Ambisome 50mg

Ambisome 50mg

Description

Amphotericin B 50mg Injection — Liposomal Antifungal for Severe and Invasive Fungal Infections

Additional Information

Ambisome® (Amphotericin B Liposomal) — Gold Standard Treatment for Severe Invasive Fungal Infections

The Safest and Most Effective Formulation of Amphotericin B for Life-Threatening Fungal Infections

Ambisome® (Amphotericin B Liposomal) is a liposomal formulation of Amphotericin B — the most potent and broad-spectrum antifungal medicine available. Ambisome encapsulates Amphotericin B within unilamellar liposomes, dramatically reducing the nephrotoxicity and infusion-related reactions associated with conventional Amphotericin B while maintaining its exceptional antifungal efficacy against a wide range of life-threatening fungal infections.

A.K. Pharma is a trusted medicine distributor in Delhi supplying genuine Ambisome (Amphotericin B Liposomal) to hospitals, haematology centres, oncology units, ICUs, and pharmacies across India. Manufactured by Gilead Sciences, Ambisome is the gold standard treatment for invasive fungal infections in immunocompromised patients where conventional antifungals have failed or cannot be used.


What is Ambisome (Amphotericin B Liposomal)?

Ambisome contains Amphotericin B encapsulated within small unilamellar liposomes — microscopic lipid vesicles approximately 80-120nm in diameter. This liposomal encapsulation fundamentally changes the pharmacokinetics and pharmacodynamics of Amphotericin B:

  • Liposomes preferentially accumulate at sites of fungal infection and in the reticuloendothelial system
  • Amphotericin B is released selectively at sites of infection
  • Reduced interaction with mammalian cell membranes — dramatically lower nephrotoxicity
  • Higher plasma concentrations achievable compared to conventional Amphotericin B
  • Longer half-life enabling once-daily dosing

Amphotericin B works by binding to ergosterol in the fungal cell membrane — forming pores that increase membrane permeability, causing leakage of essential cellular components and fungal cell death. Because mammalian cells contain cholesterol rather than ergosterol, Amphotericin B has selective fungicidal activity — the liposomal formulation further improves this selectivity.

Full prescribing information is available at the FDA label for Amphotericin B Liposomal.


Clinical Studies and Evidence

AmBiLoad Trial (High vs Standard Dose Ambisome in Invasive Aspergillosis) Published in Clinical Infectious Diseases (2007), the AmBiLoad trial compared high-dose (10mg/kg/day) vs standard-dose (3mg/kg/day) Ambisome in invasive aspergillosis — demonstrating similar efficacy with standard dosing and better tolerability.

Ambisome vs Conventional Amphotericin B (Pivotal Safety Trial) Published in Clinical Infectious Diseases (1999), the pivotal comparative trial demonstrated Ambisome achieved comparable efficacy to conventional Amphotericin B in invasive fungal infections but with dramatically reduced nephrotoxicity — serum creatinine doubling occurred in 18.9% vs 33.3% of patients — and fewer infusion-related reactions.

Empirical Therapy in Febrile Neutropenia Published in the New England Journal of Medicine (1999), a landmark trial demonstrated Ambisome was equivalent to conventional Amphotericin B for empirical antifungal therapy in febrile neutropenic patients but with significantly fewer side effects — establishing Ambisome as the preferred empirical antifungal in this high-risk population.

Visceral Leishmaniasis Studies Multiple trials have demonstrated Ambisome’s exceptional efficacy in visceral leishmaniasis (kala-azar) — achieving cure rates of 95%+ with short-course therapy — making it the treatment of choice for this indication in India.


Available Strengths

Ambisome is available as:

  • 50mg powder for concentrate for solution for infusion (vial)

Reconstituted with water for injection then further diluted in 5% glucose for IV infusion. Doses vary by indication — typically 3-5mg/kg/day for fungal infections and 3-5mg/kg/day for visceral leishmaniasis (single or divided doses depending on protocol).


Indications — What Ambisome is Used For

Invasive Fungal Infections:

  • Treatment of severe systemic and deep tissue fungal infections caused by Aspergillus, Candida, and Cryptococcus species
  • Treatment of invasive aspergillosis in patients refractory to or intolerant of conventional Amphotericin B
  • Empirical antifungal therapy in febrile neutropenic patients

Specific Infections:

  • Invasive aspergillosis
  • Invasive candidiasis including candidaemia
  • Cryptococcal meningitis — particularly in HIV patients
  • Mucormycosis
  • Fusariosis
  • Histoplasmosis
  • Coccidioidomycosis

Visceral Leishmaniasis (Kala-Azar):

  • Treatment of visceral leishmaniasis — particularly important in India where Ambisome is recommended as first-line therapy for drug-resistant kala-azar

For detailed indication information refer to MedlinePlus Amphotericin B Liposomal.


