Version December 2023
Note: Lipid-based amphotericin formulations (AmBisome) may be confused with conventional formulations (deoxycholate [Amphocin, Fungizone]) or with other lipid-based amphotericin formulations (amphotericin B lipid complex [Abelcet], amphotericin B cholesteryl sulfate complex [Amphotec]). Lipid-based and conventional formulations are not interchangeable and have different dosing recommendations. Overdoses have occurred when conventional formulations were dispensed inadvertently for lipid-based products.
Usual dosage range: IV: 3 to 6 mg/kg once daily.
Note: Premedication: For patients who experience nonanaphylactic immediate infusion-related reactions, premedicate with the following drugs 30 to 60 minutes prior to drug administration: A nonsteroidal anti-inflammatory agent ± diphenhydramine; or acetaminophen with diphenhydramine; or hydrocortisone. If the patient experiences rigors during the infusion, meperidine may be administered.
Aspergillus (systemic infection) (alternative therapy) (off-label dose): IV: 3 to 5 mg/kg once daily (Ref); doses up to 7.5 mg/kg once daily have been recommended for CNS infection (Ref). Minimum duration of treatment is 6 to 12 weeks and depends on site of infection, extent of disease and level/duration of immunosuppression. Note: Guidelines recommend amphotericin B lipid formulations be considered for invasive aspergillosis only when triazoles, specifically voriconazole, are contraindicated or not tolerated (Ref).
Candidiasis:
Candidemia (non-neutropenic patients) (alternative agent): IV: 3 to 5 mg/kg once daily; may transition to fluconazole (usually after 5 to 7 days) in clinically stable patients, with fluconazole-susceptible isolates and negative repeat cultures. Total duration of antifungal therapy is at least 2 weeks after the documented clearance of Candida from the bloodstream and resolution of candidemia-associated symptoms in patients without metastatic complications (Ref).
Candidemia (neutropenic patients) (alternative agent): IV: 3 to 5 mg/kg once daily; may transition to fluconazole during persistent neutropenia in clinically stable patients, with fluconazole-susceptible isolates and negative repeat cultures. Total duration of antifungal therapy is at least 2 weeks after the documented clearance of Candida from the bloodstream and resolution of neutropenia and candidemia-associated symptoms in patients without metastatic complications (Ref).
Central nervous system (eg, meningitis): IV: 5 mg/kg once daily (with or without oral flucytosine); step-down to fluconazole therapy is recommended after initial response to treatment (Ref).
Chronic disseminated (hepatosplenic): IV: 3 to 5 mg/kg once daily; after several weeks, transition to oral fluconazole in clinically stable, fluconazole-susceptible patients (Ref).
Empiric therapy, suspected invasive candidiasis (non-neutropenic ICU patients) (alternative agent) (off-label use):
Note: Antifungal therapy is not routinely warranted for initial management of nonneutropenic patients with sepsis. Consider use for critically ill patients with unexplained fever or unexplained hypotension despite broad-spectrum antimicrobial therapy and risk factors for invasive candidiasis (eg, indwelling venous catheter, hemodialysis, trauma or burns, recent surgery, parenteral nutrition) (Ref).
IV: 3 to 5 mg/kg once daily; treatment should continue for 14 days in patients with clinical improvement. Consider discontinuing after 4 to 5 days in patients with no clinical response (Ref).
Endocarditis (native or prosthetic valve) or infected implantable cardiac devices (eg, pacemaker, ICD, VAD): IV: 3 to 5 mg/kg once daily (with or without flucytosine); for native or prosthetic valve endocarditis, therapy should continue for at least 6 weeks after valve replacement surgery (longer durations in patients with abscesses or other complications); for patients with implantable cardiac devices, therapy should continue for 4 to 6 weeks after surgery (4 for infections limited to generator pockets and at least 6 weeks for infections involving the wires). Note: May transition to fluconazole if patient clinically stable with fluconazole-susceptible isolates in whom Candida has cleared from the bloodstream; chronic or long-term suppression with fluconazole may be required (eg, prosthetic valve, valve-replacement not possible) (Ref).
Endophthalmitis (with or without vitritis) caused by fluconazole- or voriconazole-resistant isolates: IV: 3 to 5 mg/kg once daily (with or without flucytosine) for at least 4 to 6 weeks until examination indicates resolution; for patients with vitritis or with macular involvement (with or without vitritis), an intravitreal injection of voriconazole or amphotericin B deoxycholate is also recommended (Ref).
Esophageal, refractory disease (alternative agent) (off-label use):
Note: Reserve use for patients who have inadequate response to or who are unable to take other agents (Ref).
IV: 3 mg/kg once daily. Transition to an oral antifungal once patient tolerates oral intake if susceptibility allows; total antifungal duration is 14 to 28 days (Ref).
Intra-abdominal candidiasis (alternative agent): IV: 3 to 5 mg/kg once daily; duration of therapy determined by clinical response and source control (Ref).
Osteomyelitis or septic arthritis due to Candida (alternative agent): IV: 3 to 5 mg/kg once daily for at least 2 weeks, followed by fluconazole for at least 4 weeks (septic arthritis) or for 6 to 12 months (osteomyelitis) (Ref).
Suppurative thrombophlebitis: IV: 3 to 5 mg/kg once daily; continue for at least 2 weeks after candidemia has cleared; consider transition to fluconazole in clinically stable patients with a fluconazole-susceptible isolate who have responded to initial therapy (Ref).
Coccidioidomycosis in patients with HIV (off-label use): Non-CNS infection, severe (ie, diffuse pulmonary or severely ill with extrathoracic, disseminated disease): IV: 3 to 5 mg/kg once daily until clinical improvement, then initiate triazole therapy (eg, fluconazole or itraconazole) (Ref).
