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.
EXERCISE CAUTION to prevent inadvertent Fungizone overdose. Verify the product name and dosage if dose exceeds 1.5 mg/kg (see WARNINGS, OVERDOSAGE, and DOSAGE AND ADMINISTRATION).
Amphotericin B For Injection USP
FUNGIZONE intravenous (Amphotericin B for Injection) contains amphotericin B, an antifungal polyene antibiotic obtained from a strain of Streptomyces nodosus.
FUNGIZONE (amphotericin B) is indicated for the following:
FUNGIZONE Intravenous (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.
FUNGIZONE Intravenous 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.
Published Studies Related to Fungizone (Amphotericin B)
Economic evaluation of caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia in Sweden. [2011.07]
OBJECTIVE: To evaluate the cost-effectiveness of caspofungin versus liposomal amphotericin B (L-AmB) for empirical antifungal therapy in patients with persistent fever and neutropenia in Sweden... CONCLUSION: Given the underlying assumptions and data used, caspofungin is expected to be cost-effective with at least comparable outcomes compared to L-AmB for the empirical treatment of patients with suspected fungal infections in Sweden.
Safety and efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. [2011.06.30]
BACKGROUND: Treatment options for visceral leishmaniasis (VL) in East Africa are far from satisfactory due to cost, toxicity, prolonged treatment duration or emergence of parasite resistance... The design allows repeated testing throughout the trial recruitment period while maintaining good statistical properties (Type I & II error rates) and reducing the expected sample sizes.
Single-dose liposomal amphotericin B (AmBisome(R)) for the treatment of visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. [2011.03.06]
BACKGROUND: AmBisome(R) is an efficacious, safe anti-leishmanial treatment. There is growing interest in its use, either as a single dose or in combination treatments... Results will inform the design of combination treatment studies.
Addition of aerosolized deoxycholate amphotericin B to systemic prophylaxis to prevent airways invasive fungal infections in allogeneic hematopoietic SCT: a single-center retrospective study. [2011.01]
Invasive fungal infections (IFIs) still pose major challenges in allogeneic hematopoietic SCT (HSCT), and effective antifungal prophylaxis remains a matter of debate. The aim of this retrospective study was to evaluate the toxicity and the impact of aerosolized deoxycholate amphotericin B (aero-d-AmB) on respiratory tract IFIs (airways IFIs) in a homogeneous cohort of allogeneic HSCT patients, transplanted at one institution...
Intrapulmonary disposition of amphotericin B after aerosolized delivery of amphotericin B lipid complex (Abelcet; ABLC) in lung transplant recipients. [2010.12.15]
BACKGROUND: Inhaled amphotericin preparations have been used for prophylaxis against invasive aspergillosis in lung transplant recipients. However, no published data exist regarding the pharmacokinetic profile of amphotericin B lipid complex in lung transplant recipients... CONCLUSIONS: We conclude that administration through aerosolized nebulization of amphotericin B lipid complex every 24 hr for 4 days in lung transplant recipients achieved amphotericin B concentrations in ELF above minimum inhibitory concentration of the Aspergillus nearly at 168 hr after the last inhaled dose and is well tolerated.
Clinical Trials Related to Fungizone (Amphotericin B)
Phase III, Study of Three Short Course Combination Regimens (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome® Alone for the Treatment of Visceral Leishmaniasis in Bangladesh [Recruiting]
This protocol will evaluate the efficacy and safety of various combinations of the three
drugs; AmBisome, Paromomycin and Miltefosine at reduced total dosage against the standard
treatment with a total dose of 15mg/kg of AmBisome.
To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar [Completed]
The purpose of this study is to determine whether a single bolus of dose of Amphoterin B
lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal
Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).
Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis [Completed]
Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia [Completed]
The aim of this clinical trial is to assess 25-30 patients of both sexes, between the ages
of 3 to 18 years, who are receiving intensive chemotherapy treatment for acute myeloblastic
or lymphoblastic leukemia (AML, ALL) and will be treated with aerosolised (inhalation)
amphotericin B lipid complex (AbelcetĀ®) as a prophylactic for invasive pulmonary
aspergillosis during prolonged neutropenia.
The trial will evaluate the overall tolerability of the drug and the efficacy of aerosolised
ABLC for primary prophylaxis of invasive pulmonary aspergillosis (IPA). In the event that
the working hypothesis is confirmed, aerosolised ABLC treatment would be an effective, safe
and reliable prophylactic option for IPA. It would offer an alternative to the systemic
administration of antifungal triazoles without affecting the antileukemic treatment in
pediatric patients with AL.
Ambisome and Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics [Terminated]
Administration of a single high dose (10 mg/kg) of AmBisome® no later than 72 hours after
ARNF onset followed by two 5 mg/kg doses on days 2 and 5 may provide sustained tissue levels
of amphotericin B that are as mycologically effective as those provided after administering
the standard daily dose of 3 mg/kg/day. The new dosing regimen is anticipated to be equally
clinically effective compared with the standard AmBisome® regimen when given for the
duration of neutropenic fever in patients with ARNF. In addition, the degree and incidence
of nephrotoxicity are predicted to be lower with the 3 sequential dose regimen compared to
daily dosing with 3 mg/kg because of the lower cumulative dosage (20 mg/kg versus 42 mg/kg,
respectively), which is 1 contributing factor for the development of acute renal failure.
Furthermore, the lower cumulative dose may be a cost-effective strategy for the treatment of
patients with ARNF.
Reports of Suspected Fungizone (Amphotericin B) Side Effects
Renal Failure Acute (10),
Blood Bilirubin Increased (9),
Disseminated Intravascular Coagulation (6),
Blood Pressure Decreased (6),
Gastrointestinal Haemorrhage (5),
Anaphylactic Shock (5),
Liver Disorder (5),
Duodenitis (5), more >>
Page last updated: 2011-12-09