Imipenem/Cilastatin (Monograph)

Brand name: Primaxin
Drug class: Carbapenems
Chemical name: [5R-[5α,6α(R*)]]-6-(1-Hydroxyethyl)-3-[[2-(iminomethyl)amino]ethyl]thio]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2carboxylic acid monohydrate mixt. with [R-[R*,S*-(Z)]]-7-[(2-Amino-2-carboxyethyl)thio]-2-[[(2,2-dimethylcyclopropyl) carbonyl]amino]-2-heptenoic acid monosodium salt
Molecular formula: C₁₂H₁₇N₃O₄S•H₂
CAS number: 92309-29-0

Medically reviewed by Drugs.com on Dec 4, 2023. Written by ASHP.

Introduction

Antibacterial; fixed combination of imipenem (a carbapenem β-lactam antibiotic)² ⁴ ⁶ ¹⁴⁸ ¹⁹⁶ ¹⁹⁸ and cilastatin (a renal dehydropeptidase inhibitor that prevents renal metabolism of imipenem).¹ ² ⁶ ¹⁰¹ ¹¹³ ¹²⁵ ¹³⁷ ¹⁴⁰ ¹⁴¹ ¹⁴⁵ ¹⁴⁸ ¹⁹⁶ ¹⁹⁸

Uses for Imipenem/Cilastatin

Bone and Joint Infections

Treatment of serious bone and joint infections caused by susceptible Staphylococcus aureus (penicillinase-producing strains), S. epidermidis, Enterococcus faecalis, Enterobacter, or Pseudomonas aeruginosa.¹ ¹⁴⁶ ¹⁶⁴ ¹⁶⁷ ¹⁸²

Endocarditis

Has been used for treatment of endocarditis caused by susceptible S. aureus (penicillinase-producing strains).¹ ¹⁴⁶ ¹⁸⁶ Not included in AHA guidelines for treatment of staphylococcal endocarditis in adults or pediatric patients.⁴⁵⁰ ⁴⁵²

Gynecologic Infections

Treatment of gynecologic infections (including mixed aerobic-anaerobic infections) caused by susceptible S. aureus (penicillinase-producing strains), S. epidermidis, S. agalactiae (group B streptococci), E. faecalis, Enterobacter, E. coli, Gardnerella vaginalis, Klebsiella, Proteus, Bacteroides (including B. fragilis), Bifidobacterium, Peptococcus, Peptostreptococcus, or Propionibacterium.¹ ¹⁴⁶ ¹⁷⁶ ¹⁷⁸

Intra-abdominal Infections

Treatment of intra-abdominal infections (including mixed aerobic-anaerobic infections) caused by susceptible S. aureus (penicillinase-producing strains), S. epidermidis, E. faecalis, Citrobacter, Enterobacter, E. coli, Klebsiella, Morganella morganii, Proteus, Ps. aeruginosa, Bacteroides (including B. fragilis), Bifidobacterium, Clostridium, Eubacterium, Fusobacterium, Peptococcus, Peptostreptococcus, or Propionibacterium.¹ ¹⁶⁴ ¹⁷² ¹⁷⁹ .

Respiratory Tract Infections

Treatment of lower respiratory tract infections caused by susceptible S. aureus (penicillinase-producing strains), Haemophilus influenzae, H. parainfluenzae, Acinetobacter, Enterobacter, E. coli, Klebsiella, or Serratia marcescens.¹ ¹⁶⁴ ¹⁶⁷ ¹⁷⁰ ¹⁷² ¹⁸³

ATS and IDSA state that imipenem and cilastatin (imipenem/cilastatin) is one of several options that can be included in empiric treatment regimens to provide coverage against Ps. aeruginosa in hospitalized patients with community-acquired pneumoniae (CAP) who are at risk for Ps. aeruginosa infections (e.g., those with prior Ps. aeruginosa infections, hospitalization and treatment with parenteral anti-infectives in the last 90 days).⁵¹²

Has been recommended as one of several options for initial empiric treatment in certain patients with hospital-acquired pneumonia and ventilator-associated pneumonia.⁶ ³¹⁵

Septicemia

Treatment of septicemia caused by susceptible S. aureus (penicillinase-producing strains), E. faecalis, Enterobacter, E. coli, Klebsiella, Serratia, Ps. aeruginosa, or Bacteroides (including B. fragilis).¹ ¹⁴⁶ ¹⁶⁴ ¹⁶⁷ ¹⁷⁰ ¹⁷² ¹⁸¹ ²⁶¹