Cryptococcosis:
Disseminated cryptococcosis (non-CNS or severe pulmonary disease): Induction therapy: IV: 3 to 4 mg/kg once daily with flucytosine (preferred) or fluconazole, or without a concomitant agent, for 2 weeks, followed by consolidation and maintenance therapy with fluconazole (Ref).
Meningitis: Induction therapy:
Resource-rich settings: IV: 3 to 4 mg/kg once daily with flucytosine (preferred) or fluconazole, or without a concomitant agent, for 2 weeks (Ref); doses up to 6 mg/kg/dose have been reported for treatment of meningoencephalitis and may be considered for treatment failure or high fungal burden disease (Ref). Induction therapy is followed by consolidation and maintenance therapy with fluconazole (Ref).
Resource-limited settings:
Note: This regimen has only been studied in patients with HIV (Ref).
IV: 10 mg/kg as a single dose, in combination with 14 days of fluconazole and flucytosine. Induction therapy is followed by consolidation and maintenance therapy with fluconazole (Ref).
Fungal sinusitis: IV: Limited data in immunocompromised patients have shown efficacy with 3 to 10 mg/kg once daily (Ref). Note: An azole antifungal is recommended if causative organism is Aspergillus spp or Pseudallescheria boydii (Scedosporium sp).
Fusariosis, invasive (off-label use):
IV: 3 to 5 mg/kg once daily; duration of treatment is often prolonged and depends on site of infection, severity, immune status, and response to therapy (Ref). Note: Some experts suggest combination antifungal therapy for patients with severe immunosuppression, severe disease, or increasing skin lesions or persistently positive blood cultures with monotherapy (Ref).
CNS infection: Initial: 5 mg/kg once daily in combination with voriconazole; dose escalation to 7.5 to 10 mg/kg once daily may be considered for insufficient response (Ref).
Histoplasmosis (off-label use):
Acute pulmonary disease, moderately severe to severe: Induction therapy: IV: 3 to 5 mg/kg once daily for 1 to 2 weeks, followed by itraconazole maintenance therapy (Ref).
Disseminated disease, moderately severe to severe: Induction therapy: IV: 3 mg/kg once daily for 1 to 2 weeks (patients without HIV) or at least 2 weeks (patients with HIV), followed by itraconazole maintenance therapy (Ref).
Histoplasma meningitis: Induction therapy: IV: 5 mg/kg once daily for 4 to 6 weeks, followed by itraconazole maintenance therapy (Ref).
Leishmaniasis:
Cutaneous (off-label use):
Patients without HIV: IV: 3 mg/kg once daily on days 1 through 5, and then on day 10 or on days 1 through 7. Total dose administered should be 18 to 21 mg/kg (Ref).
Patients with HIV: IV: 2 to 4 mg/kg once daily for 10 days or an interrupted schedule (eg, 4 mg/kg once daily on days 1 through 5, and then on days 10, 17, 24, 31, 38). Total dose administered should be 20 to 60 mg/kg (Ref).
Mucosal (off-label use):
Patients without HIV: IV: ~3 mg/kg once daily for a cumulative total administered dose of ~20 to 60 mg/kg (Ref).
Patients with HIV: IV: 2 to 4 mg/kg once daily for 10 days or an interrupted schedule (eg, 4 mg/kg once daily on days 1 through 5, and then on days 10, 17, 24, 31, 38). Total dose administered should be 20 to 60 mg/kg (Ref).
Visceral:
Immunocompetent: IV: 3 mg/kg once daily on days 1 through 5, and 3 mg/kg once daily on days 14 and 21; a repeat course may be given in patients who do not achieve parasitic clearance (Ref).
Immunocompromised, including patients with HIV:
Treatment, monotherapy: IV: 2 to 4 mg/kg once daily or an interrupted schedule (eg, 4 mg/kg once daily on days 1 through 5, and then on days 10, 17, 24, 31, and 38). Total dose administered: 20 to 60 mg/kg (Ref).
Treatment, combination therapy: Note: For patients with HIV and visceral leishmaniasis acquired in East Africa or Southeast Asia (Ref).
IV: 5 mg/kg as a single dose on days 1, 3, 5, 7, 9, and 11 (total dose administered: 30 mg/kg) in combination with miltefosine (Ref).
Secondary prophylaxis (chronic maintenance therapy) for patients with HIV and high risk of visceral leishmaniasis relapse (eg, CD4 count <200 cells/mm3): IV: 4 mg/kg once every 2 to 4 weeks (Ref). For patients with visceral leishmaniasis acquired in Southeast Asia, 3 to 5 mg/kg once every 3 to 4 weeks is recommended (Ref).
Meningitis (secondary to contaminated [eg, Exserohilum rostratum] steroid products), severe or in patients not improving with voriconazole monotherapy (off-label use) (Ref): IV: 5 to 6 mg/kg once daily in combination with voriconazole for ≥3 months; a higher dose (7.5 mg/kg once daily) may be considered in patients who are not improving. Note: Consult an infectious disease specialist and current CDC guidelines for specific treatment recommendations.
Osteoarticular infection (secondary to contaminated [eg, Exserohilum rostratum ] steroid products), severe or in patients with clinical instability (off-label use) (Ref): IV: 5 mg/kg once daily in combination with voriconazole for ≥3 months. Note: Consult an infectious disease specialist and current CDC guidelines for specific treatment recommendations.
Talaromycosis (formerly Penicillinosis) in patients with HIV (off-label use): IV: 3 to 5 mg/kg once daily for 2 weeks, followed by oral itraconazole for 10 weeks, followed by chronic maintenance therapy (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: Mild to severe impairment: No dosage adjustment necessary (clearance by the kidney is only 5% of total clearance (Ref)) (Ref).
Hemodialysis, intermittent (thrice weekly): Unlikely to be dialyzed (lipophilic and highly protein bound (Ref)): No supplemental dose or dosage adjustment necessary (Ref).
Peritoneal dialysis: Unlikely to be dialyzed (lipophilic and highly protein bound): No dosage adjustment necessary (Ref).
