Fungizone®

Fungizone® (Amphotericin B) for Injection

SKU: 623131001045
DIN: 00029149
SIZE: 50mg/vial
INDICATIONS: Fungizone® should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis, and esophageal candidiasis in patients with normal neutrophil counts.
DIRECTIONS: Fungizone® should be administered by slow intravenous infusion over a period of approximately 2 to 6 hours (depending on the dose). The recommended concentration for intravenous infusion in 5 % Dextrose is 0.1 mg/mL (1 mg/10 mL)

Product Description

ACTIONS AND CLINICAL PHARMACOLOGY

Amphotericin B is fungistatic or fungicidal depending on the concentration obtained in body fluids and the susceptibility of the fungus. It has been shown to exhibit a high order of in vitro activity against a broad spectrum of yeast and fungi.

The drug acts by binding to sterols present in the membrane of sensitive fungi, with the resultant change in permeability allowing leakage of a variety of small molecules. Since mammalian cell membranes also contain sterols, it has been suggested that the damage to human cells and fungal cells may share common mechanisms.

Following intravenous infusion, the antibiotic is slowly excreted by the kidneys, and demonstrable blood levels persist for at least 18 hours after the infusion is discontinued.

INDICATIONS AND CLINICAL USE

Fungizone® (amphotericin B) is specifically intended for the treatment of disseminated mycotic infections, including:

  • coccidioidomycosis;
  • cryptococcosis (torulosis);
  • disseminated candidiasis, histoplasmosis, South American leishmaniasis, North and South American blastomycosis;

mucormycosis (phycomycosis) caused by species of the genera Mucor, Rhizopus, Absidia, Entomophthora, and Basidiobolus, sporotrichosis (Sporotrichum schenckii), and aspergillosis (Aspergillus fumigatus).

CONTRAINDICATIONS

This product is contraindicated in those patients who have shown hypersensitivity to amphotericin B or any other component in the formulation unless, in the opinion of the physician, the condition requiring treatment is life-threatening and amenable only to amphotericin B therapy.

WARNINGS

Fungizone® (amphotericin B) should be administered primarily to patients with progressive, potentially fatal infections and should not be used to treat non-serious fungal infections.

In the treatment of potentially fatal fungal diseases, the possible life-saving benefit of Amphotericin B must be balanced against its untoward and dangerous side effects.

Serious Warnings and Precautions

Exercise caution to prevent inadvertent Fungizone overdose. Verify the product name and dosage pre-administration, especially if dose exceeds 1.5 mg/kg.

ADVERSE REACTIONS

While a few patients may tolerate full intravenous doses of amphotericin B without difficulty, most will exhibit some intolerance often at less than the full therapeutic dosage. The adverse reactions most commonly observed are:

General (body as a whole): fever (sometimes accompanied by shaking chills occurring within 15 to 20 minutes after initiation of treatment) malaise and weight loss.

Digestive: anorexia, nausea, vomiting, diarrhea, dyspepsia and cramping epigastric pain.

Hematologic: normochromic and normocytic anemia.

Local: local venous pain at the injection site with or without phlebitis or thrombophlebitis.

Musculoskeletal: generalized pain, including muscle and joint pains.

Neurologic: headache.

Renal: decreased renal function and renal function abnormalities including azotemia hyposthenuria, renal tubular acidosis and nephrocalcinosis, an increase in the serum creatinine level, a decrease in the serum creatinine clearance rate or a decrease in the phenol-sulfonphthalein (PSP) excretion is commonly observed. Hypokalemia with or without concomitant impairment of renal function has often been observed. Potassium replacement may be considered by oral or parenteral route. Concomitant diuretic therapy may be a predisposition for renal impairment whereas sodium repletion or supplementation may reduce the occurrence of nephrotoxicity.

DOSAGE AND ADMINISTRATION

CAUTION: Under no circumstances should a total daily dose of 1.5 mg/kg be exceeded. Amphotericin B overdoses can result in potentially fatal cardiac or cardio-respiratory arrest

Fungizone® (amphotericin B) should be administered by slow intravenous infusion. Intravenous infusion should be given over a period of approximately 2 to 6 hours (depending on the dose) observing the usual precautions for intravenous therapy.

