Atracurium Besylate Injection USP 50mg/5ml Technical Specification:

Product Name: Atracurium Besylate Injection USP 50mg/5ml
Brand Name: Atroutaj
Strength: 10mg/1ml, 25mg/2.5ml, 50mg/5ml100mg/10ml
Dosage Form: Liquid Injection
Packing: 10mg/1ml Ampoule/Vial (Single Dose)
25mg/2.5ml Ampoule/Vial (Single Dose)
50mg/5ml Ampoule/Vial (Single Dose)
100mg/10ml Ampoule/Vial (Multi Dose)
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: General Anesthetic, Muscle Relaxants
Indication: Atracurium Besilate Injection is indicated as an adjunct to general anaesthesia during surgery to relax skeletal muscles, and to facilitate endotracheal intubation and mechanical ventilation. It is also indicated to facilitate mechanical ventilation in intensive care unit (ICU) patients.
Storage: Store protected from light & moisture at a temperature between 2°C to 8°C. Do not allow to freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Atracurium Besylate Injection USP 50mg/5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Atracurium Besylate Injection USP 50mg/5ml
    Each ml contains:
    Atracurium besylate USP………….50mg
    Water for Injection USP…………….q.s.

THERAPEUTIC INDICATIONS:

Atracurium Besilate Injection is indicated as an adjunct to general anaesthesia during surgery to relax skeletal muscles, and to facilitate endotracheal intubation and mechanical ventilation. It is also indicated to facilitate mechanical ventilation in intensive care unit (ICU) patients.

DIRECTION OF USE:

For Intravenous use only.

Not for Intramuscular use.

CAUTION & Warning:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution and return the ampoule for free replacement.

DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.

SNAP-OFF AMPOULES

Warning: For IV use only with adequate general anesthesia by or under close supervision of Anesthetist.

STORAGE & DOSAGE:

STORAGE: Store protected from light & moisture at a temperature between 2°C to 8°C. Do not allow to freeze.

Keep out of the reach of children.

DOSAGE: As directed by the Physician.

Why Taj pharmaceuticals?

Unlock the advantages of choosing Taj Pharmaceuticals for Atracurium Besylate Injection. With a legacy of pharmaceutical excellence, Taj Pharmaceuticals offers a reliable source for this critical medication. Our commitment to quality assurance and patient safety is unwavering, making us a preferred choice for healthcare providers globally. At Taj Pharmaceuticals, we adhere to stringent quality control measures throughout the production process. Our Atracurium Besylate Injection undergoes rigorous testing, ensuring that it meets the highest industry standards. This dedication to quality is a testament to our mission of improving healthcare outcomes and patient well-being. In addition to quality, Taj Pharmaceuticals places a strong emphasis on affordability. We strive to make essential medications like Atracurium Besylate Injection accessible to a broader population without compromising on quality. This commitment aligns with our vision of enhancing global healthcare by making essential treatments more affordable and accessible. Choose Taj Pharmaceuticals for Atracurium Besylate Injection to experience the perfect blend of quality, affordability, and reliability. Join the healthcare professionals and institutions worldwide who trust our products to deliver exceptional results and contribute to better patient care.

What is Atracurium Besylate Injection and its uses:

Atracurium Besylate Injection is a vital medication used in the realm of anesthesia and critical care medicine. It falls under the category of neuromuscular blocking agents (NMBAs) or muscle relaxants and is typically administered intravenously. Its primary role is to induce temporary muscle relaxation and paralysis, which is essential for various medical procedures where immobilization is necessary, such as surgeries, intubation, and mechanical ventilation.

In surgical settings, Atracurium Besylate plays a crucial role, especially in procedures requiring deep anesthesia or when patients need assistance with breathing through a ventilator. In intensive care units (ICUs), it becomes a valuable tool for managing critically ill patients who require mechanical ventilation, ensuring that their breathing is controlled effectively and without resistance.

Beyond surgery and ventilation, Atracurium Besylate is utilized to aid in various medical procedures, including endotracheal intubation, which involves inserting a tube into the patient’s windpipe to maintain an open airway. Additionally, it can help manage shivering in patients undergoing therapeutic hypothermia following cardiac arrest.

It’s essential to emphasize that the administration of Atracurium Besylate Injection should only occur under the supervision of trained healthcare professionals, as incorrect dosages or improper use can lead to complications. The medication’s effects are temporary and reversible, typically subsiding once its administration is discontinued or antagonized with another appropriate medication.

How does Atracurium Besylate Injection Work:

Atracurium Besylate Injection is a neuromuscular blocking agent (NMBA) employed to induce muscle relaxation and paralysis during medical procedures. Its mechanism of action centers around the neuromuscular junction, where nerves communicate with muscles.

At the neuromuscular junction, nerve signals prompt muscle contraction by releasing a neurotransmitter called acetylcholine. Atracurium Besylate Injection interferes with this process by competitively binding to the receptors on the muscle cell’s membrane that acetylcholine normally attaches to. This competitive binding prevents acetylcholine from activating the muscle, leading to muscle relaxation and paralysis.

This pharmacological effect of Atracurium Besylate Injection is vital in healthcare settings where precise control over muscle movement is essential. It is commonly used during surgical procedures to ensure that patients remain still and to facilitate endotracheal intubation, which involves inserting a tube into the windpipe for mechanical ventilation. Additionally, it assists in managing shivering in certain medical situations.

