ℹ️ Compiled from public regulatory records · Last regulator revision: May 19, 2026🚩 Report this page
Imipenem
Active ingredient
Sold asRECARBRIO
CA Health CanadaGB MHRAUS FDAEU EMA
Drug class
-
Availability
Prescription only
Routes
Intravenous
Markets covered
4
Products on record
7
FDA reports (12 mo)
110
Overview
Imipenem is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised March 22, 2025[1]
TARO-Imipenem-Cilastatin (imipenem and cilastatin for injection) is indicated for:
TARO-Imipenem-Cilastatin may be indicated in the treatment of serious infections when caused by sensitive strains of bacteria. Where considered necessary, therapy may be initiated on the basis of clinical judgment before results of sensitivity testings are available.
Continuation of therapy should be re-evaluated on the basis of bacteriological findings and of the patient's clinical condition. Imipenem is active in vitro against a wide range of gram-positive and gram-negative aerobic and anaerobic bacteria, including most strains which are beta-lactamase producing.
Patients have responded while under treatment with imipenem and cilastatin for injection for single or mixed infections of the following body systems, when they were associated with a number of pathogenic species and strains of the genera listed: Lower Respiratory Tract Infections Urinary Tract Infections Intra-Abdominal Infections Gynecological Infections Septicemia Endocarditis caused by Staphylococcus aureus Bone and Joint Infections Skin Structure Infections TARO-Imipenem-Cilastatin is not indicated for the treatment of meningitis.
GBUnited Kingdom· MHRA
2 products
Uses
GBOfficial regulatory label· revised April 24, 2026[2]
1): • Complicated intra-abdominal infections • Severe pneumonia including hospital and ventilator associated pneumonia • Intra- and post-partum infections • Complicated urinary tract-infections. • Complicated skin and soft-tissue infections Imipenem/cilastatin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. g. national recommendations) on the appropriate use of antibacterial agents.
How to take
USUnited States· FDA
1 product
Uses
USOfficial regulatory label· revised October 10, 2022[3]
1 INDICATIONS AND USAGE Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory tract infections.
1 ) Urinary tract infections. 2 ) Intra-abdominal infections. 3 ) Gynecologic infections. 4 ) Bacterial septicemia. 5 ) Bone and joint infections. 6 ) Skin and skin structure infections. 7 ) Endocarditis. 9 ). 9 ). 9 ). 10 ). ) for intravenous use is indicated for the treatment of lower respiratory tract infections caused by susceptible strains of Staphylococcus aureus (penicillinase-producing isolates), Acinetobacter species, Enterobacter species, Escherichia coli , Haemophilus influenzae , Haemophilus parainfluenzae , Klebsiella species, Serratia marcescens .
) is indicated for the treatment of urinary tract infections (complicated and uncomplicated) caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Enterobacter species, Escherichia coli , Klebsiella species, Morganella morganii , Proteus vulgaris , Providencia rettgeri , Pseudomonas aeruginosa .
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised January 26, 2026[4]
1). • Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP. 1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
How to take
EU
Drug interactions
Known interactions involving Imipenem. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
[1]Health Canada (DPD) · 02351706 · revised March 22, 2025
[2]MHRA (UK) · PL154130021 · revised April 24, 2026
[3]FDA DailyMed · 0a1dd9b9-ada1-4b… · revised October 10, 2022 [PDF]
[4]European Medicines Agency · EMEA/H/C/004808 · revised January 26, 2026
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
] Gram-negative Aerobes Acinetobacter Citrobacter Enterobacter Escherichia coli Haemophilus influenzae Haemophilus parainfluenzae Klebsiella Morganella morganii PrTARO-Imipenem-Cilastatin (Imipenem and Cilastatin for Injection, USP) Page 5 of 57 Proteus (indole positive and indole negative strains) Providencia Pseudomonas aeruginosa Serratia marcescens Gram-positive Anaerobes Clostridium (excluding C.
difficile) Peptococcus Peptostreptococcus Gram-negative Anaerobes Bacteroides fragilis Bacteroides (non fragilis) To reduce the development of drug-resistant bacteria and maintain the effectiveness of TARO- Imipenem-Cilastatin and other antibacterial drugs, TARO-Imipenem-Cilastatin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 Pediatrics Pediatrics (<3 months): Based on the data submitted and reviewed by Health Canada, the safety and efficacy in pediatric patients <3 months has not been established. 1 Clinical Trial Adverse Reactions – Pediatrics) Pediatrics (3 months – 18 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of TARO-Imipenem-Cilastatin in pediatric patients has been established.
2 Geriatrics Geriatrics (≥ 65 years old): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. 4 Geriatrics)
How to take
CAOfficial regulatory label· revised March 22, 2025[1]
V. infusion only. An equivalent amount of cilastatin is also present in the solution. The dosage of TARO-Imipenem-Cilastatin should be determined by the severity of the infection, renal function, the antibiotic susceptibility of the causative organism(s) and the condition of the patient.