Key Benefits of Ambisome

Dramatically Reduced Nephrotoxicity The liposomal formulation reduces kidney toxicity — the major dose-limiting side effect of conventional Amphotericin B — from 33% to under 19% based on pivotal trial data. This allows higher cumulative doses to be administered safely.

Fewer Infusion-Related Reactions Ambisome causes significantly fewer infusion-related reactions (fever, rigors, chills) compared to conventional Amphotericin B — improving patient tolerance and reducing the need for pre-medication.

Broadest Antifungal Spectrum Available Ambisome covers virtually all clinically important fungal pathogens including Aspergillus, Candida, Cryptococcus, Mucorales, Fusarium, Histoplasma, and Coccidioides — making it the most versatile antifungal available.

Active Against Mucorales Ambisome is one of the first-line treatments for mucormycosis — a rapidly progressive and often fatal infection in immunocompromised patients. Unlike many azoles, Amphotericin B has proven activity against Mucor and Rhizopus species.

First-Line for Visceral Leishmaniasis in India Ambisome is recommended as first-line therapy for visceral leishmaniasis (kala-azar) by WHO and Indian health authorities — particularly for drug-resistant cases and in regions with high antimonial resistance.

Preferred in Renal Impairment The reduced nephrotoxicity of Ambisome makes it the preferred antifungal in patients with pre-existing renal impairment — a common scenario in critically ill and haematology patients.


How Ambisome Works

Fungal cell membranes contain ergosterol — a sterol unique to fungi absent in mammalian cells. Ambisome works through a fundamentally different mechanism from azole antifungals:

  • Amphotericin B molecules insert into the fungal cell membrane and bind to ergosterol
  • This creates aqueous pores or channels in the membrane
  • The pores disrupt membrane integrity — causing leakage of potassium, sodium, and other essential cellular components
  • Rapid electrolyte loss leads to fungal cell death
  • The fungicidal (killing) rather than fungistatic (inhibitory) action makes Ambisome particularly valuable in severely immunocompromised patients who cannot rely on immune clearance

The liposomal encapsulation further enhances selectivity:

  • Liposomes preferentially fuse with fungal membranes at sites of infection
  • Selective release of Amphotericin B at infection sites
  • Reduced interaction with mammalian cell membranes (cholesterol-containing)
  • Higher therapeutic index compared to conventional Amphotericin B

For a detailed mechanism overview refer to the IDSA Guidelines for Aspergillosis.


Ambisome vs Conventional Amphotericin B vs Candipoz

Feature Ambisome (Liposomal AmB) Conventional AmB Candipoz (Posaconazole)
Formulation IV liposomal infusion IV infusion Oral tablet/suspension
Nephrotoxicity Low High Minimal
Infusion Reactions Low High N/A (oral)
Mucorales Activity
Aspergillus Activity
Candida Activity
Visceral Leishmaniasis
Available at A.K. Pharma Request Quote Contact us Request Quote

Dosage and Administration

Invasive Fungal Infections:

  • 3mg/kg/day IV once daily
  • May increase to 5mg/kg/day for refractory infections

Empirical Therapy in Febrile Neutropenia:

  • 3mg/kg/day IV once daily

Cryptococcal Meningitis (HIV patients):

  • 3-4mg/kg/day IV once daily — in combination with Flucytosine for induction therapy

Mucormycosis:

  • 5-10mg/kg/day IV once daily — high doses often required

Visceral Leishmaniasis:

  • 3-5mg/kg/day on days 1-5 and day 10 (total dose 18-21mg/kg) or per local protocol

Administration:

  • Reconstitute with sterile water for injection
  • Further dilute in 5% glucose (not saline — incompatible)
  • Administer by IV infusion over 30-120 minutes through in-line filter (1 micron pore size)
  • Do not mix with other medications or electrolytes in the same line

Full dosing guidelines available at Drugs.com Amphotericin B Liposomal Dosage.


Who Should Use Ambisome

Ambisome is prescribed for:

  • Immunocompromised patients with proven or suspected invasive fungal infections
  • Haematology patients with febrile neutropenia requiring empirical antifungal therapy
  • Patients with invasive aspergillosis, candidaemia, or cryptococcal meningitis
  • Patients with mucormycosis — first-line treatment
  • Patients with visceral leishmaniasis (kala-azar) — particularly drug-resistant cases
  • Patients intolerant of or who have failed azole antifungal therapy
  • Patients with pre-existing renal impairment requiring antifungal therapy

Ambisome is prescribed by haematologists, oncologists, infectious disease specialists, and intensivists. A.K. Pharma supplies Ambisome to hospitals, haematology centres, ICUs, and pharmacies across Delhi and India.


