Imipenem, cilastatin, and relebactam

Imipenem, cilastatin, and relebactam is a combination medicine used to treat complicated infections of the urinary tract (bladder and kidneys) or infections in the stomach area (abdomen).

Imipenem, cilastatin, and relebactam is also used to treat pneumonia (a lung infection) caused by being in a hospital or using a ventilator.

Imipenem, cilastatin, and relebactam is for use in adults who have few or no other treatment options.

Imipenem, cilastatin, and relebactam may also be used for purposes not listed in this medication guide.

This medicine is given as an infusion into a vein. A healthcare provider will give you this injection.

You should receive this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication.

Imipenem, cilastatin, and relebactam will not treat a viral infection such as the flu or a common cold.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or contains blood.

You should not receive imipenem, cilastatin, and relebactam if you are allergic to imipenem, cilastatin, or relebactam.

Inform your doctor if you have ever had:

• a seizure;
• a stroke; or
• an allergic reaction to penicillin or other antibiotic medicines.

Also, let your doctor know if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Imipenem, cilastatin, and relebactam may cause serious side effects. Call your doctor right away if you have:

• tremors;
• a seizure; or
• severe stomach pain, diarrhea that is watery or bloody (even if it happens months after your last dose).

Common side effects of imipenem, cilastatin, and relebactam may include:

• increased blood pressure;
• nausea, diarrhea, vomiting;
• abnormal liver function tests;
• fever;
• headache; or
• pain, bruising, swelling, or irritation at the injection site.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Nosocomial Pneumonia:

1.25 g IV every 6 hours for 4 to 14 daysUses: For the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia due to susceptible Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, K oxytoca, K pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens

Usual Adult Dose for Pyelonephritis:

1.25 g IV every 6 hours for 4 to 14 daysComments:-Approval of this indication based on limited clinical safety and efficacy data for this drug.Use: In patients with limited or no alternative treatment options, for the treatment of complicated urinary tract infections (including pyelonephritis) due to susceptible E cloacae, E coli, K aerogenes, K pneumoniae, and P aeruginosa

Usual Adult Dose for Urinary Tract Infection:

1.25 g IV every 6 hours for 4 to 14 daysComments:-Approval of this indication based on limited clinical safety and efficacy data for this drug.Use: In patients with limited or no alternative treatment options, for the treatment of complicated urinary tract infections (including pyelonephritis) due to susceptible E cloacae, E coli, K aerogenes, K pneumoniae, and P aeruginosa

Usual Adult Dose for Intraabdominal Infection:

1.25 g IV every 6 hours for 4 to 14 daysComments:-Approval of this indication based on limited clinical safety and efficacy data for this drug.Use: In patients with limited or no alternative treatment options, for the treatment of complicated intraabdominal infections due to susceptible Bacteroides caccae, B fragilis, B ovatus, B stercoris, B thetaiotaomicron, B uniformis, B vulgatus, Citrobacter freundii, E cloacae, E coli, Fusobacterium nucleatum, K aerogenes, K oxytoca, K pneumoniae, Parabacteroides distasonis, and P aeruginosa

If you receive imipenem, cilastatin, and relebactam in a clinical setting, it is unlikely that you will miss a dose.

If your infusions are given at home and you miss a dose, call your doctor for instructions.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Tell your doctor about all your other medicines, especially:

• divalproex sodium;
• ganciclovir; or
• valproic acid.

This list is not complete. Other drugs may affect imipenem, cilastatin, and relebactam, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.