Polymyxin B sulfate: Instructions for use: Description of the drug: Price on EUROLAB

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Manufacturers: Axellia Pharmaceuticals Aps (Denmark)

Active ingredients

Polymyxin B

Disease class

Bacterial meningitis, not elsewhere classified
Conjunctivitis, unspecified
Keratitis
Purulent and unspecified otitis media
Pneumonia without specifying the pathogen
Chronic sinusitis
Phlegmon
Decubital ulcer
Osteomyelitis
Diarrhea and gastroenteritis of suspected infectious origin
Septicemia, unspecified
Other and unspecified infectious diseases
Cystitis
Urethritis and urethral syndrome

Clinical and pharmacological group

Not indicated. See instructions

Pharmacological action

Antibacterial
Bactericidal

Pharmacological group

Other antibiotics

Substance-powder of Polymyxin B sulfate (Polymyxini B sulfas)

Instructions for medical use of the drug

Description of pharmacological action

Acts primarily on gram-negative microorganisms. Absorbed on phospholipids of the membrane, increases its permeability, causes lysis of bacteria. Resilience develops slowly; causes cross-resistance with colistin. Active against Salmonella, Shigella, E.coli, Klebsiella spp., Bordetella pertussis, Haemophilus influenzae, Enterobacter, Pseudomonas aeruginosa, Vibrio cholerae (except eltor type).

Indications for use

Acute infections caused by sensitive microorganisms (Pseudomonas aeruginosa, salmonella, shigella, etc.): - internally - infectious and inflammatory diseases of the gastrointestinal tract, - injection - sepsis, bacteremia, meningitis, pneumonia, - externally (or in the cavity) - urinary tract diseases ( cystitis, urethritis), ENT organs (otitis, sinusitis, sinusitis), skin (including infected burns, abscess, phlegmon, bedsores), bones (osteomyelitis), eyes (conjunctivitis, keratitis).

Release form

Powder substance; aluminum can 0.13 kg; Powder substance; aluminum can 0.63 kg; Powder substance; aluminum can 1.25 kg;

Pharmacodynamics

Use during pregnancy

Pregnant women are prescribed for health reasons, taking into account the expected benefit to the mother and the potential risk to the fetus.

Contraindications for use

Hypersensitivity, renal dysfunction, myasthenia gravis, for external use - perforation of the eardrum, extensive skin lesions.

Side effects

Damage to the kidneys (albuminuria, cylindruria, azotemia, proteinemia, tubular necrosis, electrolyte metabolism disorders) and nervous system (dizziness, ataxia, disturbances of consciousness, vision, drowsiness, peripheral paresthesia, in predisposed patients - neuromuscular blockade, respiratory paralysis, apnea; with intrathecal introduction - meningeal symptoms), superinfection, candidiasis, allergic reactions (skin rash, itching, urticaria, eosinophilia); when taken orally - nausea, pain in the epigastric region, loss of appetite; when administered IM - pain at the injection site, IV - thrombophlebitis.

Directions for use and doses

IM, IV. Adults: IM - 0.5-0.7 mg/kg 3-4 times/day (maximum daily dose - no more than 200 mg), IV - daily dose 2 mg/kg in 2 doses with an interval of 12 hours (no more than 150 mg). Children: IM, IV, regardless of age - 0.3–0.6 mg/kg 3–4 times/day. If renal function is impaired, the dose is reduced and the intervals between doses are increased in accordance with creatinine Cl. Inside (in the form of an aqueous solution). Adults are prescribed 100 mg every 6 hours, children - 4 mg/kg 3 times a day. Course duration is 5–7 days. Externally. Every hour, 1–3 drops of a 0.1–0.25% solution in each eye (if there is a positive reaction, the intervals between injections are increased). Intrathecal. Adults and children over 2 years old - 50,000 units once a day for 3-4 days, then every other day for another 2 weeks after receiving positive results; children under 2 years old - 20,000 units/day for 3-4 days or 25,000 units once every 2 days.

Overdose

Not described.