The median duration of treatment with imipenem and cilastatin for injection in clinical trials for infections of the various body systems ranged from 6 to 10 days except for endocarditis and bone and joint infections for which the median duration of treatment was 4 weeks.
1 Dosing Considerations Dosage in Adults The dosage of TARO-Imipenem-Cilastatin in adult patients should be based on suspected or confirmed pathogen susceptibility as shown in Table 1 below. These doses should be used for patients with creatinine clearance (CrCl) of greater than or equal to 90 mL/min.
A reduction in dose must be made for patients with creatinine clearance less than 90 mL/min as shown in Table 2. It is recommended that the maximum total daily dosage not exceed 4 g/day. Table 1. Dosage of TARO-Imipenem-Cilastatin in Adult Patients with Creatinine Clearance Greater than or Equal to 90 mL/min Suspected or Proven Pathogen Susceptibility Dosage of TARO-Imipenem-Cilastatin If the infection is suspected or proven to be due to bacterial species or isolate that is susceptible (S) (CLSI) (see 15 MICROBIOLOGY) 500 mg every 6 hours OR 1000 mg every 8 hours If the infection is suspected or proven to be due to bacterial species or isolate that is intermediate (I) (CLSI) (see 15 MICROBIOLOGY) 1000 mg every 6 hours Dosage in Adult Patients with Renal Impairment Patients with creatinine clearance less than 90 mL/min require dosage reduction of TARO- Imipenem-Cilastatin as indicated in Table 2.
The serum creatinine should represent a steady state of renal function. 85) x (value calculated for males) Table 2. Dosage of TARO-Imipenem-Cilastatin for Adult Patients in Various Renal Function Groups Based on Estimated Creatinine Clearance Creatinine clearance (mL/min) Greater than or equal to 90 Less than 90 to greater than or equal to 60 Less than 60 to greater than or equal to 30 Less than 30 to greater than or equal to 15 Dosage of TARO-Imipenem- Cilastatin*,† If the infection is suspected or proven to be due to bacterial species or isolate that is susceptible (S) (CLSI) (see 15 MICROBIOLOGY) 500 mg every 6 hours 400 mg every 6 hours 300 mg every 6 hours 200 mg every 6 hours OR 1000 mg every 8 hours 500 mg every 6 hours 500 mg every 8 hours 500 mg every 12 hours Dosage of TARO-Imipenem- Cilastatin *,† If the infection is suspected or proven to be due to bacterial species or isolate that is intermediate (I) (CLSI) (see 15 MICROBIOLOGY) 1000 mg every 6 hours 750 mg every 8 hours 500 mg every 6 hours 500 mg every 12 hours * Administer doses less than or equal to 500 mg by intravenous infusion over 20 to 30 minutes.
† Administer doses greater than 500 mg by intravenous infusion over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed. In patients with creatinine clearances of less than 30 to greater than or equal to 15 mL/min, there may be an increased risk of seizures (see 7 WARNINGS AND PRECAUTIONS).
Patients with creatinine clearance less than 15 mL/min should not receive TARO-Imipenem-Cilastatin unless hemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of TARO-Imipenem-Cilastatin for patients undergoing peritoneal dialysis.
Dosage in Hemodialysis Patients When treating patients with creatinine clearances of less than 15 mL/min who are undergoing hemodialysis, use the dosage recommendations for patients with creatinine clearances of less than 30 to greater than or equal to 15 mL/min in Table 2 above (see Dosage in Adult Patients with Renal Impairment).
Both imipenem and cilastatin are cleared from the circulation during hemodialysis. The patient should receive TARO-Imipenem- Cilastatin after hemodialysis and at intervals timed from the end of that hemodialysis PrTARO-Imipenem-Cilastatin (Imipenem and Cilastatin for Injection, USP) Page 8 of 57 session.
Dialysis patients, especially those with background CNS disease, should be carefully monitored; for patients on hemodialysis, TARO-Imipenem-Cilastatin is recommended only when the benefit outweighs the potential risk of seizures. (see Dosage in Adult Patients with Renal Impairment).
2 Clinical Trial Adverse Reactions). 3 Pediatrics). Based on studies in adults, the maximum total daily dose in pediatric patients should not exceed 4 g/day (see Dosage in Adults). The recommended dosage for pediatric patients with non-CNS infections is shown in Table 3 below: Table 3: Recommended TARO-Imipenem-Cilastatin Dosage in Pediatric Patients for Non- CNS Infections Age Dose (mg/kg) *,† Frequency (hours) Greater than or equal to 3 Months of Age 15-25 mg/kg Every 6 hours * Doses less than or equal to 500 mg should be given by intravenous infusion over 20 to 30 minutes.
† Doses greater than 500 mg should be given by intravenous infusion over 40 to 60 minutes. Recommend that the maximum total daily dosage not […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]
). Case reports in the literature have shown that co-administration of carbapenems, including imipenem, to patients receiving valproic acid or divalproex sodium results in a reduction in serum valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction.
