{"id":"colistimethate-sodium","rwe":[{"pmid":"41903866","year":"2026","title":"Factors influencing the efficacy of nebulized colistimethate sodium in the treatment of severe lung infection caused by carbapenem-resistant gram-negative bacteria.","finding":"","journal":"International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases","studyType":"Clinical Study"},{"pmid":"41721931","year":"2026","title":"Intraventricular colistin for multidrug-resistant ventriculitis: the final therapeutic option?","finding":"","journal":"Neurosurgical review","studyType":"Clinical Study"},{"pmid":"41676979","year":"2026","title":"Pharmacokinetics of colistin in adult critically ill patients in South Africa.","finding":"","journal":"The Journal of antimicrobial chemotherapy","studyType":"Clinical Study"},{"pmid":"41644651","year":"2026","title":"Preheating colistimethate sodium enhances its efficacy against multi/extensively drug-resistant Gram-negative bacilli in preservation fluid.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41561283","year":"2025","title":"Preventable Pulmonary Sequelae of Measles: A Case Report of an Adult Patient With Cystic Bronchiectasis.","finding":"","journal":"Cureus","studyType":"Clinical Study"}],"_fda":{"id":"89aaab5f-68ab-4848-b9c6-a4e1051aaf4c","set_id":"13dc3525-1879-4bd8-a922-81bc1397d5af","openfda":{"unii":["XW0E5YS77G"],"route":["INTRAMUSCULAR","INTRAVENOUS"],"rxcui":["1117522"],"spl_id":["89aaab5f-68ab-4848-b9c6-a4e1051aaf4c"],"brand_name":["Colistimethate"],"spl_set_id":["13dc3525-1879-4bd8-a922-81bc1397d5af"],"package_ndc":["70594-023-09"],"product_ndc":["70594-023"],"generic_name":["COLISTIMETHATE SODIUM"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["COLISTIMETHATE SODIUM"],"manufacturer_name":["Xellia Pharmaceuticals USA LLC"],"application_number":["ANDA205356"],"is_original_packager":[true]},"version":"3","warnings":["WARNINGS Maximum daily dose calculated from colistin base activity should not exceed 5 mg/kg/day with normal renal function. Transient neurological disturbances may occur. These include circumoral paresthesia or numbness, tingling or formication of the extremities, generalized pruritus, vertigo, dizziness, and slurring of speech. For these reasons, patients should be warned not to drive vehicles or use hazardous machinery while on therapy. Reduction of dosage may alleviate symptoms. Therapy need not be discontinued, but such patients should be observed with particular care. Nephrotoxicity can occur and is probably a dosedependent effect of colistimethate sodium. These manifestations of nephrotoxicity are reversible following discontinuation of the antibiotic. Overdosage can result in renal insufficiency, muscle weakness, and apnea (see OVERDOSAGE section). See PRECAUTIONS, Drug Interactions subsection for use concomitantly with other antibiotics and curariform drugs. Respiratory arrest has been reported following intramuscular administration of colistimethate sodium. Impaired renal function increases the possibility of apnea and neuromuscular blockade following administration of colistimethate sodium. Therefore, it is important to follow recommended dosing guidelines. See DOSAGE AND ADMINISTRATION section for use in renal impairment. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Colistimethate for Injection, USP 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 antibiotic 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 antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated."],"pregnancy":["Pregnancy Teratogenic Effects Pregnancy Category C Colistimethate sodium given intramuscularly during organogenesis to rabbits at 4.15 and 9.3 mg/kg resulted in talipes varus in 2.6% and 2.9% of fetuses, respectively. These doses are 0.25 and 0.55 times the maximum daily human dose based on mg/m 2 . In addition, increased resorption occurred at 9.3 mg/kg. Colistimethate sodium was not teratogenic in rats at 4.15 or 9.3 mg/kg. These doses are 0.13 and 0.30 times the maximum daily human dose based on mg/m 2 . There are no adequate and well-controlled studies in pregnant women. Since colistimethate sodium is transferred across the placental barrier in humans, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."],"overdosage":["OVERDOSAGE Overdosage with colistimethate sodium can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death. Overdosage with the drug can also cause acute renal failure, manifested as decreased urine output and increases in serum concentrations of BUN and creatinine. As in any case of overdose, colistimethate sodium therapy should be discontinued and general supportive measures should be utilized. It is unknown whether colistimethate sodium can be removed by hemodialysis or peritoneal dialysis in overdose cases."],"description":["DESCRIPTION Colistimethate for Injection, USP is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution ), is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity). Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is C 58 H 105 N 16 Na 5 O 28 S 5 and the structural formula is represented below: Dbu is 2,4-diaminobutanoic acid; R is 5-methylheptyl in colistin A and 5-methylhexyl in colistin B Chemical Structure"],"precautions":["PRECAUTIONS General Since Colistimethate for Injection, USP is eliminated mainly by renal excretion, it should be used with caution when the possibility of impaired renal function exists. The decline in renal function with advanced age should be considered. When actual renal impairment is present, Colistimethate for Injection, USP may be used, but the greatest caution should be exercised and the dosage should be reduced in proportion to the extent of the impairment. Administration of amounts of Colistimethate for Injection, USP in excess of renal excretory capacity will lead to high serum levels and can result in further impairment of renal function, initiating a cycle which, if not recognized, can lead to acute renal insufficiency, renal shutdown, and further concentration of the antibiotic to toxic levels in the body. At this point, interference of nerve transmission at neuromuscular junctions may occur and result in muscle weakness and apnea (see OVERDOSAGE section). Signs indicating the development of impaired renal function include: diminishing urine output, rising BUN and serum creatinine and decreased creatinine clearance. Therapy with Colistimethate for Injection, USP should be discontinued immediately if signs of impaired renal function occur. However, if it is necessary to reinstate the drug, dosing should be adjusted accordingly after drug plasma levels have fallen (see DOSAGE AND ADMINISTRATION section). Prescribing Colistimethate for Injection, USP 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. Drug Interactions Certain other antibiotics (aminoglycosides and polymyxin) have also been reported to interfere with the nerve transmission at the neuromuscular junction. Based on this reported activity, they should not be given concomitantly with Colistimethate for Injection, USP except with the greatest caution. Curariform muscle relaxants (e.g., tubocurarine) and other drugs, including ether, succinylcholine, gallamine, decamethonium and sodium citrate, potentiate the neuromuscular blocking effect and should be used with extreme caution in patients being treated with Colistimethate for Injection, USP. Sodium cephalothin may enhance the nephrotoxicity of Colistimethate for Injection, USP. The concomitant use of sodium cephalothin and Colistimethate for Injection, USP should be avoided. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal carcinogenicity studies and genetic toxicology studies have not been performed with colistimethate sodium. There were no adverse effects on fertility or reproduction in rats at doses of 9.3 mg/kg/day (0.30 times the maximum daily human dose when based on mg/m 2 ). Pregnancy Teratogenic Effects Pregnancy Category C Colistimethate sodium given intramuscularly during organogenesis to rabbits at 4.15 and 9.3 mg/kg resulted in talipes varus in 2.6% and 2.9% of fetuses, respectively. These doses are 0.25 and 0.55 times the maximum daily human dose based on mg/m 2 . In addition, increased resorption occurred at 9.3 mg/kg. Colistimethate sodium was not teratogenic in rats at 4.15 or 9.3 mg/kg. These doses are 0.13 and 0.30 times the maximum daily human dose based on mg/m 2 . There are no adequate and well-controlled studies in pregnant women. Since colistimethate sodium is transferred across the placental barrier in humans, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether colistimethate sodium is excreted in human breast milk. However, colistin sulphate is excreted in human breast milk. Therefore, caution should be exercised when colistimethate sodium is administered to nursing women. Geriatric Use Clinical studies of colistimethate sodium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Pediatric Use In clinical studies, colistimethate sodium was administered to the pediatric population (neonates, infants, children and adolescents). Although adverse reactions appear to be similar in the adult and pediatric populations, subjective symptoms of toxicity may not be reported by pediatric patients. Close clinical monitoring of pediatric patients is recommended. Information for Patients Patients should be counseled that antibacterial drugs including Colistimethate for Injection, USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Colistimethate for Injection, USP is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Colistimethate for Injection, USP or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible."],"how_supplied":["HOW SUPPLIED Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to slightly yellow Iyophilized cake. NDC-70594-023-09: one individual vial. Store between 20° to 25°C (68° to 77°F). (See USP controlled room temperature). Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F), and use within 7 days."],"microbiology":["Microbiology Colistimethate sodium is a surface active agent which penetrates into and disrupts the bacterial cell membrane. It has been shown to have bactericidal activity against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: Aerobic gram-negative microorganisms Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa . Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for Colistimethate for Injection, USP please see: https://www.fda.gov/STIC."],"geriatric_use":["Geriatric Use Clinical studies of colistimethate sodium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function."],"pediatric_use":["Pediatric Use In clinical studies, colistimethate sodium was administered to the pediatric population (neonates, infants, children and adolescents). Although adverse reactions appear to be similar in the adult and pediatric populations, subjective symptoms of toxicity may not be reported by pediatric patients. Close clinical monitoring of pediatric patients is recommended."],"effective_time":"20240829","nursing_mothers":["Nursing Mothers It is not known whether colistimethate sodium is excreted in human breast milk. However, colistin sulphate is excreted in human breast milk. Therefore, caution should be exercised when colistimethate sodium is administered to nursing women."],"adverse_reactions":["ADVERSE REACTIONS The following adverse reactions have been reported: Gastrointestinal: gastrointestinal upset Nervous System: tingling of extremities and tongue, slurred speech, dizziness, vertigo, paresthesia and seizures Integumentary: generalized itching, urticaria and rash Body as a Whole: fever and anaphylaxis Laboratory Deviations: increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance Respiratory System: respiratory distress and apnea Renal System: nephrotoxicity and decreased urine output For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Xellia Pharmaceuticals USA, LLC at 1-833-295-6953, or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch/."],"contraindications":["CONTRAINDICATIONS The use of Colistimethate for Injection, USP is contraindicated for patients with a history of sensitivity to the drug or any of its components."],"drug_interactions":["Drug Interactions Certain other antibiotics (aminoglycosides and polymyxin) have also been reported to interfere with the nerve transmission at the neuromuscular junction. Based on this reported activity, they should not be given concomitantly with Colistimethate for Injection, USP except with the greatest caution. Curariform muscle relaxants (e.g., tubocurarine) and other drugs, including ether, succinylcholine, gallamine, decamethonium and sodium citrate, potentiate the neuromuscular blocking effect and should be used with extreme caution in patients being treated with Colistimethate for Injection, USP. Sodium cephalothin may enhance the nephrotoxicity of Colistimethate for Injection, USP. The concomitant use of sodium cephalothin and Colistimethate for Injection, USP should be avoided."],"general_precautions":["General Since Colistimethate for Injection, USP is eliminated mainly by renal excretion, it should be used with caution when the possibility of impaired renal function exists. The decline in renal function with advanced age should be considered. When actual renal impairment is present, Colistimethate for Injection, USP may be used, but the greatest caution should be exercised and the dosage should be reduced in proportion to the extent of the impairment. Administration of amounts of Colistimethate for Injection, USP in excess of renal excretory capacity will lead to high serum levels and can result in further impairment of renal function, initiating a cycle which, if not recognized, can lead to acute renal insufficiency, renal shutdown, and further concentration of the antibiotic to toxic levels in the body. At this point, interference of nerve transmission at neuromuscular junctions may occur and result in muscle weakness and apnea (see OVERDOSAGE section). Signs indicating the development of impaired renal function include: diminishing urine output, rising BUN and serum creatinine and decreased creatinine clearance. Therapy with Colistimethate for Injection, USP should be discontinued immediately if signs of impaired renal function occur. However, if it is necessary to reinstate the drug, dosing should be adjusted accordingly after drug plasma levels have fallen (see DOSAGE AND ADMINISTRATION section). Prescribing Colistimethate for Injection, USP 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."],"teratogenic_effects":["Teratogenic Effects Pregnancy Category C Colistimethate sodium given intramuscularly during organogenesis to rabbits at 4.15 and 9.3 mg/kg resulted in talipes varus in 2.6% and 2.9% of fetuses, respectively. These doses are 0.25 and 0.55 times the maximum daily human dose based on mg/m 2 . In addition, increased resorption occurred at 9.3 mg/kg. Colistimethate sodium was not teratogenic in rats at 4.15 or 9.3 mg/kg. These doses are 0.13 and 0.30 times the maximum daily human dose based on mg/m 2 . There are no adequate and well-controlled studies in pregnant women. Since colistimethate sodium is transferred across the placental barrier in humans, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."],"storage_and_handling":["Store between 20° to 25°C (68° to 77°F). (See USP controlled room temperature). Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F), and use within 7 days."