Amphotericin B 50 mg Injectable, Liposomal — NDC 62756-233-02 (Billing 62756-0233-02)
This is a package of Amphotericin B 50 mg Injectable, Liposomal from Sun Pharmaceutical Industries, Inc., marketed since Feb 2022 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 62756-233-02 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 62756 labeler · 233 product · 02 package
- Package marketed since
- Feb 9, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0362756233010
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 030773
- GCN: 07387
- GPI-14 (Medi-Span): 11000010401920
- HICL (First Databank): 012800
- AHFS class code: 08:14.28.00
- RxCUI (RxNorm): 967385
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Polyene Antifungal class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Amphotericin B injection is used to treat serious and potentially life-threatening fungal infections. Amphotericin B injection is in a class of medications called antifungals. It works by slowing the growth of fungi that cause infection.
Read the full MedlinePlus article ↗- It treats serious, life-threatening fungal infections. The liposomal product AmBisome is also used for fever in people with low white blood cell counts who may have a fungal infect...
- It is given slowly through a vein by healthcare professionals. Conventional amphotericin B infusions take about 2 to 6 hours, and you may get a small test dose first. Your team wil...
- Chills, fever, nausea, vomiting, diarrhea and low potassium are common. AmBisome tends to cause fewer chills and kidney effects than conventional amphotericin B. Tell your nurse ri...
- Amphotericin B can affect your kidneys and lower potassium, which can strain the heart. Your team watches your kidney function and electrolytes closely.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Amphotericin B — tap one for details:
Amphotericin B may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $213.99 | $2,139.90 / 10 injectable |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 6, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 62756-0233-01 62756-233-01 Main listing | 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE | 2022-02-09 | — | Active |
| 62756-0233-02 You're viewing this | 10 CARTON in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE | 2022-02-09 | — | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Amphotericin B 50 mg Injectable, Liposomal?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| AmBisome 50 mg/12.5mL 00469-3051-30 | Astellas | 12.5 ml | — | AB | Discontinued | — |
| Amphotericin B 50 mg 23155-0594-31 | Heritage | 1 vial | — | AB | FDA listed | — |
| Amphotericin B 50 mg/12.5mL 55150-0365-01 | Eugia | 1 vial | — | AB | FDA listed | — |
| Amphotericin B 50 mgthis 62756-0233-02 | Sun | 1 vial | — | AB | FDA listed | — |
| Amphotericin B 50 mg 62756-0954-01 | Sun | 1 vial | — | AB | FDA listed | — |
| Amphotericin B liposome 50 mg/12.5mL 67457-0926-50 | Mylan | 1 vial | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Amphotericin B Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Sun Pharmaceutical Industries, Inc. labeler code 62756
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- Capecitabine 150 mg Tablet, Film Coated NDC 62756-238-18
- Capecitabine 500 mg Tablet, Film Coated NDC 62756-239-18
- ondansetron 4 mg Tablet, Orally Disintegrating NDC 62756-240-64
- Zolpidem Tartrate 25 kg/25kg Powder NDC 62756-243-11
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Amphotericin B liposome for injection is indicated for the following: Empirical therapy for presumed fungal infection in febrile, neutropenic patients. Treatment of Cryptococcal Meningitis in HIV infected patients (see DESCRIPTION OF CLINICAL STUDIES) . Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate.
Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES) . See DOSAGE AND ADMINISTRATION for recommended doses by indication.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Amphotericin B liposome for injection is not interchangeable or substitutable on a mg per mg basis with other amphotericin B products. Different amphotericin B products are not equivalent in terms of pharmacodynamics, pharmacokinetics and dosing. Amphotericin B liposome for injection should be administered by intravenous infusion, using a controlled infusion device, over a period of approximately 120 minutes.
An in-line membrane filter may be used for the intravenous infusion of amphotericin B liposome for injection; provided THE MEAN PORE DIAMETER OF THE FILTER IS NOT LESS THAN
1.0MICRON. NOTE: An existing intravenous line must be flushed with 5% Dextrose Injection prior to infusion of amphotericin B liposome for injection. If this is not feasible, amphotericin B liposome for injection must be administered through a separate line.