Skin and Skin Structure Infections

Treatment of serious skin and skin structure infections caused by susceptible S. aureus (penicillinase-producing strains), S. epidermidis, E. faecalis, Acinetobacter, Citrobacter, Enterobacter, E. coli, Klebsiella, M. morganii, P. vulgaris, P. rettgeri, Serratia or Ps. aeruginosa.¹ ¹⁴⁶ ¹⁶⁴ ¹⁶⁷ ¹⁷⁰ ¹⁷² ¹⁷⁹ ¹⁸⁴

Treatment of serious skin and skin structure infections caused by susceptible Bacteroides (including B. fragilis), Fusobacterium, Peptococcus, or Peptostreptococcus.¹ ¹⁷⁹ ¹⁸⁴

Urinary Tract Infections (UTIs)

Treatment of complicated and uncomplicated UTIs caused by susceptible S. aureus (penicillinase-producing strains), E. faecalis, Enterobacter, E. coli, Klebsiella, M. morganii, P. vulgaris, Providencia rettgeri, or Ps. aeruginosa.¹ ¹⁴⁶ ¹⁵⁸ ¹⁶⁴ ¹⁶⁷ ¹⁷⁰ ¹⁷² ¹⁷³ ¹⁸⁰ ²⁶¹

Burkholderia Infections

Has been used for treatment of localized or septicemic melioidosis^{† [off-label]},²⁶¹ ²⁸⁰ ²⁸¹ ²⁸² ²⁸³ ²⁸⁴ a potentially life-threatening disease caused by Burkholderia pseudomallei.²⁸⁰ ²⁸² ²⁸³ Ceftazidime or meropenem usually drugs of choice for treatment of melioidosis.²⁶¹ ²⁸⁰ ²⁸¹ ²⁸² ²⁸³ ²⁸⁴ ²⁸⁵ ²⁹² B. pseudomallei is difficult to eradicate (relapse of melioidosis is common).²⁸⁰ ²⁸¹ ²⁸³ ²⁸⁵

Treatment of glanders^{† [off-label]} caused by B. mallei.²⁶¹ ⁵⁴³ Optimum regimens not identified; imipenem/cilastatin is recommended as one option for treatment of nodular skin and mucous membrane lesions caused by B. mallei based on results of in vitro susceptibility testing.⁵⁴³

Mycobacterial Infections

Recommended by ATS, CDC, IDSA, WHO, and others as a possible option for inclusion in multiple-drug regimens used for treatment of multidrug-resistant (MDR) tuberculosis^{† [off-label]} (i.e., caused by Mycobacterium tuberculosis resistant to isoniazid and rifampin).²⁵⁴ ²⁵⁵ If a carbapenem (e.g., imipenem/cilastatin) used in such regimens, these experts state that the fixed combination of amoxicillin and clavulanate (amoxicillin/clavulanate) should be administered with the carbapenem.²⁵⁴ ²⁵⁵ Patients with MDR tuberculosis are at high risk for treatment failure and acquisition of further drug resistance;²⁵⁴ ²⁵⁵ such patients should be referred to or consultation should be obtained from a specialized treatment center as identified by local or state health departments or the CDC.²⁵⁴ ²⁵⁵

Recommended by ATS, IDSA, and others as one of several preferred options for inclusion in multiple-drug regimens used for treatment of pulmonary infections caused by M. abscessus^{† [off-label]}.²⁵³

Nocardia Infections

Treatment of infections caused by Nocardia^{† [off-label]}, including pulmonary nocardiosis caused by N. asteroides and primary cutaneous nocardiosis.²⁶¹ ²⁹³ ²⁹⁴ ²⁹⁵ Co-trimoxazole or a sulfonamide alone usually recommended for Nocardia infections;²⁶¹ ²⁹² ⁵¹² alternatives include a fluoroquinolone or a carbapenem.²⁹² Multiple-drug regimens may be required.²⁶¹ ²⁹²

Rhodococcus Infections

Has been used for treatment of infections caused by Rhodococcus equi^†; used in conjunction with other anti-infectives (e.g., vancomycin).²⁶¹ ³⁰⁸ Optimum regimens not identified;²⁹⁸ multiple-drug regimens usually recommended and prolonged treatment may be required.²⁶¹ ²⁹⁷ ²⁹⁸ ²⁹⁹ ³⁰⁷ ³⁰⁸

Empiric Therapy in Febrile Neutropenic Patients

Has been used for empiric anti-infective therapy of presumed bacterial infections in febrile neutropenic patients^†.⁶ ²⁶⁵ ²⁶⁶ ²⁶⁷ ²⁶⁸ ²⁶⁹ ²⁷⁰ ²⁷¹ Used alone or in conjunction with other anti-infectives.²⁶⁸ ²⁶⁹ ²⁷¹

Imipenem/Cilastatin Dosage and Administration

Administration

Administer by IV infusion.¹ ⁵

IV Infusion

Available as powder containing a mixture of imipenem and cilastatin (imipenem/cilastatin) that must be reconstituted and diluted prior to IV infusion.¹ ⁵

For solution and drug compatibility information, see Compatibility under Stability.

