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Amphotericin B lipid complex: Pediatric drug information

Amphotericin B lipid complex: Pediatric drug information
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For additional information see "Amphotericin B lipid complex: Drug information" and "Amphotericin B lipid complex: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Abelcet
Brand Names: Canada
  • Abelcet
Therapeutic Category
  • Antifungal Agent, Systemic
Dosing: Neonatal

Medication errors, including deaths, have resulted from confusion between lipid-based forms of amphotericin (eg, Abelcet, 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.

Candidiasis, invasive

Candidiasis, invasive: Preterm and Term Neonates: Limited data available: IV: 3 to 5 mg/kg/dose once daily; treat for ≥2 weeks after the first negative blood culture AND clinical resolution (Ref).

Mucormycosis, invasive

Mucormycosis, invasive (without CNS involvement): Limited data available: Note: Prompt surgical debridement is often needed to achieve clinical cure (Ref).

Neonates: IV: 5 mg/kg/dose once daily. Total duration (including oral step-down therapy if possible) varies based on clinical and radiologic response and patient immune status; several months are often warranted, with some patients requiring lifelong therapy (Ref).

Dosing: Pediatric

Medication errors, including deaths, have resulted from confusion between lipid-based forms of amphotericin (eg, Abelcet, 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: To minimize infusion-related immediate reactions, may premedicate with the following 30 to 60 minutes prior to administration: Acetaminophen, diphenhydramine, and/or hydrocortisone. If the patient experiences rigors during the infusion, meperidine may be administered. Adequate hydration and pre-infusion administration of NS may reduce the risk of nephrotoxicity during amphotericin B treatment (Ref).

General dosing: Infants, Children, and Adolescents: IV: 3 to 5 mg/kg/dose once daily (Ref).

Aspergillosis

Aspergillosis :

Invasive: Infants, Children, and Adolescents: IV: 5 mg/kg/dose once daily; minimum duration of treatment is 6 to 12 weeks and depends on site of infection, extent of disease, and level/duration of immunosuppression (Ref).

Endocarditis: Children and Adolescents: IV: 3 to 5 mg/kg/dose once daily with or without flucytosine (Ref).

Blastomycosis, moderately severe to severe disease

Blastomycosis, moderately severe to severe disease: Infants, Children, and Adolescents: IV: 3 to 5 mg/kg/dose once daily for 1 to 2 weeks or until improvement, followed by oral itraconazole for a total of 12 months. For CNS disease, initial IV therapy at the top end of the range (5 mg/kg/dose) is recommended for 4 to 6 weeks (Ref).

Candidiasis

Candidiasis :

Invasive (alternative agent): Infants, Children, and Adolescents: IV: 3 to 5 mg/kg/dose once daily. Duration of therapy should be individualized based on clinical response and presence of deep-tissue foci; candidemia should be treated for ≥14 days from the first negative blood culture and clinical resolution (Ref). Note: In patients with HIV, consider doses at the higher end of the range (5 mg/kg/dose) (Ref).

Endocarditis: Infants, Children, and Adolescents: IV: 3 to 5 mg/kg/dose once daily with or without flucytosine. Step-down to azole therapy in clinically stable patients with susceptible isolates and negative repeat cultures. Total antifungal duration is ≥6 weeks after valve replacement surgery, with longer duration for perivalvular abscess, other complications, or a nonsurgical approach (Ref).

Esophageal (alternative agent): Adolescents with HIV: IV: 3 to 4 mg/kg/dose once daily for 14 to 21 days (Ref).

Ventriculitis or meningitis, health care-associated: Infants, Children, and Adolescents: IV: 5 mg/kg/dose once daily with or without flucytosine (Ref).

Coccidioidomycosis, severe, nonmeningeal infection

Coccidioidomycosis, severe, nonmeningeal infection: Patients with HIV:

Infants and Children: IV: 5 mg/kg/dose once daily until clinical improvement, then switch to an oral azole to complete ≥12 months of therapy. 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 an oral azole to complete ≥12 months of therapy (Ref). Note: Some experts suggest initiating the oral azole in combination with the amphotericin B product and then continuing the oral azole when amphotericin B is discontinued (Ref).

