Amphotericin B Cholesteryl Sulfate

Amphotericin B cholesteryl sulfate is used to treat invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate (conventional) ineffective doses, or where prior amphotericin B deoxycholate therapy has failed.

Amphotericin B cholesteryl sulfate is available under the following different brand names: Amphotericin B Cholesteryl Sulfate.

Dosages of Amphotericin B Cholesteryl Sulfate:

Powder for Injection

• 50 mg/vial
• 100 mg/vial

Dosage Considerations – Should be Given as Follows:

Aspergillosis

• Indicated for the treatment of invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate (conventional) ineffective doses, or where prior amphotericin B deoxycholate therapy has failed
• Adult and pediatric: 3-4 mg/kg intravenously (IV) once/day
• Initial infusion rate 1 mg/kg/hour; subsequent infusions may be shortened to infuse over 2 hours if tolerated

Test dose

• Administer immediately preceding the first dose when commencing all new courses of treatment
• Infuse a small amount of drug (e.g., 10 mL of final preparation containing between 1.6-8.3 mg) over 15-30 minutes
• Carefully observe the patient for the next 30 minutes

Common side effects of amphotericin B cholesteryl sulfate include:

• Chills
• Fever
• Low blood potassium (hypokalemia)
• Elevated serum creatinine
• Hyperbilirubinemia
• Low blood pressure (hypotension)
• Fast heart rate
• Nausea
• Vomiting
• Abnormal liver function tests
• High blood pressure (hypertension)
• Low blood oxygen
• Shortness of breath
• Headache
• Low blood magnesium
• Increased alkaline phosphatase
• Low blood platelets (thrombocytopenia)
• High blood sugar (hyperglycemia)

If your doctor has directed you to use this medication, 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 cholesteryl sulfate has no listed severe interactions with other drugs.

Amphotericin B cholesteryl sulfate has no listed serious interactions with other drugs.

Amphotericin B cholesteryl sulfate has no listed moderate interactions with other drugs.

Amphotericin B cholesteryl sulfate has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains amphotericin B cholesteryl sulfate. Do not take Amphotec if you are allergic to amphotericin B cholesteryl sulfate or any ingredients contained in this drug.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Amphotericin B Cholesteryl Sulfate?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Amphotericin B Cholesteryl Sulfate?"

Cautions

• Indicated for patients with progressive and potentially fatal fungal infections
• Do not use for noninvasive fungal infections (e.g., oral thrush, vaginal candidiasis, esophageal candidiasis) in patients with normal neutrophil counts
• Caution when coadministration with other drugs that cause hypokalemia (e.g., corticosteroids, digoxin)
• Caution with other nephrotoxic medications

Pregnancy and Lactation

Amphotericin B cholesteryl sulfate use during pregnancy may be acceptable. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk.

It is unknown whether amphotericin B cholesteryl sulfate is distributed in breast milk. Caution is advised while breastfeeding.