GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Liposomal Amphotericin B For Injection 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Liposomal Amphotericin B For Injection 50mg/vial
a) Each Vial Contains:
Amphotericin BP 
Equivalent to Amphotericin-B …………...50mg
Excipients…………………………….……q.s.
b) Sterile Water for Injection USP…20ml

THERAPEUTIC INDICATIONS:

Amphotericin B liposomal injection is used to treat fungal infections such as cryptococcal meningitis (a fungal infection of the lining of the spinal cord and brain) and visceral leishmaniasis (a parasitic disease that usually affects spleen, liver, and bone marrow) in certain people.

DIRECTION OF USE:

To be reconstituted with 12ml Sterile Water for Injection USP to each Liposomal amphotericin B Injection vial to yield a preparation congaing concentration of 4mg/ml Amphotericin B.
Use only after reading the direction on the pack insert.

CAUTION & WARNING:

CAUTION: After reconstitution do not use in case any foreign particulate matter is observed inside the vial.
Liposomal Amphotericin b Injection Amfotaj is not Interchangeable With other Amphotericin Product.
Dispersion to be protected from light during administration.
Inject the syringe contents through the filter, in to the appropriate amount of 5% Dextrose Injection (Use only one filter per vial of Amfotaj-50mg Vial).
***ICMR Approved drug for treating black fungus.
Each carton contains one pre packed disposable Sterile 5µm Syringe filter.
WARNING: Not to be sold by retail without the prescription of a Registered Medical practitioner.
Note: Amphotericin B liposomal for Injection is Not Interchangeable or Substitutable on a mg per Basis with other Amphotericin B product.

STORAGE & DOSAGE:

Storage: Store at 2°C to 8°C. Protect from light and moisture. Do not freeze.
Read enclosed leaflet for reconstitution, dosage, administration and precautions.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Dosage: As directed by Physician.

Liposomal Amphotericin B For Injection 50mg Technical Specification:

Product Name:Liposomal Amphotericin B For Injection
Brand Name:Amfotaj
Strength:50mg
Dosage Form:Lyophilised Powder Injection (Sterile) *Preservative-free
Packing:1 Vial + WFI in a Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-fungal
Indication: Amphotericin B liposomal injection is used to treat fungal infections such as cryptococcal meningitis (a fungal infection of the lining of the spinal cord and brain) and visceral leishmaniasis (a parasitic disease that usually affects spleen, liver, and bone marrow) in certain people
Storage:Store at 2°C to 8°C. Protect from light and moisture. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Liposomal Amphotericin B For Injection 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Liposomal Amphotericin B For Injection 50mg/vial
    a)Each Vial Contains:
    Amphotericin BP
    Equivalent to Amphotericin-B……………50mg
    Excipients…………………………….……q.s.
    b)Sterile Water for Injection USP…20ml

THERAPEUTIC INDICATION:

Amphotericin B liposomal injection is used to treat fungal infections such as cryptococcal meningitis (a fungal infection of the lining of the spinal cord and brain) and visceral leishmaniasis (a parasitic disease that usually affects spleen, liver, and bone marrow) in certain people.

DIRECTION OF USE:

To be reconstituted with 12ml Sterile Water for Injection USP to each Liposomal amphotericin B Injection vial to yield a preparation congaing concentration of 4mg/ml Amphotericin B. Use only after reading the direction on the pack insert.

CAUTION & Warning:

CAUTION: After reconstitution do not use in case any foreign particulate matter is observed inside the vial.
Liposomal Amphotericin b Injection Amfotaj is not Interchangeable With other Amphotericin Product.
Dispersion to be protected from light during administration.
Inject the syringe contents through the filter, in to the appropriate amount of 5% Dextrose Injection (Use only one filter per vial of Amfotaj-50mg Vial)
ICMR Approved drug for treating black fungus.
Each carton contains one pre packed disposable Sterile 5µm Syringe filter.
WARNING: Not to be sold by retail without the prescription of a Registered Medical practitioner.
Note: Amphotericin B liposomal for Injection is Not Interchangeable or Substitutable on a mg per Basis with other Amphotericin B product.