Interactions with other drugs

Shows synergism with chloramphenicol, tetracycline, sulfonamides and trimethoprim against Pseudomonas aeruginosa, Proteus, Serratia, with ampicillin - in terms of its effect on gram-negative rods, carbenicillin - Pseudomonas aeruginosa. Combine with bacitracin and nystatin. Enhances the oto- and nephrotoxicity of aminoglycosides (kanamycin, streptomycin, tobromin, neomycin, gentamicin) and the muscle relaxation caused by them, as well as by blockers of neuromuscular transmission. Reduces the concentration of heparin in the blood (forms complexes). In solutions, it is incompatible with ampicillin sodium salt, chloramphenicol, cephalosporin antibiotics, tetracycline, isotonic sodium chloride solution, amino acid solutions, heparin.

Precautions for use

Parenterally used only in a hospital setting. In case of renal failure and diseases accompanied by impaired neuromuscular transmission, correction of the dosage regimen and monitoring of renal function is necessary.

Polymyxin B

Stylab / Catalog / Antibacterial drugs / Polymyxin B

Colistin ELISA test system , which can be used to analyze the content of polymyxin B in food products of animal origin and animal feed.

Enzyme-linked immunosorbent assay (ELISA), strip plate

5151COL Colistin ELISA

Polymyxin B is a mixture of polymyxins B1, B1-I, B2, B3 and B6, cyclic polypeptides produced by the nitrogen-fixing bacterium Bacillus polymyxa. It lives in the soil, the roots of some plants and in sediments in the seas. Polymyxin B is active mainly against gram-negative microorganisms: Salmonella , Shigella, Escherichia coli , Vibrio cholerae , Pseudomonas aeruginosa , Enterobacter and many others.

In medicine, polymyxin B is prescribed orally for the treatment of infectious diseases of the gastrointestinal tract. Injections of polymyxin preparations are used for sepsis, pneumonia, and meningitis. It is used locally to treat diseases of the eyes, ENT organs, urinary tract, and skin. Polymyxin B, along with bacitracin and neomycin , is part of the drug "Neosporin", intended for the prevention of infections in skin lesions. It is also sold under the name Vellobactin-B. Polymyxin B, when taken orally, is not absorbed into the gastrointestinal tract and acts locally. After injection, it is excreted within 3-4 days with bile and urine.

In addition to its use as an antibiotic, polymyxin B is used to cleanse the blood of endotoxins. For this purpose, special cartridges are produced that are placed in dialysis systems. In analytical microbiology, polymyxin B is added to selective media to isolate specific microorganisms.

In veterinary medicine, polymyxin B is used to treat colibacillosis in birds, actinomycosis in cattle, purulent diseases, necrotic ulcers and diseases of the gastrointestinal tract in piglets, lambs and calves.

The mechanism of action of polymyxin B is due to its interaction with the membranes of microorganisms. It increases their permeability, which leads to cell destruction. Bacteria are slowly developing resistance to this antibiotic, allowing it to be widely used. However, microorganisms develop cross-resistance to polymyxin B and a chemically similar mixture of substances, colistin (polymyxin E). The mechanism of its occurrence is poorly understood.

The side effects of polymyxin B have been well studied. If taken orally, nausea and abdominal pain may occur. This antibiotic affects the kidneys, causing increased protein excretion in the urine, necrosis and disturbances in electrolyte metabolism. Polymyxin B also affects the nervous system, leading to dizziness, disturbances of consciousness, vision and muscle function, and drowsiness. In sensitive people, this drug may cause breathing problems or even stop breathing. Like other antibiotics, polymyxin B can cause allergic reactions.

Polymyxin B interacts with many antibacterial agents. It enhances the effect of tetracycline , chloramphenicol , ampicillin and sulfonamides on some bacteria. In addition, it increases the toxicity of aminoglycosides, including gentamicin and streptomycin .

