumonia: 1–2 g every 12 hr. Mild to moderate uncomplicated or complicated urinary tract infections: 0.5–1 g every 12 hr. Severe uncomplicated or complicated urinary tract infections, moderate to severe uncomplicated skin and skin structure infections, complicated intra-abdominal infections: 2 g every 12 hr. Empiric treatment of febrile neutropenia: 2 g every 8 hr.
IV (Children 1 mo–16 yr): Uncomplicated and complicated urinary tract infections, uncomplicated skin and skin structure infections, pneumonia: 50 mg/kg every 12 hr (not to exceed 2 g/dose). Febrile neutropenia: 50 mg/kg every 8 hr (not to exceed 2 g/dose).
IV (Neonates postnatal age ≥14 days): 50 mg/kg every 12 hr.
IV (Neonates postnatal age <14 days): 30 mg/kg every 12 hr; consider 50 mg/kg every 12 hr for Pseudomonas infections.

Renal Impairment

IM IV (Adults ): (See Manufacturer's specific recommendations) CCr 30–60 mL/min: 0.5–1 g every 24 hr or 2 g every 12–24 hr; CCr 11–29 mL/min: 0.5–2 g every 24 hr; CCr <11 mL/min: 250 mg–1 g every 24 hr.

(Generic available)

Powder for injection: 1 g; 2 g
Premixed infusion: 1 g/50 mL D5W; 2 g/100 mL D5W

Assess patient for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and throughout therapy.
Before initiating therapy, obtain a history to determine previous use of and reactions to penicillins or cephalosporins. Persons with a negative history of penicillin sensitivity may still have an allergic response.
Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
Observe patient for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Discontinue the drug and notify health care professional immediately if these symptoms occur. Keep epinephrine, an antihistamine, and resuscitation equipment close by in the event of an anaphylactic reaction.
Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of CDAD. May begin up to several wk following cessation of therapy.

Lab Test Considerations:

May cause positive results for Coombs' test in patients receiving high doses or in neonates whose mothers were given cephalosporins before delivery.
- May cause ↑ AST, ALT, bilirubin, BUN, and serum creatinine.
- May rarely cause leukopenia, neutropenia, thrombocytopenia, and eosinophilia.

IM: Reconstitution: Reconstitute IM doses with sterile or bacteriostatic water for injection, 0.9% NaCl, or D5W. May be diluted with lidocaine to minimize injection discomfort.
- Inject deep into a well-developed muscle mass; massage well.
- IM route should only be used for treatment of mild to moderate uncomplicated or complicated urinary tract infections due to
  Escherichia coli
  .

IV Administration:

IV: Monitor injection site frequently for phlebitis (pain, redness, swelling). Change sites every 48–72 hr to prevent phlebitis.
- If aminoglycosides are administered concurrently, administer in separate sites, if possible, at least 1 hr apart. If second site is unavailable, flush lines between medications.
Intermittent Infusion: Reconstitution: Reconstitute with 10 mL sterile water, 0.9% NaCl, or D5W for the 1-g or 2-g vials.Diluent: Dilute further in 50–100 mL of D5W, 0.9% NaCl, D10W, D5/0.9% NaCl, or D5/LR.Concentration: Maximum 40 mg/mL.
- Solution is stable for 24 hr at room temperature and 7 days if refrigerated.
Rate: Administer over 20–30 min.

Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools) and allergy.
Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.

~~Maxipime~~

NDC Code

0264- B. Braun Medical Inc.
- 0264-3193- CEFEPIME HYDROCHLORIDE AND DEXTROSE
  - 0264-3193-11- 24 CONTAINER in 1 CASE (0264-3193-11) > 50 mL in 1 CONTAINER

0264- B. Braun Medical Inc.
- 0264-3195- CEFEPIME HYDROCHLORIDE AND DEXTROSE
  - 0264-3195-11- 24 CONTAINER in 1 CASE (0264-3195-11) > 50 mL in 1 CONTAINER

0338- Baxter Healthcare Corporation
- 0338-1301- Cefepime
  - 0338-1301-41- 24 BAG in 1 BOX (0338-1301-41) > 50 mL in 1 BAG

0338- Baxter Healthcare Corporation
- 0338-1301- Cefepime
  - 0338-1301-48- 12 BAG in 1 BOX (0338-1301-48) > 100 mL in 1 BAG

