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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Reproductive toxicity studies in rats and mice do not indicate teratogenic properties.

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

Marketing authorisation number s 9. If these occur treatment should be withdrawn.

Colistimethate is secreted in breast milk, and should be administered to breastfeeding women only when clearly needed. Discontinuation of therapy and the administration of specific treatment for Clostridium difficile should be considered. Local irritation at the site of injection may occur. Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents and may occur with colistimethate sodium.

Effects may include apnoea, transient sensory disturbances such as facial paraesthesia and vertigo and, rarely, vasomotor instability, slurred speech, visual disturbances, confusion or psychosis. Find out more here.

Co-treatment with colistimethate sodium and macrolides such as azithromycin and clarithromycin, or packzge such as norfloxacin and ciprofloxacin should be undertaken with caution in patients with myasthenia gravis see section 4.

In critically ill patients, half-life has been reported to be prolonged to around h. Neurotoxicity has been reported often in association with overdose, failure to paciage dose in patients with renal insufficiency and concomitant use of either neuromuscular blocking drugs or other drugs with similar neurological effects.

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Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. The mechanism of colistin clearance, including renal handling, is equally unknown.

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.

Patients should be warned not to drive or operate machinery if these effects occur. The benefit of prolonged treatment duration should be balanced against the potentially increased risk of renal toxicity. 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.

Par Sterile Products – Products – Colistimethate

The effects are usually reversible on discontinuation of therapy. In addition, increased reabsorption occurred at 9.

Colistin clearance is decreased in renal impairment, possibly due pcakage increased conversion of CMS. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Back to top Beacon Pharmaceuticals contact details.

Colistimethate for Injection, USP (1 Vial)

Powder for Solution for Injection. CMS is eliminated predominantly by the kidneys via glomerular filtration. The potential for drug-drug interactions should be borne in mind when Colistimethate Sodium is coadministered with drugs known to inhibit or induce drug metabolising enzymes or drugs known to be substrates for renal carrier mechanisms.

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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 inserg, which become substituted with ethanolamine or aminoarabinose.

Protein binding is moderate and decreases at higher concentrations.

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

inssert Consideration should be given to co-administering intravenous colistimethate sodium with another antibacterial agent whenever this is possible, taking into account the remaining susceptibilities of the pathogen s under treatment. The dose is expressed in the US, and other parts of the world, as milligrams of colistin base activity mg CBA.

The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients see section 4. Overdose can result in neuromuscular blockade that can lead to muscular weakness, apnoea and possible respiratory arrest. 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. There is no specific antidote. No specific dosing recommendation can be made in children for intrathecal and intraventricular routes of administration.

Sign Up Log In Cancel. Naturally resistant Gram-negative bacteria, such as Proteus colixtimethate and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose.