Saturday 23 June 2012

amphotericin B


Generic Name: amphotericin B (am foe TER i sin)

Brand names: Fungizone, Fungizone For Tissue Culture, Amphocin


What is amphotericin B?

Amphotericin B is an antibiotic that fights fungal infections in the body.


Amphotericin B is used to treat serious, life-threatening fungal infections. It is not for use in treating a minor fungal infection such as a yeast infection of the mouth, esophagus, or vagina.


Amphotericin is usually given after other antifungal antibiotics have been tried without successful treatment of symptoms.


Amphotericin B may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about amphotericin B?


Do not receive this medication if you are allergic to any formulation of amphotericin B (Abelcet, AmBisome, Amphotec, or Fungizone).

Before you receive amphotericin B, tell your doctor if you are allergic to any drugs, or if you have kidney disease or heart disease.


Amphotericin B is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.


The medicine must be given slowly through an IV infusion, and can take up to 6 hours to complete.


Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.


Some people receiving an amphotericin B injection have had a reaction to the infusion (either when the medicine is injected into the vein or within 1 to 3 hours afterward). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, feverish or cold, or if have a slow heartbeat, chest tightness, or trouble breathing.

What should I discuss with my health care provider before I receive amphotericin B?


You should not receive this medication if you are allergic to any formulation of amphotericin B (Abelcet, AmBisome, Amphotec, or Fungizone).

Before you receive amphotericin B, tell your doctor if you are allergic to any drugs, or if you have:



  • kidney disease; or




  • heart disease.



If you have any of these conditions, you may need a dose adjustment or special tests to safely receive amphotericin B.


FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether amphotericin B passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is amphotericin B given?


Amphotericin B is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.


The medicine must be given slowly through an IV infusion, and can take up to 6 hours to complete.


While you are receiving your amphotericin B infusion, your caregivers will check your blood pressure, pulse, temperature, and lung function about every 30 minutes.


To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested on a regular basis. Amphotericin B can have long-lasting effects on your body. Do not miss any follow-up visits to your doctor for blood or urine tests.

Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.


What happens if I miss a dose?


Since amphotericin B is usually given while you are in the hospital, it is not likely you will miss a dose of this medication.


If you are receiving amphotericin B in an outpatient clinic, call your doctor if you will miss an appointment for your amphotericin B injection.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include slow heart rate, and shallow breathing that slows or stops.


What should I avoid while receiving amphotericin B?


Amphotericin B may lower the blood cells that help your body fight other infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.


Amphotericin B side effects


Some people receiving an amphotericin B injection have had a reaction to the infusion (either when the medicine is injected into the vein or within 1 to 3 hours afterward). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, feverish or cold, or if you have a slow heartbeat, chest tightness, or trouble breathing. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your doctor at once if you have any of these serious side effects:

  • dry mouth, increased thirst, nausea, vomiting;




  • extreme drowsiness, restless feeling, confusion;




  • urinating more or less than usual, or not at all;




  • muscle pain or weakness, fast or uneven heart rate, feeling light-headed, fainting;




  • seizure (convulsions);




  • fever, chills, body aches, flu symptoms;




  • pale skin, easy bruising or bleeding, unusual weakness; or




  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • pain, swelling, or other irritation where the needle is placed;




  • mild nausea, vomiting, diarrhea, upset stomach, loss of appetite;




  • weight loss;




  • muscle or joint aches;




  • headache;




  • warmth, redness, or tingly feeling under your skin; or




  • skin itching or mild rash.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


Amphotericin B Dosing Information


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.


What other drugs will affect amphotericin B?


Before receiving amphotericin B, tell your doctor if you are using any of the following drugs:



  • flucytosine (Ancobon);




  • digoxin (digitalis, Lanoxin, Lanoxicaps);




  • pentamidine (Nebupent, Pentam);




  • tacrolimus (Prograf);




  • muscle relaxers;




  • steroids (prednisone and others);




  • antifungal antibiotics such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox);




  • antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);




  • antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or




  • cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).



This list is not complete and there may be other drugs that can interact with amphotericin B. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More amphotericin B resources


  • Amphotericin B Use in Pregnancy & Breastfeeding
  • Amphotericin B Drug Interactions
  • Amphotericin B Support Group
  • 0 Reviews for Amphotericin B - Add your own review/rating


  • Amphotericin B Prescribing Information (FDA)

  • Amphotericin B Professional Patient Advice (Wolters Kluwer)

  • Amphotericin B Monograph (AHFS DI)

  • Amphotericin B MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fungizone Prescribing Information (FDA)

  • amphotericin b Intravenous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information



Compare amphotericin B with other medications


  • Aspergillosis, Aspergilloma
  • Aspergillosis, Invasive
  • Blastomycosis
  • Candida Infections, Systemic
  • Candida Urinary Tract Infection
  • Coccidioidomycosis
  • Coccidioidomycosis, Meningitis
  • Cryptococcal Meningitis, Immunocompetent Host
  • Cryptococcal Meningitis, Immunosuppressed Host
  • Cryptococcosis
  • Esophageal Candidiasis
  • Fungal Endocarditis
  • Fungal Infection Prophylaxis
  • Histoplasmosis, Immunocompenent Host
  • Histoplasmosis, Meningitis
  • Leishmaniasis
  • Oral Thrush
  • Paracoccidioidomycosis
  • Sporotrichosis


Where can I get more information?


  • Your pharmacist can provide more information about amphotericin B.


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