CRRT: Unlikely to be significantly dialyzed: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): Unlikely to be significantly dialyzed: No dosage adjustment necessary (Ref).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
The recommendations for dosing in patients with obesity are based upon the best available evidence and clinical expertise. Senior Editorial Team: Jeffrey F. Barletta, PharmD, FCCM; Manjunath P. Pai, PharmD, FCP; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC.
Class 1, 2, or 3 obesity (BMI ≥30 kg/m2):
IV: No dosage adjustment necessary. Use actual body weight for weight-based dose calculations; however, a maximum daily dose of 600 mg is recommended (Ref). Due to higher doses, dosing using actual body weight may be associated with increased toxicity (Ref). Refer to adult dosing for indication-specific doses.
Rationale for recommendations: There are limited data describing the effect of obesity on dosing requirements for polyene antifungals (Ref). Amphotericin B (liposomal) has a low Vd (0.11 to 0.42 L/kg), suggesting limited distribution in adipose tissue (Ref). Based on one pharmacokinetic study of amphotericin B (liposomal) in 16 patients with morbid obesity, body size had no effect on drug clearance (Ref). There are no data supporting one weight metric over another.
Refer to adult dosing.
(For additional information see "Liposomal amphotericin B: Pediatric drug information")
Medication errors, including deaths, have resulted from confusion between lipid-based forms of amphotericin (Abelcet, Amphotec, AmBisome) and conventional amphotericin B for injection. Lipid-based and conventional formulations are not interchangeable and have different dosing recommendations. Overdoses have occurred when conventional formulations were dispensed inadvertently for lipid-based products.
Note: Premedication: For patients who experience nonanaphylactic infusion-related immediate reactions, premedicate with the following drugs 30 to 60 minutes prior to drug administration: NSAID (with or without diphenhydramine) or acetaminophen with diphenhydramine or hydrocortisone. If the patient experiences rigors during the infusion, meperidine may be administered.
General dosing:
Empiric therapy: Infants, Children, and Adolescents: IV: 3 mg/kg/dose once daily
Treatment, susceptible systemic infection: Infants, Children, and Adolescents: IV: 3 to 5 mg/kg/dose once daily
Blastomycosis , invasive: Infants, Children, and Adolescents: IV: 3 to 5 mg/kg/dose once daily for initial therapy, if CNS infection 4 to 6 weeks may be needed; followed by oral itraconazole for a total of 12 months (Ref)
Candidiasis , treatment:
Invasive (Independent of HIV status): Infant, Children, and Adolescents: IV: 3 to 5 mg/kg/dose once daily (Ref); Note: In HIV-exposed/-infected patients, doses at the higher end of the range may be considered (5 mg/kg/day) (Ref).
CNS infection: Infants, Children, and Adolescents: IV: 5 mg/kg/dose once daily with or without flucytosine (Ref)
Endocarditis: Infants, Children, and Adolescents: IV: 3 to 5 mg/kg/dose once daily with or without flucytosine (Ref)
Esophageal: HIV-exposed/-infected: Adolescents: IV: 3 to 4 mg/kg/dose once daily for 14 to 21 days (Ref)
Coccidioidomycosis , invasive:
Non-HIV-exposed/-infected:
Disseminated infection, nonpulmonary: Infants, Children, and Adolescents: IV: 2 to 5 mg/kg/dose once daily with or without concomitant azole antifungal (Ref)
Pulmonary infection, diffuse: Infants, Children, and Adolescents: IV: 2 to 5 mg/kg/dose once daily for several weeks, followed by an oral azole antifungal for a total length of therapy ≥12 months (Ref)
HIV-exposed/-infected: Non-CNS infection, severe (ie, diffuse pulmonary or severely ill with extrathoracic, disseminated disease):
Infants and Children: IV: 5 mg/kg/dose once daily until clinical improvement (minimum of several weeks of therapy), then initiate triazole therapy (eg, fluconazole or itraconazole); dose may be increased to as high as 10 mg/kg/dose once daily for life-threatening infection (Ref)
Adolescents: IV: 3 to 5 mg/kg/dose once daily until clinical improvement, then switch to fluconazole or itraconazole (Ref)
Cryptococcosis , invasive:
Disseminated cryptococcosis (non-CNS or severe pulmonary disease):
Infants and Children (independent of HIV status): IV: 3 to 5 mg/kg/dose once daily with oral flucytosine; if flucytosine unavailable or not tolerated, may administer alone or in combination with high-dose fluconazole in HIV-exposed/-infected patients (Ref)
Adolescents:
Non-HIV-exposed/-infected: IV: 3 to 4 mg/kg/dose once daily for at least 14 days; may consider addition of oral flucytosine (Ref)
HIV-exposed/-infected: IV: 3 to 4 mg/kg/dose once daily with or without flucytosine or fluconazole (Ref)
Meningitis:
Non-HIV-exposed/-infected: Infants, Children, and Adolescents: IV: 5 mg/kg/dose once daily with flucytosine (Ref)
HIV-exposed/-infected:
Manufacturer’s labeling: Infants, Children, and Adolescents: IV: 6 mg/kg/dose once daily
Alternate dosing:
Infants and Children: IV: 6 mg/kg/dose once daily with or without oral flucytosine or high dose fluconazole for a minimum 2-week induction; Note: Minimum 2-week induction, followed by consolidation and chronic suppressive therapy; a longer duration of induction therapy may be necessary if CSF is not negative or lack of clinical improvement (Ref)
Adolescents: IV: 3 to 4 mg/kg/dose once daily with or without oral flucytosine or fluconazole (Ref); doses up to 6 mg/kg/dose have been reported for treatment of meningoencephalitis and may be considered for treatment failure or high fungal burden disease (Ref)
Febrile neutropenia, empiric therapy: Infants, Children, and Adolescents: IV: 3 mg/kg/dose once daily (Ref)
Histoplasmosis:
Non-HIV-exposed/-infected: Acute pulmonary disease or disseminated (non-CNS): Infants, Children, and Adolescents: IV: 3 mg/kg/dose once daily for 1 to 2 weeks followed by oral itraconazole for a total of 12 weeks; conventional amphotericin B typically preferred (Ref)
HIV-exposed/-infected:
Disseminated infection (non-CNS disease):
Infants and Children: IV: 3 to 5 mg/kg/dose once daily for at least 2 weeks for induction; if itraconazole not tolerated for consolidation therapy, may continue for 4 to 6 weeks (Ref)
Adolescents: IV: 3 mg/kg/dose once daily for at least 2 weeks for induction (Ref)
CNS disease: Infants, Children, and Adolescents: IV: 5 mg/kg/dose once daily for 4 to 6 weeks for induction, followed by consolidation therapy (Ref)
Leishmaniasis:
Visceral infection, treatment:
Immunocompetent patients: Infants, Children, and Adolescents: IV: Initial: 3 mg/kg/dose once daily on days 1 to 5 and 3 mg/kg/dose on days 14 and 21. Note: Repeat course may be given to patients who do not achieve parasitic clearance.
