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Manufacturers: Axellia Pharmaceuticals Aps (Denmark)
Active ingredients
- Amphotericin B
Disease class
- Mycosis of nails
- Mycosis of the hands
- Mycosis of the trunk
- Athlete's foot
- Candidiasis
- Pulmonary candidiasis
- Candidal septicemia
- Candidiasis of other localizations
- Coccidioidomycosis
- Histoplasmosis
- Disease caused by HIV with manifestations of candidiasis
- Disease caused by HIV with manifestations of other mycoses
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Antifungal
Pharmacological group
- Antifungal agents
Substance-powder Amphotericin B (Amphotericin B)
Instructions for medical use of the drug
Description of pharmacological action
Binds to sterols (ergosterols) of the cell membrane of sensitive fungi. As a result, the permeability of the membrane is disrupted and intracellular components enter the extracellular space.
Indications for use
Gastrointestinal candidiasis, intestinal candidiasis, candidiasis of internal organs, chronic and granulomatous disseminated forms of candidiasis, coccidiosis, cryptococcosis, histoplasmosis, North American blastomycosis, chromomycosis, mold mycosis, sporotrichosis.
Release form
powder substance; plastic bag (bag) 5 kg, lightproof bag (bag) 1. substance-powder; plastic bag (bag) 10 kg, lightproof bag (bag) 1. substance-powder; plastic bag (bag) 20 kg, lightproof bag (bag) 1. substance-powder; double-layer polyethylene bag (bag) 0.1 kg, aluminum can 1. substance-powder; two-layer polyethylene bag (bag) 0.25 kg, aluminum can 1. substance-powder; double-layer polyethylene bag (bag) 1 kg, aluminum can 1.
Pharmacodynamics
It has a fungicidal or fungistatic effect depending on the concentration in biological fluids and the sensitivity of the pathogen. Active against many pathogenic fungi, incl. Candida spp., Histoplasma capsulatum, Cryptococcus neoformans, Aspergillus spp. or leishmania.
Pharmacokinetics
When administered intravenously, it is distributed in most organs and tissues of the body; it is not detected in the cerebrospinal fluid. Penetrates through the placenta. Plasma protein binding is 90%. Excreted by the kidneys, very slowly, 2–5% in active form. May be detected in urine for 7 weeks after discontinuation. When applied topically, it is practically not absorbed.
Use during pregnancy
With caution during pregnancy (adequate and strictly controlled studies of the safety of use in pregnant women have not been conducted). Breastfeeding should be discontinued during treatment (it is not known whether amphotericin B passes into breast milk).
Contraindications for use
Hypersensitivity to amphotericin B and other components of the drug, severe liver and kidney dysfunction, diseases of the hematopoietic system, diabetes mellitus.
Side effects
With intravenous administration: From the nervous system and sensory organs: headache, polyneuropathy, blurred vision, diplopia. From the cardiovascular system and blood (hematopoiesis, hemostasis): arterial hypo- or hypertension, arrhythmia, ECG changes, anemia, leukopenia, thrombocytopenia. From the gastrointestinal tract: nausea, vomiting, diarrhea, epigastric pain, increased activity of liver enzymes. From the genitourinary system: impaired renal function, incl. increased serum creatinine concentration, proteinuria, azotemia, acidosis. Allergic reactions: skin rash, itching, Quincke's edema, bronchospasm (during inhalation). Other: increased body temperature, chills, decreased appetite, disturbances in the electrolyte composition of the blood, incl. hypokalemia, hypomagnesemia; thrombophlebitis at the injection site; Inhalation may cause sore throat, cough, runny nose.
