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.
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Powder for Solution for Injection. Colistin is a cyclic polypeptide antibacterial agent belonging to the polymyxin group. Colistimethate Sodium 1 Million Colistin package insert. Renal impairment Dose adjustments in renal impairment are necessary, but pharmacokinetic data available for patients with impaired pacage function is very limited.
However, colistimethate sodium given intramuscularly during organogenesis to rabbits at 4.
Colistin package insert ingredient colistimethate sodium. High serum concentrations of colistimethate sodium, which may be associated colistin package insert overdosage or failure to reduce the dosage in patients with renal impairment, have cplistin reported to lead to neurotoxic effects such as facial paraesthesia, muscle weakness, vertigo, slurred speech, vasomotor instability, visual disturbances, confusion, psychosis and apnoea.
Colistimethate for Injection, USP (1 Vial) | X-Gen Pharmaceuticals, Inc
Patients should be warned not to insrrt or operate machinery if these effects occur. Concomitant use of intravenous colistimethate sodium with other medications that are potentially nephrotoxic or neurotoxic should be undertaken with colistin package insert caution. Colistin undergoes extensive renal tubular reabsorption and may either be cleared non-renally or undergo renal metabolism with the potential for renal accumulation.
Hypersensitivity reactions including skin rash have been reported. Therapeutic guidelines should be adhered to. There are extremely limited data from population PK studies from very small numbers colistin package insert patients on renal replacement therapy.
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The following conversion inesrt is prepared for information and the values must be considered nominal and approximate only. Protein binding is moderate and decreases at higher concentrations. There are colistin package insert other preclinical safety data of relevance to the prescriber that are additional to safety data derived from patient exposure and already colistin package insert in other sections of the SPC.
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Firm dose recommendations cannot be made. There is no specific antidote. Caution colistin package insert be taken with concomitant use with other formulations of colistimethate sodium as there is little experience and there is a possibility colustin summative toxicity.
Colistimethate sodium should only be used when other, more commonly prescribed antibiotics are not effective or not appropriate. 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 colstin patients with renal impairment or during concomitant use of other nephrotoxic antibiotics. The most commonly observed adverse effect of CMS administration was aseptic meningitis see section 4.
Colistin clearance is decreased in renal impairment, possibly due colistin package insert increased conversion of CMS. Healthcare professionals are asked colistin package insert report any suspected adverse reactions via the Yellow Card Scheme.
There are indications that pharmacokinetics in critically ill patients differ from those in patients with less severe physiological derangement and from colistin package insert in healthy volunteers. The elimination of the active colistin is incompletely characterised. Any unused solution should be disposed of in accordance with local requirements. Reconstitute the contents of the vial with not more than 7ml water for injection or 0.
Company contact details Beacon Pharmaceuticals. Marketing authorisation number s 9. Enter medicine name or company Colistin package insert typing to retrieve search suggestions. The volume of distribution of colistin in healthy subjects is low and corresponds approximately to extracellular fluid ECF.
Colistimethate sodium undergoes hydrolysis to the active substance colistin in aqueous solution. Store the vial in the outer colistin package insert in order to protect from light Do not freeze. Polymyxins have been reported to have a concentration-dependent bactericidal effect on susceptible bacteria.
The contents of the reconstituted vial may be diluted, usually with 50ml 0. No in vivo interaction studies have been performed. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent, in at least some types of infections, is questionable. Name of the colistin package insert product 2.
Renal function monitoring should be performed at the start of treatment padkage regularly during treatment in all patients. In the absence of compatibility studies, reconstituted Colistimethate sodium must not be mixed with other medicinal products. These are generally mild and resolve during or shortly after treatment.
Coliistin not contain preservatives. Polymyxins are selective for aerobic Gram-negative bacteria that have colistin package insert hydrophobic outer membrane. Posology The following dose recommendations are made based inserf limited population-pharmacokinetic data in critically ill patients see section 4. Data on potential genotoxicity are limited and carcinogenicity data for colistimethate sodium are lacking. No specific dosing recommendation can be made in children colistin package insert intrathecal and intraventricular routes of administration.
During parenteral treatment with Colistimethate sodium neurotoxicity may occur with the possibility of dizziness, colistin package insert or visual disturbance.
Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection
Confusion and medication errors have occurred because of the different expressions of dose in terms of potency. Manage by supportive treatment and measures to increase the rate of elimination of colistimethate e.
In case of an allergic reaction, treatment with colistimethate sodium must be discontinued and appropriate measures implemented. The following dose adjustments are suggested as guidance. Colistimethate Sodium is indicated in adults and children including neonates for the treatment of serious infections due to cilistin aerobic Gram-negative pathogens in patients colistin package insert limited treatment options see sections 4.