Immunocompromised patients: Infants, Children, and Adolescents: IV: Initial: 4 mg/kg/dose once daily on days 1 to 5 and 4 mg/kg/dose on days 10, 17, 24, 31, 38
HIV-exposed/-infected:
Treatment: Adolescents: IV: 2 to 4 mg/kg/dose once daily or an interrupted schedule of 4 mg/kg/dose on days 1 to 5, and on days 10, 17, 24, 31, and 38 to achieve a total dose of 20 to 60 mg/kg (Ref)
Chronic maintenance therapy: Adolescents: IV: 4 mg/kg/dose every 2 to 4 weeks; Note: Use reserved for patients with visceral infection and CD4 count <200 cells/mm3 (Ref)
Cutaneous infection, treatment; HIV-exposed/-infected: Adolescents: IV: 2 to 4 mg/kg/dose once daily for 10 days or an interrupted schedule of 4 mg/kg/dose on days 1 to 5, and on days 10, 17, 24, 31, and 38 to achieve a total dose of 20 to 60 mg/kg (Ref)
Sporotrichosis infection (Ref):
Disseminated, pulmonary or osteoarticular disease: Adolescents: IV: 3 to 5 mg/kg/dose once daily, followed by oral itraconazole after a favorable response is seen with amphotericin initial therapy
Meningeal: Adolescents: IV: 5 mg/kg/dose once daily for 4 to 6 weeks, followed by oral itraconazole
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
End-stage renal disease (ESRD) on intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days): Poorly dialyzed.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Amphotericin B (liposomal) is associated with hypocalcemia, hypokalemia, hypomagnesemia, and hyponatremia. Depletion of these electrolytes can predispose the patient to severe adverse reactions (asthenia, rhabdomyolysis, and cardiac arrhythmias). Compared with conventional amphotericin, liposomal amphotericin is associated with fewer cases of hypokalemia and hypomagnesemia (Ref). No significant differences in frequency of hypokalemia have been observed between patients who received liposomal amphotericin and amphotericin B lipid complex at a dose of 5 mg/kg/day (Ref). Electrolyte abnormalities may continue for weeks after dose reduction or discontinuation (Ref).
Mechanism: Alters cell membrane permeability leading to intracellular leakage and various tubular defects, causing electrolyte abnormalities (Ref).
Onset: Varied; in one study, hypokalemia occurred with a median onset of 10 days (range: 3 to 54 days) (Ref).
Risk factors:
• Baseline albumin level (Ref)
• Baseline electrolyte levels (Ref)
• History of hypokalemia (Ref)
Amphotericin B (liposomal) is associated with a variety of hypersensitivity reactions, including immediate (eg, infusion-related reaction, anaphylaxis) (Ref) and type IV hypersensitivity reactions, ranging from skin rash, with or without accompanying symptoms (Ref) to drug reaction with eosinophilia and systemic symptoms (DRESS) (Ref). Acute infusion-related reactions can include fever, chills or rigors, dyspnea, hypotension, tachycardia, hypertension, hypoxia, and chest pain (Ref); symptoms generally resolve after discontinuation of the infusion and administration of an antihistamine (Ref). Based on symptom presentation, it is difficult to differentiate between anaphylaxis and infusion-related reactions, although infusion-related reactions generally occur with the first dose without previous exposure to amphotericin B compounds (Ref).
Mechanism:
Immediate hypersensitivity reactions: Dose-related, non-immunologic. Possibly related to liposomal complement activation leading to development of complement activation-related pseudoallergy (Ref) or to release of IL-1 beta, TNF-alpha, and prostaglandin E2 (Ref). Liposome rather than the amphotericin B component is likely the key factor in inducing immediate reactions (Ref). Although there are numerous case reports of anaphylaxis related to liposomal amphotericin B in the literature, none have shown an IgE-mechanism; most of the reported reactions are likely infusion-related reactions.
Type IV hypersensitivity reactions: Non–dose-related, immunologic. Maculopapular eruptions and DRESS are T-cell-mediated (Ref).
Onset:
Infusion-related reactions: Rapid; can occur with the initial dose, often within the first 5 minutes of infusion (Ref); tolerance to infusion-related reactions usually develops during therapy (Ref).
Type IV hypersensitivity reactions: Varied; maculopapular rash usually occurs 5 to 7 days after initiation (Ref) and DRESS usually occurs 1 to 8 weeks after initiation (Ref).
