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FUNGIZONE is a brand name for Amphotericin B, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ......................................................................................... 3 CONTRAINDICATION................................................................................................................. 5 WARNINGS…
Verbatim from this product's HC label. Tap a section to expand.
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.
Renal damage is often accompanied by the appearance of granular and hyaline casts, and sometimes by microhematuria. Renal dysfunction is usually reversible on discontinuance of therapy, but serious and permanent renal damage has been reported in patients given large doses for prolonged periods, especially in those receiving a total dosage exceeding 5 g.
The following adverse reactions have also been reported:
General (body as a whole): flushing. Allergic: anaphlactoid and other allergic reactions. Cardiovascular: cardiac arrest, cardiovascular toxicity including arrhythmias, ventricular fibrillation, cardiac failure, hypertension, hypotension and shock Dermatologic: maculopapular rash and pruritus (without rash).
Skin exfoliation, toxic epidermal necrolysis, and reports of Stevens-Johnson syndrome have been received during postmarketing surveillance. Digestive: acute liver failure, jaundice, liver function test abnormalities, melena or hemorrhagic gastroenteritis and hepatotoxicity.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Hematologic: coagulation defects, thrombocytopenia, leukopenia, agranulocytosis, eosinophilia, leukocytosis. 9 Neurologic: hearing loss, tinnitus, transient vertigo, blurred vision or diplopia, peripheral neuropathy, encephalopathy, convulsions and other neurologic symptoms.
Pulmonary: dyspnea, bronchospasm, non-cardiac pulmonary edema and hypersensitivity pneumonitis. Renal: hypomagnesemia, hyperkalemia, acute renal failure, anuria and oliguria. Nephrogenic diabetes insipidus has been reported during postmarketing surveillance.
Fever, nausea, vomiting, headache and malaise sometimes subside with continued administration. , acetylsalicylic acid, an antihistaminic and/or an antiemetic prior to and concurrently with amphotericin B, or by modifying the rate of infusion.
Meperidine (25 to 50 mg IV) has been shown in some patients to decrease the duration of shaking chills and fever that may accompany the infusion of amphotericin B. Addition of a small amount of heparin, rotation of the injection site, the use of a pediatric scalp-vein needle and alternate day therapy may lessen the incidence of thrombophlebitis and anorexia.
Supplemental alkali medication may decrease renal tubular acidosis complications. Extravasation may cause chemical irritation. Intravenous or intramuscular administration of small doses of adrenal corticosteroids just prior to, or during the amphotericin B infusion may decrease febrile reactions.
The dosage and duration of such corticosteroid therapy should be kept to a minimum (see PRECAUTIONS). If a severe reaction occurs during the course of an infusion, therapy should be interrupted for about 15 minutes to allow the patient to recover.
If the reaction recurs, therapy should be resumed at a lower dosage the next day. Blood transfusions may be required when reversible normocytic, normochromic anemia occurs during prolonged therapy. SYMPTOMS AND TREATMENT OF OVERDOSAGE Amphotericin B overdoses can result in potentially fatal cardiac or cardio-respiratory arrest.
, cardio- respiratory, renal, and liver function, hematologic status, serum electrolytes) and administer supportive therapy as required. Amphotericin B is not hemodialyzable. ). 5 mg/kg be exceeded. Amphotericin B overdoses can result in potentially fatal cardiac or cardio-respiratory arrest (see WARNINGS AND PRECAUTIONS and SYMPTOMS AND TREATMENT OF 10 OVERDOSAGE).
Large total doses may cause significant and permanent renal impairment. Consideration must be given to the potential risk versus the expected benefit. FUNGIZONE (Amphotericin B for Injection) 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 (see PRECAUTIONS, General). 1 mg/mL (1 mg/10 mL) (see Preparation of Solutions).
). Though not proven to be a reliable predictor of […]