Do not admix with other antibacterials.¹ ⁵

Reconstitution and Dilution

Reconstitute single-dose vials containing 250 mg of imipenem and 250 mg of cilastatin or single-dose vials containing 500 mg of imipenem and 500 mg of cilastatin by adding approximately 10 mL of compatible IV solution to provide a suspension and shake well.¹ ⁵ Suspension should appear colorless to yellow;¹ ⁵ variations in color do not affect potency.¹ ⁵

Dilute the suspension by transferring into 100 mL of a compatible IV solution.¹ ⁵ To ensure complete transfer of vial contents, add an additional 10 mL from the IV solution container to the vial and transfer back into the IV solution container.¹ ⁵ Agitate diluted solution until clear.¹ ⁵

Rate of Administration

Rate of IV infusion depends on dose of imipenem (given as imipenem/cilastatin).¹ ⁵ If nausea occurs during administration, may decrease rate of IV infusion.¹ ⁵

Imipenem doses ≤500 mg: Administer by IV infusion over 20–30 minutes.¹ ⁵

Imipenem doses >500 mg: Administer by IV infusion over 40–60 minutes.¹ ⁵

Dosage

Available as preparations containing imipenem monohydrate and cilastatin sodium; dosage usually expressed in terms of the imipenem content (as anhydrous imipenem).¹ ⁵

Pediatric Patients

Dosage of imipenem (given as imipenem/cilastatin) recommended in pediatric patients is based on age.¹ ⁵

General Dosage for Neonates

IV

Neonates <1 week of age weighing ≥1.5 kg: 25 mg/kg every 12 hours.¹ ⁵

Neonates 1–4 weeks of age weighing ≥1.5 kg: 25 mg/kg every 8 hours.¹ ⁵

General Dosage for Infants and Children

IV

Infants 1–3 months of age weighing ≥1.5 kg: 25 mg every 6 hours.¹ ⁵

Children ≥3 months of age: 15–25 mg/kg every 6 hours.¹ ⁵

Adults

Dosage of imipenem (given as imipenem/cilastatin) recommended in adults is based on imipenem susceptibility of the suspected or confirmed causative organism(s) and the patient's renal function.¹ ⁵

Infections Suspected or Proven to be Caused by Susceptible Bacteria

IV

Adults with Cl_cr ≥90 mL/minute: 500 mg every 6 hours or 1 g every 8 hours.¹ ⁵

Infections Suspected or Proven to be Caused by Bacteria with Intermediate Susceptibility

IV

Adults with Cl_cr ≥90 mL/minute: 1 g every 6 hours.¹ ⁵

Empiric Therapy in Febrile Neutropenic Patients†

IV

500 mg every 6 hours (1 g daily) has been recommended.²⁶⁵ ²⁶⁶ ²⁶⁸

Prescribing Limits

Pediatric Patients

IV

4 g daily.¹ ⁵

Adults

IV

4 g daily.¹ ⁵

Special Populations

Renal Impairment

Infections in Adults with Clcr <90 mL/minute

IV

Dosage of imipenem (given as imipenem/cilastatin) must be reduced in adults with Cl_cr <90 mL/minute.¹ ⁵ (See Table 1.)