Risk factors:
• Although slowing the rate of infusion reduces risk of developing infusion-related events for conventional amphotericin B deoxycholate, this strategy may not be necessary for liposomal amphotericin B (Ref)
• Decreased risk of infusion-related adverse reactions with liposomal amphotericin B compared to other amphotericin B formulations, including conventional amphotericin and amphotericin B lipid complex, in adults (Ref) but not in children (Ref)
• Most patients who develop a severe infusion reaction to liposomal or amphotericin can tolerate alternative formulations (Ref); although, some patients develop reactions on multiple lipid formulations (Ref)
Clinical manifestations of amphotericin B (liposomal) nephrotoxicity may range from increased serum creatinine to acute kidney injury (occasionally leading to chronic kidney disease) (Ref). Compared with amphotericin deoxycholate, liposomal amphotericin is associated with fewer nephrotoxic events (Ref). Differences between amphotericin B lipid complex and liposomal amphotericin are unclear (Ref). Liposomal amphotericin nephrotoxicity is considered reversible, but cases of persistent damage have been observed. About 30% of patients with liposomal amphotericin-associated nephrotoxicity will have complete renal recovery within 10 days of onset (Ref).
Mechanism: Dose- and time-related; may be related to maximum daily dose and/or cumulative dose. Amphotericin alters cell membrane permeability, causing alterations in tubular and vascular smooth muscle cell function; decreased renal blood flow results in reduced glomerular filtration rate and direct renal tubular toxicity (Ref).
Onset: Varied; duration of therapy prior to development of nephrotoxicity typically ranges from 3 to 21 days (Ref); median duration to onset ~3 to 4 days (Ref).
Risk factors:
• Higher daily dose (Ref)
• Longer duration of therapy (Ref)
• Baseline albumin level and albumin supplementation (Ref)
• Concurrent nephrotoxic drugs (Ref)
• Higher weight and baseline body surface area (Ref)
• Older patients (Ref)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults and pediatrics.
>10%:
Cardiovascular: Chest pain (8% to 12%), edema (12% to 14%), hypertension (8% to 20%), hypotension (7% to 14%), peripheral edema (15%), tachycardia (9% to 19%)
Dermatologic: Pruritus (11%), skin rash (5% to 25%) (table 1)
|
Drug (Amphotericin B [Liposomal]) |
Comparator |
Dose |
Indication |
Number of Patients (Amphotericin B [Liposomal]) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|---|
|
12% |
5% |
6 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
94 |
87 |
Comparator: Amphotericin B deoxycholate |
|
5% |
5% |
3 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
86 |
87 |
Comparator: Amphotericin B deoxycholate |
|
25% |
24% |
N/A |
Fungal infection, empiric therapy in febrile neutropenic patients |
343 |
344 |
Comparator: Amphotericin B deoxycholate |
|
24% |
14% |
3 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
85 |
78 |
Comparator: Amphotericin B lipid complex |
|
22% |
14% |
5 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
81 |
78 |
Comparator: Amphotericin B lipid complex |
Endocrine & metabolic: Hyperglycemia (8% to 23%), hypervolemia (8% to 12%), hypocalcemia (5% to 18%) (table 2), hypokalemia (31% to 51%) (table 3), hypomagnesemia (15% to 49%) (table 4), hyponatremia (9% to 12%) (table 5)
|
Drug (Amphotericin B [Liposomal]) |
Comparator |
Dose |
Indication |
Number of Patients (Amphotericin B [Liposomal]) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|---|
|
17% |
14% |
6 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
94 |
87 |
Comparator: Amphotericin B deoxycholate |
|
13% |
14% |
3 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
86 |
87 |
Comparator: Amphotericin B deoxycholate |
|
18% |
21% |
N/A |
Fungal infection, empiric therapy in febrile neutropenic patients |
343 |
344 |
Comparator: Amphotericin B deoxycholate |
|
11% |
5% |
3 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
85 |
78 |
Comparator: Amphotericin B lipid complex |
|
5% |
5% |
5 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
81 |
78 |
Comparator: Amphotericin B lipid complex |
|
Drug (Amphotericin B [Liposomal]) |
Comparator |
Dose |
Indication |
Number of Patients (Amphotericin B [Liposomal]) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|---|
|
51% |
48% |
6 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
94 |
87 |
Comparator: Amphotericin B deoxycholate |
|
31% |
48% |
3 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
86 |
87 |
Comparator: Amphotericin B deoxycholate |
|
43% |
51% |
N/A |
Fungal infection, empiric therapy in febrile neutropenic patients |
343 |
344 |
Comparator: Amphotericin B deoxycholate |
|
43% |
40% |
5 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
81 |
78 |
Comparator: Amphotericin B lipid complex |
|
38% |
40% |
3 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
85 |
78 |
Comparator: Amphotericin B lipid complex |
|
Drug (Amphotericin B [Liposomal]) |
Comparator |
Dose |
Indication |
Number of Patients (Amphotericin B [Liposomal]) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|---|
|
49% |
40% |
6 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
94 |
87 |
Comparator: Amphotericin B deoxycholate |
|
29% |
40% |
3 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
86 |
87 |
Comparator: Amphotericin B deoxycholate |
|
26% |
15% |
5 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
81 |
78 |
Comparator: Amphotericin B lipid complex |
|
20% |
26% |
N/A |
Fungal infection, empiric therapy in febrile neutropenic patients |
