Amphotericin: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 6, 2026

Amphotericin

Active ingredient

GB MHRA

Drug class: -
Availability: See label
Markets covered: 1
Products on record: 2

Overview

Amphotericin is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	2	March 6, 2026

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised March 6, 2026[1]

Fungizone should be administered primarily to patients with progressive, potentially fatal infections. This potent drug should not be used to treat the common forms of fungal disease which show only positive skin or serological tests.
Fungizone is specifically intended to treat cryptococcosis (torulosis); North American blastomycosis; the disseminated forms of candidosis, coccidioidomycosis and histoplasmosis; mucormycosis (phycomycosis) caused by species of the genera Mucor, Rhizopus, Absidia, Entomophthora, and Basidiobolus sporotrichosis (Sporotrichum schenckii), aspergillosis (Aspergillus fumigatus).
Amphotericin B may be helpful in the treatment of American mucocutaneous leishmaniasis but is not the drug of choice in primary therapy.

Sources & citations

[1]MHRA (UK) · PL450430039 · revised March 6, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

GBOfficial regulatory label· revised March 6, 2026[1]

Non-equivalence of amphotericin products Different amphotericin products (sodium deoxycholate, liposomal, lipid complex) are not equivalent in terms of pharmacodynamics, pharmacokinetics and dosing and so the products should not be used interchangeably without accounting for these differences.
Both the trade name, common name and dose should be verified pre-administration. 5 mg/kg be exceeded. 9). Posology Fungizone should be administered by intravenous infusion over a period of 2-6 hours. Reduction of the infusion rate may reduce the incidence of side-effects.
0 mg/kg of body weight depending on individual response and tolerance. 0 mg/kg the daily dose should be maintained at the highest level which is not accompanied by unacceptable toxicity. 5 mg/kg. Since amphotericin B is excreted slowly, therapy may be given on alternate days in patients on the higher dosage schedule.
Several months of therapy are usually necessary; a shorter period of therapy may produce an inadequate response and lead to relapse. When commencing all new courses of treatment, it is advisable to administer a test dose immediately preceding the first dose.
e. 10 mL) should be infused over 20-30 minutes and the patient carefully observed for at least a further 30 minutes. It should be noted that patient responses to the test dose may not be predictive of subsequent severe side effects. 3 mg/kg amphotericin B intravenously over a period of 2 to 6 hours.
e. 5 to 10 mg) is recommended. 5 to 1 mg/kg. e. 25 mg/kg of body weight and increased gradually. The recommended concentration for intravenous infusion is 10 mg/100 mL. Paediatric population Safety and effectiveness in paediatric patients have not been established through adequate and well-controlled studies.
Systemic fungal infections have been treated in paediatric patients with reports of side effects similar to those seen in adults. Older people No specific dosage recommendations or precautions. g. candiduria): Continuous irrigation with 50 mg Fungizone in 1 litre sterile water each day until urinary cultures are negative.
5- 200 mcg/mL) has also been reported. The urine should be alkalinised (with potassium citrate) and antifungal ointment applied to the perineal area. g. pulmonary aspergillosis): 8-40 mg amphotericin B (nebulised in sterile water or 5% Glucose) has been given daily in divided doses.
Concurrent eradication of oral and intestinal yeast reservoirs is recommended. g. coccidiodal meningitis): Patients who do not respond to fluconazole or itraconazole would be candidates for intrathecal amphotericin B therapy with or without continuation of azole treatment.
5 mg per dose, administered at intervals ranging from daily to weekly, beginning at a low dosage and increasing the dosage until the appearance of patient intolerance. Amphotericin B is irritating when injected into the CSF.
Other:
Other uses of solutions prepared using Fungizone include local instillations for the treatment of fungal infections of the ear, eye, peritoneum, lung cavities and joint spaces. 6.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised March 6, 2026[1]

The table below lists all adverse events. The list is presented by system organ class and frequency, which is defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
4. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

GBOfficial regulatory label· Warnings and precautions· revised March 6, 2026[1]

Prolonged therapy with amphotericin B is usually necessary. Unpleasant reactions are quite common when the drug is given parenterally at therapeutic dosage levels. Some of these reactions are potentially dangerous. Hence amphotericin B should be used parenterally only in hospitalised patients, or those under close clinical observation.
Accidental overdose Care must be taken when administering Fungizone to prevent overdose, which can result in potentially fatal cardiac or cardiorespiratory arrest. 9). Rapid intravenous infusion, over less than one hour, particularly in patients with renal insufficiency, has been associated with hyperkalaemia and arrhythmias and should therefore be avoided.
2). Infusion related reactions While some patients may tolerate full intravenous doses of amphotericin B without difficulty, most will exhibit some intolerance particularly during the initiation of therapy. In patients experiencing adverse reactions these may be made less severe by giving aspirin, other antipyretics, antihistamines or anti- emetics.
Pethidine (25 to 50 mg IV) has been used in some patients to decrease the duration or intensity of shaking chills and fever following amphotericin B therapy. g. 25 mg hydrocortisone. This may be administered just prior to or during amphotericin B infusion.
The dosage and duration of such corticosteroid therapy should be kept to a minimum. Administration of the drug on alternate days may decrease anorexia and phlebitis. Adding a small amount of heparin (1000 units per infusion) to the infusion, rotation of the injection site, the use of a paediatric scalp-vein needle and alternate day therapy may lessen the incidence of thrombophlebitis and coagulation problems.
Extravasation may cause chemical irritation. Corticosteroids should not be administered concomitantly unless they are necessary to control drug reactions. Renal toxicity Renal function test abnormalities are commonly observed and usually improve upon interruption of therapy; however, some permanent impairment often occurs, especially in those patients receiving large cumulative amounts (over 5 g) of amphotericin B.
Concomitant diuretic therapy may be a predisposition for renal impairment, whereas sodium repletion or supplementation may reduce the occurrence of nephrotoxicity. If serum creatinine exceeds 260 micromol/L the drug should be discontinued or the dosage markedly reduced until renal function is improved.
Weekly blood counts and serum potassium determinations are also advisable. Low serum magnesium levels have also been noted during treatment with amphotericin B. Hepatic toxicity Therapy should be discontinued if liver function test results (elevated bromsulphalein, alkaline phosphatase and bilirubin) are abnormal.
Neurotoxicity Leucoencephalopathy has been reported very occasionally following the use of amphotericin B injection in patients who received total body irradiation. Most of these patients received high cumulative doses of amphotericin B.
g. coccidioidal meningitis). Other nephrotoxic antibiotics and antineoplastic agents should not be given concomitantly except with great caution. e. essentially ‘sodium free’.

This is not medical advice. Consult a qualified healthcare professional.