Colistimethate sodium or pentasodium colistinmethanesulfonate ( mg Please see product packaging and package insert for complete expiration date and. Page Steps taken after authorisation – summary. Page Summary of Product Characteristics. Product Information Leaflet. Labelling. Product Availability · Contact Us · Make An Inquiry. () Product Summary. Colistimethate for Injection, USP Lyophilized Powder For Injection, USP.
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Each carton contains 1 or 10 vials. Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose.
The likelihood of adverse events may be related to the age, renal function and condition of the patient. The mechanism of colistin clearance, including renal handling, is equally unknown.
Par Sterile Products – Products – Colistimethate
The effects are usually reversible on discontinuation of therapy. There are no data in patients with hepatic impairment.
Discontinuation of therapy and the administration of specific treatment for Clostridium difficile should be considered. Company contact details Beacon Pharmaceuticals. Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents and may occur with colistimethate sodium. Animal studies in rats and mice do not indicate teratogenic properties. Adverse effects on renal function have been reported, usually following use of higher than recommended doses in patients with normal renal function, or failure to reduce the dose in patients with renal impairment or during concomitant use of other nephrotoxic antibiotics.
These doses are 0. Renal maturity should be taken into consideration when selecting the dose. The potential for drug-drug interactions should be isert in mind when Colistimethate Colisfimethate is coadministered with drugs known to inhibit or induce drug metabolising enzymes or drugs known to be substrates for renal carrier mechanisms.
The reconstituted Colistimethate sodium is a clear solution.
Colistimethate for Injection, USP (1 Vial)
Protein binding is moderate and decreases at higher concentrations. There are indications that pharmacokinetics in critically ill patients differ from those in patients with less severe physiological derangement and from those in healthy volunteers. Hypersensitivity to Colistimethate sodium also known as colistin or to polymyxin B. The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients see section 4.
In addition, increased reabsorption occurred at 9. The following regimes could be considered. However, colistimethate sodium given intramuscularly during organogenesis to rabbits at 4. Colistimethate sodium has been shown to induce chromosomal aberrations in human lymphocytes in vitro. Find out more here. Colistin clearance is decreased in renal impairment, possibly due to increased conversion of CMS. In critically ill patients, half-life has been reported to be prolonged to oackage h.
Confusion and medication errors have occurred because of the different expressions of colistimethte in terms of potency.
They may range from mild to lifethreatening in severity. Data supporting the posology are very limited. Colistimethate Sodium is administered intravenously as a slow infusion over 30 — 60 minutes. Colistimethate Sodium is indicated in adults and children including neonates for the treatment of serious infections due to selected aerobic Gram-negative pathogens in patients with limited treatment options see sections 4.
Renal function monitoring should be performed at the start of treatment and regularly during treatment in all patients. As the development of resistance to intravenous colistin has been reported in particular when it is used as a monotherapy, co- administration with other antibacterial should also be considered in order to prevent the emergence insertt resistance.
Colistimethate sodium should be used with extreme caution in patients with porphyria. No in vivo interaction studies have been performed.
The dose to be administered and the treatment duration should take into account the severity of the infection as well as the clinical response. Powder for Solution for Injection White lyophilised powder in a glass vial. Patients who are hypovolaemic or those receiving other potentially nephrotoxic drugs are at increased risk of nephrotoxicity from colistin see sections 4.
For children with a body weight above 40 kg, use of the dosing recommendation for adults should be considered. Consideration should be given to co-administering intravenous colistimethate sodium with another antibacterial agent whenever this is possible, taking into account the remaining susceptibilities of the pathogen s under treatment.
Colistin undergoes extensive renal tubular reabsorption and may either be cleared non-renally or undergo renal metabolism with the potential for renal accumulation. The data supporting the dose regimen in paediatric patients are very limited. However, single dose studies in human pregnancy show that Colistimethate crosses the placental barrier and there may be a risk of foetal toxicity if repeated doses are given to pregnant patients.