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Indications:

Treatment of progressive, potentially fatal infections caused by certain fungal species. Amphotericin B cholesteryl Treatment of invasive aspergillosis in patients for whom renal function impairment or unacceptable toxicity precludes use of amphotericin B deoxycholate or in patients with invasive aspergillosis in whom amphotericin deoxycholate has failed. Amphotericin B desoxycholate Treatment of potentially life-threatening infections caused by certain fungal species. Amphotericin B for injection is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioidomycosis, histoplasmosis, zygomycosis including mucormycosis caused by susceptible species of the genera Absidia , Mucor , and Rhizopus , and infections caused by related susceptible species of Conidiobolus , Basidiobolos , and sporotrichosis. Amphotericin B, lipid-based Treatment of invasive fungal infections in patients refractory to conventional amphotericin B (lipid complex); empirical treatment of febrile, neutropenic patients with presumed fungal infections (liposomal); treatment of visceral leishmaniasis (liposomal); treatment of cryptococcal meningitis in HIV-infected patients (liposomal); treatment of Aspergillus species, Candida species, and Cryptococcus species refractory to amphotericin B deoxycholate, or in patients for whom renal function impairment or unacceptable toxicity precludes use of amphotericin B deoxycholate. Unlabeled Uses Prophylaxis of fungal infections in patients with bone marrow transplantation; treatment of primary amoebic meningoencephalitis caused by Naegleria fowleri ; subconjunctival or intravitreal treatment of ocular aspergillosis; bladder irrigation for candidal cystitis; chemoprophylaxis of aspergillosis; intrathecal treatment of severe meningitis unresponsive to IV therapy; intra-articular or IM treatment of coccidioidal arthritis; intranasal or nebulized administration in immunocompromised patients at risk of aspergillosis.

Contraindications:

Hypersensitivity; lactation; do not give to patients receiving antineoplastics.

Adverse reactions:

Topical: Local irritation, pruritus and skin rash. IV infusion: Fever, chills, convulsions, malaise; nausea, vomiting, diarrhoea, anorexia; tinnitus, vertigo, hearing loss; hypotension, hypertension, cardiac arrhythmias; peripheral neuropathy; phloebitis, pain at Inj site, disturbances in renal function and renal toxicity. Potentially Fatal: Anaphylactic reaction; leucoencephalopathy. Overdosage can result in cardio-respiratory arrest.

Interactions:

Antineoplastic agents Concurrent use may enhance potential for arrhythmias, bronchospasm, renal toxicity, and shock. Azole antifungal agents (eg, fluconazole, ketoconazole) Antagonism between amphotericin B and the antifungal agent may occur. Corticosteroids and corticotropin Increased potential for hypokalemia. Cyclosporine, tacrolimus May increase nephrotoxic effects. Digitalis glycosides Amphotericin B–induced hypokalemia may potentiate digitalis toxicity. Flucytosine Increased risk of flucytosine toxicity. Leukocyte transfusions Acute pulmonary toxicity has been reported in patients receiving IV amphotericin B and leukocyte transfusions. Do not give concurrently. Nephrotoxic agents (eg, aminoglycosides) Possible synergistic nephrotoxicity. Skeletal muscle relaxants (eg, tubocurarine) Amphotericin B–induced hypokalemia may enhance curariform effect of skeletal muscle relaxant. Zidovudine Closely monitor renal and hematologic function if used with amphotericin B. Incompatibility Do not mix with other IV medications. Laboratory Test Interactions None well documented.

Warnings:

Do not use to treat noninvasive forms of fungal diseases (eg, esophageal candidiasis, oral thrush, vaginal candidiasis) in patients with normal neutrophil counts. Exercise caution to prevent inadvertent overdose. Use primarily for the treatment of progressive and potentially life-threatening fungal infections. Pregnancy Category B . Lactation Undetermined. Children Amphotericin B, lipid-based, amphotericin B cholesteryl Safety and efficacy in children younger than 1 mo of age not established. Amphotericin B desoxycholate Safety and efficacy not established. Elderly No serious unexpected adverse reactions have been reported. Hypersensitivity Anaphylaxis has been reported. Nephrotoxicity Drug is toxic; use with caution under close supervision. Renal damage is the most important toxic effect. Despite its dangerous adverse reactions, amphotericin B frequently is the only effective treatment for potentially fatal fungal diseases. Rapid infusion Rapid IV infusion has been associated with arrhythmias, hypokalemia, hypotension, and shock.

Form:

SOLUTION FOR INJECTION

Dosage and Administration

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