Amphotec

Amphotericin B injection, lipid complex (Amphotec®)

Usual Diluents

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate]

Stability / Miscellaneous

Stability:
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.

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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 admixture
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 clear.
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:

Do not reconstitute the lyophilized powder with saline or dextrose solutions, or admix the reconstituted liquid with saline or electrolytes.

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 with AMPHOTEC.

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.

HOW SUPPLIED
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)

STORAGE
Store unopened vials of AMPHOTEC at 15-30°C (59-86°F).

AMPHOTEC should be retained in the carton until time of use.

Manufactured by:
Ben Venue Laboratories, Inc., Bedford, OH 44146, USA