In some cases of co-administration of imipenem with valproic acid, breakthrough seizures have occurred. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. The concomitant use of imipenem and valproic acid/divalproex sodium is generally not recommended.
Anti -bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of TARO-Imipenem-Cilastatin is necessary, supplemental anti-convulsant therapy should be considered (see
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]
). Patients with creatinine clearance less than 15 mL/min should not receive TARO-Imipenem-Cilastatin unless hemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of TARO-Imipenem-Cilastatin for patients undergoing peritoneal dialysis.
Dosage in Hemodialysis Patients When treating patients with creatinine clearances of less than 15 mL/min who are undergoing hemodialysis, use the dosage recommendations for patients with creatinine clearances of less than 30 to greater than or equal to 15 mL/min in Table 2 above (see Dosage in Adult Patients with Renal Impairment).
Both imipenem and cilastatin are cleared from the circulation during hemodialysis. The patient should receive TARO-Imipenem- Cilastatin after hemodialysis and at intervals timed from the end of that hemodialysis PrTARO-Imipenem-Cilastatin (Imipenem and Cilastatin for Injection, USP) Page 8 of 57 session.
Dialysis patients, especially those with background CNS disease, should be carefully monitored; for patients on hemodialysis, TARO-Imipenem-Cilastatin is recommended only when the benefit outweighs the potential risk of seizures. (see Dosage in Adult Patients with Renal Impairment).
2 Clinical Trial Adverse Reactions). 3 Pediatrics). Based on studies in adults, the maximum total daily dose in pediatric patients should not exceed 4 g/day (see Dosage in Adults). The recommended dosage for pediatric patients with non-CNS infections is shown in Table 3 below: Table 3: Recommended TARO-Imipenem-Cilastatin Dosage in Pediatric Patients for Non- CNS Infections Age Dose (mg/kg) *,† Frequency (hours) Greater than or equal to 3 Months of Age 15-25 mg/kg Every 6 hours * Doses less than or equal to 500 mg should be given by intravenous infusion over 20 to 30 minutes.
† Doses greater than 500 mg should be given by intravenous infusion over 40 to 60 minutes. Recommend that the maximum total daily dosage not exceed 4 g/day. 3 Reconstitution Parenteral Products: Preparation of TARO-Imipenem-Cilastatin Solution for IV Administration TARO-Imipenem-Cilastatin is supplied as a dry powder in a single-dose vial that must be reconstituted and further diluted using aseptic technique prior to IV infusion as outlined below.
To prepare the infusion solution, contents of the vial must be reconstituted by adding approximately 10 mL of the appropriate diluent to the vial (see 11 STORAGE, STABILITY AND DISPOSAL). Withdraw 20 mL (10 mL times 2) of diluent from the appropriate infusion bag and constitute the vial with 10 mL of the diluent.
The reconstituted suspension must not be administered by direct IV infusion. After reconstitution, shake vial well and transfer resulting suspension into the remaining 80 mL of the infusion bag. Add the additional 10 mL of infusion solution to the vial and shake well to ensure complete transfer of vial contents; repeat transfer of the resulting suspension to the infusion PrTARO-Imipenem-Cilastatin (Imipenem and Cilastatin for Injection, USP) Page 9 of 57 solution before administering.
Agitate the resulting mixture until clear. For patients with renal insufficiency, a reduced dose of TARO-Imipenem-Cilastatin will be administered according to the patient's CrCl, as determined from Table 2. Prepare 100 mL of infusion solution as directed above.
Select the volume (mL) of the final infusion solution needed for the appropriate dose of TARO-Imipenem-Cilastatin as shown in Table 4. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Discard if discoloration or visible particles are observed. 4 Administration CAUTION: CONTENTS OF VIALS NOT FOR DIRECT INFUSION. Each reconstituted 500 mg dose should be given by intravenous infusion over 20 to 30 minutes. Each 1000 mg dose should be infused over 40 to 60 minutes.
In patients who develop nausea during the infusion, the rate of infusion may be slowed (see Dosage in Adults). PrTARO-Imipenem-Cilastatin (Imipenem and Cilastatin for Injection, USP) Page 10 of 57 Administer 500 mg by intravenous infusion over 20 to 30 minutes.
Administer 1000 mg by intravenous infusion over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed. 5 Missed Dose The injection schedule will be set by the doctor, who will monitor the response and condition to determine what treatment is needed.