The recommended concentration for intravenous infusion in 5 % Dextrose is 0.1 mg/mL (1 mg/10 mL)

ABOUT THE DISEASE

Aspergillosis

Aspergillosis is infection, usually of the lungs, caused by the fungus Aspergillus.

A ball of fungus fibers, blood clots, and white blood cells may form in the lungs or sinuses. People may have no symptoms or may cough up blood or have a fever, chest pain, and difficulty breathing. If fungi spread to the liver or kidneys, these organs may malfunction. Diagnosis usually involves an x-ray or computed tomography and, if possible, culture of a sample of infected material. Antifungal drugs are used, and sometimes surgery is needed to remove the fungal balls.

Coccidioidomycosis

Coccidioidomycosis is a pulmonary or hematogenously spread disseminated disease caused by the fungi Coccidioides immitis and C. posadasii; it usually occurs as an acute benign asymptomatic or self-limited respiratory infection. The organism occasionally disseminates to cause focal lesions in other tissues. Symptoms, if present, are those of lower respiratory infection or low-grade nonspecific disseminated disease. Diagnosis is suspected based on clinical and epidemiologic characteristics and confirmed by chest x-ray, culture, and serologic testing. Treatment, if needed, is usually with fluconazole, itraconazole, newer triazoles, or amphotericin B.

Cryptococcosis (torulosis)

Cryptococcosis is a pulmonary or disseminated infection acquired by inhalation of soil contaminated with the encapsulated yeast Cryptococcus neoformans or C. gattii. Symptoms are those of pneumonia, meningitis, or involvement of skin, bones, or viscera. Diagnosis is clinical and microscopic, confirmed by culture or fixed-tissue staining. Treatment, when necessary, is with azoles or amphotericin B, with or without flucytosine.

Disseminated candidiasis

Candidiasis is infection by Candida species (most often C. albicans), manifested by mucocutaneous lesions, fungemia, and sometimes focal infection of multiple sites. Symptoms depend on the site of infection and include dysphagia, skin and mucosal lesions, blindness, vaginal symptoms (itching, burning, discharge), fever, shock, oliguria, renal shutdown, and disseminated intravascular coagulation. Diagnosis is confirmed by histopathology and cultures from normally sterile sites. Treatment is with amphotericin B, fluconazole, echinocandins, voriconazole, or posaconazole.

 Histoplasmosis

Histoplasmosis is a pulmonary and hematogenous disease caused by Histoplasma capsulatum; it is often chronic and usually follows an asymptomatic primary infection. Symptoms are those of pneumonia or of nonspecific chronic illness. Diagnosis is by identification of the organism in sputum or tissue or use of specific serum and urine antigen tests. Treatment, when necessary, is with amphotericin B or an azole.

South American leishmaniasis

Leishmaniasis is a parasitic disease that is found in parts of the tropics, subtropics, and southern Europe. Leishmaniasis is caused by infection with Leishmania parasites, which are spread by the bite of infected sand flies. There are several different forms of leishmaniasis in people. The most common forms are cutaneous leishmaniasis, which causes skin sores, and visceral leishmaniasis, which affects several internal organs (usually spleen, liver, and bone marrow).

North and South American blastomycosis

Blastomycosis, infection of the skin and viscera caused by fungal organisms of the genus Blastomyces. There are two major types of blastomycosis: the North American, caused by B. dermatitidis, and the South American, caused by B. brasiliensis. In North American blastomycosis, skin and lung lesions are most common: pulmonary lesions vary in size from granulomatous nodules to confluent, diffuse areas of pus-forming inflammation involving the entire lobe of the lung. In the skin, micro-abscesses lie just beneath the epidermis, the outermost layer of the skin, and are associated with a granulomatous appearance of the surrounding skin.

