Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
AMPHOTERICIN B (UNII: 7XU7A7DROE) (AMPHOTERICIN B - UNII:7XU7A7DROE)
Sun Pharmaceutical Industries, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
AMPHOTERICIN B - AMPHOTERICIN B INJECTABLE, LIPOSOMAL SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- 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 Läs hela dokumentet