Cryptococcal meningoencephalitis, disseminated disease, or severe pulmonary infection

Cryptococcal meningoencephalitis, disseminated disease, or severe pulmonary infection:

Infants, Children, and Adolescents: Induction therapy: IV: 5 mg/kg/dose once daily as part of appropriate combination therapy for ≥2 weeks, followed by consolidation therapy with oral fluconazole. Induction therapy duration may be extended in patients who cannot receive combination therapy, who are clinically deteriorating, if CNS cultures remain positive, or if neurological complications are present (Ref).

Histoplasmosis, moderately severe to severe pulmonary or disseminated disease

Histoplasmosis, moderately severe to severe pulmonary or disseminated disease (non-CNS):

Infants, Children, and Adolescents: IV: 5 mg/kg/dose once daily for 1 to 2 weeks and until clinical improvement, followed by oral itraconazole therapy. For patients with HIV, consider treating ≥2 weeks before transition to oral therapy (Ref).

Leishmaniasis, visceral

Leishmaniasis, visceral:

Immunocompetent patients (alternative agent): Infants, Children, and Adolescents: IV: 2 to 3 mg/kg/dose once daily for 5 to 10 days (Ref).

Immunocompromised patients (alternative agent): Infants, Children, and Adolescents: IV: 3 to 5 mg/kg/dose once daily for 10 days (Ref).

Patients with HIV:

Treatment (alternative agent): 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 (for patients with a CD4 count <200 cells/mm3): Adolescents: IV: 3 mg/kg/dose every 21 days (Ref).

Mucormycosis, invasive, without CNS involvement

Mucormycosis, invasive, without CNS involvement: Limited data available: Note: Prompt surgical debridement is often needed to achieve clinical cure (Ref).

Infants, Children, and Adolescents: IV: 5 mg/kg/dose once daily. Total duration (including oral step-down therapy if possible) varies based on clinical and radiologic response and patient immune status; several months are often warranted, with some patients requiring lifelong therapy (Ref).

Sporotrichosis

Sporotrichosis:

Meningeal infection: Adolescents: IV: 5 mg/kg/dose once daily for 4 to 6 weeks, followed by oral itraconazole (Ref).

Pulmonary, osteoarticular, and disseminated infection: Adolescents: IV: 3 to 5 mg/kg/dose once daily, followed by oral itraconazole after a favorable response is seen with amphotericin initial therapy (Ref).

Dosing: Kidney Impairment: Pediatric

Infants, Children, and Adolescents:

Manufacturer's recommendations: There are no dosage adjustments provided in manufacturer's labeling (has not been studied).

Alternate recommendations: The following adjustments have been recommended (Ref):

Hemodialysis: No supplemental dosage necessary

Peritoneal dialysis: No supplemental dosage necessary

Continuous renal replacement therapy (CRRT): No supplemental dosage necessary

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling (has not been studied).

Dosing: Adult

(For additional information see "Amphotericin B lipid complex: Drug information")

Dosing guidance:

Dosage form information: Lipid-based amphotericin formulations (Abelcet) may be confused with conventional formulations (deoxycholate [Amphocin, Fungizone]) or with other lipid-based amphotericin formulations (amphotericin B liposomal [AmBisome]; 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.

Safety: To minimize infusion-related immediate reactions, premedicate with the following 30 to 60 minutes prior to administration: Acetaminophen, diphenhydramine, and/or hydrocortisone. If the patient experiences rigors during the infusion, meperidine may be administered (Ref). Pre-infusion administration of 500 mL to 1 L of NS may reduce the risk of nephrotoxicity during amphotericin B treatment (Ref).

Aspergillosis, invasive

Aspergillosis, invasive (including disseminated and extrapulmonary) (alternative agent): IV: 5 mg/kg once daily; minimum duration of treatment is 6 to 12 weeks and depends on site of infection, extent of disease, and level/duration of immunosuppression. Note: Reserve amphotericin B lipid complex as salvage therapy for those intolerant of or refractory to preferred agents (Ref).

Blastomycosis, moderately severe to severe, non-CNS disease

Blastomycosis, moderately severe to severe, non-CNS disease: IV: 3 to 5 mg/kg once daily for 1 to 2 weeks or until improvement, followed by oral itraconazole (Ref).

