Drugs List

Therapeutic Indications

Uses

Antibiotic sensitive infections

Indicated for the treatment of infections caused by cefepime-sensitive bacteria, such as:

Lower respiratory tract infections, including nosocomial pneumonia and community acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and secondary bacterial infection of acute bronchitis.
Uncomplicated and complicated urinary tract infections, including pyelonephritis.
Skin and subcutaneous infections.
Intra-abdominal infections, including peritonitis and biliary tract infections.
Gynaecological infections.
Bacterial meningitis in infants and children.
In combination with other antibacterial agents in the management of neutropenic patients with fever that is suspected to be due to bacterial infection.
Bacteraemia that occurs in association/suspected association with any of the infections listed above.

Administration

Cefepime may be administered as an injection or infusion, given intravenously or intramuscularly dependent on the indication being treated.

Intravenous administration is recommended for patients with severe or life-threatening infections, or if there is a possibility of shock.

Contraindications

Neonates under 1 month

Precautions and Warnings

Allergic disposition
Children under 2 months
Asthma
Breastfeeding
Pregnancy
Renal dialysis
Renal impairment - creatinine clearance below 50ml/minute

Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Monitor patient carefully during the first administration
Advise patient to report diarrhoea
Consider pseudomembranous colitis if patient presents with diarrhoea
Prolonged use may result in superinfection with non-susceptible organisms
Test interference: May cause false positive Coombs test
May affect results of some laboratory tests
May cause false positive for glycosuria : Benedict's / Fehling's solution
Discontinue at once if pseudomembranous colitis occurs
Discontinue if severe hypersensitivity reactions occur
Discontinue therapy if marked diarrhoea occurs
Consider dose reduction in renal impairment

Before therapy is initiated, it should be determined whether the patient has shown previous hypersensitivity to cephalosporins, penicillins, or other beta-lactam antibacterial drug. Cefalexin should be given cautiously to patients who have shown hypersensitivity any of these partial, as there is documented cross-allergenicity between the penicillins and cephalosporins.

There is a possibility of development of pseudomembranous colitis and it is therefore important to consider its diagnosis in patients who develop diarrhoea whilst taking cefepime. The condition may range in severity from mild to life threatening. If antibiotic-associated diarrhoea or colitis is suspected or confirmed, therapy should be discontinued and appropriate supportive measures should be taken.

Pregnancy and Lactation

Pregnancy

Use cefepime with caution in pregnancy.

There is limited evidence of cefepime use in pregnancy. Animal studies have shown no evidence of harmful effects during pregnancy. The manufacturer advises that caution should be exercised when cefepime is used in pregnant women.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use cefepime with caution in breastfeeding.

Cefepime is known to be excreted in human breast milk in low quantities, and as such the manufacturer recommends that caution is used when administering cefepime to breastfeeding mothers.

LactMed states that cephalosporins are not typically expected to cause harmful effects in breastfed infants, and states that cefepime is acceptable for use in nursing mothers.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Agranulocytosis
Anaemia
Anaphylactic reaction
Anaphylactic shock
Angioedema
Candidiasis
Chills
Colitis
Coma
Confusion
Constipation
Convulsions
Diarrhoea
Dizziness
Dysgeusia
Dyspnoea
Encephalopathy
Eosinophilia
Erythema
Erythema multiforme
False positive Coombs test
Gastrointestinal disorder
Haemorrhage
Hallucinations
Headache
Impaired consciousness
Increase in blood urea or creatinine
Infusion related reaction
Injection site reactions
Leukopenia
Myoclonus
Nausea
Neutropenia
Paraesthesia
Phlebitis
Pruritus
Pseudomembranous colitis
Pyrexia
Rash
Renal failure
Stevens-Johnson syndrome
Stupor
Thrombocytopenia
Toxic epidermal necrolysis
Toxic nephropathies
Urticaria
Vasodilatation
Vomiting
Vulvovaginal infections

Presentation

Parenteral formulations of cefepime.

