This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.

Background and Date of Approval

Cefepime, Enmetazobactam is a combination antibiotic used to treat serious bacterial infections that are difficult to cure with regular antibiotics. It works against harmful bacteria that are often found in hospitals and have become resistant to many older medicines. This drug was approved by the U.S. Food and Drug Administration (FDA) on January 16, 2024, for treating complicated urinary tract infections (cUTIs), including infections that reach the kidneys. The approval came after successful results from a major clinical study called the ALLIUM trial, where it worked better than another commonly used antibiotic. Doctors now consider it a valuable option for treating tough infections, especially in patients at risk of antibiotic resistance.

Mechanism of Action of undefined

This medicine works in two ways. One part attacks the outer wall of the bacteria, which is essential for their survival. Without this wall, the bacteria can’t live. The other part stops the bacteria from fighting back by blocking the enzymes they use to destroy antibiotics. When used together, these two actions make the treatment powerful enough to kill even resistant bacteria that don’t respond to many other drugs. This combination helps clear up infections more effectively and reduces the risk of treatment failure.

Uses of undefined

This medicine is approved to treat:

  • Complicated urinary tract infections (cUTIs)
  • Kidney infections (also called acute pyelonephritis)
  • Infections caused by resistant bacteria, especially those that don’t respond to standard antibiotics

Note: It is not meant for simple or common UTIs.

undefined Drug administaration and Dosage available

Cefepime and Enmetazobactam are given as an injection into a vein (IV drip). It's usually given in a hospital every 8 hours, and each dose takes about 2 hours to go into the body. The standard adult dose is 2 grams of cefepime and 0.5 grams of enmetazobactam per dose. The treatment usually lasts 7 days, but it can be longer depending on the severity of the infection. People with kidney problems may need a lower dose.

Warnings, Precautions and Side Effects of undefined

Warnings

  • Allergic Reactions: Do not take if you’re allergic to cephalosporins, penicillins, or similar antibiotics.
  • Kidney Problems: This drug can build up in people with kidney issues, so doctors adjust the dose as needed.
  • Brain Effects: Can sometimes cause confusion, dizziness, or seizures, especially in elderly patients or those with kidney problems.
  • Severe Diarrhoea: May cause an overgrowth of bad bacteria in the gut (Clostridioides difficile).
  • Drug Interactions: Avoid taking it with strong water pills (like furosemide) or other antibiotics that affect the kidneys.

Precautions

Tell your doctor if you have any kidney problems before starting treatment. This drug stays in the body longer when the kidneys aren’t working well, which can lead to side effects. If you have a history of seizures or brain-related issues, you may need extra monitoring during treatment. Also, let your doctor know about all the medicines you're taking to avoid harmful drug interactions. Regular blood and kidney tests might be done during treatment, especially if it's given for more than a week.

Side Effects

Common Side Effects:

  • Nausea or upset stomach
  • Loose stools or mild diarrhoea
  • Headache
  • Skin rash or redness
  • Pain or swelling at the injection site
  • Temporary changes in liver tests

Serious Side Effects (seek medical help):

  • Confusion, difficulty thinking clearly
  • Seizures (especially in patients with kidney issues)
  • Severe allergic reactions (swelling, itching, breathing trouble)
  • Serious diarrhoea that doesn’t go away

Word Of Advice

Always complete the full course of antibiotics, even if you start feeling better before it's over. Stopping early can allow bacteria to return and become harder to treat. If you're prone to allergies, kidney disease, or seizures, be sure to inform your doctor before starting this medicine. Do not skip doses, and always take it on time if you are being treated in a hospital. This medicine should not be used without a doctor’s supervision and is not available in oral (tablet) form.

Frequently Asked Question

References

  1. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216165Orig1s000ltr.pdf
  2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216165s000lbl.pdf
  3. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-exblifep
  4. https://pubmed.ncbi.nlm.nih.gov/36745895/
  5. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216165Orig1s000RiskR.pdf 

Disclaimer

The content provided here is for informational purposes only and should not be considered a substitute for professional medical advice, diagnosis, or treatment. Always consult your doctor or a qualified healthcare provider if you have any questions about your medical condition or treatment.