Candidiasis

Candidiasis:

Candidemia (neutropenic and nonneutropenic patients), including disseminated candidiasis (alternative agent): IV: 3 to 5 mg/kg once daily. Total duration (including oral step-down therapy) is ≥14 days after first negative blood culture and continues until signs/symptoms of candidemia and neutropenia, if present, have resolved; metastatic complications warrant a longer duration (Ref).

Cardiac device infection (including implantable cardiac defibrillator, pacemaker, ventricular assist device): IV: 3 to 5 mg/kg once daily, with or without flucytosine; step down to azole therapy in clinically stable patients with susceptible isolates and negative repeat cultures; total antifungal duration is 4 weeks after device removal for isolated generator pocket infection and ≥6 weeks after device removal for wire infection (Ref).

Chronic disseminated (hepatosplenic): IV: 3 to 5 mg/kg once daily for several weeks, followed by oral azole step-down therapy until lesion resolution and through periods of immunosuppression (Ref).

Empiric therapy, suspected invasive candidiasis (nonneutropenic ICU patients) (alternative agent):

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. For those who improve, continue empiric antifungal therapy for 2 weeks; consider discontinuing after 4 to 5 days in patients with no evidence of invasive candidiasis and no clinical response (Ref).

Endocarditis, native or prosthetic valve: IV: 3 to 5 mg/kg once daily, with or without flucytosine; step down to azole therapy in clinically stable patients with susceptible isolates and negative repeat cultures. Total antifungal duration is ≥6 weeks after valve replacement surgery, with longer duration for perivalvular abscesses, other complications, or a nonsurgical approach (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 to 4 mg/kg/day. Transition to an oral antifungal once patient tolerates oral intake if susceptibility allows; total antifungal duration is 14 to 28 days (Ref).

Intra-abdominal infection (eg, peritonitis, abdominal abscess) (alternative agent): IV: 3 to 5 mg/kg once daily. Duration of therapy depends on source control and clinical response (Ref).

Osteoarticular infection (osteomyelitis or septic arthritis) (alternative agent): IV: 3 to 5 mg/kg once daily for ≥2 weeks, followed by fluconazole. Total duration of therapy (including oral step-down therapy) is 6 to 12 months for osteomyelitis and ≥6 weeks for septic arthritis (Ref).

Thrombophlebitis, suppurative: IV: 3 to 5 mg/kg once daily; continue antifungal therapy until catheter removed and thrombus resolved, and for ≥2 weeks after candidemia (if present) has cleared (Ref).

Coccidioidomycosis, severe, nonmeningeal infection

Coccidioidomycosis, severe, nonmeningeal infection: IV: 3 to 5 mg/kg once daily until clinical improvement, then switch to an oral azole (Ref). Note: Some experts suggest initiating the oral azole at the same time as amphotericin B lipid complex and continuing the oral azole when amphotericin B lipid complex is discontinued (Ref).

Cryptococcosis

Cryptococcosis (alternative agent in patients with HIV): Disseminated disease, meningoencephalitis, or severe pulmonary disease: Induction therapy: IV: 5 mg/kg once daily in combination with flucytosine for ≥2 weeks, followed by consolidation therapy with oral fluconazole. Duration of induction therapy may be extended in patients who cannot use combination therapy or who have evidence of neurological complications (Ref).

Fungal infection, pulmonary, prophylaxis in lung transplant recipients

Fungal infection, pulmonary, prophylaxis in lung transplant recipients (alternative agent) (off-label use): Note: Optimal dose, frequency, and duration are not defined and are patient and center dependent; an example is provided, refer to institutional protocols. Usually given in combination with a systemic antifungal to prevent systemic infection (Ref).

Inhalation for nebulization (off-label route): 50 mg once daily for 4 days, then once weekly for 7 to 13 weeks; refer to institutional protocols (Ref). Note: Some experts suggest doubling the dose in patients requiring mechanical ventilation (Ref).

Fusariosis, invasive

Fusariosis, invasive: IV: 3 to 5 mg/kg once daily; duration of treatment is often prolonged and depends on the 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).

Histoplasmosis

Histoplasmosis:

Moderately severe to severe pulmonary or disseminated disease in patients who are immunocompetent or solid organ transplant recipients: IV: 5 mg/kg once daily for 1 to 2 weeks, followed by oral itraconazole (Ref).

