Fungizone

DRUG DESCRIPTION

FUNGIZONE Intravenous (Amphotericin B for Injection) contains amphotericin B, an antifungal polyene antibiotic obtained from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as [1R- (1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*,19E,21E,23E,25E,27E,29E, 31E,33R*,35S*,36R*,37S*)]-33- [(3-Amino-3,6-dideoxy-?-D-mannopyranosyl)-oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid. Structural formula:

 FUNGIZONE (amphotericin b) Structural Formula Illustration

C47H73NO17 MW 924.09

Each vial contains a sterile, nonpyrogenic, lyophilized cake (which may partially reduce to powder following manufacture) providing 50 mg amphotericin B and 41 mg sodium desoxycholate with 20.2 mg sodium phosphate as a buffer. Crystalline amphotericin B is insoluble in water; therefore, the antibiotic is solubilized by the addition of sodium desoxycholate to form a mixture which provides a colloidal dispersion for intravenous infusion following reconstitution.

At the time of manufacture the air in the vial is replaced by nitrogen.

What are the possible side effects of amphotericin B topical (Fungizone Cream, Fungizone Lotion)?

Serious side effects of amphotericin B topical use are unexpected. Stop using amphotericin B topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially...

Read All Potential Side Effects and See Pictures of Fungizone

What are the precautions when taking amphotericin b (Fungizone)?

Before using amphotericin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: white blood cell (leukocyte) transfusions, heart disease (e.g., irregular heartbeat, congestive heart failure), liver disease, kidney disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Fungizone


Fungizone Consumer (continued)

SIDE EFFECTS: Fever, shaking, chills, flushing, loss of appetite, dizziness, nausea, vomiting, headache, shortness of breath, or fast breathing may occur 1 to 3 hours after the infusion is started. In some cases, other medications (e.g., acetaminophen, diphenhydramine, corticosteroids such as hydrocortisone) may be necessary to prevent or relieve these side effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling/pain at injection site, muscle/joint pain, unusual tiredness, weakness, muscle cramping, change in the amount of urine, painful urination, numbness/tingling of arms/legs, vision changes, hearing changes (e.g., ringing in the ears), dark urine, severe stomach/abdominal pain, yellowing eyes/skin, swelling ankles/feet, fast/slow/irregular heartbeat, cold sweats, blue lips, easy bruising/bleeding, other signs of infection (e.g., fever, persistent sore throat), mental/mood changes, seizures, black stools, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using amphotericin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: white blood cell (leukocyte) transfusions, heart disease (e.g., irregular heartbeat, congestive heart failure), liver disease, kidney disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Fungizone Patient Information Including Side Effects

Brand Names: Fungizone, Fungizone For Tissue Culture

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

  • What is amphotericin B (Fungizone)?
  • What are the possible side effects of amphotericin B (Fungizone)?
  • What is the most important information I should know about amphotericin B (Fungizone)?
  • What should I discuss with my health care provider before I receive amphotericin B (Fungizone)?
  • How is amphotericin B given (Fungizone)?
  • What happens if I miss a dose (Fungizone)?
  • What happens if I overdose (Fungizone)?
  • What should I avoid while receiving amphotericin B (Fungizone)?
  • What other drugs will affect amphotericin B (Fungizone)?
  • Where can I get more information?

What is amphotericin B (Fungizone)?

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 are the possible side effects of amphotericin B (Fungizone)?

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.

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

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.

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