Calculate Cl_cr based on the Cockcroft-Gault method.¹ ⁵

Patients with Cl_cr 15 to <30 mL/minute may be at increased risk of seizures.¹ ⁵

Table 1. Dosage of Imipenem for Adults with Clcr <90 mL/minute15
Imipenem Susceptibility	Cl_cr 60 to <90 mL/minute	Cl_cr 30 to <60 mL/minute	Cl_cr 15 to <30 mL/minute
Infections suspected or proven to be caused by susceptible bacteria	400 mg every 6 hours OR 500 mg every 6 hours	300 mg every 6 hours OR 500 mg every 8 hours	200 mg every 6 hours OR 500 mg every 12 hours
Infections suspected or proven to be caused by bacteria with intermediate susceptibility	750 mg every 8 hours	500 mg every 6 hours	500 mg every 12 hours

Do not use in those with Cl_cr <15 mL/minute unless hemodialysis is initiated within 48 hours.¹ ⁵

Patients receiving hemodialysis: Use only if benefits outweigh potential risk for seizures.¹ ⁵ (See CNS Effects and Seizure Potential under Cautions.) If used in patients with Cl_cr <15 mL/minute undergoing hemodialysis, use dosage recommended for patients with Cl_cr 15 to <30 mL/minute (see Table 1).¹ ⁵ Both imipenem and cilastatin are removed by hemodialysis;¹ ⁵ administer after hemodialysis and at intervals timed from the end of that hemodialysis session.¹ ⁵ Carefully monitor dialysis patients during imipenem/cilastatin treatment, especially those with underlying CNS disease.¹ ⁵

Patients receiving peritoneal dialysis: Manufacturer states information insufficient to recommend use in such patients.¹ ⁵

Infections in Pediatric Patients with Renal Impairment

IV

Not recommended in pediatric patients weighing <30 kg with impaired renal function.¹

Geriatric Patients

No dosage adjustments except those related to renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Imipenem/Cilastatin

Contraindications

Hypersensitivity to any ingredient in the formulation.¹

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity reactions (e.g., anaphylaxis) reported with β-lactams.¹ More likely to occur in individuals with a history of sensitivity to multiple allergens.¹

If hypersensitivity occurs, immediately discontinue imipenem/cilastatin;¹ serious anaphylactic reactions require immediate emergency treatment as clinically indicated.¹

Cross-Hypersensitivity

Partial cross-allergenicity among β-lactam antibiotics, including penicillins, cephalosporins, and other β-lactams.¹

Prior to initiation of imipenem/cilastatin, make careful inquiry concerning previous hypersensitivity reactions to imipenem, cephalosporins, penicillins, other β-lactams, or other allergens.¹

CNS Effects and Seizure Potential

Seizures and other CNS effects (e.g., confusional states, myoclonic activity) have occurred, especially when recommended dosage exceeded.¹ Reported most frequently in those with CNS disorders (e.g., brain lesions, history of seizures) and/or renal impairment, but also reported in patients with no recognized or documented underlying CNS disorder or renal impairment.¹

Continue anticonvulsant therapy in those with known seizure disorders.¹ If focal tremors, myoclonus, or seizures occur, evaluate the patient neurologically, initiate anticonvulsant therapy if necessary, and determine whether imipenem dosage should be decreased or the drug discontinued.¹ Do not exceed recommended dosage, especially in those with known factors that predispose to seizures.¹

Patients with Cl_cr <30 mL/minute are at increased risk of seizures during imipenem/cilastatin treatment;¹ do not use in those with Cl_cr <15 mL/minute unless hemodialysis is initiated within 48 hours.¹ For patients undergoing hemodialysis, use only if benefits outweigh potential risk of seizures.¹

Potential for seizures may be increased if imipenem/cilastatin is used in patients receiving valproic acid or divalproex;¹ concomitant use generally not recommended.¹ (See Specific Drugs and Laboratory Tests under Interactions.)

Superinfection/Clostridioides difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible organism.¹ Careful observation of the patient is essential.¹ Institute appropriate therapy if superinfection occurs.¹

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridioides difficile (formerly Clostridium difficile).¹ C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including imipenem/cilastatin, and may range in severity from mild diarrhea to fatal colitis.¹ C. difficile produces toxins A and B which contribute to development of CDAD;¹ hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.¹

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.¹ Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.¹

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.³⁰² Initiate appropriate anti-infective therapy directed against C. difficile (e.g., fidaxomicin, vancomycin, metronidazole), supportive therapy (e.g., fluid and electrolyte management, protein supplementation), and surgical evaluation as clinically indicated.¹ ³⁰²

Ps. aeruginosa Infections

Because resistant strains of Ps. aeruginosa have emerged during imipenem /cilastatin therapy,¹³⁷ ¹⁵³ ¹⁵⁷ ¹⁶² ¹⁶³ ¹⁶⁴ ¹⁷¹ ¹⁷³ ¹⁸³ ¹⁹¹ ¹⁹⁸ ²²² ²⁴⁰ most clinicians recommend that an aminoglycoside be used concomitantly whenever the drug is used in the treatment of serious infections known or suspected to be caused by Ps. aeruginosa.¹³⁷ ¹⁴⁶ ¹⁵³ ¹⁵⁷ ¹⁶² ¹⁶³ ¹⁶⁴ ¹⁷³ ¹⁷⁴ ¹⁸³ ¹⁹¹ ¹⁹⁶ ¹⁹⁸ ²¹⁰ ²⁴⁰

