Polymyxin B for Injection USP 5,00,000Units Technical Specification:

Product Name:Polymyxin B for Injection USP 5,00,000 Units
Brand Name:Pamfotaj
Strength:7,50,000 Units, 5,00,000 Units
Dosage Form:Lyophilized
Dry Powder for Solution for Injection/Infusion
Packing:1 Vial + WFI in a Tray
Route of Administration:For I.V./ I.M./ Intrathecal 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 & Anti-biotics
Indication: Polymyxin B and trimethoprim combination is used to treat infections, including acute bacterial. They work by killing the bacteria or preventing their growth.
Storage:Protect from light and moisture, store below 2°-8°C. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Polymyxin B for Injection USP 5,00,000 Units

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Polymyxin B for Injection USP 5,00,000 Units
    Each vial Contains:
    Polymyxin B Sulphate USP
    equivalent to Polymyxin B……… 5,00,000 Units
    Excipients…………………q.s.

THERAPEUTIC INDICATION:

Polymyxin B and trimethoprim combination is used to treat eye infections, including acute bacterial conjunctivitis and blepharoconjunctivitis. Polymyxin B and trimethoprim belong to the class of medicines known as antibiotics. They work by killing the bacteria or preventing their growth.

DIRECTION OF USE:

TO BE USED IMMEDIATELY AFTER RECONSTITUTION

INTRAVENOUS: Dissolve 500,000 polymyxin B units in 300 to 500 ml solutions for parenteral 5% Dextrose Injection for continuous drip.

INTRAMUSCULAR: Dissolve 500,000 polymyxin B units in 2 ml. Sterile Water for Injection or 0.9% Sodium Chloride Injection.

INTRATHECAL: Dissolve 500,000 polymyxin B units in 10 mL 0.9 % Sodium Chloride Injection USP for 50,000 units per ml. dosage unit.

CAUTION & Warning:

CAUTION: Not recommended routinely because of severe pain at injection sites, particularly in infants and children.

When this drug is given intramuscularly, intravenously or intrathecally, it should be given only to hospitalized patients so as to provide constant supervision by a physician.

Discard unused portion.

Warning: To be sold by the retail on the prescription of a registered medical practitioner only.

STORAGE & DOSAGE:

Storage: Protect from light and moisture, store below 2°-8°C.

KEEP MEDICINE OUT OF REACH OF CHILDREN.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

FOR USAGE & RECONSTITUTION REFER LEAFLET

Dosage: As directed by Physician.

Why Taj Pharmaceuticals?

Leadership in Infection Management: Taj Pharmaceuticals is a trusted leader in infection management, epitomized by our unwavering commitment to delivering high-quality Polymyxin B for Injection. We prioritize the needs of healthcare professionals in their battle against critical infections, providing reliable solutions for patient care and recovery.

Patient-Centric Approach: Our patient-centric approach fuels continuous efforts to enhance treatment outcomes while minimizing potential side effects. Taj Pharmaceuticals understands that effective treatment is not solely about medications; it’s about improving the quality of life for individuals facing severe infections.

Stringent Quality Standards: Our manufacturing facilities adhere to rigorous quality standards, ensuring that Polymyxin B for Injection meets the highest benchmarks for purity, potency, and safety. We leverage cutting-edge technology and employ highly skilled professionals in producing this critical medication, maintaining the trust of healthcare professionals.

Global Accessibility: Taj Pharmaceuticals is committed to making Polymyxin B for Injection accessible worldwide. Regardless of geographic location, our mission is to ensure that healthcare providers and patients globally have access to this essential infection management tool.

Collaboration and Support: Beyond providing pharmaceuticals, Taj Pharmaceuticals fosters enduring partnerships with healthcare providers and institutions. This collaborative spirit empowers them to deliver the highest standard of care in the critical realm of infection management. We stand as a beacon of hope, advancing the fight against severe infections through trusted solutions.

What is Polymyxin B for Injection and its uses:

Polymyxin B for Injection is a vital antibiotic medication within the polymyxin class, primarily employed in the treatment of severe bacterial infections, especially those caused by highly resistant gram-negative bacteria. This potent antibiotic is often reserved for cases where other antibiotics have proven ineffective, particularly in the context of hospital-acquired infections. It plays a crucial role in combating multidrug-resistant bacteria, addressing the growing challenge of antibiotic resistance, and ensuring effective treatment in healthcare settings. Polymyxin B’s applications extend to cystic fibrosis patients with chronic respiratory infections and, in ophthalmic preparations, for treating eye infections caused by susceptible gram-negative bacteria. However, its use is closely monitored and reserved for situations where its benefits outweigh potential risks and side effects, making it a last-resort option under expert medical supervision.

How does Polymyxin B for Injection Work:

Polymyxin B for Injection exerts its potent antibacterial effects by targeting and disrupting the intricate structure of bacterial cell membranes, with a particular emphasis on gram-negative bacteria. This mechanism of action unfolds as follows:

Interaction with Lipopolysaccharides: Gram-negative bacteria, including notorious pathogens like Pseudomonas aeruginosa and Escherichia coli, possess an outer membrane fortified with lipopolysaccharides (LPS). Polymyxin B exhibits a strong affinity for these LPS molecules, setting the stage for its antimicrobial activity.

