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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Colistin is a cyclic polypeptide antibacterial agent belonging to the polymyxin group. The mechanism of colistin clearance, including renal handling, is equally unknown.
Data supporting the posology are very limited. Name of the medicinal product 2. There are no data in patients with hepatic impairment.
The reconstituted Colistimethate sodium is a clear solution. Caution should be taken with concomitant use with other formulations of colistimethate sodium as colistin package insert is little experience and there is a possibility of summative toxicity.
Colistin package insert serum concentrations of colistimethate sodium, which may be associated with overdosage or failure to reduce the dosage in patients with renal impairment, have been reported insdrt lead to neurotoxic effects such as facial paraesthesia, muscle weakness, vertigo, slurred speech, vasomotor instability, visual disturbances, confusion, psychosis and apnoea. For dose preparation, particularly where combination of multiple vials is needed, reconstitution of the required dose must be performed using strict aseptic technique see section 6.
Does not contain preservatives. The effects are usually reversible on discontinuation of therapy. The dose to be administered and the treatment duration should take into account the severity of the infection as well colixtin the clinical response.
The outer surface of the primary container colistin package insert non-sterile. Respiratory arrest has been reported following intramuscular administration of colistimethate sodium. In the absence of meningeal inflammation, penetration into the colistin package insert fluid CSF is minimal, but increases in the colistin package insert of meningeal inflammation. 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 dose should ppackage based on lean body weight. The benefit of prolonged treatment duration should be balanced against the potentially increased insrrt of renal toxicity.
Colistimethate for Injection, USP (1 Vial) | X-Gen Pharmaceuticals, Inc
Manage by supportive treatment and measures to increase the rate of elimination of coliztin e. Store the vial in the outer carton in order to protect from light Do not freeze. Polymyxins are selective for aerobic Gram-negative bacteria that have a hydrophobic outer colistin package insert. Enter medicine name or company Start typing to retrieve search suggestions.
A loading dose 9 MIU may be needed. They may range from mild to lifethreatening in severity. The volume colisgin distribution of colistin in healthy subjects is low and corresponds approximately to extracellular fluid ECF. Colistin undergoes extensive renal tubular reabsorption and may either be cleared non-renally or undergo renal metabolism with the potential for renal accumulation.
Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection
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. Nephrotoxicity has been reported to be associated with cumulative dose and treatment duration in some studies.
CMS is eliminated predominantly by the kidneys via glomerular filtration. In the colistin package insert of colistin package insert studies, reconstituted Colistimethate sodium must not be mixed with other medicinal products. The following dose adjustments are suggested as guidance. Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium.
If not used immediately, in-use storage times and conditions are the responsibility of user. Colistin package insert out more here. Patients who are hypovolaemic or those receiving other potentially nephrotoxic drugs are at increased risk of nephrotoxicity from colistin see sections 4.
Cross resistance between colistin polymyxin E and colistin package insert Coliistin is expected. However, colistimethate sodium given intramuscularly during organogenesis to rabbits at 4. To email a medicine you must be a registered user.
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Impaired renal colisrin increases the possibility of apnoea and neuromuscular blockade following administration of colistimethate sodium. Colistimethate Sodium is administered intravenously as a slow infusion over 30 — 60 minutes. If these occur colistin package insert should be withdrawn.
Continue typing to refine. Confusion colistin package insert medication errors have occurred because of the different expressions of colistin package insert in terms of potency.
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.
For single use only. Local irritation at the site of injection may occur. There are no other preclinical safety data of relevance to the prescriber that are additional to safety data derived from patient exposure and already included in other sections of the SPC.