Buy Amphotericin B vials 50 mg, 10 ml
  • Buy Amphotericin B vials 50 mg, 10 ml

Amphotericin B

Synthesis AKOMP
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2019-09-19
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Clinical Pharmacology

Amphotericin B is a polyene macrocyclic antibiotic with antifungal activity. Produced by Streptomyces nodosus. It has a fungicidal or fungistatic effect depending on the concentration in biological fluids and the sensitivity of the pathogen. Associated with sterols (ergosterol), located in the cell membrane of the drug-sensitive fungus. As a result, the permeability of the membrane is disturbed and the release of intracellular components into the extracellular space and lysis of the fungus occurs.

Active against most of Histoplasma capsulatum, Coccidioides immitis, Paracoccidioides braziliensis, Candida spp., Blastomyces, Cryptococcus neoformans, Sporothrix schenekii, Mukor mucedo, aprons aprons apt.

Moderately active against some of the simplest: Leishmania braziliensis, Leishmania mexicana, Naegleria fowleri.

Amphotericin B is generally resistant: Pseudallescheria boydii, Fusarium spp.

Ineffective against bacteria, rickettsia, viruses.

Indications

Progressive, life-threatening fungal infections caused by microorganisms sensitive to amphotericin B:

  • disseminated cryptococcosis, cryptococcal meningitis;
  • meningitis caused by other fungi;
  • invasive and disseminated aspergillosis;
  • North American blastomycosis;
  • disseminated forms of candidiasis;
  • coccidioidosis;
  • paracoccidioidosis;
  • histoplasmosis;
  • phycomycosis (zygomycosis);
  • chromomycosis;
  • mold mycosis;
  • disseminated sporotrichosis;
  • hyalohyphomycosis;
  • chronic mycetoma;
  • infections of the abdominal cavity (including peritonitis);
  • endocarditis;
  • endophthalmitis;
  • fungal sepsis;
  • fungal urinary tract infections;
  • visceral leishmaniasis (including in patients with immunodeficiency), American skin-visceral leishmaniasis (not a drug of choice).

Composition

1 bottle contains:

Active substance: amphotericin B 50 mg;

Excipients: sodium phosphate monosubstituted, deoxycholic acid.

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Amphotericin B

Dosage and Administration

Intravenous drip for 2-4 hours, the recommended concentration is 0.1 mg / ml. A test dose of 1 mg (base) is diluted in 20 ml of 5% dextrose solution and administered intravenously for at least 20-30 minutes under the control of blood pressure, pulse, and body temperature every 30 minutes for 2-4 hours.

With good portability, the recommended daily dose is 0.25-0.3 mg / kg, depending on the severity of the disease.

In case of hypersensitivity to the drug, diseases of the cardiovascular system, insufficiency of kidney function, treatment begins with low doses of 5-10 mg and, gradually increasing by 5-10 mg / day, adjusted to the recommended daily dose of 0.5-0.7 mg / kg.

The selection of therapeutic doses is carried out individually, depending on the type and severity of the infection. When using the drug every other day, the dose should not exceed 1.5 mg / kg (in order to avoid the development of cardiopulmonary insufficiency). The maximum daily dose is 1.5 mg / kg.

Sporotrichosis: a course dose of 2.5 g, the duration of therapy is 9 months.

Aspergillosis: course dose - 3.6 g, duration of treatment - 11 months.

Rhinocerebral phycomycosis: course dose - 3-4 g.

If therapy is interrupted for more than 7 days, it should be resumed from the lowest dose (0.25 mg / kg), gradually increasing to the desired level.

Children: intravenously, initially 0.25 mg / kg (base) per day in 5% dextrose solution for 6 hours; taking into account tolerance, the dose is gradually increased (usually by 0.125 - 0.25 mg / kg every day or every other day) up to a maximum dose of 1 mg / kg or 30 mg per 1 m2. Children should be given minimal effective doses.

To prepare a solution for intravenous administration, a solution with an initial concentration of 5 mg / ml is used. To do this, a sterile syringe (needle no less than No. 20) is applied with 10 ml of sterile water for injection without bacteriostatic additives directly into the bottle with the preparation. The contents of the vial are shaken until a clear colloidal solution is formed. To obtain a solution with a concentration of 0.1 mg / ml, dilute it with a 5% dextrose solution with a pH not lower than 4.2 at a ratio of 1:50. Before breeding, check the acidity of the available dextrose solution. The pH of the dextrose solution, as a rule, exceeds 4.2; otherwise, 1-2 ml of buffer solution should be added to it before dilution.