STORAGE & DOSAGE:

Storage: Store at 2°C to 8°C. Protect from light and moisture. Do not freeze.
Read enclosed leaflet for reconstitution, dosage, administration and precautions.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Dosage: As directed by Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals, a renowned leader in the pharmaceutical industry, stands out as the preferred provider of Liposomal Amphotericin B for Injection. Our commitment to excellence in quality, research, and patient care makes us the top choice for healthcare professionals and patients alike. With a legacy of delivering cutting-edge pharmaceutical solutions, Taj Pharmaceuticals ensures that every vial of Liposomal Amphotericin B for Injection meets stringent quality standards. Our dedication to quality assurance and adherence to global regulatory guidelines guarantee the safety and efficacy of this essential antifungal medication. At Taj Pharmaceuticals, innovation is at the core of what we do. Our state-of-the-art research and development facilities continually strive to improve drug delivery mechanisms, enhance patient outcomes, and minimize side effects associated with Liposomal Amphotericin B. We’re committed to advancing medical science for the benefit of patients worldwide. Patients and healthcare providers trust Taj Pharmaceuticals because we prioritize patient well-being above all else. Our unwavering commitment to affordability ensures that this life-saving medication remains accessible to those in need, making us a beacon of hope in the fight against fungal infections. Choose Taj Pharmaceuticals for Liposomal Amphotericin B for Injection, and experience pharmaceutical excellence that puts patients first. Together, we’re making healthcare safer and more effective, one vial at a time.

What is Liposomal Amphotericin B For Injection and its uses:

Liposomal Amphotericin B for Injection is a medication used to treat severe fungal infections, particularly in individuals with compromised immune systems. It belongs to a class of drugs known as antifungals, and its unique formulation involves encapsulating amphotericin B within liposomes (tiny fat-based particles). This liposomal formulation enhances the drug’s delivery and reduces some of the side effects associated with traditional amphotericin B formulations. Here are its primary uses:

  • Treatment of Invasive Fungal Infections: Liposomal Amphotericin B is primarily used to treat invasive fungal infections, including those caused by various species of fungi such as Candida, Aspergillus, Cryptococcus, and certain molds. These infections can be life-threatening, especially in individuals with weakened immune systems, such as those with HIV/AIDS, organ transplant recipients, or individuals undergoing chemotherapy.
  • Empirical Therapy: In some cases, when the specific type of fungal infection is not immediately known but is suspected in seriously ill patients, liposomal amphotericin B may be used as empirical therapy. This means it is administered to cover a broad range of possible fungal pathogens until a more precise diagnosis can be made.
  • Alternative to Amphotericin B Deoxycholate: Liposomal Amphotericin B is often preferred over amphotericin B deoxycholate, the traditional formulation, due to its reduced toxicity. Amphotericin B deoxycholate is known to have significant side effects, including kidney toxicity, which can be less severe with the liposomal formulation.
  • Fungal Prophylaxis: In some cases, liposomal amphotericin B may be used as prophylaxis (preventive therapy) to reduce the risk of fungal infections in high-risk individuals, such as those with severely compromised immune systems or those undergoing stem cell or bone marrow transplantation.

It’s important to note that the use of Liposomal Amphotericin B for Injection is typically reserved for severe or life-threatening fungal infections, as it is a potent medication with potential side effects. The specific dosing, duration of treatment, and choice of antifungal medication will be determined by a healthcare provider based on the patient’s condition, the type of infection, and other individual factors. Patients receiving this medication should be closely monitored for any adverse effects and have their treatment regimen adjusted as necessary.

How Does Liposomal Amphotericin B For Injection Work?

