AMPHOTERICIN B injectable, liposomal

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

AMPHOTERICIN B (UNII: 7XU7A7DROE) (AMPHOTERICIN B - UNII:7XU7A7DROE)

Disponible desde:

Sun Pharmaceutical Industries, Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. Amphotericin B liposome for injection is contraindicated in those patients who have demonstrated or have known hypersensiti

Resumen del producto:

Amphotericin B liposome for injection, 50 mg/vial is supplied as yellow colored lyophilized mass, available in single carton (NDC 62756-233-01) and in packs of ten individual vial cartons (NDC 62756-233-02). Each carton contains one pre-packaged, disposable sterile 5 micron filter. Discard unused portion. *   All trademarks are the property of their respective owners. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Medicare Limited Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. ISS. 12/2021

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

AMPHOTERICIN B - AMPHOTERICIN B INJECTABLE, LIPOSOMAL
SUN PHARMACEUTICAL INDUSTRIES, INC.
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AMPHOTERICIN B LIPOSOME FOR INJECTION
RX ONLY
DESCRIPTION
Amphotericin B liposome for injection is a sterile, non-pyrogenic
lyophilized product for
intravenous infusion. Each vial contains 50 mg of amphotericin B, USP,
intercalated into
a liposomal membrane consisting of approximately 0.64 mg alpha
tocopherol; 52 mg
cholesterol; 84 mg distearoylphosphatidylglycerol, sodium salt; 213 mg
hydrogenated
soy phosphatidylcholine. In addition, 27 mg disodium succinate
hexahydrate and 900
mg sucrose are used as a buffer. Amphotericin B liposome for injection
may contain
hydrochloric acid and/or sodium hydroxide as pH adjusters. Following
reconstitution
with Sterile Water for Injection, the resulting pH of the suspension
is between 5.0 to 6.0.
Amphotericin B liposome for injection is a true single bilayer
liposomal drug delivery
system. Liposomes are closed, spherical vesicles created by mixing
specific proportions
of amphophilic substances such as phospholipids and cholesterol so
that they arrange
themselves into multiple concentric bilayer membranes when hydrated in
aqueous
solutions. Single bilayer liposomes are then formed by
microemulsification of
multilamellar vesicles using a homogenizer. Amphotericin B liposome
for injection
consists of these unilamellar bilayer liposomes with amphotericin B
intercalated within
the membrane. Due to the nature and quantity of amphophilic substances
used, and the
lipophilic moiety in the amphotericin B molecule, the drug is an
integral part of the overall
structure of the Amphotericin B liposomes. Amphotericin B liposome for
injection
contains true liposomes that are less than 100 nm in diameter. A
schematic depiction of
the liposome is presented below.
Note: Liposomal encapsulation or incorporation into a lipid complex
can substantially
affect a drug’s functional properties relative to those of the
unencapsulated drug or
non-lipid associated drug. In addition, different liposomal o