Meningitis and Other CNS Infections

Safety and efficacy for treatment of meningitis not established;¹ not indicated in patients with meningitis.¹ High incidence of seizures reported in children 3 months to 12 years of age who received the drug for empiric treatment of bacterial meningitis.²⁴²

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of imipenem/cilastatin and other antibacterials, use only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria.¹ Prescribing imipenem/cilastatin in the absence of proven or strongly suspected bacterial infection unlikely to provide benefit to the patient and increases risk of development of drug-resistant bacteria.¹

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹

Information on test methods and quality control standards for in vitro susceptibility testing of antibacterial agents and specific interpretive criteria for such testing recognized by FDA is available at [Web].¹ ³⁵ For most antibacterials, including imipenem/cilastatin, FDA recognizes the standards published by the Clinical and Laboratory Standards Institute (CLSI).³¹ ³⁵

Laboratory Monitoring

Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy.¹

Sodium Content

Preparations of imipenem/cilastatin contain approximately 1.6 mEq (37.5 mg) of sodium per 500 mg of imipenem.¹

Specific Populations

Pregnancy

Data available from small numbers of postmarketing cases of imipenem/cilastatin use during pregnancy are insufficient to identify any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.¹

Developmental toxicity studies in animals (mice, rats, rabbits, monkeys) using imipenem and cilastatin (alone or in combination) administered at doses 0.4–2.9 times the recommended human dose (based on body surface area) showed no evidence of drug-induced fetal malformations.¹ Embryofetal development studies using imipenem/cilastatin in cynomolgus monkeys at doses similar to the recommended human dose (based on body surface area) showed an increase in embryonic loss.¹

Lactation

Imipenem is distributed into milk.²¹⁹ Data insufficient regarding presence of imipenem and cilastatin in human milk;¹ data not available on possible effects on the breast-fed child or effects on milk production.¹

Consider benefits of breast-feeding along with importance of imipenem/cilastatin to the woman; also consider potential adverse effects on breast-fed child from the drug or underlying maternal condition.¹

Pediatric Use

Use of imipenem/cilastatin in pediatric patients is supported by evidence from adequate and well-controlled trials of the drug in adults and clinical studies in pediatric patients.¹

Imipenem/cilastatin not recommended in pediatric patients weighing <30 kg with renal impairment;¹ data not available for such patients.¹

Because of risk of seizures, imipenem/cilastatin not recommended in pediatric patients with CNS infections.¹

Diluents containing benzyl alcohol should not be used to reconstitute imipenem/cilastatin for administration to neonates;¹ ²⁷² ²⁷³ injections preserved with benzyl alcohol have been associated with toxicity in neonates.¹ ²⁷² ²⁷³ While toxicity has not been demonstrated in pediatric patients >3 months of age, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity.¹

Geriatric Use

No overall differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Substantially eliminated by kidneys;¹ risk of toxicity may be greater in patients with impaired renal function.¹ Because geriatric patients are more likely to have decreased renal function, select dosage with caution; it may be useful to assess renal function periodically.¹

Dosage adjustments not required based on age;¹ adjust dosage based on renal function.¹ (See Renal Impairment under Dosage and Administration.)

Renal Impairment

Half-lives of both imipenem and cilastatin prolonged in patients with impaired renal function.¹²⁰ ¹²⁶ ¹⁸⁵

Patients with renal impairment are at increased risk for adverse CNS effects (e.g., seizures), especially if usual dosage exceeded.¹ Patients with Cl_cr <15 mL/minute should not receive imipenem/cilastatin unless hemodialysis is instituted within 48 hours.¹ Do not use in patients undergoing hemodialysis unless benefits outweigh possible risk of drug-induced seizures.¹ ²¹⁹ Monitor closely for adverse CNS effects (e.g., confusion, myoclonic activity, seizures), especially in those with CNS disease.¹

Dosage must be adjusted in adults with Cl_cr <90 mL/minute.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Adults: Most common adverse effects (>0.2%) include local reactions at the IV infusion site (phlebitis, pain, erythema, vein induration), GI effects (nausea, diarrhea, vomiting), rash, pruritus, urticaria, fever, hypotension, seizures, dizziness, somnolence.¹

