Adult Dosing

Life-threatening invasive fungal infections

• 3-4 mg/kg IV q24 hrs
• A test dose of 10 mL over 15-30mins immediately preceding the first dose is advisable

Pediatric Dosing

Life-threatening invasive fungal infections

• 3-4 mg/kg IV q24 hrs
• A test dose of 10 mL over 15-30mins immediately preceding the first dose is advisable

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate in effective doses, and in patients with invasive aspergillosis where prior amphotericin B deoxycholate therapy has failed

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• May cause anaphylactic reactions. Institute proper treatment with epinephrine, oxygen, intravenous steroids, and airway management if such reactions occur
• Immediately discontinue infusion if severe respiratory distress occurs
• Appropriately manage acute infusion related reactions with antihistamines and corticosteroids and/or by reducing the rate of infusion and by prompt administration of antihistamines and corticosteroids

Caution: Use cautiously in

• Renal impairment

Pregnancy Category:B

Breastfeeding: Safety unknown: Amphotericin B is highly protein bound, has a large molecular weight and is virtually unabsorbed orally. It is acceptable to use in nursing mothers. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 4 May 2011). Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• CNS: Confusion, dizziness, insomnia, somnolence, thinking abnormal, tremor
• CV: Cardiovascular disorder, hemorrhage, postural hypotension
• GI: Diarrhea, dry mouth, abdomen enlarged, abdominal pain, hematemesis, jaundice, stomatitis
• RESP: Apnea, asthma, cough increased, epistaxis, hyperventilation, lung disorder, rhinitis
• EENT: Eye hemorrhage
• HEMA: Anemia, coagulation disorder, decreased prothrombin
• METABOLIC: Edema, generalized edema, hypocalcemia, hypophosphatemia, peripheral edema, weight gain
• DERM: Maculopapular rash, pruritis, rash, sweating
• GU: Hematuria
• MUSC: Back pain, chest pain
• LOCAL: Injection site inflammation
• MISC: Mucous membrane disorder, pain, sepsis

• Polyene; binds to sterols (ergosterol) in the cell membrane of susceptible fungi; fungistatic or fungicidal action
• Metabolism unknown
• Excreted in urine
• Half-life: 27.5-28.2 hrs

US Trade Name(s)

• Amphotec

US Availability

Amphotec

• PWDR for INJ: 50 mg/vial (20 mL vial)
• PWDR for INJ: 100 mg/vial (50 mL vial)

Canadian Trade Name(s)

• Amphotec

Canadian Availability

Amphotec

• PWDR for INJ: 50 mg/vial
• PWDR for INJ: 100 mg/vial

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Antifungals (Systemic)

Polyenes

Infectious Disease

Antifungals (Systemic)

Polyenes