343 |
344 |
Comparator: Amphotericin B deoxycholate |
|
15% |
15% |
3 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
85 |
78 |
Comparator: Amphotericin B lipid complex |
|
Drug (Amphotericin B [Liposomal]) |
Comparator (Amphotericin B Deoxycholate) |
Dose |
Indication |
Number of Patients (Amphotericin B [Liposomal]) |
Number of Patients (Amphotericin B Deoxycholate) |
Comments |
|---|---|---|---|---|---|---|
|
12% |
9% |
3 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
86 |
87 |
Comparator: Amphotericin B deoxycholate |
|
9% |
9% |
6 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
94 |
87 |
Comparator: Amphotericin B deoxycholate |
Gastrointestinal: Abdominal pain (7% to 20%), anorexia (10% to 14%), constipation (15%), diarrhea (11% to 30%), nausea (16% to 40%), vomiting (11% to 32%)
Genitourinary: Hematuria (14%)
Hematologic & oncologic: Anemia (27% to 48%), leukopenia (15% to 17%), thrombocytopenia (6% to 13%)
Hepatic: Hyperbilirubinemia (9% to 18%), increased serum alanine aminotransferase (15%), increased serum alkaline phosphatase (7% to 22%), increased serum aspartate aminotransferase (13%)
Hypersensitivity: Infusion-related reaction (≤24%)
Local: Localized phlebitis (9% to 11%)
Nervous system: Anxiety (7% to 14%), asthenia (6% to 13%) (table 6), chills (≤48%), confusion (9% to 13%), headache (9% to 20%), insomnia (17% to 22%), pain (14%), rigors (≤48%)
|
Drug (Amphotericin B [Liposomal]) |
Comparator |
Dose |
Indication |
Number of Patients (Amphotericin B [Liposomal]) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|---|
|
13% |
11% |
N/A |
Fungal infection, empiric therapy in febrile neutropenic patients |
343 |
344 |
Comparator: Amphotericin B deoxycholate |
|
8% |
12% |
3 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
85 |
78 |
Comparator: Amphotericin B lipid complex |
|
6% |
12% |
5 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
81 |
78 |
Comparator: Amphotericin B lipid complex |
Neuromuscular & skeletal: Back pain (12%)
Renal: Increased blood urea nitrogen (7% to 21%), increased serum creatinine (14% to 47%) (table 7), nephrotoxicity (19%) (table 8)
|
Drug (Amphotericin B [Liposomal]) |
Comparator |
Dose |
Indication |
Number of Patients (Amphotericin B [Liposomal]) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|---|
|
47% |
60% |
6 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
94 |
87 |
1.5 × baseline serum creatinine; comparator: Amphotericin B deoxycholate |
|
39% |
44% |
6 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
94 |
87 |
Comparator: Amphotericin B deoxycholate |
|
35% |
60% |
3 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
86 |
87 |
1.5 × baseline serum creatinine; comparator: Amphotericin B deoxycholate |
|
35% |
60% |
3 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
86 |
87 |
1.5 × baseline serum creatinine; comparator: Amphotericin B deoxycholate |
|
21% |
33% |
6 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
94 |
87 |
2 × baseline serum creatinine; comparator: Amphotericin B deoxycholate |
|
19% |
44% |
3 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
86 |
87 |
Comparator: Amphotericin B deoxycholate |
|
14% |
33% |
3 mg/kg/day |
Cryptococcal meningitis in patients with HIV |
86 |
87 |
2 × baseline serum creatinine; comparator: Amphotericin B deoxycholate |
|
29% |
63% |
3 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
85 |
78 |
1.5 × baseline serum creatinine; comparator: Amphotericin B lipid complex |
|
26% |
63% |
5 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
81 |
78 |
1.5 × baseline serum creatinine; comparator: Amphotericin B lipid complex |
|
22% |
42% |
N/A |
Fungal infection, empiric therapy in febrile neutropenic patients |
343 |
344 |
Comparator: Amphotericin B deoxycholate |
|
20% |
49% |
3 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
85 |
78 |
Comparator: Amphotericin B lipid complex |
|
19% |
49% |
5 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
81 |
78 |
Comparator: Amphotericin B lipid complex |
|
15% |
42% |
5 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
81 |
78 |
2 × baseline serum creatinine; comparator: Amphotericin B lipid complex |
|
14% |
42% |
3 mg/kg/day |
Fungal infection, empiric therapy in febrile neutropenic patients |
85 |
78 |
2 × baseline serum creatinine; comparator: Amphotericin B lipid complex |
|
Drug (Amphotericin B [Liposomal]) |
Comparator (Amphotericin B Deoxycholate) |
Dose |
Indication |
Number of Patients (Amphotericin B [Liposomal]) |
Number of Patients (Amphotericin B Deoxycholate) |
|---|---|---|---|---|---|
|
19% |
34% |
N/A |
Fungal infection, empiric therapy in febrile neutropenic patients |
343 |
344 |
Respiratory: Cough (2% to 18%), dyspnea (18% to 23%), epistaxis (9% to 15%), pleural effusion (13%), rhinitis (11%)
1% to 10%:
Cardiovascular: Atrial fibrillation (2% to 10%), bradycardia (2% to 10%), cardiac arrhythmia (2% to 10%), cardiomegaly (2% to 10%), flushing (2% to 10%), heart valve disease (2% to 10%), orthostatic hypotension (2% to 10%), vascular disease (2% to 10%), vasodilation (2% to 10%)
Dermatologic: Alopecia (2% to 10%), cellulitis (2% to 10%), dermal ulcer (2% to 10%), diaphoresis (7%), maculopapular rash (2% to 10%), skin discoloration (2% to 10%), urticaria (2% to 10%), vesiculobullous dermatitis (2% to 10%), xeroderma (2% to 10%)
Endocrine & metabolic: Acidosis (2% to 10%), hyperchloremia (2% to 10%), hyperkalemia (2% to 10%), hypermagnesemia (2% to 10%), hypernatremia (4%), hyperphosphatemia (2% to 10%), hypophosphatemia (2% to 10%), increased lactate dehydrogenase (2% to 10%), increased nonprotein nitrogen (2% to 10%), respiratory alkalosis (2% to 10%)
