Composition, structure and packing
The tablets are yellow with a barely noticeable inclusions, with the risk.
1 tab. mixture of N-metilglyukaminovoy salt amphotericin B and N-metilglyukamina 100 mg (100,000 IU).
Excipients: potato starch, liquid hydrophobizing, lactose, talc, calcium stearate, Tween 80, ethyl cellulose.
Clinico-pharmacological group: Antifungal antibiotic.
Pharmacological action
Antifungal broad-spectrum drugs, which includes the antibiotic from the group of polyenes. Has fungicidal or fungistatic action depending on the concentration in biological fluids and the sensitivity of the parasite.
The mechanism of action of amphotericin
In based on its ability to bind with sterols (ergosterol), located in the cell membrane is sensitive to amphotericin B of the fungus. As a result of disturbed permeability of the membrane, and intracellular components fall into the extracellular space. It is active against fungi of the genus Candida, Histoplasma capsulatum, Cryptococcus neoformans, Aspergillus, Coccidioides immitans, Blastomyces dermatitidis, Sporothtrix schenckii, Fonsecaea, and Leishmania. Pharmacokinetics Distribution is distributed in most organs and tissues of the organism in the cerebrospinal fluid is not determined. Plasma protein binding is 90%. Withdrawal is derived by the kidneys, very slowly; 2-5% of the administered dose - in an active form. It can be detected in urine for 7 weeks.
Statement
gastrointestinal candidiasis;
intestinal kandidonositelstvo;
candidosis of the internal organs;
Chronic granulomatous and disseminated forms of candidiasis;
koktsidioidoz;
cryptococcosis;
histoplasmosis;
severamerikansky blastomycosis;
chromomycosis;
saprophytic mycosis;
aspergillosis;
sporotrichosis.
Dosage regimen
The drug, taken orally, after meals. Adults appointed at the initial dose of 200,000 IU (2 pi.) 2 times / day, with little effect and good tolerability of the dose is increased to 500 000 IU (5 pi.) 2 times / day. The course of treatment for localized forms of candidiasis is 10-14 days, with common forms and deep mycosis - up to 3-4 weeks.
Children appoint 2 times / day. A single dose is established depending on age: children under 2 years - 25 000 IU (1 / 4 pi.) 2-6 years of 100 000 IU (1 tab.), 6-9 years - 150 000 IU, 9-14 years - 200 000 IU (2 pi.) older than 14 years - in the same dose as adults. If necessary, and the absence of side effects, treatment can be repeated after 5-7 day break.
Side effect
On the part of the digestive system: nausea, vomiting, diarrhea, epigastric pain, increase in liver enzymes.
On the part of the hemopoietic system: hemolytic anemia, leukopenia, thrombocytopenia.
From the central nervous system and peripheral nervous system: headache, polyneuropathy, blurred vision, diplopia.
Since the cardiovascular system: hypotension, hypertension, arrhythmia.
On the part of the urinary system: renal dysfunction, including increased concentration of serum creatinine, azotemia, acidosis. Allergic reactions: skin rash, itching, Quincke's edema.
From the water-electrolyte balance: hypokalemia, gipomagniemiya.
Other: fever, chills, loss of appetite, loss of body weight.
Contraindications
chronic renal failure;
Hypersensitivity to the drug's components.
Pregnancy and lactation
There are no adequate and strictly controlled studies of the drug during pregnancy was conducted. Amphotericin B crosses the placental barrier.
If necessary, the appointment of the drug during pregnancy is necessary to evaluate the intended benefits to the mother and the potential risk to the fetus. It is not known whether amphotericin B is allocated to breast milk.
If necessary, the appointment during lactation should decide the issue of termination of breastfeeding.
Application for violations of renal function
Contraindicated in patients with chronic renal failure.
Cautions
If you have symptoms of anemia treatment drug should be discontinued.
Monitoring of laboratory parameters
In the course of therapy should be systematically monitor indicators of renal function, liver and peripheral blood picture and the content of potassium ions in the blood.
Overdose
Data on drug overdose Amfoglyukamin not available.
Drug Interactions
With simultaneous use of amphotericin B with potentially nephrotoxic antibiotics, cyclosporine, diuretics increases the risk of nephrotoxicity.
With the simultaneous use of drugs, depressing bone marrow hematopoiesis, with radiation therapy increases the risk of anemia and other hematologic complications. Amphotericin B may increase toxicity of cardiac glycosides (especially given the shortage of potassium in the body) and antidepolyaziruyuschih means blocking neuromuscular transmission.
At simultaneous application with flutsitozinom amphotericin B reduces the clearance of the latter, thus possibly increased toxic effects flutsitozina.
When combined with the use of amphotericin B SCS may enhance hypokalemia.
Terms and Conditions of storage
List B. The drug should be stored in dry, protected from light, away from children at or below 4 ° C. Shelf life - 2 years.