Directions for use and doses
IV drip (20–30 drops/min) for 3–6 hours. The solution is prepared under sterile conditions immediately before use: add 5–10 ml of water for injection to the bottle (with a sterile syringe through a puncture of the rubber stopper, having previously treated it with alcohol ). For intravenous administration, a concentration of 100–125 units in 1 ml of solvent is used. Next, the mixture is shaken until the powder is completely dissolved, the solution from the bottle is drawn into a sterile syringe using a needle and poured into a bottle with 400 ml of a sterile 5% glucose solution (no more than 50,000 units of antibiotic should be dissolved in the specified amount of solvent). The solution is prepared in a room protected from bright light. If sediment appears, the drug should not be used. The dose is set individually at the rate of 250 units/kg. Before the start of administration, 100 IU/kg is pre-administered (to determine individual tolerance), with good tolerance, no side effects, and if necessary, the dose is increased to 1000 IU/kg. Before each administration, the exact weight of the patient is determined and the dose of the drug is calculated (250 IU of the drug per 1 kg of body weight in a patient weighing 75 kg). The average total dose per course of treatment is 1,500,000–2,000,000 units (18–20 infusions). The drug is administered every other day or 1-2 times a week (risk of accumulation). The duration of treatment is at least 4–8 weeks (to avoid relapses). Children are prescribed in the following daily doses (IU/kg): At the age of 1–3 years: from 1 to 5 infusions - 75–150 IU/kg; from 6 to 10 infusions - 100–250 IU/kg; from 11 to 15 infusions - 150–350 IU/kg; from 16 to 20 infusions of 175–400 IU/kg. At the age of 4–7 years: from 1 to 5 infusions - 100–200 IU/kg; from 6 to 10 infusions - 150–300 IU/kg; from 11 to 15 infusions - 175–400 IU/kg; from 16 to 20 infusions - 200–500 IU/kg. At the age of 8–12 years: from 1 to 5 infusions - 125–250 IU/kg; from 6 to 10 infusions - 175–300 IU/kg; from 11 to 15 infusions - 200–450 IU/kg; from 16 to 20 infusions - 225–600 IU/kg. At the age of 13–18 years: from 1 to 5 infusions - 150–300 IU/kg; from 6 to 10 infusions - 200–400 IU/kg; from 11 to 15 infusions - 225–500 IU/kg; from 16 to 20 infusions - 250–700 IU/kg. The first course of treatment is 20 drip IV infusions 2 times a week, after a break of 1 month the course is repeated. The degree and number of side effects decreases with intermittent course treatment (30–40 infusions over 5–6 months). In case of intolerance, daily and course doses are reduced and the intervals between drug administration are increased. Repeated courses of treatment begin with smaller doses. Inhalation. The solution is prepared immediately before use at the rate of 50,000 units per 10 ml of sterile water for injection. Inhalations are carried out 1–2 times a day for 15–20 minutes at a rate of 1000–2000 units/kg. When using inhalers that work only on inhalation, the single dose is reduced to 5 ml (25,000 units). The course of treatment is 10–14 days, a repeat course after 7–10 days. The solution remaining in the bottle is used for inhalation within 24 hours, provided it is stored in the refrigerator.
Interactions with other drugs
When used simultaneously with potentially nephrotoxic antibiotics, cyclosporine, and diuretics, the risk of developing nephrotoxicity increases. When used simultaneously with bone marrow depressants and radiation therapy, the risk of developing anemia and other hematological disorders increases. May enhance the effects of cardiac glycosides (especially against the background of potassium deficiency in the body) and non-depolarizing peripheral muscle relaxants. When used simultaneously with flucytosine, it reduces the clearance of the latter, which may result in increased toxicity of flucytosine.
Precautions for use
When administering the drug intravenously, antipyretic and antihistamines, B vitamins, ascorbic acid, NSAIDs, iron and potassium supplements, etc. are prescribed to reduce the severity of side effects. During treatment, systematic monitoring of kidney function, liver function, blood composition and potassium levels is required. blood. If symptoms of anemia appear, treatment with Amphotericin B should be discontinued. For better tolerability of the antibiotic, it is recommended to add 10–15 drops of medical glycerin to the inhalation solution.
Storage conditions
List B.: At temperatures below 4 °C.
Best before date
24 months
ATX classification:
J Antimicrobials for systemic use
J02 Antifungal drugs for systemic use
J02A Antifungal drugs for systemic use
J02AA Antifungal antibiotics
J02AA01 Amphotericin B
Directions for use and doses
Ampholip is a sterile, pyrogen-free suspension that is dissolved to prepare a solution for intravenous administration.
For serious systemic infections, the recommended treatment dose is 5.0 mg/kg for a minimum of 14 days. Ampholip must be administered by intravenous infusion at a rate of 2.5 mg/kg/hour. When prescribing Ampholip, it is recommended to administer a test dose immediately before the first infusion. After the first infusion of Ampholip has been prepared according to the instructions, it is necessary to administer 1 mg of the drug to the patient over approximately 15 minutes. After administration of this amount of the drug, administration should be stopped and the patient's condition should be carefully monitored for 30 minutes. If the patient does not show any signs of hypersensitivity, administration can be continued. When administering Ampholip for the first time, means of cardiopulmonary resuscitation should be prepared due to the possible occurrence of anaphylactoid reactions.