In Canada, the content of polymyxin B in milk is legally limited. Its maximum permissible level is 4000 units/ml. In the European Union, the content of this antibiotic in food products is allowed not to be determined if it was used to neutralize endotoxins in vaccines, and its content did not exceed 500 μg/dose or 8 μg/kg of animal body weight. In general, in the European Union countries, polymyxin B is not allowed for use in animal husbandry and veterinary medicine. WHO/JECFA recommended maximum levels of polymyxin B are 0–2 units/ml for milk, 0–5 units/g for meat and eggs. 1 mg of polymyxin B contains about 10,000 units.

Literature

Polymyxin B. Register of medicines in Russia.
Gupta S, Govil D, Kakar PN, Prakash O, Arora D, Das S, Govil P, Malhotra A. Colistin and polymyxin B: a re-emergence. Indian J Crit Care Med. 2009 Apr-Jun;13(2):49-53.
Baradaran S, Black DJ, Keyloun KR, Hansen RN, Gillard PJ, Devine B. The Impact of Acute Kidney Injury on the Risk of Mortality and Health Care Utilization Among Patients Treated With Polymyxins for Severe Gram-Negative Infections. Open Forum Infect Dis. 2022 Aug 3;5(8):ofy191.
Anna-Lena Drangmeister, Friederike Busch, Sonja Schittko, Lutz Hartig. Polypeptide antibiotics in food control. Eurofins WEJ Contaminants GmbH, Neuländer Kamp 1, D-21079 Hamburg, Germany

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Polymyxin B

Intravenous, intramuscular, intrathecal.

Intravenous administration:

for adults and children (over 1 year of age) with normal renal function, the daily dose is 1.5-2.5 mg/kg (taking into account that 1 mg of purified polymyxin B base is equivalent to 10,000 units of polymyxin B) in 2 administrations with an interval of 12 h.

The maximum daily dose should not exceed 2.5 mg/kg.

In children under 1 year of age with normal renal function, if necessary, the daily dose can be increased to 4 mg/kg, which is divided into 2 doses and administered at intervals of 12 hours.

To prepare a solution for intravenous administration to adults, 50 mg of the drug is dissolved in 300-500 ml of 5% dextrose solution and administered drip-wise at a rate of 60-80 drops/min.

In children, a dose of the drug intended for intravenous administration is dissolved in 30-100 ml of a 5-10% dextrose solution.

Intramuscular administration

(only if intravenous administration is not possible): for adults and children (over 1 year) with normal renal function, the daily dose is 2.5-3 mg/kg in 3-4 doses every 6-8 hours.

In children under 1 year of age with normal renal function, if necessary, the daily dose can be increased to 4 mg/kg, which is divided into 4 doses and administered at intervals of 6 hours.

To prepare a solution for intramuscular administration, 50 mg of the drug is dissolved in 2 ml of a 1% solution of procaine, water for injection or 0.9% sodium chloride solution.

Intrathecal administration

(is the treatment of choice for meningitis caused by
Pseudomonas aeruginosa
): adults and children (over 2 years old) - 5 mg once a day for 3-4 days, then every other day for another 2 weeks. after receiving a negative result of bacteriological culture and normalization of glucose concentration in the cerebrospinal fluid; children under 2 years old - 2 mg once a day for 3-4 days or 2.5 mg once every 2 days. Then at a dose of 2.5 mg every other day for another 2 weeks after obtaining a negative result of bacteriological culture and normalization of glucose concentration in the cerebrospinal fluid.

Before administration, the drug (50 mg) is dissolved in 10 ml of 0.9% sodium chloride solution (concentration of the prepared solution is 5 mg/ml).

In patients with impaired renal function, the dose of the drug is reduced and the interval between doses is increased in accordance with creatinine clearance (with a creatinine clearance of 20-50 ml/min, 75-100% of the dose is used with normal renal function with an interval between doses of 12 hours; with creatinine clearance 5-20 ml/min, 50% of the dose is used for normal renal function with an interval between doses of 12 hours; with creatinine clearance less than 5 ml/min, 15% of the dose is used for normal renal function with an interval between doses of 12 hours).