Amphotericin B Deoxycholate

Amphotericin B Deoxycholate is a prescription medication used to treat the symptoms of Systemic Fungal Infections.

• Amphotericin B Deoxycholate is available under the following different brand names: Amphotericin B (conventional), AmBisome.

Common side effects of Amphotericin B Deoxycholate include:

• stomach pain, 
• nausea, 
• vomiting, 
• diarrhea, 
• trouble breathing, 
• chills, 
• weakness, and
• rash

Serious side effects of Amphotericin B Deoxycholate include:

• hives, 
• cough, 
• chest pain, 
• shortness of breath, 
• swelling in the face, lips, tongue, or throat, 
• dizziness, 
• lightheadedness, 
• sweating, 
• feeling hot or cold, 
• fast or irregular heartbeat, 
• chest tightness, 
• trouble breathing, 
• little or no urination, 
• swelling in feet or ankles, 
• tiredness, 
• shortness of breath, 
• muscle spasms or contractions, 
• numbness or tingly feeling (around the mouth, or in fingers and toes), 
• feeling jittery, 
• cough or choking feeling, 
• leg cramps, 
• constipation, 
• increased thirst or urination, 
• muscle weakness, and
• limp feeling

Rare side effects of Amphotericin B Deoxycholate include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088

Adult dosages

Powder for injection

• 50mg/vial
• Test dose: 1 mg in 20 mL of 5% dextrose solution IV over 20-30 minutes
• Loading dose: 0.25 mg/kg IV once daily

Pediatric dosages

Powder for injection

• 50mg/vial
• Test dose: 0.1 mg/kg IV, not to exceed 1 mg; administer over 20-60 min. 
• Initial dose: 0.25 mg/kg dose IV once daily/every other day
• Maintenance dose: Increase by 0.25 mg/kg increments as tolerated to 1-1.5 mg/kg/day

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Amphotericin B Deoxycholate has known severe interactions with the following drugs:
  • amikacin
  • cidofovir
  • contrast media (iodinated)
  • cyclosporine
  • ioversol
  • neomycin PO
  • streptozocin
  • tacrolimus
  • teicoplanin
• Amphotericin B Deoxycholate has serious interactions with at least 23 other drugs.
• Amphotericin B Deoxycholate has moderate interactions with at least 31 other drugs.
• Amphotericin B Deoxycholate has mild interactions with at least 31 other drugs.

This information does not contain all possible interactions or adverse effects.  Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns

• Drug should be used primarily for the treatment of patients with progressive and potentially life-threatening fungal infections; 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
• Should not be given in doses greater than 1.5 mg/kg
• Exercise caution to prevent inadvertent overdose, which may result in potentially fatal cardiac or cardiopulmonary arrest
• Verify the product name and dosage pre-administration, especially if the dose exceeds 1.5 mg/kg

Contraindications

• hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Amphotericin B Deoxycholate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Amphotericin B Deoxycholate?”

Cautions

• Therapy should be administered intravenously under close clinical observation by medically trained personnel; should be reserved for treatment of patients with progressive, potentially life-threatening fungal infections due to susceptible organisms
• Indicated for patients with progressive and potentially fatal fungal infections
• Do not use for noninvasive fungal infections (eg, oral thrush, vaginal candidiasis, esophageal candidiasis) in patients with normal neutrophil counts
• Acute reactions including fever, shaking chills, hypotension, anorexia, nausea, vomiting, headache, and tachypnea are common 1 to 3 hours after starting an intravenous infusion; reactions are usually more severe with the first few doses of amphotericin B and usually diminish with subsequent doses
• Rapid intravenous infusion has been associated with hypotension, hypokalemia, arrhythmias, and shock and should, therefore, be avoided
• Since acute pulmonary reactions have been reported in patients given therapy during or shortly after leukocyte transfusions, it is advisable to temporarily separate these infusions as far as possible and to monitor pulmonary function
• Caution when coadministration with other drugs that cause hypokalemia (eg, corticosteroids, digoxin)
• Cases of new-onset dilated cardiomyopathy with subsequent heart failure have been reported; symptoms normalized within 6 months of discontinuation
• Leukoencephalopathy has been reported following the use of amphotericin B; literature reports have suggested that total body irradiation may be a predisposition
• Amphotericin B should be used with care in patients with reduced renal function; frequent monitoring of renal function is recommended; in some patients, hydration and sodium repletion before administration may reduce the risk of developing nephrotoxicity; supplemental alkali medication may decrease renal tubular acidosis complications; however, do not withhold if the risk of infection outweighs the renal risk
• Whenever medication is interrupted for a period longer than seven days, therapy should be resumed by starting with the lowest dosage level, eg, 0.25 mg/kg of body weight, and increasing gradually

Pregnancy and Lactation

• Use may be acceptable during pregnancy.  
• Excretion in milk is unknown; due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or whether discontinue the drug, taking into account the importance of the drug to the mother