Liposomal Amphotericin B for Injection works by targeting the cell membranes of fungi and disrupting their structure and function. It is an antifungal medication that is effective against a wide range of fungal pathogens. Here’s how it works:

  • Cell Membrane Disruption: Fungi have a unique cell membrane structure that contains ergosterol, a compound absent in human cell membranes (our cell membranes contain cholesterol instead). Liposomal Amphotericin B has an affinity for ergosterol, which is crucial for the integrity and function of fungal cell membranes.
  • Binding to Ergosterol: Liposomal Amphotericin B molecules bind selectively to ergosterol in the fungal cell membrane. This binding is much stronger and specific for ergosterol than for cholesterol in human cell membranes, making the drug relatively less toxic to human cells.
  • Pore Formation: Once bound to ergosterol, Liposomal Amphotericin B disrupts the fungal cell membrane by forming pores or channels. These pores allow ions and molecules to leak out of the fungal cell, which disturbs the cell’s osmotic balance and ultimately leads to cell death.
  • Fungicidal Action: Liposomal Amphotericin B’s disruption of the fungal cell membrane is fungicidal, meaning it kills the fungus rather than merely inhibiting its growth. This is important in the treatment of severe fungal infections where complete eradication of the pathogen is necessary.
  • Enhanced Delivery: The liposomal formulation of amphotericin B is designed to enhance drug delivery. Liposomes are small lipid-based vesicles that encapsulate the drug molecules. This encapsulation helps improve the drug’s solubility, stability, and bioavailability, while also reducing the potential for toxic effects.
  • Reduced Toxicity: Compared to the traditional amphotericin B deoxycholate formulation, which is associated with more significant toxicity, liposomal amphotericin B is known for its reduced toxicity, particularly in terms of kidney toxicity. This makes it a safer option for patients, especially those with compromised immune systems who are at higher risk of fungal infections.

Overall, Liposomal Amphotericin B for Injection is a crucial tool in the treatment of severe fungal infections, particularly in immunocompromised individuals. Its selective action on fungal cell membranes and reduced toxicity compared to older formulations of amphotericin B make it a valuable choice in managing life-threatening fungal diseases.

Benefits of Liposomal Amphotericin B for Injection:

  • Broad-Spectrum Antifungal Activity: Liposomal Amphotericin B is effective against a wide range of fungal pathogens, making it valuable in treating severe and potentially life-threatening fungal infections, including those caused by Candida, Aspergillus, Cryptococcus, and various molds.
  • Potent Fungicidal Action: It is fungicidal, meaning it kills the fungus directly rather than just inhibiting its growth. This is crucial for managing serious fungal infections.
  • Reduced Toxicity: Compared to the traditional amphotericin B deoxycholate formulation, Liposomal Amphotericin B is associated with less kidney toxicity, which can be a significant concern with antifungal medications. This makes it a safer option for many patients, especially those with compromised kidney function.
  • Liposomal Formulation: The liposomal formulation improves drug delivery and bioavailability, ensuring that the medication reaches the site of infection effectively.
  • Treatment of Choice for Some Infections: Liposomal Amphotericin B is often the treatment of choice for certain fungal infections, such as invasive aspergillosis or systemic fungal infections in immunocompromised individuals, due to its efficacy and safety profile.

Side Effects of Liposomal Amphotericin B for Injection:

