Amphotericin B injection, lipid complex (Amphotec®)
Standard Dilutions [Amount of drug]
[Infusion volume] [Infusion rate]
Stability / Miscellaneous
After reconstitution, the drug should be
refrigerated at 2-8°C (36-46°F) and used within 24 hours. Do not freeze.
After further dilution with 5% Dextrose for Injection, the infusion
should be stored in a refrigerator (2-8°C) and used within 24 hours.
Store unopened vials of AMPHOTEC at 15-30°C
Partially used vials should
Retain in carton until time of use.
02 27 06
After reconstitution, the drug should be refrigerated at 2-8°C
(36-46°F) and used within 24 hours. Do not freeze. After further
dilution with 5% Dextrose for Injection, the infusion should be stored
in a refrigerator (2-8°C) and used within 24 hours. Partially used
vials should be discarded.
AMPHOTEC® is a sterile, pyrogen-free, lyophilized powder for
reconstitution and intravenous (IV) administration. AMPHOTEC consists
of a 1:1 (molar ratio) complex of amphotericin B and cholesteryl
sulfate. Upon reconstitution, AMPHOTEC forms a colloidal dispersion of
microscopic disc-shaped particles.
DOSAGE AND ADMINISTRATION
The recommended dose for adults and pediatric patients is 3 - 4 mg/kg
as required, once a day.
AMPHOTEC, reconstituted in Sterile Water for Injection, is administered
diluted in 5% Dextrose for Injection by intravenous infusion at a rate
of 1 mg/kg/hour. A test dose immediately preceding the first dose is
advisable when commencing all new courses of treatment. A small amount
of drug (e.g., 10 mL of the final preparation containing between 1.6 to
8.3 mg) should be infused over 15 to 30 minutes and the patient
carefully observed for the next 30 minutes.
The infusion time may be shortened to a minimum of 2 hours for patients
who show no evidence of intolerance or infusion-related reactions. If
the patient experiences acute reactions or cannot tolerate the infusion
volume, the infusion time may be extended.
Directions for reconstitution and preparation of infusion
AMPHOTEC must be reconstituted by addition of Sterile Water for
Injection. Using sterile syringe and a 20-gauge needle, rapidly add the
following volumes to the vial to provide a liquid containing 5 mg of
amphotericin B per mL. Shake gently by hand, rotating the vial until
all solids have dissolved. Note that the fluid may be opalescent or
50 mg/vial add 10 mL Sterile Water for Injection
100 mg/vial add 20 mL Sterile Water for Injection
For infusion, further dilute the reconstituted liquid to a final
concentration of approximately 0.6 mg/mL (range 0.16 mg/mL to 0.83 mg/mL).
The following table provides dilution recommendations:
5% Dextrose for Injection
10 – 35 mg
2 – 7 mL
35 – 70 mg
7 – 14 mL
70 – 175 mg
14 – 35 mL
175 – 350 mg
35 – 70 mL
350 – 1000 mg
70 – 200 mL
Do not reconstitute the lyophilized powder with saline or dextrose
solutions, or admix the reconstituted liquid with saline or
The use of any solution other than those recommended, or the presence
of a bacteriostatic agent (e.g., benzyl alcohol) in the solution may
cause precipitation of AMPHOTEC. Do not filter or use an in-line filter
Do not mix the infusion admixture with other drugs. If administered
through an existing intravenous line, flush with 5% Dextrose for
Injection prior to, and following, infusion of AMPHOTEC, otherwise
administer via a separate line.
Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to administration whenever solution and
container permit. Do not use if a precipitate or foreign matter is
present, or if the seal is not intact. Strict aseptic technique always
should be observed during reconstitution and dilution since no
preservatives are present in the lyophilized drug or in the solutions
used for reconstitution and dilution.
AMPHOTEC® (Amphotericin B) Cholesteryl Sulfate Complex for Injection is
a sterile lyophilized powder supplied in single use glass vials. Each
vial is individually packaged.
AMPHOTEC 50 mg in 20 mL vial (NDC 64116-025-01)
AMPHOTEC 100 mg in 50 mL vial (NDC 64116-021-01)
Store unopened vials of AMPHOTEC at 15-30°C (59-86°F).
AMPHOTEC should be retained in the carton until time of use.
Ben Venue Laboratories, Inc., Bedford, OH 44146, USA
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical
judgment. Neither GlobalRPh Inc. nor any other party involved in the
preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER
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