Maxipime


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cefepime hydrochloride

Maxipime

Pharmacologic class: Fourth-generation cephalosporin

Therapeutic class: Anti-infective

Pregnancy risk category B

Action

Interferes with bacterial cell-wall synthesis and division by binding to cell wall, causing cell to die. Active against gram-negative and gram-positive bacteria, with expanded activity against gram-negative bacteria. Exhibits minimal immunosuppressant activity.

Availability

Powder for injection: 500-mg vial, 1-g vial, 2-g vial; 1-g and 2-g piggyback bottles

Solution for injection (premixed): 1 g (50 ml in iso-osmotic dextrose), 2 g (100 ml in iso-osmotic dextrose)

Indications and dosages

Urinary tract infections (UTIs) caused by Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis

Adults: 500 mg to 1g by I.V. infusion or I.M. q 12 hours for 7 to 10 days

Severe UTIs caused by E. coli or K. pneumoniae; moderate to severe skin infections caused by Staphylococcus aureus or Streptococcus pyogenes

Adults: 2 g by I.V. infusion q 12 hours for 10 days

Febrile neutropenia

Adults and children ages 2 months to 16 years: 2 g by I.V. infusion q 8 hours for 7 days

Complicated intra-abdominal infections caused by alpha-hemolytic streptococci, E. coli, K. pneumoniae, Pseudomonas aeruginosa, Enterobacter species, or Bacteroides fragilis

Adults: 2 g by I.V. infusion q 12 hours for 7 to 10 days (given with metronidazole)

Moderate to severe pneumonia caused by K. pneumoniae, P. aeruginosa, Enterobacter species, or Streptococcus pneumoniae

Adults: 1 to 2 g by I.V. infusion q 12 hours for 10 days

Dosage adjustment

• Renal impairment

Contraindications

• Hypersensitivity to cephalosporins or penicillins

Precautions

Use cautiously in:
• renal impairment, phenylketonuria
• history of GI disease
• elderly patients
• pregnant or breastfeeding patients
• children.

Administration

• Don't mix premixed solution with other drugs.

Don't use flexible container in series connections because of risk of air embolism.
• Obtain specimens for culture and sensitivity testing as needed before starting therapy.
• Don't mix with ampicillin (at concentrations above 40 mg/ml), metronidazole, aminoglycosides, or aminophylline if ordered concurrently. Give each drug separately.
• For I.V. infusion, use small I.V. needle and infuse into large vein over 30 to 60 minutes.
• For I.M. administration, inject deep into large muscle.

Adverse reactions

CNS: headache, lethargy, paresthesia, syncope, seizures

CV: phlebitis, hypotension, palpitations, chest pain, vasodilation, thrombophlebitis

EENT: hearing loss

GI: nausea, vomiting, diarrhea, abdominal cramps, oral candidiasis, pseudomembranous colitis

GU: vaginal candidiasis, nephrotoxicity

Hematologic: lymphocytosis, eosinophilia, bleeding tendency, hemolytic anemia, hypoprothrombinemia, neutropenia, thrombocytopenia, agranulocytosis, bone marrow depression

Hepatic: hepatic failure, hepatomegaly

Musculoskeletal: arthralgia

Respiratory: dyspnea

Skin: urticaria, maculopapular or erythematous rash, redness, swelling, induration

Other: chills, fever, superinfection, pain at I.M. site, phlebitis at I.V. site, anaphylaxis, serum sickness

Interactions

Drug-drug.Aminoglycosides, loop diuretics: increased risk of nephrotoxicity

Probenecid: decreased excretion and increased blood level of cefepime

Drug-diagnostic tests.Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, eosinophils, gamma-glutamyltransferase, lactate dehydrogenase: increased levels
Coombs' test, urinary 17-ketosteroids, nonenzyme-based urine glucose tests (such as Clinitest): false-positive results

Hemoglobin, platelets, white blood cells: decreased values

Drug-herbs.Angelica, anise, arnica, asafetida, bogbean, boldo, celery, chamomile, clove, danshen, fenugreek, feverfew, garlic, ginger, ginkgo, ginseng, horse chestnut, horseradish, licorice, meadowsweet, onion, papain, passionflower, poplar, prickly ash, quassia, red clover, turmeric, wild carrot, wild lettuce, willow: increased risk of bleeding

Patient monitoring

• Assess baseline CBC and kidney and liver function test results.
• Monitor for signs and symptoms of superinfection and other serious adverse reactions.
• Monitor for inflammation at infusion site.
• Be aware that cross-sensitivity to penicillins may occur.

Patient teaching

• Instruct patient to report reduced urinary output, persistent diarrhea, bruising, petechiae, or bleeding.
• Caution patient not to take herbs without consulting prescriber.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

cefepime

(seff-e-peem) ,

Maxipime

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: fourth generation cephalosporins
Pregnancy Category: B

Indications

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.

Action

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

Therapeutic effects

Bactericidal action against susceptible bacteria.
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.

Pharmacokinetics

Absorption: Well absorbed after IM administration; IV administration results in complete bioavailability.
Distribution: Widely distributed. Crosses the placenta; enters breast milk in low concentrations. Some CSF penetration.
Protein Binding: 20%.
Metabolism and Excretion: 85% excreted unchanged in urine.
Half-life: Adults–2 hr (↑ in renal impairment); Children 2 mo–6 yr—1.7–1.9 hr.

