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Amphotret (amphotericin B) 50 mg for intravenous injection BHARAT, India

Article: B-2
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140 $
  • Interchangeable drugs with the same active ingredient:
  • Ampholip
  • Amphotret
  • Fungizome
  • Fungizone
  • compound
  • active ingredient: 1 bottle contains 50 mg of amphotericin B;
  • excipients: sodium deoxycholate, diluted phosphoric acid, sodium hydroxide.
  • Dosage form
  • Lyophilizate for solution for infusion.
  • Pharmacological group
  • Antifungal agents for systemic use. Antibiotics. ATC code J02A A01.
  • testimony
  • Systemic mycoses candidomycosis, aspergillosis, histoplasmosis, cryptococcosis, coccidioidomycosis,
  • blastomycosis, mucormycosis.
  • Treatment of potentially life-threatening fungal infections due to susceptible species.
  • Treatment of American leishmaniasis of the skin and mucous membranes.
  • Treatment of patients with persistent fever due to impaired immunity, when previous antibiotic therapy did not give the desired result.
  • Contraindications
  • The drug should not be used to treat non-invasive fungal infections.
  • The drug is contraindicated in patients with severe forms of pathology of the kidneys, liver, hematopoietic system, patients with diabetes mellitus, with hypersensitivity to amphotericin B or any other component that is part of the dosage form, except when the disease, according to the doctor, threatens the patient's life , and the pathogen is sensitive only to amphotericin
  • Dosage and administration
  • The drug should be used by slow drip infusion. Intravenous infusion of the drug should be carried out within 2-6 hours in compliance with the usual measures for intravenous infusion. The recommended concentration for intravenous infusion is 0.1 mg/ml (1 mg/10 ml). Since the drug is tolerated differently by patients, the dose should be selected and adjusted individually, taking into account the localization and intensity of the infection, which is an etiological factor.
  • Treatment is usually initiated with a daily dose of 0.25 mg/kg body weight administered over 2-6 hours. The first trial dose (1 mg in 20 ml of 5% glucose solution) administered intravenously over 20-30 minutes may be a guide, although this is not a completely reliable method for assessing individual drug tolerance. Body temperature, pulse, respiratory rate and blood pressure of the patient should be measured at intervals
  • 30 minutes for 2-4 hours. A patient with a severe and rapidly progressive fungal infection, in the absence of disorders of the cardiovascular and respiratory systems, and if he underwent a trial dose without a severe reaction, you can administer the drug intravenously at a dose of 0.3 mg / kg for 2-6 hours. A lower dose, such as 5-10 mg, is recommended in patients with impaired cardiovascular or respiratory function with a certain response to a trial dose. The dose can be gradually increased from 5-10 mg per day to the average daily dose -
  • 0.5-1 mg/kg. Currently, insufficient data has been accumulated based on controlled clinical trials to determine the dose and duration of treatment in patients with various forms of mycoses (for example, mucormycosis). The optimal dose remains unknown, and the selection of an effective and at the same time sufficiently safe dose is largely empirical. The recommended daily dose may be 1 mg/kg per day or 1.5 mg/kg every other day in case of severe infections caused by fairly resistant pathogens.
  • ATTENTION! Under any circumstances, the total daily dose should not exceed 1.5 mg/kg. An overdose of the drug can lead to cardiac arrest (see section "Overdose").
  • For children, the drug is prescribed intravenously from 5 months to 18 years. The initial daily dose is 0.25 mg/kg of body weight in 5% glucose solution when administered over 6:00. In the absence of adverse reactions, the dose can be gradually increased (usually by 0.125-0.25 mg / kg every day or every other day) up to a maximum dose of 1 mg / kg body weight.
  • Candidomycosis . In disseminated infections caused by Candida , the usual dose, which is in the range of 0.4 to 0.6 mg / kg / day, is used for 4 weeks or more. Depending on the severity of the infection, doses up to 1 mg/kg/day may be used. Treatment is continued until there are signs of a clear clinical improvement, adult patients may require total cumulative doses of the drug are 2-4 g. Smaller doses (0.3 mg / kg / day) may be needed in special cases, such as esophagitis caused by Candida . resistant to topical treatment, or when the drug is used in combination with other antifungal drugs.
  • Cryptococcosis . For non-immune compromised patients, doses as low as 0.3 mg/kg/day may usually be needed for approximately 4-6 weeks or until weekly cultures are negative within a month. Patients with immunosuppression, as well as meningitis, the drug can be prescribed in combination with other antifungal agents for 6 weeks.
  • Patients with cryptococcal meningitis who have acquired immunodeficiency syndrome (AIDS) may need higher doses (0.7-0.8 mg/kg/day) and courses of treatment may continue until
  • 12 weeks. For AIDS patients who are culture-negative after a standard course of treatment, a long-term maintenance dose, such as 1 mg/kg per week, should be considered.
  • Coccidioidosis . If it is necessary to treat primary coccidioidomycosis, the drug in doses from
  • 1 mg / kg / day to a maximum of 1.5 mg / kg / day is prescribed in cumulative doses - from
  • 0.5 to 2.5 g for adults, depending on the severity of the infection and its location. With coccidial meningitis, systemic (intravenous) and intrathecal administration of the drug is possible.
  • Blastomycosis . For severe patients with blastomycosis, it is recommended to use the drug in doses of 0.3-1 mg / kg / day in a total cumulative dose, in adults it can be from 1.5 to 2.5 g.
  • Histoplasmosis . For chronic pulmonary or disseminated histoplasmosis in adult patients, doses of approximately 0.5 to 1 mg/kg/day for a total cumulative dose of 2–2.5 g are generally recommended.
  • Aspergillosis . Aspergillosis was treated with intravenous amphotericin B for 11 months. For the treatment of severe infections, doses of 0.5-1 mg/kg/day or more are required, adults may need cumulative doses of 2-4 g (for example, with pneumonia or the presence of fungal pathogens in the blood). The duration of treatment for severe mycoses can be
  • 6-12 weeks or more.
  • Rhinocerebral mucormycosis . This active disease usually develops in association with diabetic ketoacidosis. In order for treatment with amphotericin B to be successful, rapid restoration of the degree of compensation of diabetes mellitus is absolutely necessary. Since rhinocerebral mucormycosis is usually rapidly fatal, the therapeutic approach should be more aggressive if necessary than for relatively mild mycoses.
  • Preparation of solutions.
  • Features
    • Commercial name:
    • Сhemical name:
      Amphotericin B
    • Dosage:
      50 mg
    • Release form:
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