The following buffer solution is recommended: sodium hydrophosphate (anhydrous) -1.59 g, sodium dihydrogen phosphate (anhydrous) - 0.96 g, water for injection - up to 100 ml.

Before adding to the dextrose solution, the buffer solution is sterilized by filtration through a bacterial ceramic or membrane filter or by autoclaving for 30 minutes at a pressure of 1 atm and 121 ° C.

Adverse reactions

From the digestive system: often - loss of appetite, dyspepsia, nausea, vomiting, diarrhea, gastralgia, hepatotoxicity (increased activity of "liver" enzymes, hyperbilirubinemia); infrequently - acute liver failure, hepatitis, jaundice, hemorrhagic gastroenteritis, melena.

From the nervous system: often - headache, infrequently - convulsions, transient vertigo, peripheral neuropathy, encephalopathy.

From the senses: infrequently - blurred vision, diplopia; hearing loss, tinnitus.

From the side of blood-forming organs: often - normochromic normocytic anemia; infrequently - agranulocytosis, impaired blood clotting, leukopenia, hemolytic anemia, thrombocytopenia, eosinophilia, leukocytosis.

Since the cardiovascular system: often - lowering blood pressure; infrequently - arrhythmias, including ventricular fibrillation, ECG changes, increased blood pressure, shock, cardiac arrest, heart failure.

On the part of the respiratory system: often - tachypnea; infrequently - shortness of breath, allergic pneumonitis, pulmonary edema.

From the urinary system: often - impaired renal function, including azotemia, hypokalemia, hypostenuria, renal tubular acidosis, nephrocalineosis; infrequently - acute renal failure, oliguria, anuria, nephrogenic diabetes insipidus. Preliminary administration of a 0.9% solution of sodium chloride reduces the risk of nephrotoxicity, the introduction of sodium bicarbonate is the risk of renal tubular necrosis.

Allergic reactions: often - anaphylactoid reactions, bronchospasm, sneezing; infrequently - rash, especially maculopapular, pruritus, exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Local reactions: thrombophlebitis at the injection site, chemical burn.

Other: often - fever, weight loss, myalgia, arthralgia, general weakness.

Contraindications

Laboratory indicators: hypokalemia, hyperkalemia, hypomagnesemia, hypocalcemia, hypercreatininemia.

WITHcaution:kidney diseases (including glomerulonephritis), amyloidosis, hepatitis, cirrhosis of the liver, anemia, agranulocytosis, diabetes mellitus, pregnancy.

Drug interactions

Pharmaceutically incompatible with heparin, 0.9% sodium chloride solution and other solutions containing electrolytes.

The presence of bacteriostatic additives (including benzyl alcohol) can lead to precipitation of the drug.

Synergism - with nitrofurans.

Increases the effect and toxicity of anticoagulants, theophylline and sulfonylurea drugs, flucytosine (prolongs the half-life); reduces the effect of ethinyl estradiol - the risk of "bleeding" bleeding.

Inhibitors of microsomal liver enzymes (including cimetidine, non-narcotic analgesics, antidepressants) slow down the metabolic rate, increase serum concentration (toxicity increase).

Inductors of liver microsomal enzymes (including phenytoin, rifampicin, barbiturates, carbamazepine) accelerate liver metabolism (reduced effect).

Enhances the toxic effect of cardiac glycosides (especially against the background of the initial potassium deficiency in the body) and curare-like muscle relaxants.

Glucocorticosteroids, carbonic anhydrase inhibitors, adrenocorticotropic hormones increase the risk of hypokalemia.

It can not be administered simultaneously with nephrotoxic drugs (aminoglycosides, cyclosporine, pentamidine and others) - the risk of developing renal dysfunction increases.

Antineoplastic drugs, radiation therapy and drugs that suppress bone marrow hematopoiesis, increase the risk of anemia and other hematological disorders.

Antineoplastic drugs increase nephrotoxicity, bronchospasm and lower blood pressure.

Glucocorticosteroids and corticotropin increase hypokalemia, which can lead to the development of arrhythmias. If necessary, the simultaneous appointment of these drugs should be monitored electrolyte composition of blood and ECG.