0409- Hospira, Inc.
- 0409-0217- MAXIPIME
  - 0409-0217-01- 25 VIAL, PATENT DELIVERY SYSTEM in 1 CARTON (0409-0217-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-0217-11)

0409- Hospira, Inc.
- 0409-0220- MAXIPIME
  - 0409-0220-01- 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0220-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0220-11)

0781- Sandoz Inc
- 0781-3222- Cefepime Hydrochloride
  - 0781-3222-95- 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3222-95) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0781-3222-80)

0781- Sandoz Inc
- 0781-3223- Cefepime Hydrochloride
  - 0781-3223-95- 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3223-95) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0781-3223-91)

25021- Sagent Pharmaceuticals
- 25021-121- cefepime
  - 25021-121-20- 10 VIAL in 1 CARTON (25021-121-20) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

25021- Sagent Pharmaceuticals
- 25021-121- cefepime
  - 25021-121-66- 10 VIAL in 1 CARTON (25021-121-66) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

25021- Sagent Pharmaceuticals
- 25021-122- cefepime
  - 25021-122-50- 10 VIAL in 1 CARTON (25021-122-50) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

25021- Sagent Pharmaceuticals
- 25021-122- cefepime
  - 25021-122-67- 10 VIAL in 1 CARTON (25021-122-67) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

44567- WG Critical Care, LLC
- 44567-240- Cefepime
  - 44567-240-10- 10 VIAL in 1 CARTON (44567-240-10) > 20 mL in 1 VIAL

44567- WG Critical Care, LLC
- 44567-241- Cefepime
  - 44567-241-10- 10 VIAL in 1 CARTON (44567-241-10) > 20 mL in 1 VIAL

60505- Apotex Corp.
- 60505-6144- Cefepime
  - 60505-6144-4- 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6144-4) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

60505- Apotex Corp.
- 60505-6145- Cefepime
  - 60505-6145-4- 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6145-4) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

60505- Apotex Corp.
- 60505-6146- Cefepime
  - 60505-6146-0- 1 VIAL, SINGLE-DOSE in 1 CARTON (60505-6146-0) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

60505- Apotex Corp.
- 60505-6146- Cefepime
  - 60505-6146-4- 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6146-4) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

60505- Apotex Corp.
- 60505-6147- Cefepime
  - 60505-6147-0- 1 VIAL, SINGLE-DOSE in 1 CARTON (60505-6147-0) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

60505- Apotex Corp.
- 60505-6147- Cefepime
  - 60505-6147-4- 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6147-4) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

63323- Fresenius Kabi USA, LLC
- 63323-326- Cefepime
  - 63323-326-20- 10 VIAL in 1 CARTON (63323-326-20) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-326-21)

63323- Fresenius Kabi USA, LLC
- 63323-340- Cefepime
  - 63323-340-20- 10 VIAL in 1 CARTON (63323-340-20) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-340-21)

66288- SAMSON MEDICAL TECHNOLOGIES LLC
- 66288-8100- CEFEPIME
  - 66288-8100-1- 1 BAG in 1 BAG (66288-8100-1) > 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG

66794- Piramal Critical Care Inc.
- 66794-209- Cefepime
  - 66794-209-41- 10 g in 1 CARTON (66794-209-41)

66794- Piramal Critical Care Inc.
- 66794-210- Cefepime
  - 66794-210-41- 20 g in 1 CARTON (66794-210-41)

67184- Qilu Pharmaceutical Co., Ltd.
- 67184-1002- Cefepime
  - 67184-1002-1- 10 VIAL in 1 CARTON (67184-1002-1) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

67184- Qilu Pharmaceutical Co., Ltd.
- 67184-1003- Cefepime
  - 67184-1003-1- 10 VIAL in 1 CARTON (67184-1003-1) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

67184- Qilu Pharmaceutical Co., Ltd.
- 67184-1004- Cefepime
  - 67184-1004-1- 10 VIAL in 1 CARTON (67184-1004-1) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

71288- Meitheal Pharmaceuticals Inc.
- 71288-008- Cefepime
  - 71288-008-15- 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-008-15) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-008-16)

71288- Meitheal Pharmaceuticals Inc.
- 71288-009- Cefepime
  - 71288-009-20- 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-009-20) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-009-21)

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