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Amphotericin B Dosage

Applies to the following strength(s): 50 mg ; 100 mg/mL

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Usual Adult Dose for Fungal Infection Prophylaxis

Prevention of invasive Candidiasis in solid-organ transplants: 10 to 20 mg per day IV

Prevention of invasive Candidiasis during periods of risk - ICU and Other Care Settings (stay of 3 days or longer): 0.25 mg/kg per day IV

Usual Adult Dose for Aspergillosis - Aspergilloma

0.25 mg/kg per day IV
Daily dosage may be gradually increased to 0.5 to 1 mg/kg over a period of 2 to 4 days. Total doses range from 1 to 2 g.

Usual Adult Dose for Aspergillosis - Invasive

0.5 to 0.6 mg/kg per day IV
Daily doses as high as 1 to 1.5 mg/kg have been suggested by some clinicians. Total doses of 1.5 to 4 g have been given over an 11-month period.

Usual Adult Dose for Blastomycosis

0.5 to 1 mg/kg per day IV
A total dose ranging from 1.5 to 2.5 g is needed for life-threatening disease. Patients with CNS infection should receive 0.7 to 1 mg/kg per day (total dose, at least 2 g).

Usual Adult Dose for Candida Urinary Tract Infection

Candiduria: 0.3 to 1 mg/kg per day IV for 1 to 7 days
Bladder irrigation: 5 to 50 mg/L instilled into the bladder for 60 to 90 minutes and drained 4 times a day for 2 to 5 days

Usual Adult Dose for Candidemia

Nonneutropenia: 0.6 to 1 mg/kg per day IV
Treatment duration should last 14 days after last positive blood culture and resolution of signs and symptoms.

Neutropenia: 0.7 to 1 mg/kg per day IV
Treatment duration should last 14 days past last positive blood culture and resolution of signs and symptoms.

Meningitis: 0.7 to 1 mg/kg per day IV plus flucytosine
Therapy should be administered for a minimum of 4 weeks after resolution of all signs and symptoms associated with the infection.

Endocarditis: 0.6 to 1 mg/kg per day IV for at least 6 weeks after valve replacement; flucytosine may be used concomitantly

Chronic disseminated: 0.6 to 0.7 mg/kg per day IV
Treatment duration may last 3 to 6 months and resolution or calcification of radiologic lesions.

The addition of oral flucytosine may be considered for HIV-infected patients with invasive candidiasis.

Usual Adult Dose for Coccidioidomycosis

Respiratory infection: 0.5 to 1 mg/kg per day IV to a maximum of 1.5 mg/kg per day for 4 to 12 weeks

Usual Adult Dose for Coccidioidomycosis - Meningitis

0.01 to 1.5 mg intrathecal injection
It is administered at intervals ranging from daily to weekly, beginning at a low dose and increasing until patient intolerance appears. Concomitant azole therapy is started.

Usual Adult Dose for Cryptococcal Meningitis - Immunocompetent Host

0.7 to 1 mg/kg per day IV for 6 to 10 weeks
Therapy is given concomitantly with flucytosine.

Usual Adult Dose for Cryptococcal Meningitis - Immunosuppressed Host

0.7 to 1 mg/kg per day IV plus flucytosine for 2 weeks followed by fluconazole for a minimum of 10 weeks

Usual Adult Dose for Cryptococcosis

Pulmonary: 0.5 to 1 mg/kg per day IV for 6 to 10 weeks
Total dose: 1 to 2 g

The addition of oral flucytosine may be considered.

Usual Adult Dose for Esophageal Candidiasis

Severe and/or refractory esophageal candidiasis: 0.25 mg/kg per day IV
If tolerated, dosage may be gradually increased over 2 to 4 days to 0.3 to 0.7 mg/kg per day. Total doses range from 100 to 200 mg.

This drug should not be used to treat noninvasive fungal infections in patients with normal neutrophil counts.

Usual Adult Dose for Fungal Endocarditis

0.25 mg/kg per day IV
Dosage may be gradually increased to 1 to 1.5 mg/kg per day over a period of 2 to 4 days. Total doses range from 1.5 to 3 g.

Usual Adult Dose for Histoplasmosis - Immunocompenent Host

Pulmonary: 0.7 mg/kg per day IV

Usual Adult Dose for Histoplasmosis - Meningitis

0.7 to 1 mg/kg per day IV to complete a 35 mg/kg total dose over 3 to 4 months

Usual Adult Dose for Oral Thrush

Refractory or pharyngeal candidiasis: 0.25 mg/kg per day IV
Dosage may be gradually increased to 0.3 mg/kg per day over a period of 2 to 4 days. Total doses range from 100 to 200 mg.

This drug should not be used to treat noninvasive fungal infections in patients with normal neutrophil counts.

Usual Adult Dose for Paracoccidioidomycosis

0.4 to 0.5 mg/kg per day IV to a maximum dose of 1.5 mg/kg per day in potentially fatal infections
Prolonged therapy is usually required.

Usual Adult Dose for Sporotrichosis

0.4 to 0.5 mg/kg per day IV for 2 to 3 months
Therapy has ranged up to 9 months with a total dose up to 2.5 g.

