Monograph Details

Infections & Infestations > Fungal infections
AMPHOTEC
Manufacturer
Three Rivers Pharmaceuticals, LLC
Legal Classification
Rx
Pharmacological Class
Polyene.
Generic Name
Amphotericin B cholesteryl sulfate complex 50mg/vial, 100mg/vial; pwd for IV infusion after reconstitution and dilution.
Indications
Invasive aspergillosis in patients who are refractory to, or intolerant of, conventional amphotericin B therapy.
Adults and Children
See literature. Give test dose first. Initially 3–4mg/kg once daily as needed. Infuse at 1mg/kg/hr over at least 2 hrs (or longer if warranted).
Precautions
Pretreat with corticosteroids, antihistamines, and/or decrease infusion rate to minimize infusion reactions. Monitor renal and hepatic function, CBC, PT, electrolytes (esp. K+ with concomitant digoxin). Stop infusion if severe respiratory distress occurs. Pregnancy (Cat.B). Nursing mothers: not recommended.
Interactions
Antineoplastics may potentiate renal toxicity, bronchospasm, hypotension. Corticosteroids, ACTH may potentiate hypokalemia. Cyclosporine, tacrolimus, aminoglycosides, pentamidine may increase renal toxicity. May increase flucytosine toxicity. May antagonize ketoconazole, fluconazole, other imidazoles.
Adverse Reactions
Infusion reactions (chills, fever, hypo- or hypertension, tachypnea), GI upset, abnormal liver function test, headache, thrombocytopenia, hypokalemia, hypomagnesemia, bilirubinemia, increased creatinine and alkaline phosphatase, hypocalcemia, hyperglycemia, dyspnea, hypoxia, sweating, others.
How Supplied
Single-dose vials—1
Additional Resources
Related Prescribing Note