Instructions for Amphotericin B 50 mg
Release form:
lyophilizate d/r-ra prigot d/info 50K UNITS: fl 10 ml 1, 5 or 10 pcs
Description:
Lyophilizate for the preparation of infusion solution in the form of a porous mass of yellow, odorless, or almost odorless, is hygroscopic.
1 fl
Amphotericin B 50,000 UNITS
Auxiliary substances: sodium phosphate is a single-substituted, deoxycholic acid.
10 ml (1) bottles - cardboard packs.
10 ml (5) bottles - cardboard packs.
10 ml (10) bottles - cardboard packs.
ATC codes
J02AA01 Amphotericin B
Clinical-pharmacological groups / Group affiliation
Antifungal antibiotic
Active substance
Amphotericin B
Pharmacotherapy group
Antifungal agent
storage conditions
List B. In a dry, dark place at a temperature of 2 to 10 ° C. Store in places inaccessible to children.
Shelf life
Shelf life - 4 years.
Testimony
Progressive, life-threatening fungal infections caused by amphotericin-sensitive microorganisms:
Disseminated cryptococcosis, cryptococcal meningitis;
meningitis caused by other fungi;
invasive and disseminated aspergillosis;
North American blastomycosis;
Disseminated forms of candidiasis;
coccidioidosis;
paracoccidioidosis;
histoplasmosis;
ficomycosis (zygomycosis);
chromomycosis;
mold;
Disseminated sporotrichosis
hyalogyfomycosis;
chronic mycetoma;
Abdominal infections (including peritonitis);
endocarditis;
endophthalmite;
fungal sepsis;
fungal urinary tract infections;
visceral leishmaniasis (including in immunocompromised patients), american skin-visceral leishmaniasis (not a drug Amphotericin B of choice).
Method of use, course and dosage Amphotericin B
Intravenously drip for 2-4 h, the recommended concentration is 0.1 mg/ml. A test dose of 1 mg (base) is diluted in 20 ml of 5% of the dextrose solution and intravenously administered for at least 20-30 minutes under the control of arterial pressure, pulse, and body temperature every 30 minutes for 2-4 hours.
If tolerable, the recommended daily dose is 0.25-0.3 mg/kg depending on the severity of the disease.
When the preparation is highly sensitive, cardiovascular diseases and kidney failure are treated at low doses of 5-10 mg and gradually increased by 5-10 mg/day, the recommended daily dose is 0.5-0.7 mg/kg.
The selection of therapeutic doses is carried out individually depending on the type and severity of infection. For daily use, the dose should not exceed 1.5 mg/kg (to avoid the development of cardiopulmonary failure). The maximum daily dose is 1.5 mg/kg.
Sporotrichosis: course dose 2.5 g, duration of therapy - 9 months.
Aspergillosis: The course dose is 3.6 g and the duration of treatment is 11 months.
Rhinocerebral phycomycosis: course dose - 3-4 g
In the case of interruption of therapy for more than 7 days, it should be resumed at the lowest dose (0.25 mg/kg), gradually increasing to the desired level.
Children: intravenously, first 0.25 mg/kg (base) per day in 5% dextrose solution for 6 h; taking into account tolerability, the dose is gradually increased (usually by 0.125 - 0.25 mg/kg each day or every other day) to a maximum dose of 1 mg/kg or 30 mg per 1 m2. Children are injected at the lowest effective doses.
The following buffer solution is recommended: sodium hydrogen phosphate (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.
Application for kidney disorders
With care in kidney diseases (including glomerulonephritis).
Use in liver disorders
With caution in hepatitis, liver cirrhosis.
Terms of Sale
On prescription.
Use in children
Children are injected at the lowest effective doses.
Nosology (ICD codes) Amphotericin B
B37.5
Candidiasis meningitis
B37.6
Candida endocarditis
B37.7
Candidiasis sepsis
B38
Coccidioidomycosis
B39
Histoplasmosis
B40
Blastomycosis
B41
Paracocydiidomycosis
B42
Sporotrichosus
B43
Chromomycosis and theomytic abscess
B44
Aspergillosis
B45
Cryptococcosis
B46
Zygomycosis
B47
Mitsetoma
B55.0
Visceral leishmaniasis
H45.1
Endophthalmite for diseases classified in other headings
I33
Acute and subacute endocarditis
K65.8
Other peritonitis
N10
Acute tubuloinsterstitial nephritis (acute pielonephritis)
N11
Chronic tubulointerstitial nephritis (chronic pyelonephritis)
N30
Cystitis
N34
Urethritis and urethral syndrom
Pharmacological effect Amphotericin B
Polyene macrocyclic antibiotic with antifungal activity. Produced by Streptomyces nodosus. It has fungicidal or fungistatic action depending on the concentration in biological fluids and on the sensitivity of the causative agent. It binds to sterols (ergosterols) in the cell membrane of the drug-sensitive Amphotericin B fungus. As a result, the permeability of the membrane is impaired and intracellular components enter the extracellular space and the fungus lysis.
Active on most strains of Histoplasma capsulatum, Coccidioides immitis, Paracoccidioides braziliensis, Candida spp., Blastomyces dermatidis, Rhodotorula spp., Cryptococcus neoformans, Sporothrix schenekii, Mucor mucedo, Rhizopus spp., Absidia spp., Basodiobolus ranarum, Aspergillus fumigatus.
Moderately active in some protozoa: Leishmania braziliensis, Leishmania mexicana, Naegleria fowleri.
Amphotericin B is usually resistant to: Pseudallescheria boydii, Fusarium spp.
Ineffective against bacteria, rickettsia, viruses.