Possible Side Effects

Common side effects include fever, chills, rigors (significantly less than conventional AmB), nausea, vomiting, headache, and elevated creatinine.

Serious side effects include:

  • Nephrotoxicity — monitor renal function regularly though significantly less than conventional AmB
  • Hypokalaemia and hypomagnesaemia — monitor and replace electrolytes
  • Infusion-related reactions — pre-medication with paracetamol and antihistamine may be used
  • Hepatotoxicity — monitor liver function tests
  • Anaphylaxis — rare but serious allergic reactions may occur

Full side effect information available at FDA Ambisome Safety Information.


Precautions

  • Monitor renal function, serum electrolytes (potassium, magnesium), and liver function tests regularly during therapy
  • Replace potassium and magnesium as needed — hypokalaemia increases risk of cardiac arrhythmias
  • Avoid concomitant nephrotoxic drugs (aminoglycosides, cyclosporine, tacrolimus, cisplatin) where possible
  • Use with extreme caution in patients with pre-existing severe renal impairment
  • Do not mix with normal saline or lactated Ringer’s solution — use 5% glucose only
  • Administer through in-line filter with pore size no less than 1 micron
  • Test dose (1mg over 10 minutes) may be administered before first infusion in patients at risk of anaphylaxis

Storage and Handling

  • Store unreconstituted vials at 2°C-8°C in refrigerator
  • Protect from light
  • After reconstitution store at 2°C-8°C and use within 24 hours
  • After dilution in glucose for infusion use immediately or within 6 hours at room temperature or 24 hours at 2°C-8°C
  • Do not freeze reconstituted or diluted solution

As a responsible medicine distributor in Delhi, A.K. Pharma maintains strict cold chain requirements during storage and supply of Ambisome, ensuring product integrity for every unit supplied to hospitals and ICUs across India.


Manufacturer Information

Ambisome (Amphotericin B Liposomal) is manufactured by Gilead Sciences, a global biopharmaceutical company specialising in antifungal, antiviral, and oncology medicines. Ambisome received FDA approval in August 1997 and remains the reference liposomal Amphotericin B formulation. A.K. Pharma supplies only genuine Ambisome sourced from authorized Gilead distributors.


Related Anti Fungal Medicines Available at A.K. Pharma


Frequently Asked Questions

Q. What is Ambisome used for? Ambisome (Amphotericin B Liposomal) is used to treat severe invasive fungal infections including aspergillosis, candidiasis, cryptococcal meningitis, and mucormycosis. It is also the first-line treatment for visceral leishmaniasis (kala-azar) in India. More information available at MedlinePlus.

Q. What is the generic name of Ambisome? The generic name of Ambisome is Amphotericin B Liposomal. It belongs to the polyene antifungal class of medicines.

Q. How is Ambisome different from conventional Amphotericin B? Ambisome encapsulates Amphotericin B in liposomes — reducing nephrotoxicity from 33% to under 19% and dramatically reducing infusion-related reactions while maintaining equivalent antifungal efficacy. This allows higher doses to be administered more safely.

Q. Is Ambisome used for kala-azar in India? Yes. Ambisome is recommended as first-line therapy for visceral leishmaniasis (kala-azar) in India — particularly for drug-resistant cases. It achieves cure rates of 95%+ and is included in the National Kala-Azar Elimination Programme.

Q. Is Ambisome available in India? Ambisome can be supplied to hospitals, haematology centres, and ICUs across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi — for availability and pricing.

Q. What is the price of Ambisome in India? Ambisome price in India varies by pack size. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.

Q. How to order Ambisome from A.K. Pharma? You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.

Q. Does A.K. Pharma supply Ambisome in bulk? Yes. A.K. Pharma supplies Ambisome in bulk to hospitals, haematology centres, ICUs, and pharmacies across Delhi and India. Contact us for bulk pricing and availability.


Why Order Ambisome from A.K. Pharma?

  • Licensed medicine distributor in Delhi with all required drug licenses
  • 100% genuine Ambisome sourced from authorized Gilead distributors
  • Cold chain maintained throughout storage and supply
  • Bulk supply available for hospitals and ICUs
  • Prompt response to all quote requests
  • Serving haematologists and infectious disease specialists across Delhi NCR and India

Contact A.K. Pharma for Ambisome Supply 📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052 📞 011 4172 6999 📱 WhatsApp: +91 9810034827 🌐 akpharma.in

Related Products

Quote Request Form


Quote Request Form