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Typical serum and urine levels following a single 150 mg dose of Colistimethate for Injection, USP IM or IV in normal adult subjects are shown in Figure 1. Figure 1: Typical serum and urine levels following a single 150 mg dose of Colistimethate for Injection, USP IM or IV in normal adult subjects Higher serum levels were obtained at 10 minutes following IV administration. Serum concentration declined with a half-life of 2 to 3 hours following either intravenous or intramuscular administration in adults and in the pediatric population, including premature infants. Average urine levels ranged from about 270 mcg/mL at 2 hours to about 15 mcg/mL at 8 hours after intravenous administration and from 200 to about 25 mcg/mL during a similar period following intramuscular administration. Figure 1 Microbiology Colistimethate sodium is a surface active agent which penetrates into and disrupts the bacterial cell membrane. It has been shown to have bactericidal activity against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: Aerobic gram-negative microorganisms Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa . Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for Colistimethate for Injection, USP please see: https://www.fda.gov/STIC."],"indications_and_usage":["INDICATIONS AND USAGE Colistimethate for Injection, USP is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa . This antibiotic is not indicated for infections due to Proteus or Neisseria . Colistimethate for Injection, USP has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Colistimethate for Injection, USP may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Colistimethate for Injection, USP and other antibacterial drugs, Colistimethate for Injection, USP should be used only to treat or prevent 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."],"information_for_patients":["Information for Patients Patients should be counseled that antibacterial drugs including Colistimethate for Injection, USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Colistimethate for Injection, USP is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Colistimethate for Injection, USP or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible."],"spl_unclassified_section":["2530-B Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of colistimethate and other antibacterial drugs, colistimethate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. FOR INTRAMUSCULAR AND INTRAVENOUS USE","Rx only Prescribing Information as of June, 2023 Manufactured for: Xellia Pharmaceuticals USA, LLC Buffalo Grove, IL 60089 Novaplus is a registered trademark of Vizient, Inc. Made in Denmark Logo"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Important: Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium equivalent to 150 mg colistin base activity per vial. Reconstitution for Intravenous or Intramuscular Administration The 150 mg vial should be reconstituted with 2 mL Sterile Water for Injection, USP. The reconstituted solution provides colistimethate sodium at a concentration equivalent to 75 mg/mL colistin base activity. During reconstitution swirl gently to avoid frothing. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions are observed, the product should not be used. Dosage Adults and Pediatric Patients - Intravenous or Intramuscular Administration The dose of Colistimethate for Injection, USP should be 2.5 to 5 mg/kg per day of colistin base in 2 to 4 divided doses for patients with normal renal function, depending on the severity of the infection. In obese individuals, dosage should be based on ideal body weight. The daily dose and frequency should be reduced for the patients with renal impairment. Suggested modifications of dosage schedule for patients with renal impairment are presented in Table 1. Table 1 Suggested Modification of Dosage Schedules of Colistimethate for Injection, USP for Adults with Impaired Renal Function Degree of Renal Impairment Normal Mild Moderate Severe Note: The suggested total daily dose is calculated from colistin base activity. Creatinine Clearance (mL/min) ≥80 50-79 30-49 10-29 Dosage Schedule 2.5 to 5 mg/kg, divided into 2 to 4 doses per day 2.5 to 3.8 mg/kg, divided into 2 doses per day 2.5 mg/kg, once daily or divided into 2 doses per day 1.5 mg/kg every 36 hours INTRAVENOUS ADMINISTRATION Direct Intermittent Administration - Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours. Continuous Infusion - Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of Colistimethate for Injection, USP to one of the following: 0.9% NaCI 5% dextrose in 0.9% NaCI 5% dextrose in water 5% dextrose in 0.45% NaCI 5% dextrose in 0.225% NaCI lactated Ringer's solution 10% invert sugar solution There are not sufficient data to recommend usage of colistimethate for injection with other drugs or other than the above listed infusion solutions. Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment. The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management. Any final intravenous infusion solution containing colistimethate sodium should be freshly prepared and used for no longer than 24 hours. INTRAMUSCULAR ADMINISTRATION 1. For Intramuscular Injection, administer by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh). Store reconstituted solution for intramuscular injection in a refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F), and use within 7 days."],"spl_product_data_elements":["Colistimethate colistimethate sodium Colistimethate Sodium Colistimethate Colistin"],"dosage_and_administration_table":["
Table 1 Suggested Modification of Dosage Schedules of Colistimethate for Injection, USP for Adults with Impaired Renal Function
Degree of Renal Impairment
NormalMildModerateSevere
Note: The suggested total daily dose is calculated from colistin base activity.