It’s important to note that the muscle relaxation induced by Atracurium Besylate Injection is temporary and reversible. Once its administration is discontinued or antagonized by other medications, muscle function gradually returns to normal. This precise control over muscle activity contributes to the safety and effectiveness of various medical procedures.

Benefits of Atracurium Besylate Injection:

Atracurium Besylate Injection offers several key benefits in medical practice. Firstly, it is primarily used to induce muscle relaxation and paralysis, which is crucial during various medical procedures, such as surgeries and endotracheal intubation. This muscle relaxation enhances surgical precision by ensuring that patients remain still, reducing the risk of unintended muscle contractions that could disrupt procedures. Additionally, in intensive care units (ICUs), Atracurium Besylate helps manage patients on mechanical ventilators, ensuring effective control of their breathing, and allowing for proper oxygenation and recovery. Furthermore, it can also aid in controlling shivering in patients undergoing therapeutic hypothermia following cardiac arrest, contributing to temperature management.

Side Effects of Atracurium Besylate Injection:

While Atracurium Besylate Injection is valuable in medical settings, it is not without potential side effects. The primary side effect is the intended muscle paralysis, which is necessary for procedures but can extend to respiratory muscles, necessitating mechanical ventilation. Some patients may also experience a drop in blood pressure (hypotension), which could be concerning for individuals with cardiovascular issues. In rare instances, histamine release may occur, leading to symptoms like flushing, rash, or breathing difficulties. To mitigate risks, it should only be administered by trained healthcare professionals in controlled settings, with careful monitoring to ensure safety and effectiveness. Patients should openly discuss any concerns with their healthcare providers to make informed decisions about its use.

Frequently Asked Questions About Atracurium Besylate Injection:

Certainly, here are some frequently asked questions about Atracurium Besylate Injection:

  1. What is Atracurium Besylate Injection used for?

Atracurium Besylate Injection is primarily used to induce muscle relaxation and paralysis during medical procedures, including surgeries, endotracheal intubation, and mechanical ventilation.

  1. How does Atracurium Besylate Injection work?

It works by blocking the transmission of nerve signals to skeletal muscles, preventing muscle contractions. This muscle relaxation is temporary and reversible.

  1. Is Atracurium Besylate Injection safe?

Atracurium Besylate is generally safe when administered by trained healthcare professionals in controlled medical settings. However, it can have side effects, and its use should be closely monitored.

  1. What are the side effects of Atracurium Besylate Injection?

Side effects may include temporary paralysis, hypotension (low blood pressure), histamine release (rare), and the need for mechanical ventilation during administration.

  1. Can Atracurium Besylate Injection be used outside of medical settings?

No, this medication should only be used in clinical settings under the supervision of trained healthcare providers due to its potential side effects and need for precise dosing and monitoring.

  1. How is Atracurium Besylate Injection administered?

It is typically administered intravenously by a healthcare professional. The dosage and rate of administration depend on the specific medical procedure and the patient’s condition.

  1. Is Atracurium Besylate Injection suitable for all patients?

Not necessarily. It should be used with caution in patients with certain medical conditions, such as cardiovascular issues. Healthcare providers will assess each patient’s suitability for the medication.

  1. Is the paralysis induced by Atracurium Besylate reversible?

Yes, the muscle relaxation and paralysis are temporary. Once the medication is discontinued or antagonized with another medication, muscle function gradually returns to normal.

  1. Can Atracurium Besylate Injection be used during pregnancy or breastfeeding?

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

  1. Are there any alternatives to Atracurium Besylate for muscle relaxation during medical procedures?

Yes, there are other neuromuscular blocking agents (NMBAs) available, and the choice of medication depends on the specific medical situation and patient characteristics. Healthcare providers will determine the most suitable option.

As Atracurium Besylate Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Atracurium Besylate 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

Atracurium Besylate 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 Atracurium Besylate 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
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Atracurium Besylate Injection USP 10mg/ml
B. Atracurium Besylate Injection USP 25mg/2.5ml
C. Atracurium Besylate Injection USP 50mg/5ml
D. Atracurium Besylate Injection USP 100mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Atracurium Besylate Injection USP 10mg/ml
Each ml contains:
Atracurium besylate USP………….10mg
Water for Injection USP…………….q.s.

b) Atracurium Besylate Injection USP 25mg/2.5ml
Each ml contains:
Atracurium besylate USP…………………….25mg
Water for Injection USP………………………..q.s.

c) Atracurium Besylate Injection USP 50mg/5ml
Each ml contains:
Atracurium besylate USP…………………….50mg
Water for Injection USP………………………..q.s.


d) Atracurium Besylate Injection USP 100mg/10ml
Each ml contains:
Atracurium besylate USP…………………….100mg
Water for Injection USP………………………..q.s.

THERAPEUTIC INDICATIONS:

Atracurium Besilate Injection is indicated as an adjunct to general anaesthesia during surgery to relax skeletal muscles, and to facilitate endotracheal intubation and mechanical ventilation. It is also indicated to facilitate mechanical ventilation in intensive care unit (ICU) patients.

DIRECTION OF USE:

For Intravenous use only.
Not for Intramuscular use.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution and return the ampoule for free replacement.
DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
SNAP-OFF AMPOULES
WARNING: For IV use only with adequate general anesthesia by or under close supervision of Anesthetist.

STORAGE & DOSAGE:

STORAGE: Store protected from light & moisture at a temperature between 2°C to 8°C.
Do not allow to freeze.
Keep out of the reach of children.
DOSAGE: As directed by the Physician.