5 OVERDOSAGE In case of overdosage, discontinue TARO-Imipenem-Cilastatin, treat symptomatically and institute supportive measures as required. Imipenem-cilastatin sodium is cleared by hemodialysis. Usefulness of this procedure in the overdosage setting is questionable.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 5 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition […]
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[1]
TARO-IMIPENEM-CILASTATIN IS CONTRAINDICATED IN PATIENTS WHO ARE HYPERSENSITIVE TO THIS DRUG OR TO ANY INGREDIENT IN THE FORMULATION, INCLUDING ANY NON-MEDICINAL INGREDIENT, OR COMPONENT OF THE CONTAINER. FOR A COMPLETE LISTING, SEE 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised April 24, 2026[2]
Posology The dose recommendations for Imipenem/cilastatin represent the quantity of imipenem/cilastatin to be administered. 1). g. in neutropenic patients with a fever) should be treated with 1000 mg/1000 mg administered every 6 hours.
A reduction in dose is necessary when creatinine clearance is ≤ 90 ml/min. (see Table 1). The maximum total daily dose should not exceed 4000 mg/4000 mg per day Renal impairment To determine the reduced dose for adults with impaired renal function: 1.
e. 2000/2000, 3000/3000 or 4000/4000 mg) that would usually be applicable to patients with normal renal function should be selected. 2. From table 1, the appropriate reduced dose regimen is selected according to the patient's creatinine clearance.
For infusion times see Method of administration. If TOTAL DAILY DOSE is: 2000 mg/day If TOTAL DAILY DOSE is: 3000 mg/day IF TOTAL DAILY DOSE is: 4000 mg/day Creatinine clearance (mL/min) is: ≥90 (normal) 500 q6h 1000 q8h 1000 q6h reduced dosage (mg) for patients with renal impairment: <90 - ≥60 400 q6h 500 q6h 750 q8h <60 - ≥30 300 q6h 500 q8h 500 q6h <30 - ≥15 200 q6h 500 q12h 500 q12h Patients with a creatinine clearance of ≤15 ml/min These patients should not receive Imipenem/cilastatin unless haemodialysis is instituted within 48 hours.
Patients on haemodialysis When treating patients with creatinine clearances of ≤ 15ml/min who are undergoing dialysis use the dose recommendation for patients with creatinine clearances of 15 to 29 ml/min (see table 1). Both imipenem and cilastatin are cleared from the circulation during haemodialysis .
The patient should receive Imipenem/cilastatin after haemodialysis and at 12 hour intervals timed from the end of that haemodialysis session. 4). Currently there are inadequate data to recommend use of Imipenem/cilastatin for patients on peritoneal dialysis.
2). 2). Paediatric population ≥ 1 year of age For paediatric patients ≥ 1 year of age, the recommended dose is 15 or 25 mg/kg/dose administered every 6 hours. g. in neutropenic patients with a fever) should be treated with 25 mg/kg administered every 6 hours.
Paediatric population <1 year of age Clinical data are insufficient to recommend dosing for children less than 1 year of age. Paediatric population with renal impairment Clinical data are insufficient to recommend dosing for paediatric patients with renal impairment (serum creatinine > 2 mg/dl).
See section
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised April 24, 2026[2]
2%). 2%). Increases in serum transaminases and in alkaline phosphatase are also commonly reported. The following adverse reactions have been reported in clinical studies or during post- marketing experience.
All adverse reactions are listed under system organ class and frequency:
Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
g. exanthematous) Uncommon urticaria, pruritus Rare toxic epidermal necrolysis, angioedema, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis Skin and subcutaneous tissue disorders Very rare hyperhidrosis, skin texture changes Musculoskeletal and connective tissue disorders Very rare polyarthralgia, thoracic spine pain Renal and urinary disorders Rare acute renal failure, oligurial/anuria, polyuria, urine discoloration (harmless and should not be confused with haematuria).
The role of Imipenem/cilastatin in changes in renal function is difficult to assess, since factors predisposing to pre-renal azotemia or to impaired renal function usually have been present. Reproductive system ad breast disorders Very rare pruritus vulvae Uncommon fever, local pain and induration at the injection site, erythema at the injection siteGeneral disorders and administration site condition Very rare Chest discomfort, asthenia/weakness common increases in serum transaminases, increases in serum alkaline phosphatase Investigations Uncommon A positive direct Coombs´test, prolonged prothrombin time, decreased haemoglobin, increases in serum bilirubin, elevations in serum creatinine, elevations in blood urea nitrogen Paediatric population (≥ 3 months of age) In studies of 178 paediatric patients ≥ 3 months of age, the reported adverse reactions were consistent with those reported for adults.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard
GBOfficial regulatory label· Warnings and precautions· revised April 24, 2026[2]
4. 6) prior to administration. Each dose of ≤ 500 mg/500 mg should be given by intravenous infusion over 20 to 30 minutes. Each dose > 500 mg/500 mg should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed.
1. g. g. penicillins or cephalosporins). 4 Special warnings and precautions for use General The selection of imipenem/cilastatin to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria.
Hypersensitivity Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens.
3). If an allergic reaction to imipenem/cilastatin occurs, discontinue the therapy immediately. Serious anaphylactic reactions require immediate emergency treatment. Hepatic Hepatic function should be closely monitored during treatment with imipenem/cilastatin due to the risk of hepatic toxicity (such as increase in transaminases, hepatic failure and fulminant hepatitis).
Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with Imipenem/cilastatin. 2). Haematology A positive direct or indirect Coombs test may develop during treatment with imipenem/cilastatin.
Antibacterial spectrum The antibacterial spectrum of imipenem/cilastatin should be taken into account especially in life-threatening conditions before embarking on any empiric treatment. g. bacterial skin and soft-tissue infections, to imipenem/cilastatin, caution should be exercised.
The use of imipenem/cilastatin is not suitable for treatment of these types of infections unless the pathogen is already documented and known to be susceptible or there is a very high suspicion that the most likely pathogen(s) would be suitable for treatment.
Concomitant use of an appropriate anti-MRSA agent may be indicated when MRSA infections are suspected or proven to be involved in the approved indications. 1). 5). Clostridium difficile Antibiotic-associated colitis and pseudomembranous colitis have been reported with imipenem/cilastatin and with nearly all other anti-bacterial agents and may range from mild to life-threatening in severity.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised April 24, 2026[2]
1. g. g. penicillins or cephalosporins).
This is not medical advice. Consult a qualified healthcare professional.
) is indicated for the treatment of intra-abdominal infections caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Staphylococcus epidermidis , Citrobacter species, Enterobacter species, Escherichia coli , Klebsiella species, Morganella morganii , Proteus species, Pseudomonas aeruginosa , Bifidobacterium species, Clostridium species, Eubacterium species, Peptococcus species, Peptostreptococcus species, Propionibacterium species, Bacteroides species including B.
fragilis , Fusobacterium species. ) is indicated for the treatment of gynecologic infections caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Staphylococcus epidermidis , Streptococcus agalactiae (Group B streptococci), Enterobacter species, Escherichia coli , Gardnerella vaginalis , Klebsiella species, Proteus species, Bifidobacterium species, Peptococcus species, Peptostreptococcus species, Propionibacterium species, Bacteroides species including B.
fragilis . ) is indicated for the treatment of bacterial septicemia caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Enterobacter species, Escherichia coli , Klebsiella species, Pseudomonas aeruginosa , Serratia species, Bacteroides species including B.
fragilis . ) is indicated for the treatment of bone and joint infections caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Staphylococcus epidermidis , Enterobacter species, Pseudomonas aeruginosa .
) is indicated for the treatment of skin and skin structure infections caused by susceptible strains of Enterococcus faecalis , Staphylococcus aureus (penicillinase-producing isolates), Staphylococcus epidermidis , Acinetobacter species, Citrobacter species, Enterobacter species, Escherichia coli , Klebsiella species, Morganella morganii , Proteus vulgaris , Providencia rettgeri , Pseudomonas aeruginosa , Serratia species, Peptococcus species, Peptostreptococcus species, Bacteroides species including B.
fragilis , Fusobacterium species. ) is indicated for the treatment of endocarditis caused by susceptible strains of Staphylococcus aureus (penicillinase-producing isolates). ) is not indicated in patients with meningitis because safety and efficacy have not been established.
4 )] . 2 )] . Periodic assessment of organ system functions, including renal, hepatic and hematopoietic, is advisable during prolonged therapy. ) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
How to take
USOfficial regulatory label· revised October 10, 2022[3]
1 ). 1 ). 2 ). 3 ). 4 ). 5 ). ) in adult patients should be based on suspected or confirmed pathogen susceptibility as shown in Table 1 below. ) represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution.
These doses should be used for patients with creatinine clearance of greater than or equal to 90 mL/min. 3 )] . Recommend that the maximum total daily dosage not exceed 4 g/day. Administer 500 mg by intravenous infusion over 20 to 30 minutes.
Administer 1,000 mg by intravenous infusion over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed. 4 )] . 4 )] . 1 )] . ) as indicated in Table 3 . The serum creatinine should represent a steady state of renal function.
) for Adult Patients in Various Renal Function Groups Based on Estimated Creatinine Clearance (CLcr) * Administer doses less than or equal to 500 mg by intravenous infusion over 20 to 30 minutes. Discard unused portion of the infusion solution.
† Administer doses greater than 500 mg by intravenous infusion over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed. 6 )] . ) unless hemodialysis is instituted within 48 hours. ) for patients undergoing peritoneal dialysis.
3 )]. Both imipenem and cilastatin are cleared from the circulation during hemodialysis. ) after hemodialysis and at intervals timed from the end of that hemodialysis session. 2 )]. ) for administration to neonates because it has been associated with toxicity in neonates.
While toxicity has not been demonstrated in pediatric patients greater than three months of age, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Contents of the vials must be reconstituted by adding approximately 10 mL of the appropriate diluent to the vial.
) range from colorless to yellow. Variations of color within this range do not affect the potency of the product. The reconstituted suspension must not be administered by direct Intravenous Infusion. After reconstitution, shake vial well and transfer the resulting suspension to 100 mL of an appropriate infusion solution before administering by intravenous infusion.