Severe disseminated disease in patients with HIV (alternative agent): IV: 5 mg/kg once daily for ≥2 weeks or until clinically improved, followed by oral itraconazole (Ref).

Leishmaniasis, visceral

Leishmaniasis, visceral (off-label use):

Chronic maintenance therapy (secondary prophylaxis) for patients with HIV and a CD4 count <200 cells/mm3: IV: 3 mg/kg once every 21 days. Continue until CD4 count is ≥350 cells/mm3, HIV viral load undetectable for 6 months, and no symptoms of relapse (Ref).

Treatment:

Immunocompetent: IV: 2 to 3 mg/kg once daily for 5 to 10 days (Ref).

Immunocompromised: IV: 3 to 5 mg/kg once daily for 10 days (Ref).

Mucormycosis, invasive

Mucormycosis, invasive (without CNS involvement): Note: Prompt surgical debridement is often needed to achieve clinical cure (Ref).

IV: 5 to 10 mg/kg once daily; may step down to oral therapy (eg, isavuconazole, posaconazole) based on patient response. Total duration (including oral step-down therapy) varies based on clinical and radiologic response and patient immune status; several months are often warranted, with some patients requiring lifelong therapy (Ref).

Neutropenic fever, empiric antifungal therapy

Neutropenic fever, empiric antifungal therapy (off-label use):

Note: Recommended for patients with persistent or recurrent fever after ≥4 days of antimicrobial therapy when the duration of neutropenia is expected to exceed 7 days (Ref).

IV: 5 mg/kg once daily (Ref).

Sporotrichosis

Sporotrichosis:

Meningeal infection: IV: 5 mg/kg once daily for 4 to 6 weeks, followed by oral itraconazole (Ref).

Pulmonary, osteoarticular, and disseminated infection: IV: 3 to 5 mg/kg once daily, followed by oral itraconazole after a favorable response is seen with amphotericin initial therapy (Ref).

Dosing: Kidney Impairment: Adult

Manufacturer's labeling: No dosage adjustment provided in manufacturer's labeling (has not been studied).

Alternate recommendations (Ref):

Intermittent hemodialysis: Not hemodialyzable; no supplemental dosage necessary.

Peritoneal dialysis: No supplemental dosage necessary.

CRRT: No supplemental dosage necessary.

Dosing: Liver Impairment: Adult

No dosage adjustment provided in manufacturer's labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Nervous system: Chills (18%)

Renal: Increased serum creatinine (11%)

Miscellaneous: Fever (14%), multi-organ failure (11%)

1% to 10%:

Cardiovascular: Chest pain (3%), hypertension (5%), hypotension (8%)

Dermatologic: Skin rash (4%)

Endocrine & metabolic: Hypokalemia (5%)

Gastrointestinal: Abdominal pain (4%), diarrhea (6%), gastrointestinal hemorrhage (4%), nausea (9%), vomiting (8%)

Hematologic & oncologic: Anemia (4%), leukopenia (4%), thrombocytopenia (5%)

Hepatic: Hyperbilirubinemia (4%)

Infection: Sepsis (7%)

Nervous system: Headache (6%), pain (5%)

Renal: Renal failure syndrome (5%)

Respiratory: Dyspnea (7%), respiratory failure (8%), respiratory system disorder (4%)

<1%: Hypersensitivity: Anaphylaxis

Frequency not defined:

Cardiovascular: Acute myocardial infarction, cardiac arrhythmia (including ventricular fibrillation) cardiomyopathy, heart failure, pulmonary embolism, shock, thrombophlebitis

Dermatologic: Erythema multiforme, exfoliative dermatitis, maculopapular rash, pruritus

Endocrine & metabolic: Acidosis, hypercalcemia, hyperglycemia, hyperkalemia, hyperuricemia, hypocalcemia, hypoglycemia, hypophosphatemia, increased lactate dehydrogenase, weight loss

Gastrointestinal: Anorexia, cholangitis, cholecystitis, dyspepsia, epigastric pain, increased serum amylase, melena, stomach cramps

Genitourinary: Anuria, dysuria, impotence, oliguria

Hematologic & oncologic: Disorder of hemostatic component of blood, hematologic disease (including eosinophilia), leukocytosis

Hepatic: Acute hepatic failure, hepatic sinusoidal obstruction syndrome, hepatitis, hepatomegaly, jaundice