Infusion time may be reduced to approximately 60 minutes in patients in whom the treatment is well-tolerated. If the patient experiences discomfort during infusion, the duration of infusion may be increased. The recommended initial dose of amphotericin B liposome for injection for each indication for adult and pediatric patients is as follows: Indication Dose (mg/kg/day) Empirical therapy 3 Systemic fungal infections: Aspergillus Candida Cryptococcus 3 to 5 Cryptococcal meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES ) 6 Dosing and rate of infusion should be individualized to the needs of the specific patient to ensure maximum efficacy while minimizing systemic toxicities or adverse events.
Doses recommended for visceral leishmaniasis are presented below: Visceral Leishmaniasis Dose (mg/kg/day) Immunocompetent patients 3 (days 1 to 5) and 3 on days 14, 21 Immunocompromised patients 4 (days 1 to 5) and 4 on days 10, 17, 24, 31, 38 For immunocompetent patients who do not achieve parasitic clearance with the recommended dose, a repeat course of therapy may be useful. For immunocompromised patients who do not clear parasites or who experience relapses, expert advice regarding further treatment is recommended.
For additional information see DESCRIPTION OF CLINICAL STUDIES. Directions for Reconstitution, Filtration and Dilution Read This Entire Section Carefully Before Beginning Reconstitution Amphotericin B liposome for injection must be reconstituted using Sterile Water for Injection, USP (without a bacteriostatic agent). Vials of amphotericin B liposome for injection containing 50 mg of amphotericin B are prepared as follows: Reconstitution 1.
Aseptically add 12 mL of Sterile Water for Injection, USP to each amphotericin B liposome for injection vial to yield a preparation containing 4 mg amphotericin B/mL. CAUTION: DO NOT RECONSTITUTE WITH SALINE OR ADD SALINE TO THE RECONSTITUTED CONCENTRATION, OR MIX WITH OTHER DRUGS. The use of any solution other than those recommended, or the presence of a bacteriostatic agent in the solution, may cause precipitation of amphotericin B liposome for injection.
2. Immediately after the addition of water, SHAKE THE VIAL VIGOROUSLY for 30 seconds to completely disperse the amphotericin B liposome for injection. Amphotericin B liposome for injection forms a yellow, translucent suspension.
Visually inspect the vial for particulate matter and continue shaking until completely dispersed. Filtration and Dilution 3. Calculate the amount of reconstituted (4 mg/mL) amphotericin B liposome for injection to be further diluted.
4. Withdraw this amount of reconstituted amphotericin B liposome for injection into a sterile syringe. 5.
Attach the 5 micron filter provided to the syringe. Inject the syringe contents through the filter, into the appropriate amount of 5% Dextrose Injection (use only one filter per vial of amphotericin B liposome for injection). 6.
Amphotericin B liposome for injection must be diluted with 5% Dextrose Injection to a final concentration of 1 mg/mL to 2 mg/mL prior to administration. Lower concentrations (… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Amphotericin B liposome for injection is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk.
⚠️ Warnings ▾
WARNINGS Anaphylaxis has been reported with amphotericin B deoxycholate and other amphotericin B-containing drugs, including amphotericin B liposome for injection. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of amphotericin B liposome for injection.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse events are based on the experience of 592 adult patients (295 treated with amphotericin B liposome for injection and 297 treated with amphotericin B deoxycholate) and 95 pediatric patients (48 treated with amphotericin B liposome for injection and 47 treated with amphotericin B deoxycholate) in Study 94-0-002, a randomized double-blind, multicenter study in febrile, neutropenic patients. Amphotericin B liposome for injection and amphotericin B were infused over two hours. The incidence of common adverse events (incidence of 10% or greater) occurring with amphotericin B liposome for injection compared to amphotericin B deoxycholate, regardless of relationship to study drug, is shown in the following table: Empirical Therapy Study 94-0-002 Common Adverse Events Adverse Event by Body System Amphotericin B Liposome for Injection N=343 % Amphotericin B N=344 % Body as a Whole Abdominal pain 19.8
21.8Asthenia 13.1
10.8 Back pain 12
7.3Blood product transfusion reaction 18.4
18.6Chills 47.5
75.9Infection 11.1
9.3 Pain 14