Gastrointestinal: Aphthous stomatitis (2% to 10%), dyspepsia (2% to 10%), dysphagia (2% to 10%), enlargement of abdomen (2% to 10%), eructation (2% to 10%), fecal incontinence (2% to 10%), flatulence (2% to 10%), gastrointestinal hemorrhage (10%), gingival hemorrhage (2% to 10%), hematemesis (2% to 10%), hemorrhoids (2% to 10%), hiccups (2% to 10%), increased serum amylase (2% to 10%), intestinal obstruction (2% to 10%), oral hemorrhage (2% to 10%), rectal disease (2% to 10%), stomatitis (2% to 10%), xerostomia (2% to 10%)
Genitourinary: Dysuria (2% to 10%), toxic nephrosis (2% to 10%), urinary incontinence (2% to 10%), vaginal hemorrhage (2% to 10%)
Hematologic & oncologic: Bruise (2% to 10%), decreased prothrombin time (2% to 10%), disorder of hemostatic components of blood (2% to 10%), hemophthalmos (2% to 10%), hemorrhage (2% to 10%), hypoproteinemia (2% to 10%), petechia (2% to 10%), prolonged prothrombin time (2% to 10%), purpuric disease (2% to 10%)
Hepatic: Hepatic injury (2% to 10%), hepatic sinusoidal obstruction syndrome (formerly known as hepatic veno-occlusive disease) (2% to 10%), hepatomegaly (2% to 10%)
Hypersensitivity: Facial edema (2% to 10%), hypersensitivity reaction (2% to 10%), type IV hypersensitivity reaction (2% to 10%)
Local: Inflammation at injection site (2% to 10%)
Nervous system: Abnormality in thinking (2% to 10%), agitation (2% to 10%), coma (2% to 10%), depression (2% to 10%), dizziness (7% to 9%), drowsiness (2% to 10%), dysesthesia (2% to 10%), dystonia (2% to 10%), hallucination (2% to 10%), malaise (2% to 10%), nervousness (2% to 10%), paresthesia (2% to 10%), seizure (2% to 10%), tremor (2% to 10%)
Neuromuscular & skeletal: Arthralgia (2% to 10%), myalgia (2% to 10%), neck pain (2% to 10%), ostealgia (2% to 10%)
Ophthalmic: Conjunctivitis (2% to 10%), dry eye syndrome (2% to 10%)
Renal: Acute kidney injury (2% to 10%), renal failure syndrome (2% to 10%), renal function abnormality (2% to 10%)
Respiratory: Asthma (2% to 10%), atelectasis (2% to 10%), dry nose (2% to 10%), flu-like symptoms (2% to 10%), hemoptysis (2% to 10%), hyperventilation (2% to 10%), hypoxia (6% to 8%), pharyngitis (2% to 10%), pneumonia (2% to 10%), pulmonary edema (2% to 10%), respiratory failure (2% to 10%), respiratory insufficiency (2% to 10%), sinusitis (2% to 10%)
Postmarketing:
Dermatologic: Erythema of skin
Genitourinary: Hemorrhagic cystitis
Hematologic & oncologic: Agranulocytosis
Hypersensitivity: Anaphylaxis (Bates 1995, Laing 1994, Schenider 1998), angioedema (Nath 2014), drug reaction with eosinophilia and systemic symptoms (Hagihara 2015)
Neuromuscular & skeletal: Rhabdomyolysis (Marking 2014)
Respiratory: Bronchospasm, cyanosis, hypoventilation
Hypersensitivity to amphotericin B deoxycholate or any component of the formulation
Disease-related concerns:
• Heart failure: In a scientific statement from the American Heart Association, amphotericin has been determined to be an agent that may cause direct myocardial toxicity (magnitude: moderate/major) (AHA [Page 2016]).
Other warnings/precautions:
• Leukocyte transfusions: Acute pulmonary toxicity has been reported in patients receiving simultaneous leukocyte transfusions and amphotericin B.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Intravenous:
Generic: 50 mg (1 ea)
Suspension Reconstituted, Intravenous [preservative free]:
AmBisome: 50 mg (1 ea) [contains cholesterol, distearoyl phosphatidylglycerol, hydrogenated soy phosphatidylcholine, sodium succinate hexahydrate, sucrose, tocopherol, dl-alpha (vit e)]
Generic: 50 mg (1 ea)
Yes
Suspension (reconstituted) (AmBisome Intravenous)
50 mg (per each): $360.05
Suspension (reconstituted) (Amphotericin B Liposome Intravenous)
50 mg (per each): $305.69 - $305.70
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Intravenous:
AmBisome: 50 mg (1 ea) [contains cholesterol, distearoyl phosphatidylglycerol, hydrogenated soy phosphatidylcholine, sodium succinate hexahydrate, sucrose, tocopherol, dl-alpha (vit e)]
IV: Administer via intravenous infusion, over a period of approximately 2 hours. Infusion time may be reduced to approximately 1 hour in patients in whom the treatment is well-tolerated. If the patient experiences discomfort during infusion, the duration of infusion may be increased. Existing intravenous line should be flushed with D5W before and after infusion (if not feasible, administer through a separate line). An in-line membrane filter (not less than 1 micron) may be used.
For a patient who experiences chills, fever, hypotension, nausea, or other nonanaphylactic immediate infusion-related reactions, premedicate with the following drugs, 30 to 60 minutes prior to drug administration: A nonsteroidal (eg, ibuprofen, choline magnesium trisalicylate) ± diphenhydramine or acetaminophen with diphenhydramine or hydrocortisone. If the patient experiences rigors during the infusion, meperidine may be administered.
Preinfusion administration of NS 500 to 1,000 mL IV appears to reduce the risk of nephrotoxicity during amphotericin B treatment (Ref).
Parenteral: IV: Do not use in-line filter less than 1 micron to administer AmBisome. Flush line with D5W prior to infusion; infusion of diluted AmBisome should start within 6 hours of preparation; infuse over 2 hours; infusion time may be reduced to 1 hour in patients who tolerate the treatment. If the patient experiences discomfort during infusion, the duration of infusion may be increased. Discontinue if severe respiratory distress occurs.