The tablets are yellow with a barely noticeable inclusions, with the risk.
1 tab. mixture of N-metilglyukaminovoy salt amphotericin B and N-metilglyukamina 100 mg (100,000 IU).
Excipients: potato starch, liquid hydrophobizing, lactose, talc, calcium stearate, Tween 80, ethyl cellulose.
Clinico-pharmacological group: Antifungal antibiotic.
Pharmacological action
Antifungal broad-spectrum drugs, which includes the antibiotic from the group of polyenes. Has fungicidal or fungistatic action depending on the concentration in biological fluids and the sensitivity of the parasite.
The mechanism of action of amphotericin
In based on its ability to bind with sterols (ergosterol), located in the cell membrane is sensitive to amphotericin B of the fungus. As a result of disturbed permeability of the membrane, and intracellular components fall into the extracellular space. It is active against fungi of the genus Candida, Histoplasma capsulatum, Cryptococcus neoformans, Aspergillus, Coccidioides immitans, Blastomyces dermatitidis, Sporothtrix schenckii, Fonsecaea, and Leishmania. Pharmacokinetics Distribution is distributed in most organs and tissues of the organism in the cerebrospinal fluid is not determined. Plasma protein binding is 90%. Withdrawal is derived by the kidneys, very slowly; 2-5% of the administered dose - in an active form. It can be detected in urine for 7 weeks.
Statement
gastrointestinal candidiasis;
intestinal kandidonositelstvo;
candidosis of the internal organs;
Chronic granulomatous and disseminated forms of candidiasis;
koktsidioidoz;
cryptococcosis;
histoplasmosis;
severamerikansky blastomycosis;
chromomycosis;
saprophytic mycosis;
aspergillosis;
sporotrichosis.
Dosage regimen
The drug, taken orally, after meals. Adults appointed at the initial dose of 200,000 IU (2 pi.) 2 times / day, with little effect and good tolerability of the dose is increased to 500 000 IU (5 pi.) 2 times / day. The course of treatment for localized forms of candidiasis is 10-14 days, with common forms and deep mycosis - up to 3-4 weeks.
Children appoint 2 times / day. A single dose is established depending on age: children under 2 years - 25 000 IU (1 / 4 pi.) 2-6 years of 100 000 IU (1 tab.), 6-9 years - 150 000 IU, 9-14 years - 200 000 IU (2 pi.) older than 14 years - in the same dose as adults. If necessary, and the absence of side effects, treatment can be repeated after 5-7 day break.
Side effect
On the part of the digestive system: nausea, vomiting, diarrhea, epigastric pain, increase in liver enzymes.
On the part of the hemopoietic system: hemolytic anemia, leukopenia, thrombocytopenia.
From the central nervous system and peripheral nervous system: headache, polyneuropathy, blurred vision, diplopia.
Since the cardiovascular system: hypotension, hypertension, arrhythmia.
On the part of the urinary system: renal dysfunction, including increased concentration of serum creatinine, azotemia, acidosis. Allergic reactions: skin rash, itching, Quincke's edema.
From the water-electrolyte balance: hypokalemia, gipomagniemiya.
Other: fever, chills, loss of appetite, loss of body weight.
Contraindications
chronic renal failure;
Hypersensitivity to the drug's components.
Pregnancy and lactation
There are no adequate and strictly controlled studies of the drug during pregnancy was conducted. Amphotericin B crosses the placental barrier.
If necessary, the appointment of the drug during pregnancy is necessary to evaluate the intended benefits to the mother and the potential risk to the fetus. It is not known whether amphotericin B is allocated to breast milk.
If necessary, the appointment during lactation should decide the issue of termination of breastfeeding.
Application for violations of renal function
Contraindicated in patients with chronic renal failure.
Cautions
If you have symptoms of anemia treatment drug should be discontinued.
Monitoring of laboratory parameters
In the course of therapy should be systematically monitor indicators of renal function, liver and peripheral blood picture and the content of potassium ions in the blood.
Overdose
Data on drug overdose Amfoglyukamin not available.
Drug Interactions
With simultaneous use of amphotericin B with potentially nephrotoxic antibiotics, cyclosporine, diuretics increases the risk of nephrotoxicity.
With the simultaneous use of drugs, depressing bone marrow hematopoiesis, with radiation therapy increases the risk of anemia and other hematologic complications. Amphotericin B may increase toxicity of cardiac glycosides (especially given the shortage of potassium in the body) and antidepolyaziruyuschih means blocking neuromuscular transmission.
At simultaneous application with flutsitozinom amphotericin B reduces the clearance of the latter, thus possibly increased toxic effects flutsitozina.
When combined with the use of amphotericin B SCS may enhance hypokalemia.
Terms and Conditions of storage
List B. The drug should be stored in dry, protected from light, away from children at or below 4 ° C. Shelf life - 2 years.
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