Amphotericin B Emulsion Injection 5mg/ml Technical Specification:

Product Name:Amphotericin B Emulsion Injection
Brand Name:Amfotaj
Strength:5mg/ml (50mg/10ml)
Dosage Form:Sterile Liquid for Injection (Emulsion)
Packing:10ml Single dose Vial +1 5µ syringe filter
Route of Administration:For I.V. Infusion use for hospitalized patients 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 injection is used to treat fungal infections including BLACK FUNGAL INFECTION. It works by slowing the growth of fungi that cause infection.
Storage:Store at a temperature between 2°C to 8°C. Protect from light & moisture. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Amphotericin B Emulsion Injection 5mg/ml

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Amphotericin B Emulsion Injection 5mg/ml
    Each vial contains:
    Amphotericin B USP……………………5mg
    Excipients……………………………..q.s
    Water for Injections USP……………q.s to 1ml

THERAPEUTIC INDICATIONS:

Amphotericin B injection is used to treat serious and potentially life-threatening fungal infections including BLACK FUNGAL INFECTION. Amphotericin B injection is in a class of medications called antifungals. It works by slowing the growth of fungi that cause infection.

DIRECTION OF USE:

For intravenous infusion to hospitalized patient only.
Please refer to the accompanying package insert for detailed dosage, direction for use and precautions.

CAUTION & WARNING:

CAUTION: 

This Injection should not be use if it contains visible particulate matter.
Shake well before use.
Discard any unused portion after initial use.
Dispersion should be protected from light during administration.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner. 

STORAGE & DOSAGE:

Storage:  Store at a temperature between 2°C to 8°C.
Protect from light & moisture.
Do not freeze.
Keep all medicines out of reach of children.

Dosage: The recommended daily dosage for adults and children is 5mg/kg given as single infusion, administered intravenously at a rate of about 2.5mg/kg/hour. 

For Kala Azar: The recommended total dose for adults and children for the treatment of Visceral Leishmaniasis (Kala Azar) is 15mg/kg and can be administered in any one of the following dosing regimens. 

  1. A single dose of 15mg/kg/day administered over a period of 4 hours (not recommended for children below 5 years of age) 
  2. A dose of 5mg/kg/day on three alternative days. 
  3. A dose of 7.5mg/kg/day on two alternative days. 

For Febrile neutropenia: The recommended dose id 5mg/kg/day.

Why Taj Pharmaceuticals?

Experience the Taj Pharmaceuticals advantage when it comes to Amphotericin B Emulsion Injection. Our decades of pharmaceutical expertise and state-of-the-art manufacturing facilities ensure that every batch meets stringent quality standards, providing healthcare professionals and patients with peace of mind. At Taj Pharmaceuticals, we prioritize patient safety and efficacy above all else. Our Amphotericin B Emulsion Injection is meticulously crafted to combat fungal infections effectively, supported by comprehensive research and development. We maintain rigorous quality control processes throughout production to guarantee consistent and reliable results. Choose Taj Pharmaceuticals for Amphotericin B Emulsion Injection and benefit from our commitment to advancing healthcare. With a global reputation for excellence, we remain dedicated to enhancing the well-being of individuals worldwide through innovative pharmaceutical solutions.

what is Amphotericin B Emulsion Injection and its uses?

Amphotericin B Emulsion Injection is a medication used primarily to treat serious fungal infections, particularly those caused by a group of fungi known as “yeasts” and “molds.” This medication is a potent antifungal agent and is considered a critical component in the treatment of severe fungal infections when other antifungal drugs are ineffective or not suitable.

Here are some of the key uses of Amphotericin B Emulsion Injection:
  • Systemic Fungal Infections: It is commonly used to treat systemic fungal infections, which can affect internal organs and body systems. These infections can be life-threatening and typically occur in individuals with weakened immune systems, such as those undergoing chemotherapy, organ transplant recipients, or people with advanced HIV/AIDS.
  • Invasive Aspergillosis: Amphotericin B is often prescribed for the treatment of invasive aspergillosis, a fungal infection caused by the Aspergillus species. This infection can affect the lungs, sinuses, and other organs, particularly in immunocompromised patients.
  • Candidiasis: It is effective against candidiasis, which is a fungal infection caused by the Candida species. Candidiasis can manifest as oral thrush, vaginal yeast infections, or invasive bloodstream infections, and Amphotericin B may be used in severe cases.
  • Cryptococcal Meningitis: The medication can also be used in the treatment of cryptococcal meningitis, a fungal infection that affects the membranes surrounding the brain and spinal cord.
  • Fungal Endocarditis: Amphotericin B Emulsion Injection can be considered for the treatment of fungal endocarditis, a rare but serious condition involving fungal infection of the heart valves.

