Cefepime dihydrochloride monohydrate

Table of contents

• What is cefepime dihydrochloride monohydrate?
• How does cefepime dihydrochloride monohydrate work?
• Which conditions is cefepime dihydrochloride monohydrate studied for?
• How is cefepime dihydrochloride monohydrate given?
• What do the clinical trials show?
• Who can take part in these trials?
• What side effects are known?

What is cefepime dihydrochloride monohydrate?

Cefepime dihydrochloride monohydrate is a chemically synthesised beta-lactam antibiotic classified under ATC code J01DE01.^[2] It belongs to the cephalosporin class of antibiotics, which are widely used to treat bacterial infections. The substance is already authorised as a medicine in Hungary, with authorisation records held by APTA MEDICA INTERNACIONAL D.O.O.^[2] In the United Kingdom, products containing cefepime dihydrochloride monohydrate include Renapime 1g and 2g powder for solution for injection or infusion, and EXBLIFEP, a combination product that also contains enmetazobactam.^[4]

How does cefepime dihydrochloride monohydrate work?

As a beta-lactam antibiotic, cefepime works by interfering with the construction of the bacterial cell wall. Beta-lactam antibiotics bind to proteins that bacteria need to build their protective outer layer, which causes the bacteria to weaken and die. The trials listed in the registry measure how well cefepime reaches a target concentration in the blood over time, specifically the proportion of the dosing interval during which the drug concentration stays above the minimum inhibitory concentration (MIC) — the lowest concentration needed to stop bacterial growth.^[1]

Which conditions is cefepime dihydrochloride monohydrate studied for?

• Suspected or proven infection in critically ill children — a Phase 3 trial compares extended versus intermittent infusion of cefepime and other beta-lactams in paediatric intensive care.^[1]
• Pleural infections — a Phase 3 trial uses cefepime as one of several antibiotics in patients with complicated pleural infections.^[3]
• Sepsis — a low-intervention trial studies individualised dosing of cefepime and other beta-lactams in intensive care unit patients with sepsis caused by gram-negative bacilli.^[2]

How is cefepime dihydrochloride monohydrate given?

In the clinical trials, cefepime dihydrochloride monohydrate is given as a solution for injection or infusion. The route of administration is intravenous, either as a bolus injection or as an intravenous infusion.^[2] In one trial, the dose used is 150 mg per kilogram of body weight.^[1] In another trial, a total daily dose of 6 grams is given by infusion.^[2] The product information for authorised products describes powder for solution for injection or infusion in 1g and 2g strengths.^[4]

What do the clinical trials show?

Three clinical trials involving cefepime dihydrochloride monohydrate are currently authorised in the EU Clinical Trials Information System. None of them has reported results yet. The trials are at different stages: two are Phase 3 trials and one is a low-intervention trial. The largest trial enrols 672 participants with sepsis in intensive care units and measures the number of ICU-free days at day 28.^[2] A Phase 3 paediatric trial with 110 participants measures how often the drug concentration stays above the MIC for the entire dosing interval.^[1] A second Phase 3 trial with 244 participants uses cefepime as one of several antibiotics and measures treatment failure at 30 days, defined as death, need for thoracic surgery, or additional intrapleural enzyme therapy.^[3]

Who can take part in these trials?

The trials enrol different patient groups. The paediatric trial includes critically ill children with suspected or proven infection who require treatment with beta-lactam antibiotics.^[1] The pleural infection trial includes patients with complicated pleural infections.^[3] The sepsis trial includes adult intensive care unit patients with gram-negative bacilli infection.^[2] Detailed eligibility criteria are available in the trial records.

What side effects are known?

The supplementary source provided does not contain specific side effect information for cefepime dihydrochloride monohydrate. The product information for authorised products containing this active ingredient would list known side effects, but these are not included in the source data provided.