Amphotericin B can enhance the toxicity of cardiac glycosides (due to hypokalemia).

Simultaneous administration with imidazoles (including fluconazole, itraconazole, ketoconazole, miconazole, clotrimazole) can lead to the development of resistance to amphotericin B. Combined treatment with imidazoles with amphotericin B should be administered with caution.

It can not be administered simultaneously with nephrotoxic drugs (aminoglycosides, cyclosporine, pentamidine and others) - the risk of developing renal dysfunction increases.

Extends the muscle relaxant effect of depolarizing muscle relaxants.

The leukocyte mass should be administered at a significant interval after the administration of amphotericin B (the risk of developing complications of the respiratory system).

Overdosage

Symptoms: cardiac arrest and respiratory depression.

Treatment: symptomatic. It is necessary to monitor cardiac and respiratory activity, liver and kidney function, the picture of peripheral blood and the content of electrolytes and to prescribe supportive therapy. Not removed during hemodialysis.

Before resuming treatment, the patient’s condition should be stabilized.

  • Brand name: Amphotericin B
  • Active ingredient: Amphotericin B
  • Dosage form: Lyophilisate for preparation of solution for infusions
  • Manufacturer: Synthesis AKOMP
  • Country of Origin: Russia

Studies and clinical trials of Amphotericin B (Click to expand)

  1. Failure of fluconazole prophylaxis to reduce mortality or the requirement of systemic amphotericin B therapy during treatment for refractory acute myeloid leukemia : Results of a prospective randomized Phase III study
  2. Amphotericin B both inhibits and enhances T-cell proliferation: Inhibitory effect is mediated through H2O2 production via cyclooxygenase pathway by macrophages
  3. Successful combination of amphotericin therapy and surgical resection for fungal necrotizing pneumoniae in a child receiving chemotherapy for leukemia
  4. A Chiral β,δ-Dioxo-ϵ-sulfinyl Ester in a Convergent Enantioselective Synthesis towards the C1–C13 Polyol Fragment of Amphotericin B
  5. Amphotericin B toxicity as related to the formation of oxidatively modified low-density lipoproteins
  6. Amphotericin B plus 1,3-BIS (2-chloroethyl)-1-nitrosourea (BCNU-NSC NO. 409962) in advanced cancer. Phase I and preliminary phase II results
  7. Phase II study of 1,3-Bis (2-chloroethyl)-1-nitrosourea (BCNU, NSC #409962) with amphotericin B in bronchogenic carcinoma
  8. Clinical value of empirical amphotericin B in patients with acute myelogenous leukemia
  9. Effects of amphotericin B on combination chemotherapy of metastatic sarcomas
  10. Antifungal treatment by amphotericin B and 5-fluorocytosine delays the recovery of normal hematopoietic cells after intensive cytostatic therapy for acute myeloid leukemia
  11. Antifungal prophylaxis during remission induction therapy for acute leukemia fluconazole versus intravenous amphotericin B
  12. The effect of serum albumin on the aggregation state and toxicity of amphotericin B
  13. Heat-induced superaggregation of amphotericin B modifies its interaction with serum proteins and lipoproteins and stimulation of TNF-α
  14. Asymmetric Synthesis of the C(33) – C(37) Fragment of Amphotericin B
  15. Randomized trial of fluconazole versus low-dose amphotericin B in prophylaxis against fungal infections in patients undergoing hematopoietic stem cell transplantation
  16. Liposomal amphotericin B as antifungal prophylaxis in bone marrow transplant patients
  17. Granulocyte transfusion therapy and amphotericin B: Adverse reactions?
  18. A meta-analysis of topical amphotericin B for the treatment of chronic rhinosinusitis
  19. Encephalopathy with parkinsonian features in children following bone marrow transplantations and high-dose amphotericin B
  20. Cytosine arabinoside and amphotericin B-induced parkinsonism
  21. An Amphotericin B–Fluorescein Conjugate as a Powerful Probe for Biochemical Studies of the Membrane
  22. An Amphotericin B–Fluorescein Conjugate as a Powerful Probe for Biochemical Studies of the Membrane
  23. Targeted Delivery of Amphotericin B to Cells by Using Functionalized Carbon Nanotubes
  24. Synthesis of 35-Deoxy Amphotericin B Methyl Ester: A Strategy for Molecular Editing

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