Pediatric patients ≥3 months of age: Most common adverse effects (>1%) include diarrhea, gastroenteritis, vomiting, IV site irritation, phlebitis, rash, urine discoloration.¹

Neonates and infants <3 months of age: Most common adverse effects (>1%) include convulsions, diarrhea, oliguria/anuria, oral candidiasis, rash, tachycardia.¹

Drug Interactions

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Aminoglycosides	In vitro evidence of additive or synergistic antibacterial effects against E. faecalis, S. aureus, and Listeria monocytogenes¹³ ¹⁹ ¹⁰³ ¹⁰⁶ ¹⁰⁹ ¹³⁹
β-Lactam anti-infectives	In vitro evidence of antagonism with other β-lactam anti-infectives against Enterobacteriaceae and Ps. aeruginosa³ ¹³ ⁵⁴ ¹⁰² ¹⁰⁷ ¹¹¹ ¹³⁷ ¹⁹⁸ ²⁴⁰ ²⁴⁴ ²⁴⁷	Clinical importance unclear; probably should not be used in conjunction with other β-lactam anti-infectives⁵⁴ ¹⁰² ²¹⁰ ²⁴⁰
Chloramphenicol	In vitro evidence of antagonism with chloramphenicol against K. pneumoniae¹⁰⁴ ¹¹¹	If used concomitantly, consider administering chloramphenicol a few hours after imipenem¹⁰⁴
Co-trimoxazole	In vitro evidence of synergistic antibacterial effect against Nocardia asteroides¹⁰⁸	Clinical importance unclear¹⁰⁸
Ganciclovir	Generalized seizures reported with concomitant use¹	Do not use concomitantly unless potential benefits outweigh possible risks¹
Probenecid	Increased plasma concentrations and half-life of imipenem¹	Concomitant use not recommended¹
Tests for glucose	Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution¹³²	Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)¹³²
Valproic acid, divalproex	Concomitant use with carbapenems, including imipenem/cilastatin, has resulted in decreased valproic acid concentrations, which may fall below therapeutic range and increase risk of breakthrough seizures¹	Concomitant use generally not recommended; if seizures are well-controlled on valproic acid or divalproex, consider antibacterials other than carbapenems; if concomitant use necessary, consider supplemental anti-convulsant therapy¹

Imipenem/Cilastatin Pharmacokinetics

Absorption

Neither imipenem nor cilastatin appreciably absorbed from GI tract; must be given parenterally.¹²⁵ ¹⁴³

Plasma Concentrations

Following a 500-mg or 1-g dose of imipenem (given as imipenem/cilastatin by IV infusion over 20 minutes), peak plasma concentrations of imipenem antimicrobial activity range from 21–58 or 41–83 mcg/mL, respectively, and decline to ≤1 mcg/mL at 4–6 hours after the dose.¹ Peak plasma concentrations of cilastatin are 31–49 mcg/mL after the 500-mg dose and 56–88 mcg/mL after the 1-g dose.¹

No accumulation of imipenem or cilastatin occurs following multiple doses in patients with normal renal function.¹

Distribution

Extent

Following IV administration, imipenem distributed into saliva, ²⁰⁸ sputum, ¹ ²⁰⁸ ²¹⁵ aqueous humor, ¹ ²¹⁵ bone, ¹ ¹⁸² ²⁰⁸ ²¹⁵ bile, ¹ ²¹⁵ reproductive organs, ¹ myometrium, ²¹⁵ endometrium, ²¹⁵ heart valve, ²¹⁵ intestine, ²¹⁵ and pleural, ¹ interstitial, ¹ blister, ¹⁴² and wound²⁰⁸ ²¹⁵ fluids.

Only low imipenem concentrations distribute into CSF following IV administration.¹ ¹¹⁷ ¹⁸⁸ ²⁰⁵

Both imipenem and cilastatin cross the placenta and are distributed into cord blood and amniotic fluid.²⁰⁹ ²⁵¹ Imipenem is distributed into milk.²¹⁹

Plasma Protein Binding

Imipenem: 13–21%.¹ ¹²⁵

Cilastatin: Approximately 40%.¹

Elimination

Metabolism

If imipenem is administered alone, the drug is partially hydrolyzed in kidneys by dehydropeptidase I (DHP I) to a microbiologically inactive metabolite.¹ ¹¹³ ¹²⁵ ¹⁴⁰ ¹⁴³ ¹⁴⁸ Concurrent administration of cilastatin (a renal dehydropeptidase inhibitor) prevents metabolism of imipenem by DHP I.¹ ² ¹¹³ ¹¹⁸ ¹²⁰ ¹²⁵ ¹³⁷ ¹⁴⁰ ¹⁴¹ ¹⁴⁸ ¹⁹⁶ ¹⁹⁸

