Amphotericin B

Amphotericin B
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. 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. Amphotericin B for Injection should no be given in doses greater than 1.5 mg/kg. EXERCISE CAUTION to prevent inadvertent overdosage, which may result in potentially fatal cardiac or cardiopulmonary arrest. Verify the product name and dosage pre-administration, especially if dose exceeds 1.5 mg/kg.

Overview

Amphotericin B is a antifungal, anti-Infective Agent, antiprotozoal , Dermatological Agent and Polyene that is FDA approved for the treatment of invasive 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.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypotension, thrombophlebitis, injection site pain, diarrhea, indigestion, loss of appetite, nausea, vomiting, normocystic normochromic anemia, arthralgia, myalgia, headache, tachypnea, fever, malaise and shivering..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Amphotericin B for Injection should be administered by slow intravenous infusion. Intravenous infusion should be given over a period of approximately 2 to 6 hours (depending on the dose) observing the usual precautions for intravenous therapy. The recommended concentration for intravenous infusion is 0.1 mg/mL (1mg/10mL). Since patient tolerance varies greatly, the dosage of amphotericin B must be individualized and adjusted according to the patient's clinical status (e.g., site and severity of infection, etiologic agent, cardio-renal function, etc.). A single intravenous test dose (1 mg in 20 mL of 5% dextrose solution) administered over 20 to 30 minutes may be preferred. The patient's temperature, pulse, respiration, and blood pressure should be recorded every 30 minutes for 2 to 4 hours.

In patients with good cardio-renal function and a well tolerated test dose, therapy is usually initiated with a daily dose of 0.25 mg/kg of body weight. However, in those patients having severe and rapidly progressive fungal infection, therapy may be initiated with a daily dose of 0.3 mg/kg of body weight. In patients with impaired cardio-renal function or a severe reaction to the test dose, therapy should be initiated with smaller daily doses (i.e., 5 to 10 mg). Depending on the patient's cardio-renal status, doses may gradually be increased by 5 to 10 mg per day to final daily dosage of 0.5 to 0.7 mg/kg.

There are insufficient data presently available to define total dosage requirements and duration of treatment necessary for eradication of specific mycoses. The optimal dose is unknown. Total daily dosage may range up to 1.0 mg/kg per day or up to 1.5 mg/kg when given on alternate days.

• Sporotrichosis: Therapy with intravenous amphotericin B for sporotrichosis has ranged up to nine months with a total dose up to 2.5 g.
• Aspergillosis: Aspergillosis has been treated with amphotericin B intravenously for a period up to 11 months with a total dose up to 3.6 g.
• Rhinocerebral phycomycosis: This fulminating disease generally occurs in association with diabetic ketoacidosis. It is, therefore, imperative that diabetic control be restored in order for treatment with Amphotericin B for Injection to be successful. In contradistinction, pulmonary phycomycosis, which is more common in association with hematologic malignancies, is often an incidental finding at autopsy. A cumulative dose of at least 3 g of amphotericin B is recommended to treat rhinocerebral phycomycosis. Although a total dose of 3 to 4 g will infrequently cause lasting renal impairment, this would seem a reasonable minimum where there is clinical evidence of invasion of deep tissue. Since rhinocerebral phycomycosis usually follows a rapidly fatal course, the therapeutic approach must necessarily be more aggressive than that used in more indolent mycoses.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Systemic Aspergillosis with HIV Coinfection

• Dosage
  • Amphotericin B deoxycholate 1 mg/kg/day IV
  • Amphotericin B lipid formulation 5 mg/kg/day IV

Esophagus Candidiasis

• Dosage: 0.3–0.7 mg/kg daily IV

Treatment and Prophylaxis of Coccidioidomycosis-HIV Coinfection

• Dosage:
  • Amphotericin B deoxycholate 0.7–1.0 mg/kg IV daily
  • Lipid formulation amphotericin B 4–6 mg/kg IV daily

Community Acquired Pneumonia

• Antibiotic Spectrum
  • Histoplasmosis
  • Blastomycosis
  • Coccidioides

Treatment of HIV-Cryptoccocosis Coinfection

• Dosage
  • Amphotericin B lipid complex 5 mg/kg IV daily plus flucytosine 25 mg/kg orally 4 times daily
  • Amphotericin B deoxycholate 0.7 to 1 mg/kg IV daily plus flucytosine* 25 mg/kg orally 4 times daily

Candidemia un Non-Neutropenic Patients

• Dosage
  • Amphotericin B deoxycholate: 0.5–1.0 mg/kg daily IV
  • Amphotericin B Lipid Formulation: 3–5 mg/kg daily IV

Febrile Neutropenia

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Amphotericin B in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Amphotericin B in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Candidiasis in HIV Co-Infected Patients

Candidemia un Non-Neutropenic Patients

• Dosage
  • Amphotericin B deoxycholate: 0.5–1.0 mg/kg daily IV
  • Amphotericin B Lipid Formulation: 3–5 mg/kg daily IV

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Amphotericin B in pediatric patients.

Contraindications

• Condition1

Warnings

WARNING See full prescribing information for complete Boxed Warning. 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. Amphotericin B for Injection should no be given in doses greater than 1.5 mg/kg. EXERCISE CAUTION to prevent inadvertent overdosage, which may result in potentially fatal cardiac or cardiopulmonary arrest. Verify the product name and dosage pre-administration, especially if dose exceeds 1.5 mg/kg.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Amphotericin B in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Amphotericin B in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Amphotericin B in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Amphotericin B during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Amphotericin B with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Amphotericin B with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Amphotericin B with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Amphotericin B with respect to specific gender populations.

Race

There is no FDA guidance on the use of Amphotericin B with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Amphotericin B in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Amphotericin B in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Amphotericin B in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Amphotericin B in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Amphotericin B in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Amphotericin B in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Amphotericin B in the drug label.

Pharmacology

There is limited information regarding Amphotericin B Pharmacology in the drug label.

Mechanism of Action

Structure

File:Amphotericin B01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Amphotericin B in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Amphotericin B in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Amphotericin B in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Amphotericin B in the drug label.

How Supplied

Storage

There is limited information regarding Amphotericin B Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Amphotericin B in the drug label.

Precautions with Alcohol

• Alcohol-Amphotericin B interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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