It’s important to note that Amphotericin B is a potent medication with potentially serious side effects, including kidney damage and infusion-related reactions. Therefore, its use is typically reserved for severe fungal infections when other antifungal drugs have proven ineffective or when the infection is life-threatening. The specific use and dosage of Amphotericin B Emulsion Injection should be determined by a healthcare professional based on the patient’s condition, the type of fungal infection, and their overall health status. Patients receiving this medication should be closely monitored for potential side effects, and healthcare providers will make adjustments as needed during the course of treatment.

How does Amphotericin B Emulsion Injection work?

Amphotericin B Emulsion Injection is an antifungal medication that is used to treat a variety of fungal infections. It works by disrupting the structure and function of fungal cell membranes, which are different from human cell membranes. Here’s how it works:

  • Binding to Ergosterol: Fungal cell membranes contain a sterol compound called ergosterol, which is absent in human cell membranes. Amphotericin B has a high affinity for ergosterol. When it encounters fungal cells, it binds strongly to the ergosterol molecules embedded in the fungal cell membrane.
  • Pore Formation: The binding of Amphotericin B to ergosterol in the fungal cell membrane results in the formation of channels or pores. These pores disrupt the integrity of the fungal cell membrane.
  • Cellular Leakage: The pores created by Amphotericin B allow the leakage of essential cellular components, such as ions and molecules, from the fungal cell. This disruption in the membrane’s integrity leads to an imbalance of electrolytes and disrupts the normal functioning of the fungal cell.
  • Cell Death: The leakage of cellular contents, along with the damage to the fungal cell membrane, ultimately leads to cell death. As a result, the growth and multiplication of the fungal cells are inhibited, and the infection is controlled.
  • Broad-Spectrum Activity: Amphotericin B has a broad spectrum of antifungal activity, making it effective against a wide range of fungal species, including yeasts and molds.

It’s important to note that while Amphotericin B is a potent antifungal agent, it is also associated with significant side effects, including potential kidney toxicity and infusion-related reactions. Due to these potential adverse effects, the use of Amphotericin B Emulsion Injection is typically reserved for serious and life-threatening fungal infections when other antifungal treatments have failed or are not suitable. Patients receiving this medication are closely monitored by healthcare professionals to minimize the risks and ensure the best possible outcome.

Benefits and Side Effects of Amphotericin B Emulsion Injection:

Amphotericin B Emulsion Injection is a potent antifungal medication used to treat serious fungal infections. While it can be highly effective in combating fungal infections, it is also associated with both benefits and potential side effects. Here’s a breakdown of its benefits and side effects:

Benefits:

  • Effective Against a Wide Range of Fungi: Amphotericin B is effective against a broad spectrum of fungal species, including yeasts and molds. This makes it a valuable treatment option for a variety of serious fungal infections.
  • Treatment of Life-Threatening Infections: It is often used when other antifungal medications are ineffective or when the infection is life-threatening. Amphotericin B can be a critical tool in managing severe fungal infections, especially in individuals with compromised immune systems.
  • High Efficacy: Amphotericin B has a strong fungicidal effect, meaning it actively kills fungal cells and inhibits their growth, making it a potent treatment option for serious fungal infections.

Side Effects:

  • Nephrotoxicity (Kidney Damage): One of the most significant side effects of Amphotericin B is its potential to cause kidney damage. This can lead to impaired kidney function and electrolyte imbalances. Patients receiving this medication require close monitoring of their kidney function.
  • Infusion-Related Reactions: Amphotericin B infusion can cause fever, chills, nausea, vomiting, headache, and muscle pain. These reactions are more common with the traditional form of the medication and less so with newer formulations like the emulsion. Pre-medications are often given to mitigate these side effects.
  • Electrolyte Imbalances: The drug can lead to imbalances in electrolytes such as potassium and magnesium, which can have adverse effects on the heart and other organs. Monitoring of electrolyte levels is essential during treatment.
  • Anemia and Blood Disorders: Amphotericin B can lead to anemia and other blood disorders in some individuals.
  • Liver Function Abnormalities: It may cause elevated liver enzymes and liver function abnormalities in some patients.
  • Allergic Reactions: Although rare, allergic reactions to Amphotericin B can occur and may manifest as rash, itching, swelling, or difficulty breathing.
  • Local Irritation: When administered through an IV, it can cause local irritation at the injection site.
  • Other Side Effects: Other potential side effects include gastrointestinal symptoms (e.g., diarrhea), muscle and joint pain, and low blood pressure.