When administering Ampholip intravenously, the pore size of the filter in the infusion system should not be less than 15 microns.
Ampholip can be used in patients with diabetes.
Use in pediatrics
For systemic fungal infections in children, Ampholip is prescribed in doses comparable to those used in adults, per 1 kg of body weight. Side effects that occur when the drug is administered to children are similar to those noted in adults.
Use in elderly patients
For systemic fungal infections in elderly patients, Ampholip is prescribed in doses comparable to those used in adults, per 1 kg of body weight.
Use in patients with neutropenia
Ampholip is used for systemic fungal infections in patients with severe neutropenia due to oncohematological disease or the use of cytostatics or immunosuppressants.
Use in patients with kidney or liver disease
For systemic fungal infections in patients with kidney or liver diseases, Ampholip is prescribed in doses per 1 kg of body weight (see section “Special Instructions”).
Method for preparing a solution for intravenous administration
Immediately before use, the drug should be stored at room temperature for 1-2 hours. To obtain a solution for intravenous administration, the bottle must be shaken thoroughly until the sediment disappears and added to a 5% dextrose solution for intravenous use. The ready-to-use solution for intravenous administration should have a concentration of 1 mg/ml.
When using IV systems that were previously installed for other purposes, it is necessary to flush the system with 5% glucose solution for injection. If this is not possible, then Ampholip should be administered through a separate line.
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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before you start using Amphotericin B, you should consult your doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.
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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Amphotericin B is provided for informational purposes and is not intended for prescribing treatment without the participation of a physician. Patients need to consult a specialist!
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Indications for use
Ampholip is indicated for the treatment of severe invasive candidiasis.
Ampholip is also indicated as a second treatment for the treatment of severe systemic mycoses in patients who have not responded to conventional amphotericin B or other systemic antifungals; in those who have renal impairment or other contraindications to the use of conventional amphotericin B, or in patients who have developed amphotericin B nephrotoxicity. Ampholip is indicated as a second-line treatment for the treatment of invasive aspergillosis, cryptococcal meningitis and disseminated cryptococcosis in HIV patients, fusarium, coccidioidomycosis, zygomycosis and blastomycosis.
Interaction with other drugs
Nephrotoxic drugs
Ampholip is a potentially nephrotoxic drug; therefore, patients receiving concurrent therapy with nephrotoxic drugs require careful monitoring of renal function.
Zidovudine
In a study of amphotericin B in dogs, cases of myelotoxicity and nephrotoxicity were observed with the simultaneous use of Ampholip and zidovudine. Therefore, if parallel therapy with zidovudine is necessary, careful monitoring of renal and hematological function is required.
Cyclosporine
With the simultaneous use of Ampholip and cyclosporine, an increase in serum creatinine is possible, so it is necessary to monitor this indicator throughout therapy.
Flucytosine
When using Ampholip with flucytosine simultaneously, it should be taken into account that Ampholip can enhance the toxic effect of flucytosine by increasing cellular uptake and reducing renal excretion.
Inhibitors and inducers of microsomal oxidation in the liver
Inhibitors of microsomal oxidation in the liver (including cimetidine, non-narcotic analgesics, antidepressants) - slow down the metabolic rate, increase the concentration in the blood serum (increased toxicity). Inducers of microsomal oxidation in the liver accelerate biotransformation in the liver, which may lead to reduced effectiveness.
Other:
Ampholip increases the effectiveness and toxicity of anticoagulants, nitrofurans; theophylline and sulfonylureas (extends the half-life); reduces the effectiveness of ethinyl estradiol - the risk of breakthrough bleeding.
The interaction of Ampholip with other drugs has not been studied to date. According to the data obtained, conventional amphotericin B interacts with antineoplastic drugs, corticosteroids and corticotropin (ACTN), digitalis glycosides and muscle relaxants.
Pharmaceutical interactions
Ampholip is incompatible with heparin, saline and other solutions containing electrolytes. The drug must not be mixed with other medications. The presence of bacteriostatic additives (including benzyl alcohol) can lead to precipitation of the drug.
Release form
Concentrate (lipid complex) for the preparation of a solution for intravenous administration of 5 mg/ml in glass bottles of 2 ml, 10 ml and 20 ml.
Each bottle is in a cardboard box with attached instructions for medical use.