Drugs List

Therapeutic Indications

Uses

Antibiotic sensitive infections

Indicated for the treatment of infections caused by cefepime-sensitive bacteria, such as:

Lower respiratory tract infections, including nosocomial pneumonia and community acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and secondary bacterial infection of acute bronchitis.
Uncomplicated and complicated urinary tract infections, including pyelonephritis.
Skin and subcutaneous infections.
Intra-abdominal infections, including peritonitis and biliary tract infections.
Gynaecological infections.
Bacterial meningitis in infants and children.
In combination with other antibacterial agents in the management of neutropenic patients with fever that is suspected to be due to bacterial infection.
Bacteraemia that occurs in association/suspected association with any of the infections listed above.

Dosage

Adults

Children

Patients with Renal Impairment

Administration

Cefepime may be administered as an injection or infusion, given intravenously or intramuscularly dependent on the indication being treated.

Intravenous administration is recommended for patients with severe or life-threatening infections, or if there is a possibility of shock.

Contraindications

Neonates under 1 month

Precautions and Warnings

Allergic disposition
Children under 2 months
Asthma
Breastfeeding
Pregnancy
Renal dialysis
Renal impairment - creatinine clearance below 50ml/minute

Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Monitor patient carefully during the first administration
Advise patient to report diarrhoea
Consider pseudomembranous colitis if patient presents with diarrhoea
Prolonged use may result in superinfection with non-susceptible organisms
Test interference: May cause false positive Coombs test
May affect results of some laboratory tests
May cause false positive for glycosuria : Benedict's / Fehling's solution
Discontinue at once if pseudomembranous colitis occurs
Discontinue if severe hypersensitivity reactions occur
Discontinue therapy if marked diarrhoea occurs
Consider dose reduction in renal impairment

Before therapy is initiated, it should be determined whether the patient has shown previous hypersensitivity to cephalosporins, penicillins, or other beta-lactam antibacterial drug. Cefalexin should be given cautiously to patients who have shown hypersensitivity any of these partial, as there is documented cross-allergenicity between the penicillins and cephalosporins.

There is a possibility of development of pseudomembranous colitis and it is therefore important to consider its diagnosis in patients who develop diarrhoea whilst taking cefepime. The condition may range in severity from mild to life threatening. If antibiotic-associated diarrhoea or colitis is suspected or confirmed, therapy should be discontinued and appropriate supportive measures should be taken.

Pregnancy and Lactation

Pregnancy

Use cefepime with caution in pregnancy.

There is limited evidence of cefepime use in pregnancy. Animal studies have shown no evidence of harmful effects during pregnancy. The manufacturer advises that caution should be exercised when cefepime is used in pregnant women.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use cefepime with caution in breastfeeding.

Cefepime is known to be excreted in human breast milk in low quantities, and as such the manufacturer recommends that caution is used when administering cefepime to breastfeeding mothers.

LactMed states that cephalosporins are not typically expected to cause harmful effects in breastfed infants, and states that cefepime is acceptable for use in nursing mothers.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Agranulocytosis
Anaemia
Anaphylactic reaction
Anaphylactic shock
Angioedema
Candidiasis
Chills
Colitis
Coma
Confusion
Constipation
Convulsions
Diarrhoea
Dizziness
Dysgeusia
Dyspnoea
Encephalopathy
Eosinophilia
Erythema
Erythema multiforme
False positive Coombs test
Gastrointestinal disorder
Haemorrhage
Hallucinations
Headache
Impaired consciousness
Increase in blood urea or creatinine
Infusion related reaction
Injection site reactions
Leukopenia
Myoclonus
Nausea
Neutropenia
Paraesthesia
Phlebitis
Pruritus
Pseudomembranous colitis
Pyrexia
Rash
Renal failure
Stevens-Johnson syndrome
Stupor
Thrombocytopenia
Toxic epidermal necrolysis
Toxic nephropathies
Urticaria
Vasodilatation
Vomiting
Vulvovaginal infections

Effects on Laboratory Tests

A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions, or with copper sulfate test tablets. Tests based on glucose oxidation reactions may be safely used.

A false positive result for Coombs' test may occur.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: December 2018

Reference Sources

Summary of Product Characteristics: Renapime 1g powder for solution for injection/infusion. Renasciencepharm Ltd. Revised December 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Cefepime Last revised: October 31, 2018
Last accessed: December 12, 2018