Thursday, February 18, 2016

Amphotericin B Stability and Administration

Availability
  • Amphotericin deoxycholate 50mg (Photericin B and Amphotret)
Storage / Stability:
  • Prior to reconstitution FUNGIZONE Intravenous should be stored in the refrigerator, 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 1 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
  • Reconstitute only with sterile water without preservatives, not bacteriostatic water.
  • Benzyl alcohol, sodium chloride, or other electrolyte solutions may cause precipitation. 
  • Label: REFRIGERATE.  
Alternative
  • Short-term exposure (<24 hours) to light during I.V. infusion does not appreciably affect potency
  • Reconstituted solutions with sterile water for injection and kept in the dark remain stable for 24 hours at room temperature and 1 week when refrigerated
  • Stability of parenteral admixture at room temperature (25°C): 24 hours; at refrigeration (4°C): 2 days  
Test dose
  • A single intravenous test dose (1 mg in 20 mL of 5% dextrose solution) administered over 20 to 30 minutes may be preferred.
  • The patient’s temperature, pulse, respiration, and blood pressure should be recorded every 30 minutes for 2 to 4 hours
Administration
  • An initial concentrate of 5 mg amphotericin B per mL is first prepared by rapidly expressing 10 mL Sterile Water for Injection, USP without a bacteriostatic agent directly into the lyophilized cake.
  • Shake the vial immediately until the colloidal solution is clear.
  • The infusion solution, providing 0.1 mg amphotericin B per mL, is then obtained by further dilution (1:50) with 5% Dextrose Injection, USP of pH above 4.2
  • Administration recommendations:
  • To be infused: 20-30 mins
Alternative administration
  • Treatment dose:
    • Dose <50 mg: further dilute in 500 ml of compatible diluents.
    • Dose >50 mg: further dilute in 1 L of compatible diluents.
  • To be infused: 2-6 hrs
  • Max concentration:
    • 0.1 mg/ml (peripheral)
    • 0.25 mg/ml (central)
References:
  1. Drug Information Leaflet
  2. http://www.globalrph.com/ampho_B_dilution.htm

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