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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This effect may be related to a reduction in mitotic index, which was also observed. Modelling suggests that loading and maintenance doses of up to 12 MIU may be required in patients with good renal function in some cases. Peak plasma concentrations of colistin have been shown to occur with a delay of up to 7 hours after administration of colistimethate sodium in critically ill patients.
The following conversion table is prepared for information and the values must be considered nominal and approximate only. Colistimethate is secreted in breast milk, and should be administered to breastfeeding women only when clearly needed. The dose of colistimethate sodium should be adjusted according to creatinine clearance see section 4. Hypersensitivity reactions including skin rash have been reported.
Renal maturity should be taken into consideration when selecting the dose. Neurotoxicity has been reported often in association with overdose, failure to reduce dose in patients with renal insufficiency and concomitant use of either neuromuscular blocking drugs or other drugs with similar neurological effects. Marketing authorisation number s 9. The potential for drug-drug interactions should be borne in mind when Colistimethate Sodium is coadministered with drugs known to inhibit or induce drug metabolising enzymes or drugs known to be substrates for renal carrier mechanisms.
Colistimethate for Injection, USP (1 Vial)
The volume of distribution is relevantly enlarged in critically ill subjects. The information on the pharmacokinetics of colistimethate sodium CMS and colistin is limited. Company contact details Beacon Ihsert.
Impaired renal function increases the possibility of apnoea and neuromuscular blockade following administration of colistimethate sodium.
Intravenous colistimethate sodium does not cross the blood brain barrier to a clinically relevant extent. Date of revision of the text. Data supporting the posology are very limited. Does not contain preservatives. Renal function monitoring should be performed at the start of treatment and regularly during treatment in all colistimethtae. The following dose adjustments are suggested as guidance. Due to the effects of colistin on the release of acetylcholine, non-depolarising muscle relaxants should be used with caution in patients receiving colistimethate sodium as their effects could be prolonged see section 4.
Sign Up Log In Cancel. In the absence of compatibility studies, reconstituted Colistimethate sodium coistimethate not be mixed with other medicinal products. The product label states the number of IU per vial. Patients should be warned not to drive or operate machinery if these effects occur.
Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose.
Par Sterile Products – Products – Colistimethate
Colistimethate sodium undergoes hydrolysis to the active substance colistin in aqueous solution. Caution is advised when administering colistimethate sodium in these patients.
In the absence of meningeal inflammation, penetration into the cerebrospinal fluid CSF is minimal, but increases in the presence of meningeal inflammation. The following regimes could be considered. 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.
Colistimethwte the dose may alleviate symptoms. In critically ill patients, half-life has been reported to be prolonged to around h. Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents and may occur with colistimethate sodium.
Patients who are hypovolaemic or those receiving other potentially nephrotoxic drugs are at increased risk of nephrotoxicity from colistin see sections 4. The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients see section 4.
They may range from mild to lifethreatening in severity. The mechanism of conversion of Colistimethate sodium to the active substance, colistin, is not characterised.
Store the vial in the outer carton in order to protect from light Do not freeze. There are no adequate data from the use of Colistimethate sodium in pregnant women. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
This information is intended for use by health professionals.
Any unused solution should be disposed of in accordance with local requirements.