Repeat transfer of the resulting suspension with an additional 10 mL of infusion solution to ensure complete transfer of vial contents to the infusion solution. Agitate the resulting mixture until clear. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Discard unused portion of the infusion solution where applicable. 5 )] , maintains satisfactory potency for 4 hours at room temperature or for 24 hours under refrigeration (5°C). ). ) with, or physically add to, other antibacterial drugs.
) may be administered concomitantly with other antibacterial drugs, such as aminoglycosides.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 110 reports total. [5]
Drug Ineffective 18
Off Label Use 12
Epilepsy 9
Product Use In Unapproved Indication 7
Rash 6
Trichoglossia 6
Nausea 5
Septic Shock 5
White Blood Cell Count Decreased 5
Condition Aggravated 4
Hypotension 4
Neutrophil Count Decreased 4
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised October 10, 2022[3]
6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in the Warnings and Precautions section. 1 ). 1 ). 1 ). gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
). ). ) -treated adult patients. 2% of the patients or reported since the drug was marketed are listed within each body system in order of decreasing severity [see Table 5 ]. 2% of Adult Patients Listed within Each Body System in Order of Decreasing Severity Body System Adverse Reactions Gastrointestinal Pseudomembranous Colitis (the onset of Pseudomembranous colitis symptoms), Hemorrhagic Colitis Gastroenteritis Abdominal Pain Glossitis Tongue Papillar Hypertrophy Heartburn Pharyngeal Pain Increased Salivation CNS Encephalopathy Confusion Myoclonus Paresthesia Vertigo Headache Special Senses Hearing Loss Tinnitus Respiratory Chest Discomfort Dyspnea Hyperventilation Thoracic Spine Pain Cardiovascular Palpitations Tachycardia Skin Erythema Multiforme Angioneurotic Edema Flushing Cyanosis Hyperhidrosis Skin Texture Changes Candidiasis Pruritus Vulvae Local Administration site Infused vein infection Body as a Whole Polyarthralgia Asthenia/Weakness Renal Oliguria/Anuria Polyuria Adverse Laboratory Changes The following adverse laboratory changes were reported during clinical trials: Hepatic: Increased alanine aminotransferase (ALT or SGPT), aspartate aminotransferase (AST or SGOT), alkaline phosphatase, bilirubin, and lactate dehydrogenase (LDH) Hemic: Increased eosinophils, positive Coombs test, increased WBC, increased platelets, decreased hemoglobin and hematocrit, increased monocytes, abnormal prothrombin time, increased lymphocytes, increased basophils Electrolytes: Decreased serum sodium, increased potassium, increased chloride Renal: Increased BUN, creatinine Urinalysis: Presence of urine protein, urine red blood cells, urine white blood cells, urine casts, urine bilirubin, and urine urobilinogen.
2% Adverse Laboratory Changes The following adverse laboratory changes were reported in studies of 178 pediatric patients 3 months of age: increased AST (SGOT), decreased hemoglobin/hematocrit, increased platelets, increased eosinophils, increased ALT (SGPT), increased urine protein, decreased neutrophils.
The following adverse laboratory changes were reported in studies of 135 patients (neonates to 3 months of age): increased eosinophils, increased AST (SGPT), increased serum creatinine, increased/decreased platelet count, increased/decreased bilirubin, increased ALT (SGPT), increased alkaline phosphatase, increased/decreased hematocrit.
). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ) Body System Adverse Reactions Gastrointestinal Hepatitis (including fulminant hepatitis) Hepatic failure Jaundice Staining of the teeth and/or tongue Hematologic Pancytopenia Bone marrow depression Thrombocytopenia Neutropenia Leukopenia Hemolytic anemia CNS Tremor Psychic disturbances including hallucinations Dyskinesia Agitation Special Senses Taste perversion Skin Stevens-Johnson syndrome Toxic epidermal necrolysis Body as a whole Drug fever Renal Acute renal failure Urine discoloration Adverse Laboratory Changes Adverse laboratory changes reported since the drug was marketed were: Hematologic: agranulocytosis.
Examination of published literature and spontaneous adverse reactions reports suggested a similar spectrum of adverse reactions in adult and pediatric patients.
USOfficial regulatory label· Warnings and precautions· revised October 10, 2022[3]
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. 1 ). ). 2 ). ), to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations.
The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. 3 ). ) and may range in severity from mild diarrhea to fatal colitis. 4 ). 1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams.
These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another beta-lactam.
), careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens. ) occurs, discontinue the drug immediately. Serious anaphylactic reactions require immediate emergency treatment as clinically indicated.
2 )]. 6 )] . However, there have been reports of CNS adverse experiences in patients who had no recognized or documented underlying CNS disorder or compromised renal function. Anticonvulsant therapy should be continued in patients with known seizure disorders.