In South American blastomycosis, the portal of entry is usually the nasopharynx (the part of the alimentary canal between the cavity of the mouth and the esophagus that is continuous with the nasal passages); swelling and ulceration of the mouth or nose may cause the infection to spread to the nearby lymph nodes; primary lesions may also occur in the lymphoid tissues in the lower abdomen. In both North and South American varieties, the infection may spread not only to the lymph nodes but also to such organs as the brain, bones, liver, spleen, and adrenals.

Mucormycosis (phycomycosis)         

Mucormycosis (also called zygomycosis) is a rare infection caused by organisms that belong to a group of fungi called Mucoromycotina. At one time these fungi were called Zygomycota, but this scientific name has recently been changed. These fungi are typically found in the soil and in association with decaying organic matter, such as leaves, compost piles or rotten wood. Mucormycosis needs to be treated with antifungal medication prescribed by a health care provider. These medications are given by mouth or through a vein. Skin infections with the fungus may require surgery to cut away the infected tissue.

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PRODUCT MONOGRAPH

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PRESCRIBING INFORMATION

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FREQUENTLY ASKED QUESTIONS

What is Fungizone®?
Fungizone® is an antifungal medication that fights infections caused by fungus. 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.

What are the possible side effects of Fungizone®?

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pale skin, easy bruising;
  • blood in your stools;
  • a light-headed feeling, like you might pass out;
  • seizure (convulsions);
  • jaundice (yellowing of the skin or eyes);
  • build-up of fluid in your lungs–anxiety, sweating, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate;
  • signs of a kidney problem–little or no urination; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;
  • low potassium–confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or
  • signs of new infection–fever, chills, flu symptoms, mouth and throat ulcers, rapid and shallow breathing.

Common side effects may include:

  • nausea, vomiting, stomach pain, diarrhea;
  • upset stomach, loss of appetite;
  • muscle or joint pain;
  • headache, ringing in your ears;
  • pain, bruising, or swelling where the medicine was injected;
  • weight loss; or

flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What is the most important information I should know about Fungizone®?

This medicine is for serious, life-threatening fungal infections. It is not for use in treating a minor fungal infection (yeast infection) of the mouth, esophagus, or vagina.

Do not use amphotericin B in larger amounts than recommended. An overdose can cause death.

What should I discuss with my doctor before taking Fungizone®?

You should not receive this medicine if you are allergic to any formulation of amphotericin B.

To make sure amphotericin B is safe for you, tell your doctor if you have:

  • heart disease;
  • diabetes;
  • kidney disease;
  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
  • if you are receiving blood transfusions; or
  • if you are receiving radiation treatments.

Amphotericin B is not expected to harm 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. You should not breast-feed while using this medicine.

How should Fungizone® be taken?

Amphotericin B is injected into a vein through an IV. A healthcare provider will give you this injection. The medicine must be given slowly through an IV infusion and can take from 2 to 6 hours to complete. Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when amphotericin B is injected. Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.

While receiving amphotericin B, you may need frequent blood tests. Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine. Amphotericin B will not treat a viral infection such as the common cold or flu.

What should I do if I forget a dose of the medication?

Call your doctor for instructions if you miss an appointment for your amphotericin B injection.

What should I avoid while taking Fungizone®?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

What other drugs will affect Fungizone®?

Other drugs may interact with amphotericin B, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using

Where can I get more information?

Your doctor or pharmacist can provide more information about amphotericin B

What should I do in case of an overdose or accidental taking of Vepesid®?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amphotericin B can be fatal.
How should this product be stored?
Prior to reconstitution, Fungizone® (amphotericin B) should be stored in the refrigerator (2 – 8°C), protected against exposure to light. The concentrate (5 mg amphotericin B per mL after reconstitution with 10 mL Sterile Water for Injection U.S.P.) may be stored in the dark, at room temperature for 24 hours, or at refrigerator temperature (2 – 8°C) for one week with minimal loss of potency and clarity. Any unused material should then be discarded. Solutions prepared for intravenous infusion (0.1 mg or less amphotericin B/mL) should be used promptly after preparation and should be protected from light during administration.