POLYMYXIN B Powder for solution for injection (2011)
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Περιεχόμενα
Name of the medicinal product
POLYMYXIN B FOR INJECTION USP.
Summary product information
Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Intravenous,<br />Intramuscular,<br />Intrathecal,<br />Ophthalmic (topical and subconjunctivally) Powder ...
Indications and clinical use
Polymyxin B for Injection USP (polymyxin B sulphate) is indicated for the treatment of patients with the following infections, when caused by susceptible strains of the designated aerobic gramnegative ...
Contraindications
Patients who are hypersensitive to polymyxins, including polymyxin B sulphate, or to any component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the ...
Warnings and precautions
Serious Warnings and Precautions Polymyxin B for Injection USP is nephrotoxic therefore renal function should be assessed prior to and regularly during treatment. Dose adjustment is required in patients ...
Adverse reactions
Adverse Drug Reaction Overview The most common drug-related adverse reactions are nephrotoxicity and neurotoxicity, pain at the injection site, urticaria, and electrolyte imbalance. Clinical Trial Adverse ...
Drug interactions
Overview Concomitant administration of diuretics and potential nephrotoxic and/or neurotoxic agents including antimicrobials increases the likelihood of renal toxicity, whereas non-polarizing muscle relaxants ...
Dosage and administration
Dosing Considerations Polymyxin B for Injection USP may be administered intravenously, intramuscularly or intrathecally only to hospitalized patients under constant supervision by a physician. Dosage should ...
Overdosage
For management of a suspected drug overdose, contact your regional Poison Control Centre. Polymyxin-induced toxicity associated with overdose has been reported. Overdose of polymyxin can result in neuromuscular ...
Action and clinical pharmacology
Mechanism of Action The antibiotic lipopeptide polymyxin is a large molecular weight detergent. Polymyxin acts by way of three known mechanisms. Polymyxins interact electrostatistically with the outer ...
Storage and stability
<u>Before reconstitution:</u> Store at room temperature (15-30°C). Protect from light. Retain in carton until time of use. <u>After reconstitution for Intravenous, Intramuscular, Intrathecal and Ophthalmic ...
Dosage forms, composition and packaging
Polymyxin B for Injection USP is available as a powder for solution. It is available in single vial cartons containing 50 mg/vial (500,000 units) as polymyxin B sulphate. Polymyxin B for Injection USP ...
Pharmaceutical information
Drug Substance <u>Proper name:</u> Polymyxin B Sulphate <u>Chemical name:</u> N-[4-amino-1-[[1-[[4-amino-1-oxo-1-[[6,9,18-tris(2-aminoethyl)15 benzyl-3-(1-hydroxyethyl)12(2-methylpropyl)-2,5,8,11,14,17,20-heptaoxo-1,4,7,10,13,16,19-heptazacyclotricos-21-yl]amino]butan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1-oxobutan-2-yl] ...
Detailed pharmacology
Safety Pharmacology Safety pharmacology studies on delayed ventricular repolarization (QT/QTc), respiratory and central nervous system are not available. Pharmacokinetic/Pharmacodynamic Parameters The ...
Clinical trials
Data from original clinical studies are no longer available.
Microbiology
Polymyxin B sulphate is isolated from Bacillus polymyxa. Polymyxins are rapidly bactericidal and target the bacterial cell membrane. Mode of Action Lipopolypeptide polymyxins (polymyxin B/colistin) are ...
Toxicology
Information not available.
Marketing authorization holder
SteriMax Inc., 1-2735 Matheson Blvd. East, Mississauga ON, L4W 4M8
Submission control number
143565
Date of revision
November 9, 2011
References
1) Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Twentieth Information Supplement. 2010; M100-S20: Vol. 30 No. 1 2) Clinical and Laboratory ...
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