AMPHOTERICIN B injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

XGen Pharmaceuticals DJB, Inc.

INN (International Name):

AMPHOTERICIN B

Composition:

AMPHOTERICIN B 50 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia , Mucor and Rhizopus , and infections due to related susceptible species of Conidiobolus and Basidiobolus , and sporotrichosis. Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy. This product is contraindicated in those patients who have shown hypersensitivity to amphote

Product summary:

Amphotericin B for Injection USP Available as single vials providing 50 mg amphotericin B as a yellow to orange lyophilized cake (which may partially reduce to powder following manufacture). NDC 39822-1055-5. Retain in carton until time of use. Prior to reconstitution Amphotericin B for Injection USP should be stored under refrigeration, 2˚ to 8˚C (36˚to 46˚F), protected against exposure to light. The concentrate (5 mg amphotericin B per mL after reconstitution with 10 mL Sterile Water for Injection USP) may be stored in the dark, at room temperature for 24 hours, or at refrigerator temperatures for one week with minimal loss of potency and clarity. Any unused material should then be discarded. Solutions prepared for intravenous infusion (0.1 mg or less amphotericin B per mL) should be used promptly after preparation and should be protected from light during administration. Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814 Revised October 2020 AM-PI-05 Printed in the USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPHOTERICIN B- AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
XGEN PHARMACEUTICALS DJB, INC.
----------
AMPHOTERICIN B FOR INJECTION USP
RX ONLY
WARNING
This drug should be used primarily for treatment of patients with
progressive and
potentially life-threatening fungal infections; it should not be used
to treat
noninvasive forms of fungal disease such as oral thrush, vaginal
candidiasis and
esophageal candidiasis in patients with normal neutrophil counts.
Amphotericin B for Injection should not be given in doses greater than
1.5 mg/kg.
EXERCISE CAUTION to prevent inadvertent overdosage, which may result
in
potentially fatal cardiac or cardiopulmonary arrest (see WARNINGS,
OVERDOSAGE and DOSAGE AND ADMINISTRATION). Verify the product name
and dosage pre-administration, especially if dose exceeds 1.5 mg/kg.
DESCRIPTION
Amphotericin B for Injection USP contains amphotericin B, an
antifungal polyene
antibiotic obtained from a strain of _Streptomyces nodosus_.
Amphotericin B is designated
chemically as [1R- (1R*, 3S*, 5R*, 6R*, 9R*, 11R*, 15S*, 16R*, 17R*,
18S*, 19E, 21E,
23E, 25E, 27E, 29E, 31E, 33R*, 35S*, 36R*, 37S*)] -33-[(3-Amino-3,
6-dideoxy-β-D-
mannopyranosyl)-oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-
14,39-dioxabicyclo [33.3.1]
nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic
acid. Structural formula:
Each vial contains a sterile, nonpyrogenic, lyophilized cake (which
may partially reduce to
powder following manufacture) providing 50 mg amphotericin B and 41 mg
sodium
desoxycholate buffered with 20.2 mg sodium phosphates (consisting of
mono and
dibasic sodium phosphate, phosphoric acid and sodium hydroxide).
Crystalline
amphotericin B is insoluble in water; therefore, the antibiotic is
solubilized by the addition
of sodium desoxycholate to form a mixture which provides a colloidal
dispersion for
intravenous infusion following reconstitution.
At the time of manufacture the air in the vial is replaced by
nitrogen.
CLINICAL PHARMACOLOGY
MICROBIOLOGY
Amphotericin B sh