amphotericin b
Drug Details
- Generic Name
- amphotericin b
- Brand Names
- N/A
- Application Number
- Sponsor
- Jubilant HollisterStier LLC
- NDC Codes
- 1
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- N/A
- Active Ingredients
- AMPHOTERICIN B
Indications and Usage
INDICATIONS AND USAGE Amphotericin B liposome for injection is indicated for the following: Empirical therapy for presumed fungal infection in febrile, neutropenic patients. Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES) . Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate. Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES) . See DOSAGE AND ADMINISTRATION for recommended doses by indication.
Warnings
WARNINGS Anaphylaxis has been reported with amphotericin B deoxycholate and other amphotericin B-containing drugs, including amphotericin B liposome for injection. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of amphotericin B liposome for injection.