Ambisome (Amphotericin B Liposome) – Invasive Fungal Diseases | HongKong DengYue Medicine

Ambisome Amphotericin B Liposome Application Scope

AmBisome is indicated for the treatment of serious systemic and/or deep mycoses, including:

• Visceral leishmaniasis

• Empirical treatment of presumed fungal infections in febrile neutropenic patients

• Systemic or disseminated infections due to Candida, Aspergillus, or Cryptococcus species in patients who are refractory to or intolerant of conventional amphotericin B therapy or who have renal impairment

  

Ambisome  Amphotericin B Liposome Characteristics

• Ingredients: Contains 50 mg of amphotericin B

• Properties:​ Sterile, non-pyrogenic lyophilized powder for intravenous infusion

• Packaging Specification:​ Available in 50 mg vials

• Storage: Store at 2–8°C (refrigerated), and protect from light. Do not freeze. Reconstituted solution should be used within 24 hours if stored at 2–8°C

• Expiry Date:Refer to the expiration date on the packaging. Do not use beyond this date

• Executive Standard: ​Complies with the United States Pharmacopeia (USP) standards

• Approval Number: FDA Approval No. 050740

• Date of Revision: March 2012

• Manufacturer: Astellas Pharma US, Inc

Guidelines for the Use of Ambisome Amphotericin B Liposome

• Dosage and Administration:

  • Recommended Dose: Adults and children ≥1 month: 3–5 mg/kg/day

  • Administration:

    • Administer under the supervision of qualified healthcare personnel

    • Monitor for infusion-related reactions

    • Adjust dosage based on clinical response and toleranc

  • Missed Dose:​ If a dose is missed, administer as soon as possible unless it is near the time for the next dose. Do not double the dose to make up for a missed dose.

• Adverse Reactions:

  • Common Adverse Reactions:

    • Fever

    • Chills

    • Nausea

    • Headache

    • Hypotension

    • Electrolyte imbalances (e.g., hypokalemia, hypomagnesemia)

  • Serious Adverse Reactions:

    • Nephrotoxicity

    • Anaphylactic reactions

    • Severe infusion-related reactions

    • Hepatotoxicity

    ​

• Contraindications: Hypersensitivity to amphotericin B or any component of the formulation

• Precautions:

  • Use with caution in patients with pre-existing renal dysfunction

  • Monitor vital signs and laboratory parameters during treatment

  • Hydration may reduce the risk of nephrotoxicity

  • Not recommended for non-invasive fungal infections

Ambisome Interactions

• Flucytosine: Concomitant use may increase the risk of flucytosine toxicity; consider dose adjustments.

• Corticosteroids: May enhance the risk of hypokalemia.

• Other nephrotoxic agents (e.g., aminoglycosides, cyclosporine): Concomitant use may increase the risk of nephrotoxicity; monitor renal function closely.

• Neuromuscular blocking agents: Risk of enhanced neuromuscular blockade due to hypokalemia.

• Antifungal agents (e.g., ketoconazole, itraconazole): Potential antagonistic effects; monitor therapeutic efficacy.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.