Hypersensitivity: Hypersensitivity reaction (including nonimmune anaphylaxis)

Local: Injection-site reaction (including inflammation at injection site)

Nervous system: Cerebrovascular accident, encephalopathy, extrapyramidal reaction, malaise, myasthenia, peripheral neuropathy, seizure, vertigo (transient)

Ophthalmic: Diplopia, visual impairment

Otic: Deafness, hearing loss, tinnitus

Renal: Increased blood urea nitrogen, renal insufficiency, renal tubular acidosis

Respiratory: Asthma, bronchospasm, hemoptysis, pleural effusion, pulmonary edema, tachypnea, wheezing

Postmarketing:

Endocrine & metabolic: Hypomagnesemia (Malani 2005)

Hepatic: Hepatotoxicity (including increased serum alanine aminotransferase, increased alkaline phosphatase, increased serum aspartate aminotransferase) (Moghnieh 2016)

Hypersensitivity: Infusion-related reaction (Moghnieh 2016)

Renal: Increased serum creatinine (Safdar 2010)

Contraindications

Hypersensitivity to amphotericin or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis: Has been reported with amphotericin B-containing drugs; facilities for cardiopulmonary resuscitation should be available during administration due to the possibility of anaphylactic reaction. If severe respiratory distress occurs, the infusion should be immediately discontinued; during the initial dosing, the drug should be administered under close clinical observation.

• Infusion reactions: Acute reactions (including fever and chills) may occur 1-2 hours after starting an intravenous infusion. These reactions are usually more common with the first few doses and generally diminish with subsequent doses. Infusion has been rarely associated with hypotension, bronchospasm, arrhythmias, and shock.

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]).

Concurrent drug therapy issues:

• Antineoplastics: Concurrent use with antineoplastic agents may enhance the potential for renal toxicity, bronchospasm or hypotension; use with caution.

• Nephrotoxic drugs: Concurrent use of amphotericin B with other nephrotoxic drugs may enhance the potential for drug-induced renal toxicity.

Other warnings/precautions:

• Leukocyte transfusions: Acute pulmonary toxicity has been reported in patients receiving leukocyte transfusions and amphotericin B; amphotericin B lipid complex and concurrent leukocyte transfusions are not recommended.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intravenous [preservative free]:

Abelcet: 5 mg/mL (20 mL)

Generic Equivalent Available: US

No

Pricing: US

Suspension (Abelcet Intravenous)

5 mg/mL (per mL): $6.30

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.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intravenous:

Abelcet: 5 mg/mL (20 mL)

Additional Information

The lipid portion of amphotericin B lipid complex formulation contains 0.045 kcal per 5 mg; for patients receiving parenteral nutrition, adjustment to the amount of lipids may be necessary (Sacks 1997).

Administration: Pediatric

To minimize infusion-related immediate reactions, may premedicate with the following 30 to 60 minutes prior to administration: Acetaminophen, diphenhydramine, and/or hydrocortisone. If the patient experiences rigors during the infusion, meperidine may be administered. Adequate hydration and pre-infusion administration of NS may reduce the risk of nephrotoxicity during amphotericin B treatment (Ref).

Parenteral: IV: Must be diluted prior to administration. Flush line with D5W prior to infusion. Gently shake the IV container of diluted drug to ensure that contents are thoroughly mixed, then administer at a rate of 2.5 mg/kg/hour (over 2 hours for 5 mg/kg/dose). Do not use an in-line filter during administration. If infusion time exceeds 2 hours, mix the contents by gently rotating the infusion bag every 2 hours.

Administration: Adult

IV: To minimize infusion-related immediate reactions, premedicate with the following 30 to 60 minutes prior to administration: Acetaminophen, diphenhydramine, and/or hydrocortisone. If the patient experiences rigors during the infusion, meperidine may be administered (Ref).

Administer at an infusion rate of 2.5 mg/kg/hour (eg, over 2 hours for 5 mg/kg). May prolong infusion over >2 hours if necessary to reduce infusion-related reaction (Ref). Invert infusion container several times prior to administration and every 2 hours during infusion if it exceeds 2 hours. Do not use an in-line filter during administration. Flush line with dextrose; normal saline may cause precipitate.

Pre-infusion administration of 1 L of NS may reduce the risk of nephrotoxicity during amphotericin B treatment (Ref).