12.8 Sepsis 14
11.3 Cardiovascular System Chest pain 12
11.6Hypertension 7.9
16.3Hypotension 14.3
21.5Tachycardia 13.4
20.9Digestive System Diarrhea 30.3
27.3Gastrointestinal hemorrhage 9.9
11.3Nausea 39.7
38.7Vomiting 31.8
43.9Metabolic and Nutritional Disorders Alkaline phosphatase increased 22.2
19.2ALT (SGPT) increased 14.6 14 AST (SGOT) increased 12.8
12.8Bilirubinemia 18.1
19.2 BUN increased 21
31.1Creatinine increased 22.4
42.2Edema 14.3
14.8 Hyperglycemia 23
27.9Hypernatremia 4.1 11 Hypervolemia 12.2
15.4Hypocalcemia 18.4
20.9Hypokalemia 42.9
50.6Hypomagnesemia 20.4
25.6Peripheral edema 14.6
17.2Nervous System Anxiety 13.7 11 Confusion 11.4
13.4Headache 19.8
20.9Insomnia 17.2
14.2Respiratory System Cough increased 17.8
21.8 Dyspnea 23
29.1Epistaxis 14.9
20.1Hypoxia 7.6
14.8Lung disorder 17.8
17.4Pleural effusion 12.5
9.6Rhinitis 11.1 11 Skin and Appendages Pruritus 10.8
10.2Rash 24.8
24.4 Sweating 7
10.8Urogenital System Hematuria 14 14 Amphotericin B liposome for injection was well tolerated. Amphotericin B liposome for injection had a lower incidence of chills, hypertension, hypotension, tachycardia, hypoxia, hypokalemia, and various events related to decreased kidney function as compared to amphotericin B deoxycholate. In pediatric patients (16 years of age or less) in this double-blind study, amphotericin B liposome for injection compared to amphotericin B deoxycholate had a lower incidence of hypokalemia (37% versus 55%), chills (29% versus 68%), vomiting (27% versus 55%), and hypertension (10% versus 21%).
Similar trends, although with a somewhat lower incidence, were observed in open-label, randomized Study 104-14 involving 205 febrile neutropenic pediatric patients (141 treated with amphotericin B liposome for injection and 64 treated with amphotericin B deoxycholate). Pediatric patients appear to have more tolerance than older individuals for the nephrotoxic effects of amphotericin B deoxycholate. The following adverse events are based on the experience of 244 patients (202 adult and 42 pediatric patients) of whom 85 patients were treated with amphotericin B liposome for injection 3 mg/kg, 81 patients were treated with amphotericin B liposome for injection 5 mg/kg and 78 patients were treated with amphotericin B lipid complex 5 mg/kg in Study 97-0-034, a randomized double-blind, multicenter study in febrile, neutropenic patients.
Amphotericin B liposome for injection and amphotericin B lipid complex were infused over two hours. The incidence of adverse events occurring in more than 10% of subjects in one or more arms regardless of relationship to study drug are summarized in the following table: Empirical Therapy Study 97-0-034 Common Adverse Events Adverse Event by Body System Amphotericin B Liposome for Injection 3 mg/kg/day N=85 % Amphotericin B Liposome for Injection 5 mg/kg/day N=81 % Amphotericin B Lipid Complex 5 mg/kg/day… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
Drug Interactions No formal clinical studies of drug interactions have been conducted with amphotericin B liposome for injection. However, the following drugs are known to interact with amphotericin B and may interact with amphotericin B liposome for injection: Antineoplastic Agents Concurrent use of antineoplastic agents may enhance the potential for renal toxicity, bronchospasm, and hypotension. Antineoplastic agents should be given concomitantly with caution.
Corticosteroids and Corticotropin (ACTH) Concurrent use of corticosteroids and ACTH may potentiate hypokalemia, which could predispose the patient to cardiac dysfunction. If used concomitantly, serum electrolytes and cardiac function should be closely monitored. Digitalis Glycosides Concurrent use may induce hypokalemia and may potentiate digitalis toxicity.
When administered concomitantly, serum potassium levels should be closely monitored. Flucytosine Concurrent use of flucytosine may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion. Azoles (e.g. ketoconazole, miconazole, clotrimazole, fluconazole, etc.) In vitro and in vivo animal studies of the combination of amphotericin B and imidazoles suggest that imidazoles may induce fungal resistance to amphotericin B.
Combination therapy should be administered with caution, especially in immunocompromised patients. Leukocyte Transfusions Acute pulmonary toxicity has been reported in patients simultaneously receiving intravenous amphotericin B and leukocyte transfusions. Other Nephrotoxic Medications Concurrent use of amphotericin B and other nephrotoxic medications may enhance the potential for drug-induced renal toxicity.
Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications. Skeletal Muscle Relaxants Amphotericin B-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g. tubocurarine) due to hypokalemia. When administered concomitantly, serum potassium levels should be closely monitored.
🔄 Drug / Laboratory Test Interactions ▾
Drug-Laboratory Interactions: Serum phosphate false elevation False elevations of serum phosphate may occur when samples from patients receiving amphotericin B liposome for injection are analyzed using the PHOSm assay (e.g. used in Beckman Coulter analyzers including the Synchron LX20). This assay is intended for the quantitative determination of inorganic phosphorus in human serum, plasma or urine samples.
🤰 Pregnancy ▾
Pregnancy There have been no adequate and well-controlled studies of amphotericin B liposome for injection in pregnant women. Systemic fungal infections have been successfully treated in pregnant women with amphotericin B deoxycholate, but the number of cases reported has been small. Segment II studies in both rats and rabbits have concluded that amphotericin B liposome for injection had no teratogenic potential in these species.
In rats, the maternal non-toxic dose of amphotericin B liposome for injection was estimated to be 5 mg/kg (equivalent to 0.16 to 0.8 times the recommended human clinical dose range of 1 mg/kg to 5 mg/kg) and in rabbits, 3 mg/kg (equivalent to 0.2 to 1 times the recommended human clinical dose range), based on body surface area correction. Rabbits receiving the higher doses, (equivalent to 0.5 to 2 times the recommended human dose) of amphotericin B liposome for injection experienced a higher rate of spontaneous abortions than did the control groups.
Amphotericin B liposome for injection should only be used during pregnancy if the possible benefits to be derived outweigh the potential risks involved.
🧒 Pediatric Use ▾
Pediatric Use Pediatric patients, age 1 month to 16 years, with presumed fungal infection (empirical therapy), confirmed systemic fungal infections or with visceral leishmaniasis have been successfully treated with amphotericin B liposome for injection. In studies which included 302 pediatric patients administered amphotericin B liposome for injection, there was no evidence of any differences in efficacy or safety of amphotericin B liposome for injection compared to adults. Since pediatric patients have received amphotericin B liposome for injection at doses comparable to those used in adults on a per kilogram body weight basis, no dosage adjustment is required in this population.
Safety and effectiveness in pediatric patients below the age of one month have not been established. (See DESCRIPTION OF CLINICAL STUDIES - Empirical Therapy in Febrile Neutropenic Patients and DOSAGE AND ADMINISTRATION ).
🧓 Geriatric Use ▾
Elderly Patients Experience with amphotericin B liposome for injection in the elderly (65 years or older) comprised 72 patients. It has not been necessary to alter the dose of amphotericin B liposome for injection for this population. As with most other drugs, elderly patients receiving amphotericin B liposome for injection should be carefully monitored.
🆘 Overdosage ▾
OVERDOSAGE The toxicity of amphotericin B liposome for injection due to overdose has not been defined. Repeated daily doses up to 10 mg/kg in pediatric patients and 15 mg/kg in adult patients have been administered in clinical trials with no reported dose-related toxicity. Management If overdosage should occur, cease administration immediately.
Symptomatic supportive measures should be instituted. Particular attention should be given to monitoring renal function. Hemodialysis or peritoneal dialysis do not appear to significantly affect the elimination of amphotericin B liposome for injection.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics The assay used to measure amphotericin B in the serum after administration of amphotericin B liposome for injection does not distinguish amphotericin B that is complexed with the phospholipids of amphotericin B liposome for injection from amphotericin B that is uncomplexed. The pharmacokinetic profile of amphotericin B after administration of amphotericin B liposome for injection is based upon total serum concentrations of amphotericin B. The pharmacokinetic profile of amphotericin B was determined in febrile neutropenic cancer and bone marrow transplant patients who received 1 to 2 hour infusions of 1 mg/kg/day to 5 mg/kg/day amphotericin B liposome for injection for 3 to 20 days.
