COLISTIMETHATE PACKAGE INSERT PDF

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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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. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. Data on potential genotoxicity are limited and carcinogenicity data for colistimethate sodium are lacking.

These are generally mild and resolve during or shortly after treatment. The dose is expressed in the US, and other parts of the world, as milligrams of colistin base activity mg CBA. The outer surface of the primary container is non-sterile. Medicinal products that inhibit peristalsis should not be given. Colistin is a cyclic polypeptide antibacterial agent belonging to the polymyxin group.

It is colistimethaye to consider this diagnosis in patients who develop diarrhoea during or after the use of colistimethate sodium see section 4. To bookmark a medicine you must sign up and log in.

Cross resistance between colistin polymyxin E and polymyxin B is expected. Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ethanolamine or aminoarabinose. In the absence of compatibility studies, reconstituted Colistimethate sodium must not be mixed with other medicinal products. 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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Resistance Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, cokistimethate become substituted with ethanolamine or aminoarabinose. J01XB01 Mechanism of nisert Colistin is a cyclic polypeptide antibacterial agent belonging to the polymyxin group.

Therapeutic guidelines should be adhered to. Overdose can result in neuromuscular blockade that can lead to muscular weakness, apnoea and possible respiratory arrest. Caution is advised when administering colistimethate sodium in these patients.

Reconstitute the contents of colistimetyate vial with not more than 7ml water for injection or 0. This information is intended for use by health professionals. Name of the medicinal product 2. They may range from mild to lifethreatening in severity.

The following dose adjustments are suggested as guidance. Polymyxins are selective for aerobic Gram-negative bacteria that have a hydrophobic outer membrane.

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

Renal impairment Dose adjustments in renal impairment are necessary, but pharmacokinetic data available for patients with impaired renal function is very limited. The mechanism of conversion of Colistimethate sodium to the active substance, colistin, is not characterised. The following conversion table is prepared for information and the values must be considered nominal and approximate only. CMS is packagw predominantly by the kidneys via glomerular filtration.

Colistimethate for Injection, USP (1 Vial)

Colistimethate sodium has been shown to induce chromosomal aberrations in human lymphocytes in vitro. Twice daily dosing is recommended. Firm dose recommendations cannot be made. 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.

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Hypersensitivity to Colistimethate sodium also known as colistin or to polymyxin B. Discontinuation of therapy and the administration of specific treatment for Clostridium difficile should be considered.

For single use only. The information on the pharmacokinetics of colistimethate sodium CMS and colistin is limited. Manage by supportive treatment and measures to increase the rate of elimination of colistimethate e. After infusion of colistimethate sodium the inactive pro-drug is converted to the active colistin. In case of an allergic reaction, treatment with colistimethate sodium must be discontinued and appropriate measures implemented.

Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium. This effect may be related to a reduction in mitotic index, which was also observed. The mechanism of colistin clearance, including renal handling, is equally unknown.

Marketing authorisation number s 9. During parenteral treatment with Colistimethate sodium neurotoxicity may occur with the possibility of dizziness, confusion or visual disturbance. Colistimethate Sodium 1 Million I.

The most appropriate time interval to the first maintenance dose has not been established.

Par Sterile Products – Products – Colistimethate

No in vivo interaction studies have been performed. Renal maturity should be taken into consideration when selecting the dose. Data supporting the posology are very limited.