Inhalation (off-label route): Obtain appropriate volume to administer the prescribed dose with an appropriate nebulizer (eg, compressor) using a flow rate of 7 to 8 L/min and inhaled over at least 10 to 15 minutes (Ref); refer to nebulizer manufacturer's information for usage instructions and volume specifications or may use mechanical ventilator. A bronchodilator may be administered prior to dose (Ref).

Storage/Stability

Intact vials should be stored at 2°C to 8°C (35°F to 46°F); do not freeze. Protect intact vials from exposure to light. Solutions in D5W for infusion are stable for 48 hours under refrigeration and for an additional 6 hours at room temperature.

Use

Treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy (FDA approved in pediatric patients [age not specified] and adults).

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (liposomal forms with conventional counterparts) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care Settings).

Other safety concerns:

Lipid-based amphotericin formulations (Abelcet) may be confused with conventional formulations (Fungizone) or with other lipid-based amphotericin formulations (amphotericin B liposomal [AmBisome]; amphotericin B cholesteryl sulfate complex [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.

Metabolism/Transport Effects

None known.

Drug Interactions

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

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 drug interactions program

Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects 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 increase nephrotoxic effects of Aminoglycosides. Amphotericin B may increase neurotoxic effects of Aminoglycosides. Risk C: Monitor

Amisulpride (Oral): May increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor

Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Arsenic Trioxide: Amphotericin B may increase hypotensive effects of Arsenic Trioxide. Amphotericin B may increase QTc-prolonging effects 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 increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Blood Pressure Lowering Agents: May increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid

Cardiac Glycosides: Amphotericin B may increase adverse/toxic effects of Cardiac Glycosides. Risk C: Monitor

Colistimethate: Amphotericin B may increase nephrotoxic effects 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 increase hypokalemic effects of Amphotericin B. Risk C: Monitor

CycloSPORINE (Systemic): Amphotericin B may increase nephrotoxic effects of CycloSPORINE (Systemic). Amphotericin B may increase serum concentration of CycloSPORINE (Systemic). Risk C: Monitor

Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Dichlorphenamide: Amphotericin B may increase hypokalemic effects of Dichlorphenamide. Risk C: Monitor

DroNABinol: May increase 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

DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor

Flucytosine: Amphotericin B may increase adverse/toxic effects of Flucytosine. Amphotericin B may increase serum concentration of Flucytosine. Risk C: Monitor

Foscarnet: May increase nephrotoxic effects of Amphotericin B. Management: Avoid concomitant use of foscarnet and amphotericin B, unless the expected benefits of combined treatment outweigh the risks. If combined, monitor renal function closely. Risk D: Consider Therapy Modification

Ganciclovir-Valganciclovir: May increase nephrotoxic effects of Amphotericin B. Risk C: Monitor

Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor

Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor

Methoxyflurane: May increase nephrotoxic effects of Amphotericin B. Risk X: Avoid

Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor

Obinutuzumab: May increase hypotensive effects 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 increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor

Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may decrease therapeutic effects of Saccharomyces boulardii. Risk X: Avoid

Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Tacrolimus (Systemic): Amphotericin B may increase nephrotoxic effects of Tacrolimus (Systemic). Risk C: Monitor

Vancomycin: May increase nephrotoxic effects of Amphotericin B. Risk C: Monitor

Dietary Considerations

If on parenteral nutrition, may need to adjust the amount of lipid infused. The lipid portion of amphotericin B (lipid complex) formulation contains 0.045 kcal per 5 mg (Sacks 1997).

Pregnancy Considerations

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; Pilmus 2015).

Monitoring Parameters

Serum creatinine, BUN, liver function tests, serum electrolytes (especially potassium and magnesium), CBC, vital signs, fluid balance, and urine output. Monitor for infusion-related reactions.

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

Note: Exhibits nonlinear kinetics; volume of distribution and clearance from blood increases with increasing dose.

Distribution: High tissue concentration found in the liver, spleen, and lung ; Vd: Increases with higher doses (likely reflects increased uptake by tissues); 131 L/kg with 5 mg/kg/day

Half-life elimination: 173 hours following multiple doses

Excretion: 0.9% of dose excreted in urine over 24 hours; effects of hepatic and renal impairment on drug disposition are unknown

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