Time/action profile

ROUTEONSETPEAKDURATION
IMrapid1–2 hr12 hr
IVrapidend of infusion12 hr

Contraindications/Precautions

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;Patients with hepatic dysfunction or poor nutritional status (may be at ↑ risk of bleeding);Geriatric patients (dose adjustment due to age-related ↓ in renal function may be necessary); Obstetric / Lactation: Pregnancy and lactation (safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • seizures (↑ risk in renal impairment) (life-threatening)
  • encephalopathy
  • headache

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • diarrhea
  • nausea
  • vomiting

Dermatologic

  • rashes (most frequent)
  • pruritis
  • urticaria

Hematologic

  • bleeding
  • eosinophilia
  • hemolytic anemia
  • neutropenia
  • thrombocytopenia

Local

  • pain at IM site (most frequent)
  • phlebitis at IV site (most frequent)

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)
  • superinfection
  • fever

Interactions

Drug-Drug interaction

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

Route/Dosage

Intramuscular (Adults) Mild-to-moderate uncomplicated or complicated urinary tract infections due to Escherichia coli—0.5–1 g every 12 hr.
Intravenous (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.
Intravenous (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).
Intravenous (Neonates postnatal age ≥14 days) 50 mg/kg every 12 hr.
Intravenous (Neonates postnatal age <14 days) 30 mg/kg every 12 hr; consider 50 mg/kg every 12 hr for Pseudomonas infections.

Renal Impairment

Intramuscular Intravenous (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.

Availability (generic available)

Powder for injection: 500 mg, 1 g, 2 g
Premixed containers: 1 g/50 mL D5W, 2 g/100 mL D5W

Nursing implications

Nursing assessment

  • 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 pseudomembranous colitis. May begin up to several weeks 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 ↑ serum AST, ALT, bilirubin, BUN, and creatinine.
    • May rarely cause leukopenia, neutropenia, thrombocytopenia, and eosinophilia.

Potential Nursing Diagnoses

Risk for infection (Indications,  Side Effects)
Diarrhea (Adverse Reactions)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Intramuscular: 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.
  • Intravenous Administration
  • pH: 4.0–6.0.
  • Intravenous: 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: Reconstitute with 5 mL sterile water, 0.9% NaCl, or D5W for the 500-mg vial, or 10 mL 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.
  • Y-Site Compatibility: amikacin, amphotericin B lipid complex, ampicillin-sulbactam, anidulafungin, azithromycin, aztreonam, bivalirudin, bleomycin, bumetanide, buprenorphine, butorphanol, calcium gluconate, carboplatin, carmustine, cyclophosphamide, cytarabine, dactinomycin, daptomycin, dexamethasone sodium phosphate, dexmedetomidine, docetaxel, doxacurium, doxorubicin liposome, eptifibatide, fenoldopam, fluconazole, fludarabine, fluorouracil, foscarnet, furosemide, gentamicin, granisetron, hetastarch, hydrocortisone sodium phosphate, hydrocortisone sodium succinate, hydromorphone, imipenem-cilastatin, insulin, ketamine, leucovorin, levofloxacin, linezolid, lorazepam, melphalan, mesna, methotrexate, methylprednisolone sodium succinate, metronidazole, milrinone, octreotide, oxytocin, paclitaxel, palonosetron, pamidronate, pancuronium, piperacillin-tazobactam, potassium acetate, ranitidine, remifentanil, rocuronium, sargramostim, sodium acetate, sodium bicarbonate, sufentanil, telavancin, thiotepa, ticarcillin-clavulanate, tigecycline, tirofiban, tobramycin, trimethoprim/sulfamethoxazole, vasopressin, zidovudine, zoledronic acid
  • Y-Site Incompatibility: acetylcysteine, acyclovir, alemtuzumab, amphotericin B cholesteryl, amphotericin B colloidal, amphotericin B liposome, argatroban, caspofungin, chlorpromazine, ciprofloxacin, cisplatin, dacarbazine, daunorubicin, dexrazoxane, diazepam, diltiazem, diphenhydramine, dolasetron, doxorubicin hydrochloride, droperidol, enalaprilat, epirubicin, erythromycin, etoposide, etoposide phosphate, famotidine, filgrastim, floxuridine, ganciclovir, gemcitabine, haloperidol, hydroxyzine, idarubicin, ifosfamide, irinitecan, magnesium sulfate, mannitol, mechlorethamine, meperidine, metoclopramide, midazolam, mitomycin, mitoxantrone, nalbuphine, nesiritide, ondansetron, oxaliplatin, pantoprazole, pemetrexed, phenytoin, prochlorperazine, promethazine, quinupristin/dalfopristin, streptozocin, tacrolimus, theophylline, vecuronium, vinblastine, vincristine, vinorelbine, voriconazole

Patient/Family Teaching

  • 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.

Evaluation/Desired Outcomes

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

Maxipime

(măk′sə-pēm′)
A trademark for the drug cefepime hydrochloride.

Maxipime®

Cefepime, see there.
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