For a patient who experiences chills, fever, hypotension, nausea, or other nonanaphylactic infusion-related reactions, premedicate with the following drugs, 30 to 60 minutes prior to drug administration: A nonsteroidal (eg, ibuprofen,) with or without diphenhydramine or acetaminophen with diphenhydramine or hydrocortisone. If the patient experiences rigors during the infusion, meperidine may be administered.
Cryptococcal meningitis in patients with HIV: Treatment of cryptococcal meningitis in patients with HIV.
Fungal infections, empiric therapy: Empiric treatment for presumed fungal infection in patients with febrile neutropenia.
Fungal infections, systemic therapy: Treatment of systemic infections caused by Aspergillus sp, Candida sp, and/or Cryptococcus sp in patients refractory to conventional amphotericin B deoxycholate therapy or when renal impairment or unacceptable toxicity precludes the use of the deoxycholate formulation.
Leishmaniasis (visceral): Treatment of visceral leishmaniasis.
Candidiasis, empiric therapy (non-neutropenic ICU patients); Candidiasis, esophageal, refractory disease; Coccidioidomycosis in patients with HIV; Fungal meningitis (secondary to contaminated [eg, Exserohilum rostratum] steroid products); Fungal osteoarticular infections (secondary to contaminated [eg, E. rostratum] steroid products); Fusariosis, invasive; Histoplasmosis; Leishmaniasis (cutaneous and mucosal); Mucormycoses; Talaromycosis (formerly Penicillinois) in patients with HIV
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.
AmBisome may be confused with Ambisolm, Ambisom
Amphotericin B liposomal may be confused with amphotericin B
Lipid-based amphotericin formulations (AmBisome) may be confused with conventional formulations (Amphocin, Fungizone) or with other lipid-based amphotericin formulations (Abelcet, Amphotec)
Large overdoses have occurred when conventional formulations were dispensed inadvertently for lipid-based products. Single daily doses of conventional amphotericin formulation never exceed 1.5 mg/kg.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification
Aminoglycosides: Amphotericin B may enhance the nephrotoxic effect of Aminoglycosides. Amphotericin B may enhance the neurotoxic effect of Aminoglycosides. Risk C: Monitor therapy
Amisulpride (Oral): May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy
Arginine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Arsenic Trioxide: Amphotericin B may enhance the hypotensive effect of Arsenic Trioxide. Amphotericin B may enhance the QTc-prolonging effect of Arsenic Trioxide. Management: When possible, avoid concurrent use of arsenic trioxide with drugs that can cause electrolyte abnormalities, such as amphotericin B. Risk D: Consider therapy modification
Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination
Cardiac Glycosides: Amphotericin B may enhance the adverse/toxic effect of Cardiac Glycosides. Risk C: Monitor therapy
Colistimethate: Amphotericin B may enhance the nephrotoxic effect of Colistimethate. Management: Avoid coadministration of colistimethate and amphotericin B whenever possible due to the potential for additive or synergistic nephrotoxicity. If coadministration cannot be avoided, closely monitor renal function. Risk D: Consider therapy modification
Corticosteroids (Systemic): May enhance the hypokalemic effect of Amphotericin B. Risk C: Monitor therapy
CycloSPORINE (Systemic): Amphotericin B may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Amphotericin B may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy
Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Dichlorphenamide: Amphotericin B may enhance the hypokalemic effect of Dichlorphenamide. Risk C: Monitor therapy
DroNABinol: May increase the serum concentration of Amphotericin B. Specifically, dronabinol may displace amphotericin B from its protein-binding sites, leading to an increased concentration of active, unbound drug. Risk C: Monitor therapy
DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy
Flucytosine: Amphotericin B may enhance the adverse/toxic effect of Flucytosine. Amphotericin B may increase the serum concentration of Flucytosine. Risk C: Monitor therapy
Foscarnet: May enhance the nephrotoxic effect of Amphotericin B. Risk X: Avoid combination
Ganciclovir-Valganciclovir: May enhance the nephrotoxic effect of Amphotericin B. Risk C: Monitor therapy
Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Levodopa-Foslevodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Foslevodopa. Risk C: Monitor therapy
Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Methoxyflurane: May enhance the nephrotoxic effect of Amphotericin B. Risk X: Avoid combination
Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy
Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification
Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy
Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may diminish the therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination
Silodosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Amphotericin crosses the placenta and enters the fetal circulation. Amphotericin B is recommended for the treatment of serious systemic fungal diseases in pregnant women; refer to current guidelines (IDSA [Pappas 2016]; King 1998; Pilmis 2015).
It is not known if amphotericin is excreted into breast milk. Due to its poor oral absorption, systemic exposure to the nursing infant is expected to be decreased; however, because of the potential for toxicity, breast-feeding is not recommended by the manufacturer (Mactal-Haaf 2001).
If on parenteral nutrition, may need to adjust the amount of lipid infused. The lipid portion of amphotericin B (liposomal) formulation contains 0.27 kcal per 5 mg (Sacks 1997).
Renal function (monitor frequently during therapy), electrolytes (especially potassium and magnesium), liver function tests, CBC, temperature; monitor input and output; monitor for signs of hypokalemia (eg, muscle weakness, cramping, drowsiness, ECG changes); monitor cardiac function if used concurrently with corticosteroids; hypersensitivity reactions, including immediate (eg, infusion-related reaction, anaphylaxis) and type IV hypersensitivity reactions (eg, skin rash, DRESS).
Binds to ergosterol altering cell membrane permeability in susceptible fungi and causing leakage of cell components with subsequent cell death. Proposed mechanism suggests that amphotericin causes an oxidation-dependent stimulation of macrophages (Lyman 1992).
Note: Exhibits nonlinear kinetics (greater than proportional increase in serum concentration with an increase in dose)
Distribution: Vd: 0.1 to 0.16 L/kg
Half-life elimination: 7 to 10 hours (following a single 24-hour dosing interval); Terminal half life: 100 to 153 hours (following multiple dosing up to 49 days)
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