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Cilastatin

Generic Name
Cilastatin
Brand Names
Primaxin, Recarbrio
Drug Type
Small Molecule
Chemical Formula
C16H26N2O5S
CAS Number
82009-34-5
Unique Ingredient Identifier
141A6AMN38

Overview

Cilastatin is an inhibitor of renal dehydropeptidase, an enzyme responsible for both the metabolism of thienamycin beta-lactam antibiotics as well as conversion of leukotriene D4 to leukotriene E4. Since the antibiotic, imipenem, is one such antibiotic that is hydrolyzed by dehydropeptidase, cilastatin is used in combination with imipenem to prevent its metabolism. The first combination product containing both drugs was approved by the FDA in November of 1985 under the trade name Primaxin, marketed by Merck & Co. A newer triple-drug product was approved in July 2019 under the trade name Recarbrio which also contains relebactam.

Background

Cilastatin is an inhibitor of renal dehydropeptidase, an enzyme responsible for both the metabolism of thienamycin beta-lactam antibiotics as well as conversion of leukotriene D4 to leukotriene E4. Since the antibiotic, imipenem, is one such antibiotic that is hydrolyzed by dehydropeptidase, cilastatin is used in combination with imipenem to prevent its metabolism. The first combination product containing both drugs was approved by the FDA in November of 1985 under the trade name Primaxin, marketed by Merck & Co. A newer triple-drug product was approved in July 2019 under the trade name Recarbrio which also contains relebactam.

Indication

Cilastatin is indicated, in combination with imipenem with or without relebactam, for the treatment of bacterial infections including respiratory, skin, bone, gynecologic, urinary tract, and intra-abdominal as well as septicemia and endocarditis.

Associated Conditions

  • Bacterial Septicemia
  • Bone and Joint Infections
  • Complicated Intra-Abdominal Infections (cIAIs)
  • Complicated Urinary Tract Infection
  • Endocarditis caused by staphylococcus aureus
  • Gynecological Infection
  • Intraabdominal Infections
  • Lower respiratory tract infection bacterial
  • Neutropenic Fever
  • Pyelonephritis
  • Skin and Subcutaneous Tissue Bacterial Infections
  • Surgical Site Infections
  • Uncomplicated Urinary Tract Infections
  • Hepatic abscess

FDA Approved Products

Imipenem and Cilastatin
Manufacturer:WG Critical Care, LLC
Route:INTRAVENOUS
Strength:500 mg in 1 1
Approved: 2022/02/28
NDC:44567-705
PRIMAXIN IV
Manufacturer:Merck Sharp & Dohme LLC
Route:INTRAVENOUS
Strength:500 mg in 100 mL
Approved: 2022/05/24
NDC:0006-3552
Imipenem and Cilastatin
Manufacturer:Fresenius Kabi USA, LLC
Route:INTRAVENOUS
Strength:250 mg in 20 mL
Approved: 2020/11/01
NDC:63323-349
PRIMAXIN IV
Manufacturer:Merck Sharp & Dohme LLC
Route:INTRAVENOUS
Strength:250 mg in 100 mL
Approved: 2022/05/24
NDC:0006-3514
Imipenem and Cilastatin
Manufacturer:Fresenius Kabi USA, LLC
Route:INTRAVENOUS
Strength:250 mg in 20 mL
Approved: 2020/08/31
NDC:63323-349

Singapore Approved Products

Imipenem + Cilastatin Mevon Powder for solution for Injection 500 mg + 500 mg
Manufacturer:ACS DOBFAR S.p.A (Filling of Drug product sterile bulk), ACS Dobfar S.p.A. 2: Addetta Plant (Drug product bulk)
Form:INJECTION, POWDER, FOR SOLUTION
Strength:500mg
Online:Yes
Approved: 2013/03/20
Approval:SIN14329P
IMIPENEM /CILASTATIN KABI POWDER FOR SOLUTION FOR INFUSION 500MG/500MG
Manufacturer:ACS Dobfar S.p.A (primary and secondary packager), ACS Dobfar SpA (sterile bulk blend)
Form:INJECTION, POWDER, FOR SOLUTION
Strength:500mg/ vial
Online:Yes
Approved: 2015/03/26
Approval:SIN14765P
Imipenem/Cilastatin Labatec IV powder for Injection 500mg/500mg
Manufacturer:ACS Dobfar S.p.A, ACS Dobfar SpA (Intermediate)
Form:INJECTION, POWDER, FOR SOLUTION
Strength:500mg
Online:Yes
Approved: 2014/08/13
Approval:SIN14589P
IMCIL POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/500MG PER VIAL
Manufacturer:ANFARM HELLAS S.A., ACS DOBFAR S.P.A (DP INTERMEDIATE)
Form:INJECTION, POWDER, FOR SOLUTION
Strength:500mg
Online:Yes
Approved: 2021/07/21
Approval:SIN16280P

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