The pharmacokinetics of amphotericin B after administration of amphotericin B liposome for injection is nonlinear such that there is a greater than proportional increase in serum concentrations with an increase in dose from 1 mg/kg/day to 5 mg/kg/day. The pharmacokinetic parameters of total amphotericin B (mean ± SD) after the first dose and at steady state are shown in the table below. Pharmacokinetic Parameters of Amphotericin B Liposome for Injection Dose 1 mg/kg/day 2.5 mg/kg/day 5 mg/kg/day Day 1 n = 8 Last n = 7 1 n = 7 Last n = 7 1 n = 12 Last n = 9 Parameters Cmax (mcg/mL) 7.3 ± 3.8 12.2 ± 4.9 17.2 ± 7.1 31.4 ± 17.8 57.6 ± 21 83 ±
35.2AUC0-24 (mcg•hr/mL) 27 ± 14 60 ± 20 65 ± 33 197 ± 183 269 ± 96 555 ± 311 t½(hr) 10.7 ± 6.4 7 ± 2.1 8.1 ± 2.3 6.3 ± 2 6.4 ± 2.1 6.8 ±
2.1Vss (L/kg) 0.44 ± 0.27 0.14 ± 0.05 0.40 ± 0.37 0.16 ± 0.09 0.16 ± 0.10 0.10 ±
0.07Cl (mL/hr/kg) 39 ± 22 17 ± 6 51 ± 44 22 ± 15 21 ± 14 11 ± 6 Distribution Based on total amphotericin B concentrations measured within a dosing interval (24 hours) after administration of amphotericin B liposome for injection, the mean half-life was 7 to 10 hours. However, based on total amphotericin B concentration measured up to 49 days after dosing of amphotericin B liposome for injection, the mean half-life was 100 to 153 hours. The long terminal elimination half-life is probably a slow redistribution from tissues.
Steady state concentrations were generally achieved within 4 days of dosing. Although variable, mean trough concentrations of amphotericin B remained relatively constant with repeated administration of the same dose over the range of 1 mg/kg/day to 5 mg/kg/day, indicating no significant drug accumulation in the serum. Metabolism The metabolic pathways of amphotericin B after administration of amphotericin B liposome for injection are not known.
Excretion The mean clearance at steady state was independent of dose. The excretion of amphotericin B after administration of amphotericin B liposome for injection has not been studied. Pharmacokinetics in Special Populations Renal Impairment The effect of renal impairment on the disposition of amphotericin B after administration of amphotericin B liposome for injection has not been studied.
However, amphotericin B liposome for injection has been successfully administered to patients with preexisting renal impairment (see DESCRIPTION OF CLINICAL STUDIES ). Hepatic Impairment The effect of hepatic impairment on the disposition of amphotericin B after administration of amphotericin B liposome for injection is not known. Pediatric and Elderly Patients The pharmacokinetics of amphotericin B after administration of amphotericin B liposome for injection in pediatric and elderly patients has not been studied; however, amphotericin B liposome for injection has been used in pediatric and elderly patients (see DESCRIPTION OF CLINICAL STUDIES ).
Gender and Ethnicity The effect of gender or ethnicity on the pharmacokinetics of amphotericin B after administration of amphotericin B liposome for injection is not known.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Amphotericin B liposome for injection, 50 mg/vialis supplied as yellow colored lyophilized mass, available in single carton (NDC 62756-233-01) and in packs of ten individual vial cartons (NDC 62756-233-02). Each carton contains one pre-packaged, disposable sterile 5 micron filter. Discard unused portion. * All trademarks are the property of their respective owners.
Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Limited Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. ISS.
04/2026
📋 Description ▾
DESCRIPTION Amphotericin B liposome for injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains amphotericin B, USP 50 milligrams (mg), intercalated into a liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cholesterol 52 mg; distearoylphosphatidylglycerol, sodium salt 84 mg; hydrogenated soy phosphatidylcholine 213 mg, together with disodium succinate hexahydrate 27 mg; and sucrose 900 mg. Amphotericin B liposome for injection may also contain hydrochloric acid and/or sodium hydroxide as pH adjusters.
Following reconstitution with Sterile Water for Injection, the resulting pH of the suspension is between 5.0 to 6.0. Amphotericin B liposome for injection is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions.
Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. Amphotericin B liposome for injection consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the Amphotericin B liposomes.
Amphotericin B liposome for injection contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below. Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug.
In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products. Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced 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-ß-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 (CAS No.1397-89-3). Amphotericin B has a molecular formula of C 47 H 73 NO 17 and a molecular weight of 924.09 g/mol. The structure of amphotericin B is shown below: spl-ampho-lipo-structure spl-amphotercin-structure
⚠️ Precautions ▾
PRECAUTIONS General As with any amphotericin B-containing product the drug should be administered by medically trained personnel. During the initial dosing period, patients should be under close clinical observation. Amphotericin B liposome for injection has been shown to be significantly less toxic than amphotericin B deoxycholate; however, adverse events may still occur.