) re-examined to determine whether it should be decreased, or the antibacterial drug discontinued. ), to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures.
Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. ) and valproic acid/divalproex sodium is generally not recommended. Antibacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised October 10, 2022[3]
) is contraindicated in patients who have shown hypersensitivity to any component of this product. ) ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
It is recommended that Recarbrio should be used to treat infections due to aerobic Gram-negative organisms in patients with limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases.
1). 3 Table 1: Recommended doses for adult patients with a CrCl ≥ 90 mL/min*† Type of infection Dose of Recarbrio (imipenem/cilastatin/ relebactam) Frequency Infusion time (minutes) Duration of treatment Hospital-acquired pneumonia, including ventilator associated pneumonia†‡ 500 mg/500 mg/250 mg Every 6 hours 30 7 to 14 days Infections due to aerobic Gram-negative organisms in patients with limited treatment options† 500 mg/500 mg/250 mg Every 6 hours 30 Duration in accordance with the site of infection§ *As calculated using the Cockcroft-Gault formula.
4). ‡Includes bacteraemia, in association with, or suspected to be associated with, HAP or VAP. , for cIAI and cUTI the recommended treatment duration is 5 to 10 days; treatment may continue up to 14 days. 5 mg/kg) Every 8 hours 60 *As measured by estimated glomerular filtration rate (eGFR) calculated using the bedside Schwartz formula.
The recommended treatment duration for paediatric patients with HAP/VAP is the same as for adults. For treatment of infections due to aerobic Gram-negative organisms in paediatric patients with limited treatment options, duration of treatment should be based on prescriber discretion.
1. Special populations Renal impairment Adult patients who have a CrCl less than 90 mL/min require dose reduction of imipenem/cilastatin/relebactam as indicated in Table 3. For patients with fluctuating renal function, CrCl should be monitored.
73 m2 require a dose reduction of imipenem/cilastatin/relebactam as indicated in Table 3. Imipenem/cilastatin/relebactam is not recommended in paediatric patients weighing less than 30 kg with renal impairment. 73 m2]†) Recommended dose of Recarbrio (imipenem/cilastatin/relebactam) (mg)‡ Less than 90 to greater than or equal to 60 400/400/200 Less than 60 to greater than or equal to 30 300/300/150 Less than 30 to greater than or equal to 15 200/200/100 End stage renal disease (ESRD) on haemodialysis§ 200/200/100 *CrCl calculated using the Cockcroft-Gault formula for adult patients.
†eGFR calculated using the bedside Schwartz formula for paediatric patients weighing ≥ 30 kg. ‡Administer intravenously. See Tables 1 and 2 for infusion duration and dosing frequency. §Administration should be timed to follow haemodialysis.
Imipenem, cilastatin, and relebactam are cleared from the circulation during haemodialysis. 6). 73 m2 should not receive imipenem/cilastatin/relebactam unless haemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of imipenem/cilastatin/relebactam for patients undergoing peritoneal dialysis.
2). 2). Paediatric population The safety and efficacy of imipenem/cilastatin/relebactam in children weighing less than 30 kg with renal impairment, children weighing less than 2 kg, or preterm infants (less than 37 weeks post- menstrual age) have not been established.
No data are available. Method of administration For intravenous infusion. 6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised January 26, 2026[4]
Summary of the safety profile The most frequently occurring adverse reaction (≥ 2 %) in adult patients receiving imipenem/cilastatin plus relebactam in pooled Phase 2 studies of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI), including pyelonephritis (N = 431) was diarrhoea.
The most frequently occurring adverse reactions (≥ 2 %) in patients receiving Recarbrio in a Phase 3 study of HAP or VAP (N = 266) were diarrhoea, alanine aminotransferase increased, and aspartate aminotransferase increased. Tabulated summary of adverse reactions The following adverse reactions have been reported during Phase 2 (imipenem/cilastatin plus relebactam including 431 patients) and Phase 3 (Recarbrio including 266 patients) clinical studies and with imipenem/cilastatin in clinical studies or during post-marketing experience with imipenem/cilastatin (see Table 4).
Adverse reactions are classified according to MedDRA System Organ Class and frequency.
Frequency categories are derived according to the following conventions:
Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1 000 to < 1/100), Rare (≥ 1/10 000 to < 1/1 000), Very rare (< 1/10 000), and not known (cannot be estimated from the available data). 1). Eighty-five participants were enrolled and treated in the imipenem/cilastatin/relebactam arm out of whom there were 10 adolescents, 31 children aged 6 to less than 12 years, 21 from 2 years to less than 6 years, 15 from 3 months to less than 2 years, and 8 from birth (full-term) to less than 3 months.
Based on this data, adverse reactions were generally comparable to those observed in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised January 26, 2026[4]
8). 5 These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. Before initiating therapy with imipenem/cilastatin/relebactam, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta-lactams, and other allergens.
