Colistimethate sodium or pentasodium colistinmethanesulfonate ( mg Please see product packaging and package insert for complete expiration date and. PACKAGE INSERT. Colistimethate for Injection- resistant chronic infections due to colistin sensitive strains of gram-negative pathogenic bacilli. It is particularly. Colistin Package Insert PDF – Free download as PDF File .pdf), Text File .txt) or read online for free. Colistin-package-insert-pdf.
|Country:||Turks & Caicos Islands|
|Published (Last):||16 June 2018|
|PDF File Size:||19.40 Mb|
|ePub File Size:||10.96 Mb|
|Price:||Free* [*Free Regsitration Required]|
Hypersensitivity to Colistimethate colisitn also known as colistin or to polymyxin B. Resistant bacteria are characterised by modification of the phosphate groups of colistin package insert, which become substituted with ethanolamine or aminoarabinose. Antibiotic-associated colitis and pseudomembranous colitis have been reported with pacoage all antibacterial agents and may occur with colistimethate sodium. Show table of contents Colistin package insert table of contents 1. Qualitative and quantitative composition 3.
Overdose can also cause acute renal failure characterised by decreased urine output and increased serum concentrations of BUN and creatinine. Data on potential genotoxicity are limited and carcinogenicity data for colistimethate sodium are lacking. Data supporting the posology are very limited.
The following dose recommendations are made based on limited population-pharmacokinetic data colisstin critically ill patients see colistin package insert 4. Colistimethate sodium undergoes hydrolysis to the active substance colistin in aqueous solution.
Polymyxins are selective for aerobic Gram-negative bacteria that have a hydrophobic outer membrane.
The product label states the number of IU per vial. Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine colistin package insert aminoarabinose.
Colistimethate for Injection, USP (1 Vial)
Enter medicine name or company Start typing to retrieve search suggestions. The potential for drug-drug interactions should be borne in mind colistin package insert Colistimethate Sodium is coadministered with drugs known to inhibit or induce drug metabolising enzymes or drugs known to be substrates for renal carrier mechanisms.
Firm dose recommendations cannot be made. Company contact details Beacon Pharmaceuticals.
They may range from mild packagee lifethreatening in severity. Reporting suspected adverse reactions after colistin package insert of the medicinal product is important. Name of the medicinal product 2.
The information on the pharmacokinetics of colistimethate sodium CMS and colistin is limited.
Colistimethate for Injection, USP (1 Vial) | X-Gen Pharmaceuticals, Inc
Colistimethate sodium colistin package insert only be used when other, more commonly prescribed antibiotics are not effective or not appropriate. The benefit of prolonged treatment duration should be balanced against the potentially increased risk of renal toxicity. The reconstituted Colistimethate sodium is a clear solution. Colistimethate colistin package insert be used in pregnancy only if the benefit to the mother outweighs the potential risk to the foetus.
Hypersensitivity reactions including skin rash have been reported. Reducing the dose may alleviate symptoms. Insegt products that inhibit peristalsis should not be colistin package insert. Colistimethate sodium is known to reduce the presynaptic release of acetyl-choline at the neuromuscular junction and should be used in patients with myasthenia gravis with the greatest caution and only if clearly needed.
Colistimethate Sodium is administered intravenously as a slow infusion over 30 — 60 minutes. Reproductive toxicity studies in rats and mice do not indicate teratogenic properties. The mechanism of colistin clearance, including colistin package insert handling, is equally unknown.
FDA Internet Application Site (Accessdata) Error
Clinical experience with such doses is however extremely limited and safety has not been established. For single use only. The following dose adjustments are suggested colistin package insert guidance. Effects may include apnoea, transient sensory disturbances such as facial paraesthesia and vertigo and, rarely, vasomotor instability, slurred speech, visual disturbances, colistin package insert or psychosis.
If not used immediately, in-use storage times colistin package insert conditions are the responsibility of user.
The mechanism of conversion of Colistimethate sodium to the active substance, colistin, is not characterised.
This effect may be related to a reduction in mitotic index, which was also observed. Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium. In critically ill patients, half-life has been reported to be prolonged to around h. J01XB01 Mechanism of action Colistin is a cyclic polypeptide antibacterial agent belonging to the polymyxin group. The effects are usually reversible on discontinuation of therapy.
Each carton contains 1 or 10 vials. There are no adequate data from the use of Colistimethate sodium in pregnant women. Overdose can result in neuromuscular blockade that can lead to muscular weakness, apnoea and possible respiratory arrest. Polymyxins have been reported to have a concentration-dependent bactericidal effect on susceptible bacteria.
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. Protein binding is moderate and decreases at higher concentrations.
To email a medicine you must be a registered user. There is no specific colistin package insert. As necessary, expert advice should be sought when the local prevalence of resistance is colistin package insert that the utility of the agent, in at least some types of infections, is questionable. Posology The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients see section 4.
The dose should be based on lean body weight. Hydrolysis of colistimethate is significantly increased when reconstituted and diluted below its critical micelle concentration of about 80, IU per ml. Manage by supportive treatment and measures to increase the rate of elimination of colistimethate e.