It’s crucial to note that the choice to use Amphotericin B Emulsion Injection is typically reserved for cases where the benefits outweigh the potential risks and side effects, particularly in severe and life-threatening fungal infections. Healthcare providers closely monitor patients receiving this medication to manage and mitigate side effects while ensuring effective treatment of the fungal infection. Patients should discuss the potential benefits and risks with their healthcare provider before starting treatment with Amphotericin B Emulsion Injection.

Frequently Asked Questions About Amphotericin B Emulsion Injection:

Certainly! Here are some frequently asked questions (FAQs) about Amphotericin B Emulsion Injection:

  1. What is Amphotericin B Emulsion Injection used for?

Amphotericin B Emulsion Injection is used to treat serious fungal infections, particularly those that are life-threatening or unresponsive to other antifungal medications.

  1. How does Amphotericin B Emulsion Injection work?

It works by binding to ergosterol in fungal cell membranes, disrupting their structure and creating pores that lead to leakage of cellular contents, ultimately causing fungal cell death.

  1. What are common fungal infections treated with Amphotericin B Emulsion Injection?

It is used to treat infections such as invasive aspergillosis, candidiasis, cryptococcal meningitis, and other systemic fungal infections.

  1. How is Amphotericin B Emulsion Injection administered?

It is typically administered as an intravenous (IV) infusion in a healthcare setting. The dosage and duration of treatment depend on the specific infection and patient’s condition.

  1. What are the potential side effects of Amphotericin B Emulsion Injection?

Common side effects include fever, chills, nausea, vomiting, kidney damage, electrolyte imbalances, and infusionrelated reactions. Less common side effects may include anemia, liver function abnormalities, and allergic reactions.

  1. How is kidney damage monitored during treatment with Amphotericin B Emulsion Injection?

Kidney function is closely monitored through regular blood tests, including serum creatinine and glomerular filtration rate (GFR) measurements.

  1. Are there any pre-medications given to reduce side effects?

Yes, pre-medications such as antipyretics, antihistamines, and corticosteroids may be administered before Amphotericin B infusion to minimize fever, chills, and other infusion related reactions.

  1. Can Amphotericin B Emulsion Injection be used during pregnancy or breastfeeding?

It should be used during pregnancy or breastfeeding only if the potential benefits outweigh the risks, and under the supervision of a healthcare provider.

  1. Are there any drug interactions with Amphotericin B Emulsion Injection?

Yes, it can interact with certain medications, such as diuretics and other nephrotoxic drugs. It’s essential to inform your healthcare provider about all the medications you are taking.

  1. Is there a generic version of Amphotericin B Emulsion Injection available?

Generic versions of Amphotericin B may be available, but the specific formulations and brands may vary depending on your location and healthcare provider’s prescription.

  1. Can Amphotericin B Emulsion Injection be administered at home?

Typically, it is administered in a healthcare facility under the supervision of trained medical personnel due to the potential for serious side effects and the need for careful monitoring during treatment.

  1. How long does the treatment with Amphotericin B Emulsion Injection usually last?

The duration of treatment varies depending on the type and severity of the fungal infection. It can range from several weeks to several months in some cases.

It’s important to consult with a healthcare provider for personalized information and guidance regarding the use of Amphotericin B Emulsion Injection and any specific questions or concerns you may have about its use and potential side effects.

As Amphotericin B Emulsion Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Amphotericin B Emulsion 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

Amphotericin B Emulsion 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 Amphotericin B Emulsion 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

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Amphotericin B Emulsion Injection 5mg/ml (Amfotaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Amphotericin B Emulsion Injection 5mg/ml
Each vial contains:
Amphotericin B USP……5mg
Excipients………………………………….q.s
Water for Injections USP…………...q.s to 1ml

THERAPEUTIC INDICATIONS:

Amphotericin B injection is used to treat serious and potentially life-threatening fungal infections including BLACK FUNGAL INFECTION. Amphotericin B injection is in a class of medications called antifungals. It works by slowing the growth of fungi that cause infection.

DIRECTION OF USE:

For intravenous infusion to hospitalized patient only.
Please refer to the accompanying package insert for detailed dosage, direction for use and precautions.

CAUTION & WARNING:

CAUTION:
This Injection should not be use if it contains visible particulate matter. Shake well before use.
Discard any unused portion after initial use.
Dispersion should be protected from light during administration.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

STORAGE:
Store at a temperature 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
Do not freeze.
Protect from direct light & moisture.
KEEP OUT OF REACH OF CHILDREN.
DOSAGE: As directed by the Physician.