If an allergic reaction to imipenem/cilastatin/relebactam occurs, treatment must be discontinued immediately. Serious anaphylactic reactions require immediate emergency treatment. 8). Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with imipenem/cilastatin/relebactam.
2). Central nervous system (CNS) CNS adverse reactions, such as seizures, confusional states, and myoclonic activity have been reported during treatment with imipenem/cilastatin, especially when recommended doses of imipenem were exceeded.
, brain lesions or history of seizures) and/or compromised renal function. Special awareness should be made to neurological symptoms or convulsions in children with known risk factors for seizures, or on concomitant treatment with medicinal products lowering the seizures threshold.
Increased seizure potential due to interaction with valproic acid The concomitant use of imipenem/cilastatin/relebactam and valproic acid/divalproex sodium is not recommended. Antibacterials other than carbapenems should be considered to treat infections in patients whose seizures are well-controlled on valproic acid or divalproex sodium.
5). Clostridioides difficile-Associated Diarrhoea (CDAD) Clostridioides difficile-associated diarrhoea (CDAD) has been reported with imipenem/cilastatin/relebactam. CDAD may range in severity from mild diarrhoea to fatal colitis. 8). Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, discontinuation of therapy with imipenem/cilastatin/relebactam, and the administration of specific treatment for C. difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Patients with CrCl ≥ 150 mL/min Based on pharmacokinetic-pharmacodynamic analyses, the dose of imipenem/cilastatin/relebactam that is recommended for patients with CrCl of ≥ 90 mL/min may not be sufficient to treat patients with HAP or VAP and CrCl > 250 mL/min, or patients with cIAI or cUTI and CrCl > 150 mL/min.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised January 26, 2026[4]
1. Hypersensitivity to any other carbapenem antibacterial agent. 4).
This is not medical advice. Consult a qualified healthcare professional.
8). Discontinuation of therapy with imipenem/cilastatin and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given. Meningitis Imipenem/cilastatin is not recommended for the therapy of meningitis.
Renal impairment Imipenem/cilastatin accumulates in patients with reduced kidney function. 2 and the subheading “Central nervous system” in this section. Central nervous system CNS adverse reactions such as myoclonic activity, confusional states, or seizures have been reported, especially when recommended doses based on renal function and body weight were exceeded.
g. brain lesions or history of seizures) and/or compromised renal function in whom accumulation of the administered entities could occur. 2). Anticonvulsant therapy should be continued in patients with a known seizure disorder. Special awareness should be made to neurological symptoms or convulsions in children with known risk factors for seizures, or on concomitant treatment with medicinal products lowering the seizures threshold.
If focal tremors, myoclonus, or seizures occur, patients should be evaluated neurologically and placed on anticonvulsant therapy if not already instituted. If CNS symptoms continue, the dose of Imipenem/cilastatin should be decreased or discontinued.
73 m2 should not receive Imipenem/cilastatin unless haemodialysis is instituted within 48 hours. 2). Paediatric population Clinical data are insufficient to recommend the use of Imipenem/cilastatin in children under 1 year of age or paediatric patients with impaired renal function (serum creatinine >2 mg/dl).
See also above under Central nervous […]
3 )]. Close adherence to the recommended dosage and dosage schedules is urged, especially in patients with known factors that predispose to convulsive activity. ), and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.
difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C.
difficile, and surgical evaluation should be instituted as clinically indicated. ) may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Consideration should be given to using alternative therapies for these patients. 2). There is inadequate information to recommend usage of imipenem/cilastatin/relebactam for patients undergoing peritoneal dialysis. Limitations of the clinical data Patients who were immunocompromised, including those with neutropenia, were excluded from clinical studies.
2 % (33/535) of patients had bacteraemia at baseline. Patients with limited treatment options The use of imipenem/cilastatin/relebactam to treat patients with infections due to aerobic Gram- negative organisms who have limited treatment options is based on experience with imipenem/cilastatin, pharmacokinetic-pharmacodynamic analysis for imipenem/cilastatin/relebactam, and on limited data from a randomised clinical study in which 21 evaluable patients were treated with imipenem/cilastatin/relebactam and 10 evaluable patients were treated with colistin and imipenem/cilastatin for infections caused by imipenem-non-susceptible organisms.
Limitations of the spectrum of antibacterial activity Imipenem does not have activity against methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus epidermidis (MRSE) or against Enterococcus faecium. Alternative or additional antibacterial agents should be used when these pathogens are known or suspected to be contributing to the infectious process.
The inhibitory spectrum of relebactam includes class A beta-lactamases (such as extended-spectrum beta-lactamases (ESBLs) and Klebsiella pneumoniae carbapenemase (KPC)) and Class C beta- lactamases including Pseudomonas-derived cephalosporinase (PDC).
1). Non-susceptible organisms The use of imipenem/cilastatin/relebactam may result in the overgrowth of non-susceptible organisms, which may require interruption of treatment or other appropriate measures. 8). 9 % of the WHO (World Health […]