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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For children with a body weight above 40 kg, use of the dosing recommendation for adults should be considered.
If not used immediately, in-use storage times and conditions are the responsibility of user. After infusion of colistimethate sodium the inactive colistimethae is converted to the active colistin.
Par Sterile Products – Products – Colistimethate
Powder for Solution for Injection White lyophilised powder in a glass vial. Each carton contains 1 or 10 vials. Find out more here. Store the vial in the outer carton in order to protect from light Do not freeze.
Marketing authorisation holder 8. To view the changes to a medicine you must ihsert up and log in. Colistin undergoes extensive renal tubular cklistimethate and may either be cleared non-renally or undergo renal metabolism with the potential for renal accumulation.
There are limited clinical data on the efficacy and safety of intravenous colistimethate sodium. The effects are usually reversible on discontinuation of therapy. The volume of distribution of colistin in healthy subjects is low and corresponds approximately to extracellular fluid ECF. Hydrolysis of colistimethate is significantly increased when reconstituted and diluted below its critical micelle concentration of about 80, IU per ml.
Qualitative and quantitative composition 3. The most appropriate time interval to the first maintenance dose has not been established. 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.
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. Any unused solution should be disposed of in accordance with local requirements.
Hypersensitivity to Colistimethate sodium also known as colistin or to polymyxin B. The product label states the number of IU per vial. Therapeutic guidelines should be adhered to. 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. Respiratory arrest has been reported following intramuscular administration of colistimethate sodium.
In addition, increased reabsorption occurred at 9. It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of colistimethate sodium see section 4.
Colistimethate for Injection, USP (1 Vial) | X-Gen Pharmaceuticals, Inc
Renal maturity should be taken into consideration when selecting the dose. The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients see section packagd. The packagd 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.
Twice daily dosing is recommended. For single use only. The mechanism of colistin clearance, including renal handling, is equally unknown. Manage by supportive treatment and measures to increase the rate of elimination of colistimethate e. The volume of distribution is relevantly enlarged in critically ill subjects.
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Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection
Does not contain preservatives. Renal impairment Dose adjustments in renal impairment are necessary, but pharmacokinetic data available for patients with impaired renal function is ijsert limited. The mechanism of conversion of Colistimethate sodium to the active substance, colistin, is not characterised. 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.
Discontinuation of therapy and the administration of specific treatment for Clostridium difficile should be considered. Reporting suspected adverse reactions after authorisation of the medicinal product is important. During parenteral treatment with Colistimethate sodium neurotoxicity may occur with the possibility of dizziness, confusion or visual cokistimethate.
Reproductive toxicity studies in rats and mice do not indicate teratogenic properties.
CMS is eliminated predominantly by the kidneys via glomerular filtration. The dose is expressed in the US, and other parts of the world, as milligrams of colistin base activity mg CBA.
Firm dose recommendations cannot be made. Local irritation at the site of injection may occur. There are extremely limited data from population PK studies from very small numbers of patients on renal replacement therapy.
Colistimethate for Injection, USP (1 Vial)
Reconstitute the contents of the vial with not more than 7ml water for injection or 0. Caution is advised when administering colistimethate sodium in these patients. Animal studies in rats and mice do not indicate teratogenic properties.