Creatinine Clearance (mL/min)≥8050-7930-4910-29
Dosage Schedule2.5 to 5 mg/kg, divided into 2 to 4 doses per day2.5 to 3.8 mg/kg, divided into 2 doses per day2.5 mg/kg, once daily or divided into 2 doses per day1.5 mg/kg every 36 hours
","
INTRAVENOUS ADMINISTRATION
Direct Intermittent Administration - Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours.Continuous Infusion - Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of Colistimethate for Injection, USP to one of the following: 0.9% NaCI 5% dextrose in 0.9% NaCI 5% dextrose in water 5% dextrose in 0.45% NaCI 5% dextrose in 0.225% NaCI lactated Ringer's solution 10% invert sugar solutionThere are not sufficient data to recommend usage of colistimethate for injection with other drugs or other than the above listed infusion solutions.Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment.The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management. Any final intravenous infusion solution containing colistimethate sodium should be freshly prepared and used for no longer than 24 hours.
INTRAMUSCULAR ADMINISTRATION
1. For Intramuscular Injection, administer by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh). Store reconstituted solution for intramuscular injection in a refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F), and use within 7 days.
"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 150 mg Vial Carton NDC 70594-023-09 Colistimethate for Injection, USP Colistin base activity 150 mg*/vial Rx Only For Intramuscular and Intravenous Use 1 x 150 mg vial novaplus ™ Principal Display Panel - 150 mg Vial Carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal carcinogenicity studies and genetic toxicology studies have not been performed with colistimethate sodium. There were no adverse effects on fertility or reproduction in rats at doses of 9.3 mg/kg/day (0.30 times the maximum daily human dose when based on mg/m 2 )."]},"tags":[{"label":"Polymyxin-class Antibacterial","category":"class"},{"label":"Peptide","category":"modality"},{"label":"Intramuscular","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Enterobacter Infection","category":"indication"},{"label":"Infection due to Escherichia coli","category":"indication"},{"label":"Klebsiella Infections","category":"indication"},{"label":"Pseudomonas Aeruginosa Infections","category":"indication"},{"label":"Pseudomonas Respiratory Tract Infection in Cystic Fibrosis","category":"indication"},{"label":"Ph Health","category":"company"},{"label":"Approved 1970s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"151 reports"},{"date":"","signal":"HOSPITALISATION","source":"FDA FAERS","actionTaken":"122 reports"},{"date":"","signal":"ACUTE KIDNEY INJURY","source":"FDA FAERS","actionTaken":"75 reports"},{"date":"","signal":"INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS","source":"FDA FAERS","actionTaken":"71 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"70 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"67 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"66 reports"},{"date":"","signal":"CYSTIC FIBROSIS","source":"FDA FAERS","actionTaken":"60 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"59 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"56 reports"}],"drugInteractions":[{"drug":"aminoglycosides","severity":"major","mechanism":"interference with nerve transmission at the neuromuscular junction","management":"use with the greatest caution; avoid concomitant use if possible","clinicalEffect":"increased risk of neuromuscular blockade"},{"drug":"polymyxin","severity":"major","mechanism":"interference with nerve transmission at the neuromuscular junction","management":"use with the greatest caution; avoid concomitant use if possible","clinicalEffect":"increased risk of neuromuscular blockade"},{"drug":"curariform muscle relaxants (e.g., tubocurarine)","severity":"major","mechanism":"potentiation of neuromuscular blocking effect","management":"use with extreme caution; monitor closely for respiratory depression","clinicalEffect":"enhanced neuromuscular blockade"},{"drug":"ether","severity":"major","mechanism":"potentiation of neuromuscular blocking effect","management":"use with extreme caution; monitor closely for respiratory depression","clinicalEffect":"enhanced neuromuscular blockade"},{"drug":"succinylcholine","severity":"major","mechanism":"potentiation of neuromuscular blocking effect","management":"use with extreme caution; monitor closely for respiratory depression","clinicalEffect":"enhanced neuromuscular blockade"},{"drug":"gallamine","severity":"major","mechanism":"potentiation of neuromuscular blocking effect","management":"use with extreme caution; monitor closely for respiratory depression","clinicalEffect":"enhanced neuromuscular blockade"},{"drug":"decamethonium","severity":"major","mechanism":"potentiation of neuromuscular blocking effect","management":"use with extreme caution; monitor closely for respiratory depression","clinicalEffect":"enhanced neuromuscular blockade"},{"drug":"sodium citrate","severity":"major","mechanism":"potentiation of neuromuscular blocking effect","management":"use with extreme caution; monitor closely for respiratory depression","clinicalEffect":"enhanced neuromuscular blockade"},{"drug":"sodium cephalothin","severity":"major","mechanism":"enhancement of nephrotoxicity","management":"avoid concomitant use; if necessary, monitor renal function closely","clinicalEffect":"increased risk of kidney damage"}],"commonSideEffects":[{"effect":"seizures","drugRate":"reported","severity":"unknown"},{"effect":"nephrotoxicity","drugRate":"reported","severity":"unknown"},{"effect":"anaphylaxis","drugRate":"reported","severity":"unknown"},{"effect":"apnea","drugRate":"reported","severity":"unknown"},{"effect":"respiratory distress","drugRate":"reported","severity":"unknown"},{"effect":"decreased urine output","drugRate":"reported","severity":"unknown"},{"effect":"decreased creatinine clearance","drugRate":"reported","severity":"unknown"},{"effect":"elevated creatinine","drugRate":"reported","severity":"unknown"},{"effect":"increased blood urea nitrogen (BUN)","drugRate":"reported","severity":"unknown"},{"effect":"generalized itching","drugRate":"reported","severity":"unknown"},{"effect":"urticaria","drugRate":"reported","severity":"unknown"},{"effect":"rash","drugRate":"reported","severity":"unknown"},{"effect":"fever","drugRate":"reported","severity":"unknown"},{"effect":"slurred speech","drugRate":"reported","severity":"unknown"},{"effect":"dizziness","drugRate":"reported","severity":"unknown"},{"effect":"vertigo","drugRate":"reported","severity":"unknown"},{"effect":"paresthesia","drugRate":"reported","severity":"unknown"},{"effect":"tingling of extremities and tongue","drugRate":"reported","severity":"unknown"}],"contraindications":["Patients with a history of sensitivity to Colistimethate for Injection, USP or any of its components."],"specialPopulations":{"Pregnancy":"Colistimethate sodium given intramuscularly during organogenesis to rabbits at 4.15 and 9.3 mg/kg resulted in talipes varus in 2.6% and 2.9% of fetuses, respectively. These doses are 0.25 and 0.55 times the maximum daily human dose based on mg/m2. In addition, increased resorption occurred at 9.3 mg/kg. Colistimethate sodium was not teratogenic in rats at 4.15 or 9.3 mg/kg. These doses are 0.13 and 0.30 times the maximum daily human dose based on","Geriatric use":"Clinical studies of colistimethate sodium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function.","Paediatric use":"In clinical studies, colistimethate sodium was administered to the pediatric population (neonates, infants, children and adolescents). Although adverse reactions appear to be similar in the adult and pediatric populations, subjective symptoms of toxicity may not be reported by pediatric patients. Close clinical monitoring of pediatric patients is recommended.","Hepatic impairment":"In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function."}},"trials":[],"aliases":[],"company":"Ph Health","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=COLISTIMETHATE SODIUM","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:45:16.440038+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Colistimethate Sodium","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:45:23.828384+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:45:21.611806+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:45:15.541411+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=COLISTIMETHATE SODIUM","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:45:22.125121+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:45:14.509697+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:45:14.509720+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:45:24.297244+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Cell membrane inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:45:23.828332+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:46:09.210753+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201441/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:45:23.488192+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"ADVERSE REACTIONS The following adverse reactions have been reported: Gastrointestinal: gastrointestinal upset Nervous System: tingling of extremities and tongue, slurred speech, dizziness, vertigo, paresthesia and seizures Integumentary: generalized itching, urticaria and