Laboratory Tests Patient management should include laboratory evaluation of renal, hepatic and hematopoietic function, and serum electrolytes (particularly magnesium and potassium). Drug-Laboratory Interactions: Serum phosphate false elevation False elevations of serum phosphate may occur when samples from patients receiving amphotericin B liposome for injection are analyzed using the PHOSm assay (e.g. used in Beckman Coulter analyzers including the Synchron LX20). This assay is intended for the quantitative determination of inorganic phosphorus in human serum, plasma or urine samples.
Drug Interactions No formal clinical studies of drug interactions have been conducted with amphotericin B liposome for injection. However, the following drugs are known to interact with amphotericin B and may interact with amphotericin B liposome for injection: Antineoplastic Agents Concurrent use of antineoplastic agents may enhance the potential for renal toxicity, bronchospasm, and hypotension. Antineoplastic agents should be given concomitantly with caution.
Corticosteroids and Corticotropin (ACTH) Concurrent use of corticosteroids and ACTH may potentiate hypokalemia, which could predispose the patient to cardiac dysfunction. If used concomitantly, serum electrolytes and cardiac function should be closely monitored. Digitalis Glycosides Concurrent use may induce hypokalemia and may potentiate digitalis toxicity.
When administered concomitantly, serum potassium levels should be closely monitored. Flucytosine Concurrent use of flucytosine may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion. Azoles (e.g. ketoconazole, miconazole, clotrimazole, fluconazole, etc.) In vitro and in vivo animal studies of the combination of amphotericin B and imidazoles suggest that imidazoles may induce fungal resistance to amphotericin B.
Combination therapy should be administered with caution, especially in immunocompromised patients. Leukocyte Transfusions Acute pulmonary toxicity has been reported in patients simultaneously receiving intravenous amphotericin B and leukocyte transfusions. Other Nephrotoxic Medications Concurrent use of amphotericin B and other nephrotoxic medications may enhance the potential for drug-induced renal toxicity.
Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications. Skeletal Muscle Relaxants Amphotericin B-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g. tubocurarine) due to hypokalemia. When administered concomitantly, serum potassium levels should be closely monitored.
Carcinogenesis, Mutagenesis, Impairment of Fertility No long term studies in animals have been performed to evaluate carcinogenic potential of amphotericin B liposome for injection. Amphotericin B liposome for injection has not been tested to determine its mutagenic potential. A Segment I Reproductive Study in rats found an abnormal estrous cycle (prolonged diestrus) and decreased number of corpora lutea in the high dose groups (10 mg/kg and 15 mg/kg, doses equivalent to human doses of 1.6 mg/kg and 2.4 mg/kg based on body surface area considerations).
Amphotericin B liposome for injection did not affect fertility or days to copulation. There were no effects on male reproductive function. Pregnancy There have been no adequate and well-controlled studies of amphotericin B liposome for injection in pregnant women.
Systemic fungal infections have been successfully treated in pregnant women with amphotericin B deoxycholate, but th… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers Many drugs are excreted in human milk. However, it is not known whether amphotericin B is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or whether to discontinue the drug, taking into account the importance of the drug to the mother.
🔬 Clinical Studies ▾
DESCRIPTION OF CLINICAL STUDIES Eleven clinical studies supporting the efficacy and safety of amphotericin B liposome for injection were conducted. This clinical program included both controlled and uncontrolled studies. These studies, which involved 2,171 patients, included patients with confirmed systemic mycoses, empirical therapy, and visceral leishmaniasis.
Nineteen hundred and forty-six (1946) episodes were evaluable for efficacy, of which 1,280 (302 pediatric and 978 adults) were treated with amphotericin B liposome for injection. Three controlled empirical therapy trials compared the efficacy and safety of amphotericin B liposome for injection to amphotericin B. One of these studies was conducted in a pediatric population, one in adults, and a third in patients aged 2 years or more.
