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Ampholip has a fungicidal and / or fungistatic effect depending on the concentration in biological fluids and the sensitivity of the pathogen. The mechanism of action of amphotericin B is based on its ability to bind to sterols (ergosterols) located in the cell membrane of the amphotericinin-sensitive fungus. As a result, the permeability of the membrane is disrupted, and the intracellular components enter the extracellular space.
Is active in vitro for most strains Histoplasma capsulatum, Coccidioides immitis, Candida spp., Blastomyces dermatitidis, Rhodotorula, Cryptococcus neoformans, Sporothrix schenkii, Mucor mucedo, Aspergillus spp.
Distributed in most organs and tissues of the body, in the cerebrospinal fluid is determined in small quantities. Plasma protein binding is 90%. Excreted by the kidneys, very slowly. 2–5% of the administered dose is excreted in active form. May be detected in the urine within 7 weeks after discontinuation of the drug.
- treatment of severe systemic and / or deep mycoses in children (including in premature infants with low birth weight) and adults, including: disseminated candidiasis; disseminated cryptococcosis and cryptococcal meningitis; invasive and disseminated aspergillosis; coccidioidomycosis; North American blastomycosis; histoplasmosis; hyalohyphomycosis; mucoromicosis; chronic mycetoma; visceral leishmaniasis in children and adults (as a primary therapy, including in patients with immunodeficiency); American skin-visceral leishmaniasis;
- treatment of systemic mycoses in AIDS patients and in immunocompromised patients, including resulting from antitumor therapy;
- prevention of invasive fungal infections, including in patients with neutropenia in malignant neoplasms, as well as in transplantation of parenchymal organs and bone marrow (both in children and adults).
1 ml of concentrate for solution for infusion contains:
active substance: Amphotericin B lipid complex (in terms of amphotericin B) 5 mg
Excipients: dimyristoyl phosphatidylcholine, dimyristoyl phosphatidylglycerol, sodium chloride, water for injection
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Dosage and Administration
IV, drip for 30–60 minutes. In the event of adverse reactions, the infusion time should be increased to 90–120 minutes. The recommended concentration of the active substance is 1 mg / ml. The average dose rate of the drug is 1-3 grams and is achieved over a period of 2-4 weeks.
With systemic mycosis Treatment usually begins with a dose of 1 mg / kg / day, which, if necessary, is gradually increased to 3 mg / kg / day, in some cases to 5 mg / kg / day.
For the prevention of invasive fungal diseases during transplantation of parenchymal organs Ampholip is prescribed for 5 days after transplantation at a dose of 1 mg / kg / day.
Patients with HIV infection complicated by disseminated cryptococcosis, the drug is prescribed in a daily dose of 3 mg / kg for 42 days. After the end of the main course, a longer maintenance therapy may be necessary due to the risk of recurrent infection.
In the treatment of visceral leishmaniasis Ampholip is used at a dose of 1–1.5 mg / kg / day for 21 days, or 3 mg / kg / day for 10 days. In immunocompromised patients, a dose of 1–1.5 mg / kg / day can also be used for 21 days, but after the main course is over, supportive therapy or repeated courses of treatment may be necessary due to the risk of recurrent infection.
For the prevention of invasive fungal infections in patients with neutropenia caused by chemotherapy or the use of high doses of GCS, the drug is prescribed in a dose of 2 mg / kg / day until the restoration of the level of neutrophils to 0.5 · 109/ l.
For children the drug is prescribed in doses comparable to those used in adults, per 1 kg of body weight.
In the appointment of the drug to elderly patients dose adjustment is not required.
The method of preparation of the infusion solution
Immediately before use, the drug should be stored at room temperature for 1-2 hours.
To obtain an infusion solution, the vial should be shaken thoroughly - until the sediment disappears and add to 5% dextrose solution for intravenous administration. Ready to use infusion solution should have a concentration of 1 mg / ml.
From the digestive tract and liver: nausea, vomiting (less than 3%); increased liver enzymes. As a rule, impaired liver function does not progress with increasing dose of the drug. Patients after liver transplantation may significantly increase the level of alkaline phosphatase.
From the urinary system: there are reports of transient decline in renal function, incl. increased serum creatinine, azotemia, hypokalemia, acidosis.
Other: rarely - fever, chills, headaches. There are reports of pain in the back and chest, in rare cases - strong. A characteristic symptom is the occurrence of pain in the lower back a few minutes after the start of the infusion.
- hypersensitivity to amphotericin B and other components of the drug;
- severe violations of the liver and kidneys;
- diseases of the hematopoietic system (anemia, agranulocytosis);
Increases the effectiveness and toxicity of anticoagulants, nitrofurans; theophylline and sulfonylurea drugs (lengthens the half-life); reduces the effectiveness of ethinyl estradiol (the risk of breakthrough bleeding).
Inhibitors of microsomal oxidation in the liver (including cimetidine, non-narcotic analgesics, antidepressants) slow down the metabolic rate, increase the concentration in serum (increased toxicity). Inductors of microsomal oxidation in the liver (including phenytoin, rifampicin, barbiturates, carbamazepine) accelerate liver biotransformation (decreased effectiveness).
With simultaneous use of ampholipa with flucytosine, it should be taken into account that ampholip can enhance the toxic effect of flucytosine by increasing cell uptake and reducing renal excretion.
Ampholip is incompatible with heparin, physiological and other solutions containing electrolytes. The drug should not be mixed with other drugs. The presence of bacteriostatic additives (including benzyl alcohol) may cause the drug to precipitate.
Pregnancy and Lactation
The safety of the drug during periods of pregnancy and lactation has not been established.
Use of the drug during pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus. If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.
The likelihood of toxic effects increases with long-term treatment with ampholip.
During the period of use of the drug, regular (at least 1 time per week) laboratory monitoring of the function of the kidneys, liver and hematopoietic system is necessary. With special care, Ampholip should be prescribed to patients receiving nephrotoxic drugs at the same time.
When prescribing the drug to patients with diabetes mellitus, it should be borne in mind that 1 bottle of Ampholip contains about 900 mg of sucrose.
The introduction of ampholip to patients on hemodialysis is possible only after completion of the dialysis procedure.
When prescribing ampholypus to patients taking potassium drugs, it is necessary to carefully monitor the level of potassium and magnesium in the blood plasma.
Back pain, periodically appearing with the on / in the introduction, passes after the cessation of the infusion or with a decrease in the rate of administration and usually does not occur again.
Despite the fact that during the treatment period with Ampholipum, no significant changes were observed on the part of the blood coagulation system, it is necessary to take into account that the use of Ampholip in the usual dosage form may cause hemolysis.
When using systems for intravenous injection, previously established for other purposes, it is necessary to wash the system with 5% glucose solution for injections. If this is not possible, then Ampholip should be administered through a separate system.
Treatment: in case of overdose, immediately discontinue the drug and carefully monitor kidney function.
- Brand name: Ampholip
- Active ingredient: Amphotericin B Lipid Complex
- Manufacturer: Bharat Sirams & Vaksins Limited
- Country of Origin: India