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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The volume of distribution of colistin in healthy subjects is low and corresponds approximately to extracellular fluid ECF. Posology The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients see section 4.
It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of colistimethate sodium see section 4. Colistimethate sodium should only be used when other, more commonly prescribed antibiotics are not effective or not appropriate. Polymyxins are selective for aerobic Gram-negative bacteria that have a hydrophobic outer membrane.
The volume of distribution is relevantly enlarged in critically ill subjects. The dose to be administered and the treatment duration should take into account the severity of the infection as well as the clinical response. Colistimethate Sodium is indicated in colistimehate and children including neonates for colistimethat treatment of serious infections due to selected aerobic Gram-negative pathogens in patients with limited treatment options see sections 4.
Colistimethate for Injection, USP (1 Vial)
Back to top Beacon Pharmaceuticals contact details. Further, the effect of immature renal and metabolic function on the conversion of colistimethate sodium to colistin is not known. 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.
Manage by supportive treatment and measures to increase the rate of elimination of colistimethate e. The following dose adjustments are suggested as guidance.
The contents of the reconstituted vial may be diluted, usually with 50ml 0. During parenteral treatment with Colistimethate sodium neurotoxicity may occur with the possibility of dizziness, confusion or visual disturbance.
Colistimethate should be used in pregnancy only if the benefit to the mother outweighs the potential risk to the foetus. The data supporting the dose regimen in paediatric patients are very limited. Company contact details Beacon Pharmaceuticals. Powder for Solution for Injection White lyophilised powder in a glass vial. High 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 to lead to neurotoxic effects such as facial paraesthesia, muscle weakness, vertigo, slurred speech, vasomotor instability, visual disturbances, confusion, psychosis and apnoea.
The loading dose applies to patients with normal and impaired renal functions including those on renal replacement therapy. Discontinuation of therapy and the administration of specific treatment for Clostridium difficile should be considered. The following regimes could be considered. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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. Caution should be taken with concomitant use with other formulations of colistimethate sodium as there is little experience and there is a possibility of summative toxicity.
Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose. Active ingredient colistimethate sodium.
The most commonly observed adverse effect of CMS administration was aseptic meningitis see section 4. However, colistimethate sodium given intramuscularly during organogenesis to rabbits at 4. Cross resistance between colistin polymyxin E and polymyxin B is expected.
Marketing authorisation holder 8. In the absence of compatibility studies, reconstituted Colistimethate sodium must not be mixed with other medicinal products.
There are no adequate data from the use of Colistimethate sodium in pregnant women. Data supporting the posology are very limited. Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium.
Store the vial in the outer carton in order to protect from light Do not freeze. Clinical experience with such doses is however extremely limited and safety has not been folistimethate.
Consideration should be given to co-administering intravenous colistimethate sodium with another antibacterial agent whenever this is possible, taking into account the remaining volistimethate of the pathogen s under treatment.
Find out more here. Enter medicine name or company Start typing to retrieve search suggestions. During reconstitution swirl gently to avoid frothing.
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.
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Par Sterile Products – Products – Colistimethate
There are extremely limited data from population PK studies from very small numbers of patients on renal replacement therapy. Respiratory arrest has been reported following intramuscular administration of colistimethate sodium. The most appropriate time interval to the first maintenance dose has not been established. This information is intended for use by health professionals.
The following conversion table is prepared for information and the values must be inseert nominal and approximate only. Continue typing to refine. Patients who are hypovolaemic or those receiving other potentially nephrotoxic drugs are at increased risk of nephrotoxicity from colistin see sections 4. Colistin clearance is decreased in renal impairment, possibly due to increased conversion of CMS.