The drug FUNGIZON® is administered intravenously slowly for 2-6 hours with observance of the usual precautions for intravenous infusions. The recommended concentration of the drug solution is 0.1 mg / ml. Doses of the drug are selected individually depending on the tolerability of the drug, localization, intensity of infection, etiology (pathogen), etc.
Usually, treatment with the drug starts with the introduction of a daily dose of 0.25 mg / kg body weight for 2-6 hours. To determine the tolerability of the drug, intravenous administration of a test dose (1 mg of the drug in 20 ml of a 5% solution of dextrose) can be used for 20-30 minutes, but the result of this sample does not give absolutely reliable results. The body temperature, pulse, respiratory rate and blood pressure of the patient should be measured with an interval of 30 minutes for 2-4 hours.With a severe and rapidly progressive fungal infection, a dose of 0.3 mg / kg for 2-6 hours can be administered in a patient with a full heart and kidney function and in the absence of serious adverse reactions to the test dose. If cardiac and renal function is impaired, or if there are serious adverse reactions to the test dose, it is recommended that a second dose, for example, up to 5-10 mg. The dose can be gradually increased by 5-10 mg per day, up to a daily dose of 0.5-1 mg / kg.
In severe infections caused by less sensitive pathogens, the total daily dose may be up to 1 mg / kg per day or up to 1.5 mg / kg every other day. ATTENTION: The total daily dose should not exceed 1.5 mg / kg body weight. An overdose of the drug may lead to cardiac or cardiopulmonary arrest, including fatal outcome.
Candidamycosis. With disseminated and / or deep infections caused by Candida, the usual dose of FUNGUISON® is 0.4 to 0.6 mg / kg / day for four weeks or more. Depending on the severity of the infection, the dose may be increased to 1 mg / kg / day. Treatment continues until signs of apparent clinical improvement.General cumulative doses for adult patients can be increased to 2-4 g. In some cases (for example, in the treatment of candidal esophagitis resistant to topical treatment, as well as with the use of the preparation FUNGIZON® in combination with other antifungal drugs), a smaller dose (0 , 3 mg / kg / day).
Cryptococcosis. The usual dose of the drug for patients with intact immune system is 0.3 mg / kg / day for about 4-6 weeks or until weekly crops produce negative results throughout the month. For the treatment of patients with impaired immunity, as well as for patients with meningitis, the drug FUNGIZION® can be used in combination with other antifungal drugs for 6 weeks. For patients in serious condition, as well as in the treatment with FUNGUISON® in the form of monotherapy, the daily dose of the drug can be increased.
For patients with cryptococcal meningitis and acquired immunodeficiency syndrome (AIDS), higher doses (0.7-0.8 mg / kg / day) and longer treatment up to 12 weeks may be required.If the results of seeding are negative after a standard course of treatment, AIDS patients may be prescribed long-term therapy, for example, at a dose of 1 mg / kg per week.
Coccidioidomycosis. In the treatment of primary coccidioidomycosis in adult patients, FUNGIZON® is used at a dose of 1 or at most 1.5 mg / kg / day to a total cumulative dose of 0.5-2.5 g, depending on the severity and localization of the infection.
With coccidioid meningitis, systemic and intrathecal administration of the drug may be required.
Blastomycosis. For adult patients with blastomycosis in severe condition, doses of 0.3-1 mg / kg / day to a total cumulative dose of 1.5-2.5 g are recommended.
Histoplasmosis. For chronic pulmonary or disseminated histoplasmosis, adult doses of 0.5-1 mg / kg / day are recommended for adult patients up to a total cumulative dose of 2- 2.5 g.
Aspergillosis. In aspergillosis the drug is prescribed for a long time, there are reports of a course of treatment for up to 11 months. To treat severe infections in adult patients (eg pneumonia or fungemia), doses of 0.5-1 mg / kg / day or more, with cumulative doses up to 2-4 g, may be required. Treatment of deep mycoses may last 6-12 weeks or more .
Rhinocerebral mucormycosis. This lightning-fast developing disease usually occurs against the background of diabetic ketoacidosis. In order for treatment with FUNGUISON® to be successful, it is necessary to achieve the restoration of glycemic control as soon as possible. In connection with the fact that rhinocerebral mukoromycosis rapidly acquires a life-threatening character, treatment should be more aggressive than with other fungal diseases. Doses of the drug are usually 0.7-1.5 mg / kg / day.
Pediatric Use
The safety and efficacy of the drug in children during controlled clinical trials has not been established. In the treatment of systemic fungal infections in children, no unusual side effects were observed.
Preparation of solutions
ATTENTION: It is necessary to strictly follow the rules of asepsis in the preparation of the buffer and the infusion solution of the preparation, since the solutions of the preparation are prepared without the addition of preservatives and bacteriostatic substances.
Solutions and auxiliary materials used to prepare the dosage form must be sterile. Do not use saline solutions to dissolve the drug.
When using any diluent, except as noted above, or in the presence of a bacteriostatic substance (eg benzyl alcohol), the preparation may precipitate. Do not use concentrate or infusion solution of the drug if there are any signs of sedimentation or foreign inclusions.
A membrane filter can be placed in the intravenous infusion system, whose pore diameter should be not less than 1 micron for passage of a colloidal solution of a preparation.
Preparation of the concentrate (5 mg / ml).
A sterile syringe (needle no. 20) is quickly injected directly into the vial with a preparation of 10 ml of sterile water for injection without bacteriostatic additives, directing the stream to the contents of the vial.
Immediately after the injection of water, the vial is shaken to form a clear colloidal solution.
Concentrate (5 mg / ml) should be used freshly prepared. Preparation of a solution for infusions
The required amount is taken from the prepared concentrate and diluted to a concentration of 0.1 mg / ml (1:50) with a 5% solution of dextrose for injection with a pH of not lower. 4.2. If the pH of the dextrose solution is lower than 4.2, then 1-2 ml of buffer should be added to dilute it before dilution.
It is recommended to use a buffer solution of the following composition: Sodium phosphate disubstituted (anhydrous) 1.59 g Sodium phosphate mono-substituted (anhydrous) 0.96 g Water for injection up to 100 ml
Before adding dextrose to the solution, the buffer should be sterilized by filtration, through a bacterial ceramic or membrane filter or by autoclaving for 30 minutes at a pressure of 1 atm. and a temperature of 121 ° C.
Solution for infusion (0.1 mg / ml) should be used freshly prepared, during the introduction it does not need protection from light.