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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Colistin undergoes extensive renal tubular reabsorption and may either be cleared non-renally or undergo renal metabolism with the potential for renal accumulation. The following dose adjustments are suggested as guidance. This information is intended for use by health professionals.
Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection
There are no other preclinical safety data of relevance to the prescriber that are additional to safety data derived from patient exposure and already included in other sections of the SPC. Clinical experience with such doses is however extremely limited and safety has not been established. Colistimethate sodium has ijsert shown to induce chromosomal aberrations in human lymphocytes in vitro. If not used immediately, in-use storage times and conditions are the responsibility of user.
Colistimethate colistimehate secreted in breast milk, and should be administered to breastfeeding women only when clearly needed. Patients who are hypovolaemic or those receiving other potentially nephrotoxic drugs are at increased risk of nephrotoxicity from colistin see sections 4. The dose is expressed in the US, and other parts of the world, as milligrams of colistin base psckage mg CBA. Marketing authorisation holder 8.
Store the vial in the outer carton colistkmethate order to protect from light Do not freeze. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. Last updated on eMC: In addition, increased reabsorption occurred at 9. Effects may include apnoea, transient sensory disturbances such as facial paraesthesia and vertigo and, rarely, vasomotor instability, slurred speech, visual disturbances, confusion or psychosis.
Colistimethate sodium should only be used when other, more commonly prescribed antibiotics are not effective or not appropriate.
Co-treatment with colistimethate sodium and macrolides 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. Resistance Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ibsert or aminoarabinose. Protein binding is moderate and decreases at higher concentrations.
The information on the pharmacokinetics of colistimethate sodium CMS and colistin is limited.
Colistimethate for Injection, USP (1 Vial) | X-Gen Pharmaceuticals, Inc
Colistin is a cyclic polypeptide antibacterial agent belonging to the polymyxin group. Overdose can result in neuromuscular blockade that can lead to muscular weakness, apnoea and possible respiratory arrest. During parenteral treatment with Colistimethate sodium neurotoxicity may occur with the possibility of dizziness, confusion or visual disturbance.
Concomitant use of intravenous colistimethate sodium with other medications that are potentially nephrotoxic or neurotoxic should be undertaken insedt great caution.
There are packagd data in patients with hepatic impairment. 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. The loading dose applies to patients with normal and impaired renal functions including those on renal replacement therapy.
The most commonly observed adverse effect of CMS administration was aseptic meningitis see section 4. There is no specific antidote. The volume of distribution of colistin in healthy subjects is low and corresponds approximately to extracellular fluid ECF. Reproductive toxicity studies in rats and mice do not indicate teratogenic properties. The dose to be administered and the treatment duration should take into account the severity of the infection as well as the clinical response.
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If these occur treatment should be withdrawn. Colistimethate sodium should be used with extreme caution in patients with porphyria. Marketing authorisation number s 9. No specific dosing recommendation lnsert be made in children for intrathecal and intraventricular routes of administration. Dose adjustments in renal impairment are necessary, but pharmacokinetic data available for patients with impaired renal function is very limited.
Par Sterile Products – Products – Colistimethate
No in vivo interaction studies have been performed. The dose of colistimethate sodium should be adjusted according to creatinine clearance see section 4. Each carton contains 1 or 10 vials.