rash Body as a Whole: fever and anaphylaxis Laboratory Deviations: increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance Respiratory System: respiratory distress and apnea Renal System: ne","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:45:27.914604+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:45:30.492628+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA205356","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:45:14.509724+00:00"}},"allNames":"coly-mycin m","offLabel":[],"synonyms":["colistimethate","colistimethate sodium","colistinmethanesulfonic acid","Colimycin M","Colimycin sodium methanesulfonate","colistin sulfomethate","colistin sodium methanesulfonate","pentasodium colistinmethanesulfonate","colistin sulphomethate","colobreathe"],"timeline":[{"date":"1970-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from PAR STERILE PRODUCTS to Ph Health"},{"date":"1970-06-04","type":"positive","source":"DrugCentral","milestone":"FDA approval (Par Sterile Products)"},{"date":"2008-04-17","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 3 manufacturers approved"}],"aiSummary":"Coly-Mycin M is an intravenous antibiotic used to treat various bacterial infections, including osteomyelitis and gram-negative bacterial infections. It works by inhibiting the cell membrane, a mechanism that disrupts bacterial cell function.","approvals":[{"date":"1970-06-04","orphan":false,"company":"PAR STERILE PRODUCTS","regulator":"FDA"}],"brandName":"Coly-Mycin M","ecosystem":[{"indication":"Enterobacter Infection","otherDrugs":[{"name":"colistin","slug":"colistin","company":"Par Sterile Products"}],"globalPrevalence":null},{"indication":"Infection due to Escherichia coli","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"aztreonam","slug":"aztreonam","company":"Bristol Myers Squibb"}],"globalPrevalence":null},{"indication":"Klebsiella Infections","otherDrugs":[{"name":"colistin","slug":"colistin","company":"Par Sterile Products"}],"globalPrevalence":null},{"indication":"Pseudomonas Aeruginosa Infections","otherDrugs":[{"name":"colistin","slug":"colistin","company":"Par Sterile Products"}],"globalPrevalence":null},{"indication":"Pseudomonas Respiratory Tract Infection in Cystic Fibrosis","otherDrugs":[],"globalPrevalence":890552}],"mechanism":{"modality":"Small Molecule","drugClass":"Polymyxin-class Antibacterial","explanation":"","oneSentence":"","technicalDetail":"Colistimethate Sodium is a polymyxin-class antibiotic that exerts its bactericidal effect by binding to the bacterial cell membrane, specifically to the lipid A moiety of lipopolysaccharides, disrupting membrane integrity and function, and ultimately leading to cell lysis and death."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Colistin","title":"Colistin","extract":"Colistin, also known as polymyxin E, is an antibiotic medication used as a last-resort treatment for multidrug-resistant Gram-negative infections including pneumonia. These may involve bacteria such as Pseudomonas aeruginosa, carbapenem-resistant Klebsiella pneumoniae (CRKP), or Acinetobacter. It comes in two forms: colistimethate sodium can be injected into a vein, injected into a muscle, or inhaled, and colistin sulfate is mainly applied to the skin or taken by mouth. Colistimethate sodium is a prodrug; it is produced by the reaction of colistin with formaldehyde and sodium bisulfite, which leads to the addition of a sulfomethyl group to the primary amines of colistin. Colistimethate sodium is less toxic than colistin when administered parenterally. In aqueous solutions, it undergoes hydrolysis to form a complex mixture of partially sulfomethylated derivatives, as well as colistin. Resistance to colistin began to appear as of 2015.","wiki_history":"== History ==\nColistin was first isolated in Japan in 1949 by Y. Koyama, from a flask of fermenting Bacillus polymyxa var. colistinus, and became available for clinical use in 1959.\n\nColistimethate sodium, a less toxic prodrug, became available for injection in 1959. In the 1980s, polymyxin use was widely discontinued because of nephro- and neurotoxicity. As multi-drug resistant bacteria became more prevalent in the 1990s, colistin started to get a second look as an emergency solution, in spite of toxicity.\n\nColistin has also been used in agriculture, particularly in China from the 1980s onwards. Chinese production for agriculture exceeded 2700 tons in 2015. China banned colistin use for livestock growth promotion in 2016."