Amphotericin B is an antibiotic that has antifungal effects.
Release form and composition
A lyophilisate is made to prepare a solution for infusion with a content of 50000 IU of amphotericin B in 1 bottle.
Auxiliary components of the drug are deoxycholic acid, monosodium phosphate.
In bottles of 10 ml.
Indications for use
According to the instructions, Amphotericin B is indicated for the treatment of fungal infections, namely:
- Cryptococcal meningitis and meningitis caused by other types of fungi, disseminated cryptococcosis;
- North American blastomycosis;
- Disseminated and invasive aspergillosis;
- Disseminated forms of candidiasis;
- Chronic mycetoma;
- Mold mycosis;
- Disseminated sporotrichosis;
- Infections of the abdominal cavity (peritonitis, etc.);
- Fungal sepsis;
- Visceral leishmaniasis, American skin-visceral leishmaniasis;
- Fungal infections of the urinary tract.
According to the instructions, Amphotericin B should not be used in the following cases:
- Chronic renal failure;
- Hypersensitivity to the active or auxiliary components of the drug.
When using Amphotericin B, care should be taken when:
- Kidney disease (glomerulonephritis and others);
- Cirrhosis of the liver;
Dosing and Administration
According to the instructions, Amphotericin B is prescribed intravenously for 2-4 hours at the optimal dose of 0.1 mg / ml.
To prepare the lyophilisate, dilute 1 mg of the drug in 20 mg of dextrose 5%. Intravenous administration should take at least half an hour with the control of the pulse, pressure and body temperature.
In the case of good tolerability Amphotericin B is prescribed in a dose of 0.25-0.3 mg per kg of body weight, depending on the severity of the disease.
In the presence of diseases of the cardiovascular system, hypersensitivity to the active substance of the drug, lung and kidney function insufficiency, therapy starts with low doses - 5-10 mg, increasing them by 5-10 mg per day up to the recommended one - 0.5-0.7 mg per kg of weight.
The therapeutic dose of amphotericin B is determined by the doctor individually, depending on the severity and type of infection. The maximum daily dose of the drug is 1.5 mg per kg of body weight.
With sporotrichosis, a course dose of 2.5 g is prescribed. The duration of treatment is 9 months.
With aspigillosis, the course dose of amphotericin B is 3.6 g with a duration of therapy of 11 months.
In rhinocerebral phycomycosis, the course dose of the medicine is 3-4 g.
If the patient takes a break in treatment for a week or more, the continuation of therapy should be carried out with the minimum allowable dosages.
Children Amphotericin B is administered intravenously. The initial dose is 0.25 mg per kg of body weight per day for 6 hours. With good tolerance, the dosage can be increased (every day by 0.125-0.25 mg) up to a maximum of 1 mg per kg of weight.
The use of amphotericin B may cause the following side effects:
- The digestive system: nausea, vomiting, dyspepsia, gastralgia, diarrhea, loss of appetite;
- Nervous system: convulsions, headache, encephalopathy, peripheral neuropathy;
- Sense organs: hearing loss, visual disturbances, tinnitus, diplopia;
- Hematopoietic system: agranulocytosis, leukopenia, impaired blood coagulation, thrombocytopenia, leukocytosis, hemolytic anemia, eosinophilia;
- Respiratory system: shortness of breath, tachypnea, pulmonary edema;
- Cardiovascular system: arrhythmias, lowering blood pressure, ECG changes, cardiac arrest, shock, high blood pressure, heart failure;
- Urinary system: impaired renal function, acute renal failure, anuria, oliguria, nephrogenic diabetes insipidus (the risk of nephrotoxicity reduces the previously administered sodium chloride solution to 0.9%);
- Local reactions: chemical burn, thrombophlebitis at the injection site;
- Allergies: bronchospasm, anaphylactoid reactions, exfoliative dermatitis, toxic epidermal necrolysis, maculopapular rash, pruritus;
- Other: weight loss, arthralgia, myalgia, fever, weakness.
For the preparation of an infusion for intravenous administration, a solution with an initial concentration of 5 mg / ml is used. Take 10 ml of sterile water for injection into a sterile syringe and bring it directly into the bottle with the preparation. To form a clear solution, the contents of the vial are shaken. To obtain a solution with a concentration of 0.1 mg / ml, it should be diluted with a dextrose solution of 5% in the ratio of 1/50. Care must be taken that the pH of the dextrose solution is not below 4.2, otherwise dextrose should be diluted with a buffer solution (1-2 ml).
The buffer solution is water for injection (up to 100 ml), sodium dihydrogen phosphate (0.96 g), sodium hydrogen phosphate (1.59 g). Before adding a buffer solution to dextrose, it must be sterilized by filtration through a bacterial membrane or ceramic filter (autoclaving for half an hour at a pressure of 1 atm and 121 ° C).
The use of Amphotericin B is advisable in the treatment of life-threatening and progressive fungal infections. Do not use the medicine for the treatment of superficial mycoses, such as candidiasis of the vagina, oral cavity, esophagus in patients with normal levels of neutrophils in the blood.
In case of an overdose of Amphotericin B, respiratory and heart failure may occur. Therefore, during the period of drug administration, it is recommended to monitor the heart, kidneys and liver, electrolyte content and peripheral blood picture.
Analogues of Amphotericin B are drugs Fungizon and Amphocil.
Terms and conditions of storage
Amphotericin B refers to List B drugs from prescription drugstores. Store the drug is recommended at a cool temperature (2 -10 ° C) for no longer than 4 years.