In addition, a controlled empirical therapy trial comparing the safety of amphotericin B liposome for injection to Abelcet®* (amphotericin B lipid complex) was conducted in patients aged 2 years or more. One controlled trial compared the efficacy and safety of amphotericin B liposome for injection to amphotericin B in HIV patients with cryptococcal meningitis. One compassionate use study enrolled patients who had failed amphotericin B deoxycholate therapy or who were unable to receive amphotericin B deoxycholate because of renal insufficiency.
Empirical Therapy in Febrile Neutropenic Patients Study 94-0-002, a randomized, double-blind, comparative multicenter trial, evaluated the efficacy of amphotericin B liposome for injection (1.5 mg/kg/day to 6 mg/kg/day) compared with amphotericin B deoxycholate (0.3 mg/kg/day to 1.2 mg/kg/day) in the empirical treatment of 687 adult and pediatric neutropenic patients who were febrile despite having received at least 96 hours of broad spectrum antibacterial therapy. Therapeutic success required (a) resolution of fever during the neutropenic period, (b) absence of an emergent fungal infection, (c) patient survival for at least 7 days post therapy, (d) no discontinuation of therapy due to toxicity or lack of efficacy, and (e) resolution of any study-entry fungal infection.
The overall therapeutic success rates for amphotericin B liposome for injection and the amphotericin B deoxycholate were equivalent. Results are summarized in the following table. Note: The categories presented below are not mutually exclusive.
Empirical Therapy in Febrile Neutropenic Patients: Randomized, Double-Blind Study in 687 Patients Amphotericin B Liposome for Injection 3 mg/kg/day Amphotericin B 0.6 mg/kg/day Number of patients receiving at least one dose of study drug 343 344 Overall Success 171 (49.9%) 169 (49.1%) Fever resolution during neutropenic period 199 (58%) 200 (58.1%) No treatment emergent fungal infection 300 (87.5%) 301 (87.7%) Survival through 7 days post study drug 318 (92.7%) 308 (89.5%) Study drug not prematurely discontinued due to toxicity or lack of efficacy* 294 (85.7%) 280 (81.4%) * 8 and 10 patients, respectively, were treated as failures due to premature discontinuation alone.
This therapeutic equivalence had no apparent relationship to the use of prestudy antifungal prophylaxis or concomitant granulocytic colony stimulating factors. The incidence of mycologically confirmed and clinically diagnosed, emergent fungal infections are presented in the following table. Amphotericin B liposome for injection and amphotericin B were found to be equivalent with respect to the total number of emergent fungal infections.
Empirical Therapy in Febrile Neutropenic Patients: Emergent Fungal Infections Amphotericin B Liposome for Injection 3 mg/kg/day Amphotericin B 0.6 mg/kg/day Number of patients receiving at least one dose of study drug 343 344 Mycologically confirmed fungal infection 11 (3.2%) 27 (7.8%) Clinically diagnosed fungal infection 32 (9.3%) 16 (4.7%) Total emergent fungal infections 43 (12.5%) 43 (12.5%) Mycologically confirmed fungal infections at study-entry were cured in 8 of 11 patients in the amphote… [Excerpted — this section continues on DailyMed.]
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility No long term studies in animals have been performed to evaluate carcinogenic potential of amphotericin B liposome for injection. Amphotericin B liposome for injection has not been tested to determine its mutagenic potential. A Segment I Reproductive Study in rats found an abnormal estrous cycle (prolonged diestrus) and decreased number of corpora lutea in the high dose groups (10 mg/kg and 15 mg/kg, doses equivalent to human doses of 1.6 mg/kg and 2.4 mg/kg based on body surface area considerations).
Amphotericin B liposome for injection did not affect fertility or days to copulation. There were no effects on male reproductive function.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- Vial NDC 62756-233-01 Amphotericin B Liposome for Injection 50 mg/vial Amphotericin B liposome for injection is Not Interchangeable or Substitutable on a mg per mg Basis with other Amphotericin B Products. Must be reconstituted and further diluted For Intravenous Infusion Only Sterile, nonpyrogenic Rx only One Single-Dose Vial sun vial label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-Show Box NDC 62756-233-01 Amphotericin B Liposome for Injection, 50 mg/vial Amphotericin B liposome for injection is Not Interchangeable or Substitutable on a mg per mg Basis with other Amphotericin B Products. Must be reconstituted and further diluted For Intravenous Infusion Only Sterile, nonpyrogenic Rx only One Single-Dose Vial SUN PHARMA sun carton label
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| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
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