Imipenem also is metabolized to some extent by a nonrenal mechanism unrelated to DHP I² ¹¹⁵ ¹⁴⁰ ²⁰⁴ to an inactive metabolite identical to that formed by renal DHP I; this nonspecific hydrolysis is unaffected by concurrent administration of cilastatin.² ¹⁴⁰ ²⁰⁴

Cilastatin is partially metabolized in the kidneys to N-acetylcilastatin,² ¹²⁵ ¹⁴⁰ ¹⁴⁸ which also is an effective inhibitor of DHP I.²

Elimination Route

Imipenem, cilastatin, and their metabolites eliminated principally in urine.² ¹¹⁵ ¹²³ ¹²⁵ ¹⁴⁰ ¹⁴⁸

Both imipenem and cilastatin are removed by hemodialysis;¹²⁰ ¹²⁶ ¹⁴⁰ ¹⁸⁵

Half-life

IV imipenem in adults with normal renal function: Distribution half-life averages 0.23–0.31 hours¹¹⁴ ¹²² ¹²⁴ and elimination half-life averages 0.85–1.35 hours.¹ ¹¹⁴ ¹²² ¹²⁴ ¹²⁵ ¹⁴⁰ ¹⁴³

IV cilastatin in adults with normal renal function: Elimination half-life of 0.83–1.1 hours.¹ ¹¹⁴ ¹¹⁶ ¹²⁵ ¹⁴⁰

IV imipenem/cilastatin in infants and children: Elimination half-life of imipenem averages 1–1.3 hours in children¹⁴⁴ and 1.5–2.6 hours in neonates.¹¹⁷ ¹¹⁸ Elimination half-life of cilastatin is 3.1–8.8 hours in neonates.¹¹⁷ ¹¹⁸

Special Populations

Serum half-lives of both imipenem and cilastatin are prolonged in patients with impaired renal function; half-life of cilastatin is prolonged to a greater extent than that of imipenem.¹²⁰ ¹²⁶ ¹⁸⁵

In healthy geriatric adults, mean plasma half-lives of imipenem and cilastatin are similar to half-lives expected in individuals with slight renal impairment.¹

Stability

Storage

Parenteral

Powder for Injection, for IV use

Single-dose vials of powder: <25°C.¹ ⁵

Following reconstitution with compatible IV solution, suspension maintains satisfactory potency for 4 hours at room temperature or for 24 hours when refrigerated (5°C).¹ ⁵ Do not freeze reconstituted suspensions or final diluted solutions of the drug.¹ ⁵

Compatibility

Parenteral

Solution Compatibility

Compatible
Dextrose 5%¹
Dextrose 5% in sodium chloride 0.225, 0.45, or 0.9%¹
Sodium chloride 0.9%¹
Incompatible
Dextrose 5% in Ringer’s injection, lactated^HID
Ringer’s injection, lactated^HID
Sodium lactate (1/6) M^HID

Drug Compatibility

Y-Site CompatibilityHID
Compatible
Acyclovir sodium
Amifostine
Anidulafungin
Aztreonam
Caspofungin acetate
Ceftazidime-avibactam sodium
Ceftolozane sulfate-tazobactam sodium
Cisatracurium besylate
Colistimethate sodium
Defibrotide sodium
Diltiazem HCl
Docetaxel
Eravacycline dihydrochloride
Famotidine
Fludarabine phosphate
Foscarnet sodium
Granisetron HCl
Idarubicin HCl
Insulin, regular
Linezolid
Melphalan HCl
Meropenem
Meropenem-vaborbactam
Methotrexate sodium
Ondansetron HCl
Plazomicin sulfate
Propofol
Remifentanil HCl
Tacrolimus
Tedizolid phosphate
Teniposide
Thiotepa
Tigecycline
Vasopressin
Vinorelbine tartrate
Zidovudine
Incompatible
Allopurinol sodium
Amiodarone HCl
Azithromycin
Etoposide phosphate
Fluconazole
Gallium nitrate
Gemcitabine HCl
Lorazepam
Meperidine HCl
Midazolam HCl
Milrinone lactate
Sargramostim
Sodium bicarbonate
Variable
Filgrastim
Telavancin HCl