},"commercial":{"launchDate":"1970","_launchSource":"DrugCentral (FDA 1970-06-04, PAR STERILE PRODUCTS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/731","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=COLISTIMETHATE%20SODIUM","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=COLISTIMETHATE SODIUM","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Colistin","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:16:42.664195","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:46:09.930846+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"colistimethate sodium","indications":{"approved":[{"name":"Enterobacter Infection","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults and children with infections due to sensitive strains of Enterobacter aerogenes"},{"name":"Infection due to Escherichia coli","source":"DrugCentral","snomedId":71057007,"regulator":"FDA","eligibility":"Adults and children with infections due to sensitive strains of Escherichia coli"},{"name":"Klebsiella Infections","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults and children with infections due to sensitive strains of Klebsiella pneumoniae"},{"name":"Pseudomonas Aeruginosa Infections","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults and children with infections due to sensitive strains of Pseudomonas aeruginosa"},{"name":"Pseudomonas Respiratory Tract Infection in Cystic Fibrosis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Children with cystic fibrosis and Pseudomonas respiratory tract infections","prevalenceClass":"1-5 / 10 000","globalPrevalence":890552,"prevalenceMethod":"orphanet","prevalenceSource":"Orphanet (ORPHANET)"}],"offLabel":[],"pipeline":[]},"currentOwner":"Ph Health","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT06488794","phase":"PHASE2,PHASE3","title":"Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia","status":"NOT_YET_RECRUITING","sponsor":"University Hospital Fattouma Bourguiba","startDate":"2027-01-01","conditions":["Ventilator Associated Pneumonia"],"enrollment":400,"completionDate":"2028-12-31"},{"nctId":"NCT06368804","phase":"PHASE2","title":"Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis","status":"RECRUITING","sponsor":"Centre Hospitalier Intercommunal Creteil","startDate":"2024-09-15","conditions":["Bronchiectasis"],"enrollment":196,"completionDate":"2028-09-15"},{"nctId":"NCT06834971","phase":"NA","title":"Colistin Methanesulfonate Sodium Inhalation for Prophylaxis of Ventilator-Associated Pneumonia (CIVAP): A Prospective, Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial","status":"RECRUITING","sponsor":"Qilu Hospital of Shandong University","startDate":"2025-07-15","conditions":["Ventilator-Associated Pneumonia (VAP)"],"enrollment":508,"completionDate":"2026-12"},{"nctId":"NCT06051513","phase":"NA","title":"Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection","status":"RECRUITING","sponsor":"Southeast University, China","startDate":"2023-11-27","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":404,"completionDate":"2025-12-31"},{"nctId":"NCT06893835","phase":"PHASE4","title":"Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline","status":"ACTIVE_NOT_RECRUITING","sponsor":"Beni-Suef University","startDate":"2024-12-01","conditions":["Infection in ICU"],"enrollment":132,"completionDate":"2025-06-30"},{"nctId":"NCT06702943","phase":"","title":"Comparing Tigecycline Vs. Colistimethate in CNS Infections","status":"NOT_YET_RECRUITING","sponsor":"Ain Shams University","startDate":"2024-12-01","conditions":["Central Nervous System Infections"],"enrollment":70,"completionDate":"2027-06"},{"nctId":"NCT06570850","phase":"PHASE4","title":"Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection","status":"RECRUITING","sponsor":"Chiang Mai University","startDate":"2023-04-01","conditions":["Infection Due to Carbapenem Resistant Acinetobacter"],"enrollment":188,"completionDate":"2025-07"},{"nctId":"NCT05542446","phase":"PHASE4","title":"Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation","status":"TERMINATED","sponsor":"St. Anne's University Hospital Brno, Czech Republic","startDate":"2022-09-01","conditions":["Colistin"],"enrollment":8,"completionDate":"2024-01-19"},{"nctId":"NCT06198764","phase":"PHASE3","title":"A Clinical Trial for the Treatment of Carbapenem Resistant Gram-negative Bacterial Infection With Colistimethate Sodium for Injection","status":"RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2023-07-06","conditions":["Mental Health Issue"],"enrollment":80,"completionDate":"2026-03"},{"nctId":"NCT03460704","phase":"PHASE3","title":"Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.","status":"TERMINATED","sponsor":"Zambon SpA","startDate":"2018-01-29","conditions":["Non Cystic Fibrosis Bronchiectasis"],"enrollment":287,"completionDate":"2022-03-15"},{"nctId":"NCT03093974","phase":"PHASE3","title":"Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. 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