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.

Author: Tygoll Gardabar
Country: Netherlands
Language: English (Spanish)
Genre: Music
Published (Last): 13 March 2008
Pages: 127
PDF File Size: 16.79 Mb
ePub File Size: 20.86 Mb
ISBN: 548-8-12358-157-4
Downloads: 18822
Price: Free* [*Free Regsitration Required]
Uploader: Yohn

FDA Internet Application Site (Accessdata) Error

J01XB01 Mechanism of action Colistin is colisstin cyclic polypeptide antibacterial agent belonging to the polymyxin group. Polymyxins work by damaging the cell membrane and the resulting physiological colistin package insert are lethal to the bacterium.

Since the colistin package insert of action of the polymyxins is different from that of other antibacterial agents, resistance to colistin and polymyxin by the above mechanism alone would not be expected to result in resistance to other drug classes.

The elimination of the active colistin is incompletely characterised. CMS is eliminated predominantly by the kidneys via glomerular filtration.

Marketing authorisation number s 9.

Colistimethate for Injection, USP (1 Vial) | X-Gen Pharmaceuticals, Inc

The following conversion table is prepared for information and the values must be considered nominal and approximate only. Colistin package insert of revision of the text.

Colistin clearance is decreased in renal impairment, possibly due to increased conversion of CMS. Any unused colistin package insert should be disposed of in accordance with local requirements. Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose. Renal function monitoring should be performed at the start packaage treatment and regularly during inser in all patients.

Further, the effect of immature renal and colisstin function on the conversion of colistimethate sodium to colistin colistin package insert not known. In case of an allergic reaction, treatment with colistimethate sodium must be discontinued and appropriate measures implemented. As the development of resistance to intravenous colistin has been reported in particular when it is used as a monotherapy, co- administration with other antibacterial should also be considered in order to prevent the emergence of resistance.

Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ethanolamine or aminoarabinose.

Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection

As necessary, expert advice packge be sought when the local prevalence of resistance is such that the utility of the agent, in at least some types of infections, is colistin package insert. Intravenous colistimethate sodium does not cross the blood brain barrier to a clinically relevant extent. The likelihood of adverse events may paxkage related to the age, renal function and condition of the patient.

Colistimethate Sodium is indicated in adults and children including colistin package insert for the treatment of clistin infections due to selected aerobic Colistin package insert pathogens in patients with limited treatment options see sections 4. In the absence of meningeal inflammation, penetration into the cerebrospinal fluid CSF is minimal, but increases in the presence of meningeal inflammation. Colistimethate should be used in pregnancy only if the benefit to the mother outweighs the potential risk to the foetus.

This site uses cookies. Back to top Beacon Pharmaceuticals contact details.

In addition, increased reabsorption occurred at 9. The dose to be administered and the treatment duration should take into account the severity of the infection as well as the clinical response.

The mechanism of colistin clearance, including renal handling, is equally colistin package insert. Animal studies in rats and mice do not indicate teratogenic properties. Monitoring should be performed for perioral paraesthesia and paraesthesia in the extremities, which are signs of overdose see section 4.

colistin package insert The dose is expressed in the US, and other parts of the world, as milligrams of colistin base activity mg CBA. It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of colistimethate sodium see section 4. The use of intrathecal or colistin package insert administration of colistimethate sodium in the treatment of meningitis was not systematically investigated in clinical trials and is supported by case reports only.

Enter medicine name or company Start typing to retrieve search suggestions. Posology The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients see section 4. Each carton contains 1 or 10 vials. Co-treatment with colistimethate sodium and onsert such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin should be undertaken with caution in patients with myasthenia gravis see section 4.

The benefit of inserg treatment duration should be balanced against the potentially increased risk of renal toxicity. Colistin package insert binding is moderate and decreases at higher concentrations. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

Polymyxins have colistin package insert reported to have a concentration-dependent bactericidal effect on susceptible bacteria.

The insret of conversion of Colistimethate sodium colistin package insert the active substance, colistin, is not characterised. Local irritation at the site of injection may occur.

Reproductive toxicity studies in rats and mice do not indicate teratogenic properties. However, colistimethate sodium given intramuscularly during organogenesis to rabbits at 4.