  • Infusion-Related Reactions: During or shortly after the infusion of Liposomal Amphotericin B, some individuals may experience fever, chills, rigors, nausea, vomiting, or headache. These symptoms are usually mild and can be managed with premedications.
  • Renal Toxicity: While Liposomal Amphotericin B is less nephrotoxic (kidney-toxic) than the traditional formulation, it can still affect kidney function in some patients. Regular monitoring of kidney function is essential during treatment.
  • Electrolyte Imbalances: Liposomal Amphotericin B may lead to imbalances in electrolytes, such as potassium and magnesium, which can have various effects on the body. Monitoring and management of electrolyte levels are necessary.
  • Hypokalemia: Low blood potassium levels (hypokalemia) can occur and may require supplementation.
  • Liver Function Abnormalities: Some patients may experience elevated liver enzyme levels while taking Liposomal Amphotericin B. Regular liver function tests are necessary during treatment.
  • Anemia: It can cause a decrease in red blood cell count, leading to anemia.
  • Allergic Reactions: Although rare, allergic reactions to Liposomal Amphotericin B are possible and may include skin rashes, itching, or swelling.
  • Other Rare Side Effects: Less commonly, Liposomal Amphotericin B may cause muscle pain, back pain, or low blood pressure.

It’s important to note that the benefits of Liposomal Amphotericin B often outweigh the potential side effects, especially in the context of treating severe fungal infections where the medication can be life-saving. Healthcare providers carefully assess the risks and benefits for each patient and closely monitor for adverse effects during treatment. Patients receiving this medication should communicate any concerning symptoms to their healthcare team promptly.

Frequently Asked Questions About Liposomal Amphotericin B for Injection:

Certainly, here are some frequently asked questions (FAQs) about Liposomal Amphotericin B for Injection:

  1. What is Liposomal Amphotericin B for Injection used for?

Liposomal Amphotericin B is primarily used to treat severe fungal infections, particularly in individuals with compromised immune systems.

  1. How does Liposomal Amphotericin B work?

Liposomal Amphotericin B disrupts the cell membranes of fungi by binding to ergosterol, a compound unique to fungal cell membranes. This disrupts the integrity of the fungal cells and ultimately leads to their death.

  1. What types of fungal infections can Liposomal Amphotericin B treat?

Liposomal Amphotericin B is effective against a broad spectrum of fungal pathogens, including Candida, Aspergillus, Cryptococcus, and various molds.

  1. Is Liposomal Amphotericin B less toxic than the traditional formulation?

Yes, Liposomal Amphotericin B is associated with reduced kidney toxicity compared to the traditional amphotericin B deoxycholate formulation, making it a safer option for many patients.

  1. What are the common side effects of Liposomal Amphotericin B?

Common side effects may include infusionrelated reactions (fever, chills), renal toxicity, electrolyte imbalances, liver function abnormalities, anemia, and hypokalemia (low blood potassium).

  1. Is Liposomal Amphotericin B safe for pregnant or breastfeeding individuals?

The safety of Liposomal Amphotericin B during pregnancy and breastfeeding is a matter for discussion between the patient and their healthcare provider. The potential benefits and risks must be carefully weighed.

  1. How is Liposomal Amphotericin B administered?

Liposomal Amphotericin B is typically administered as an intravenous (IV) infusion by a healthcare professional in a clinical setting.

  1. Is Liposomal Amphotericin B available as an oral medication?

No, Liposomal Amphotericin B is not available in oral form. It is administered intravenously due to its limited bioavailability when taken orally.

  1. How long is the treatment duration for fungal infections with Liposomal Amphotericin B?

The treatment duration with Liposomal Amphotericin B varies depending on the type and severity of the fungal infection. Treatment may last for several weeks or more.

  1. Can Liposomal Amphotericin B interact with other medications?

Liposomal Amphotericin B may interact with certain medications. Patients should inform their healthcare provider about all medications and supplements they are taking to avoid potential drug interactions.

  1. Is Liposomal Amphotericin B suitable for children and infants?

Liposomal Amphotericin B can be used in pediatric populations, but the dosing and administration should be determined by a pediatric infectious disease specialist or healthcare provider experienced in treating children.

Always consult with a healthcare professional for personalized information and guidance regarding the use of Liposomal Amphotericin B for Injection and its suitability for your specific medical condition.

As Liposomal Amphotericin B for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Liposomal Amphotericin B for Injection product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Liposomal Amphotericin B for Injection Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Liposomal Amphotericin B for Injection, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593