Actions and Spectrum

Fixed combination of imipenem monohydrate and the sodium salt of cilastatin.¹ Imipenem is carbapenem antibiotic² ⁴ ¹⁴⁸ ¹⁹⁶ ¹⁹⁸ structurally and pharmacologically related to meropenem and ertapenem.¹ ² ³ Cilastatin is a specific and reversible inhibitor of dehydropeptidase I (DHP I).¹ ² ¹⁰¹ ¹²⁵ ¹⁴⁰ ¹⁴¹ ¹⁴⁵ ¹⁴⁸ ¹⁹⁶ ¹⁹⁸
Concomitant use of cilastatin prevents in vivo metabolism of imipenem by DHP I and results in urinary concentrations of active imipenem that are higher than could be obtained following use of the antibiotic alone.¹ ² ¹¹³ ¹²⁵ ¹³⁷ ¹⁴⁰ ¹⁴¹ ¹⁴⁸ ¹⁹⁶ ¹⁹⁸
Usually bactericidal in action.¹
Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.¹
Spectrum of activity includes many gram-positive and -negative aerobic bacteria and some gram-positive and -negative anaerobic bacteria.¹ Stable in the presence of a variety of β-lactamases (including penicillinases, cephalosporinases, and extended-spectrum β-lactamases).¹
Gram-positive aerobes: Active in vitro and in clinical infections against Enterococcus faecalis, Staphylococcus aureus (including penicillinase-producing strains), S. epidermidis, Streptococcus agalactiae (group B streptococci), S. pneumoniae, and S. pyogenes (group A β-hemolytic streptococci).¹ Also active in vitro against S, saprophyticus, groups C and G streptococci, viridans streptococci, Bacillus, Listeria monocytogenes, and Nocardia.¹ Methicillin-resistant staphylococci are resistant.¹
Gram-negative aerobes: Active in vitro and in clinical infections against Acinetobacter, Citrobacter, Enterobacter, Escherichia coli, Gardnerella vaginalis, Haemophilus influenzae, H. parainfluenzae, Klebsiella, Morganella morganii, Proteus vulgaris, Providencia rettgeri, Pseudomonas aeruginosa, and Serratia (including S. marcescens).¹ Also active in vitro against Aeromonas hydrophila, Alcaligenes, Capnocytophaga, H. ducreyi, Neisseria gonorrhoeae, Pasteurella, and P. stuartii.¹
Anaerobes: Active in vitro and in clinical infections against Bacteroides (including B. fragilis), Bifidobacterium, Clostridium, Eubacterium, Fusobacterium, Peptococcus, Peptostreptococcus, and Propionibacterium.¹ Also active in vitro against Prevotella bivia, P. disiens, P. melaninogenica, and Veillonella.¹

Advice to Patients

Advise patients that antibacterials, including imipenem/cilastatin, should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).¹
Importance of completing full course of therapy, even if feeling better after a few days.¹ Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with imipenem/cilastatin or other antibacterials in the future.¹
Inform patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment.¹ Importance of informing clinician of any previous hypersensitivity reactions to imipenem, other carbapenems, β-lactams, or other allergens.¹
Inform patients that seizures have been reported with imipenem/cilastatin and closely related antibacterials; importance of informing clinician of any CNS disorders such as stroke or history of seizures.¹
Importance of informing clinicians if taking valproic acid or sodium valproate.¹ Valproic acid concentrations in the blood may drop below the therapeutic range when used with imipenem/cilastatin.¹ If treatment with the drug is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed.¹
Advise patients that diarrhea is a common problem caused by antibacterials, including imipenem/cilastatin, and usually resolves when the antibacterial is discontinued.¹ Frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection.¹ Importance of contacting a clinician if severe watery and bloody diarrhea occurs.¹
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.¹
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹
Importance of informing patient of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Imipenem and Cilastatin Sodium
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion	250 mg (of anhydrous imipenem) and 250 mg (of cilastatin)*	Imipenem and Cilastatin for Injection, for IV Infusion
		500 mg (of anhydrous imipenem) and 500 mg (of cilastatin)*	Imipenem and Cilastatin for Injection, for IV Infusion
			Primaxin I.V.	Merck

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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HID. ASHP injectable drug information. Imipenem-Cilastatin Sodium. American Society of Health-System Pharmacists; Updated May 1, 2020. Accessed [date]. Note that would be XML tagged as part of the citation. https://injectables.ashp.org

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