Usual Adult Dose for Leishmaniasis

Treatment of American cutaneous leishmaniasis (caused by L braziliense or L mexicana: 0.25 to 0.5 mg/kg per day IV
Dosage may be gradually increased to 0.5 to 1 mg/kg daily, at which time the drug is usually then given on alternate days. Duration of treatment may last from 3 to 12 weeks depending on severity of disease. Total dose ranges from 1 to 3 g.

Visceral Leishmaniasis: 0.5 to 1 mg/kg per day IV on alternate days for 14 to 20 doses

Maximum dose: 50 mg per day
Total dose: 1.5 to 2 g

Usual Pediatric Dose for Blastomycosis

0.25 mg/kg per day IV
Total dose: greater than or equal to 30 mg/kg

Usual Pediatric Dose for Candidemia

0.6 to 1 mg/kg per day IV for 14 to 21 days after resolution of signs and symptoms and negative repeat blood cultures

The addition of oral flucytosine may be considered for HIV-infected patients with invasive candidiasis.

Usual Pediatric Dose for Cryptococcal Meningitis - Immunosuppressed Host

HIV-infected patient: 0.25 to 1 mg/kg per day IV

The addition of oral flucytosine may be considered.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Prior to initiation of IV amphotericin B therapy, a test dose is recommended to determine tolerance. The test dose recommended for adults is 1 mg in 20 mL of 5% Dextrose in water infused IV over 20 to 30 minutes. The test dose recommended for neonates, infants, and children is 0.1 mg/kg/dose (maximum dose: 1 mg).

In patients with good cardiorenal function and a well tolerated test dose, therapy is usually initiated with a daily dose of 0.25 mg/kg.

In patients having a severe and rapidly progressive fungal infection, therapy may be initiated with a daily dose of 0.3 mg/kg of body weight. Some clinicians suggest higher initial IV doses (0.5 to 1 mg/kg/day) in patients presenting with severe, life-threatening infections. Daily doses may be gradually increased to 1 mg/kg over a period of 2 to 4 days.

In patients with impaired cardiorenal 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 cardiorenal status, dosage may be increased by 5 to 10 mg/day to a final dosage of 0.5 to 0.7 mg/kg per day.

Whenever there is an interruption in therapy for a period longer than seven days, therapy should be resumed by starting with the lowest dosage, e.g., 0.25 mg/kg of body weight, and increased gradually to desired dosage.

Alternate Day Regimen: After completing one week of therapy, serum concentrations can be maintained by administering double the daily (to a maximum of 1.5 mg/kg) dosage on alternate days. Slowly increase dosage every other day until it is twice the previous daily dosage. If the therapy is stopped for more than a week, the manufacturer recommends that the usual initial dose (0.25 mg/kg/day) be used and gradually increased.

Precautions

Intravenously administered amphotericin B 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 desoxycholate should not be administered at doses greater than 1.5 mg/kg. Potentially fatal cardiac or cardiopulmonary arrest may occur with inadvertent overdose. The product name and dosage should be verified if the dose exceeds 1.5 mg/kg.

Prior to the start of therapy with amphotericin B, a test dose is recommended to determine tolerance. The patient's temperature, pulse, respiration, and blood pressure should be recorded every 30 minutes, for 2 to 4 hours.

Amphotericin B should be administered IV only under close clinical observation by medically trained personnel. Acute reactions including fever, shaking chills, hypotension, anorexia, nausea, vomiting, headache, and tachypnea are common 1 to 3 hours after starting an IV infusion. These reactions are usually more severe with the first few doses and usually diminish with subsequent doses. Rapid IV infusion has been associated with hypotension, hypokalemia, arrhythmias, and shock, and should therefore, be avoided.

Whenever there is an interruption in therapy for a period longer than seven days, therapy should be resumed by starting with the lowest dosage, e.g., 0.25 mg/kg of body weight, and increased gradually to desired dosage.

Acute pulmonary reactions have been reported in patients given amphotericin B during or shortly after leukocyte transfusions. These infusions should be separated as far apart as possible and pulmonary function should be closely monitored.

An inline membrane filter of greater than or equal to 1 micron mean pore diameter may be used when administering infusion.

Amphotericin B can be nephrotoxic and should be used with care in patients with reduced renal function. Frequent monitoring of renal function is recommended. Hydration and sodium repletion prior to amphotericin B use may reduce the risk of developing nephrotoxicity.

Dialysis

Amphotericin B desoxycholate is not hemodialyzed.

Other Comments

Total daily doses may range up to 1 mg/kg per day or up to 1.5 mg/kg when given on alternate days. To minimize the side effects of IV amphotericin B, pretreatment with acetaminophen 650 mg orally, diphenhydramine 25 to 50 mg IV, and hydrocortisone 25 to 50 mg IV is often recommended.

The IV solution is prepared as 0.1 mg/mL infusion and delivered IV slowly over 2 to 6 hours once a day.

Current guidelines for prevention of amphotericin-induced nephrotoxicity in children include infusion of saline at 10 to 15 mL/kg before administration of the drug.

Amphotericin B continuous infusion (a rate less than 0.08 mg/kg/hour) has been associated with a significant reduction in renal impairment when compared to a 4-hour infusion (p less than 0.001).

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