Disruption of Cell Membranes: Polymyxin B, once bound to the LPS in the bacterial outer membrane, initiates a disruptive cascade. It interferes with the normal functioning of the LPS, leading to structural breaches in the bacterial cell membrane.

Leakage of Cell Contents: This breach in the cell membrane’s integrity causes a consequential and critical event— the leakage of essential cell contents. Ions and proteins, fundamental to bacterial survival, escape from the compromised bacterium.

Cell Death and Immune Response: The combined effects of disrupted cell membrane integrity, loss of essential cell components, and impaired cellular functions culminate in the demise of the bacterial cell. The weakened bacterium becomes more vulnerable to immune system attacks and clearance.

Polymyxin B for Injection’s exceptional effectiveness stems from its unique ability to target and disrupt the outer membranes of gram-negative bacteria. This property makes it an invaluable antibiotic, particularly in cases where other antibiotics have proven ineffective, especially against multidrug-resistant strains of gram-negative bacteria. However, it’s imperative to underscore that Polymyxin B usage demands cautious monitoring by healthcare professionals due to its potential toxicity to the kidneys and nervous system, especially when administered at high doses or over extended periods.

Benefits of Polymyxin B for Injection:

Polymyxin B for Injection offers several critical advantages in the realm of antibiotic therapy. First and foremost, it stands as a potent weapon against multidrug-resistant bacterial infections. When conventional antibiotics fail to combat these stubborn pathogens, Polymyxin B serves as a crucial last-resort treatment option, demonstrating its efficacy in the face of therapeutic challenges. Its broad spectrum of activity extends to a diverse range of gram-negative bacteria, making it a versatile tool in the fight against infections. Notably, Polymyxin B finds its stronghold in treating hospital-acquired infections, including those associated with ventilators, urinary tracts, and the bloodstream. These infections are often characterized by multidrug-resistant strains, reinforcing the pivotal role of Polymyxin B in healthcare settings. Additionally, its use aligns with the principles of antibiotic stewardship, addressing the urgent need for viable treatments in the context of antibiotic resistance.

Common Side Effects of Polymyxin B for Injection:

While Polymyxin B for Injection offers critical benefits, it is not without potential side effects that warrant vigilance. Foremost among these concerns is kidney toxicity, emphasizing the need for close monitoring of renal function during treatment. Neurotoxicity represents another possible side effect, with symptoms ranging from confusion to muscle weakness, necessitating careful neurological assessment. Though relatively rare, allergic reactions to Polymyxin B are a possibility, characterized by symptoms like hives, itching, and rash. Neuromuscular blockade, a condition in which muscle weakness or paralysis may occur, is a concern, especially in patients with underlying neuromuscular conditions. Superinfections, gastrointestinal disturbances, and local reactions at the injection site also feature among potential side effects, highlighting the importance of comprehensive patient monitoring and supportive care.

The decision to utilize Polymyxin B for Injection hinges on a careful consideration of its benefits in treating otherwise untreatable infections versus the potential risks and side effects. Healthcare providers employ a vigilant and personalized approach, with frequent monitoring, to maximize the benefits while minimizing adverse effects and complications for patients in need of this critical antibiotic therapy.

Frequently Asked Questions About Polymyxin B for Injection:

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

  1. What is Polymyxin B for Injection and how does it work?

Polymyxin B for Injection is an antibiotic medication used to treat severe bacterial infections, particularly those caused by multidrug resistant gram negative bacteria. It works by disrupting the cell membranes of these bacteria, leading to their death.

  1. When is Polymyxin B for Injection prescribed?

Polymyxin B for Injection is prescribed when other antibiotics have proven ineffective, especially against multidrug resistant gram negative bacteria. It is often used in hospital settings for serious infections.

  1. What types of bacteria does Polymyxin B for Injection target?

Polymyxin B is effective against a wide range of gram negative bacteria, including Pseudomonas aeruginosa, Klebsiella pneumoniae, and Acinetobacter baumannii.

  1. How is Polymyxin B for Injection administered?

It is typically administered intravenously (IV) by a healthcare professional in a hospital setting. The dosage and duration of treatment are determined by the treating physician.

  1. What are the potential side effects of Polymyxin B for Injection?

Common side effects may include kidney toxicity, neurotoxicity, allergic reactions, neuromuscular blockade, superinfections, gastrointestinal disturbances, and local reactions at the injection site. However, not everyone will experience these side effects.

  1. Can Polymyxin B for Injection be used during pregnancy and breastfeeding?

Its use during pregnancy and breastfeeding should be carefully considered and discussed with a healthcare provider, weighing the potential benefits against any potential risks to the fetus or infant.

  1. Are there any drug interactions with Polymyxin B for Injection?

Polymyxin B may interact with other medications, so it’s crucial to inform your healthcare provider about all the drugs you are taking, including over the counter and herbal supplements.

  1. How is the effectiveness of Polymyxin B for Injection monitored during treatment?

Regular monitoring of kidney function and neurological status is essential during treatment with Polymyxin B. Additionally, the treating physician will assess the clinical response to the medication.

These FAQs provide essential information about the use of Polymyxin B for Injection. Patients and caregivers should consult with their healthcare providers for personalized information and guidance regarding this medication in their specific medical situations.

Polymyxin B for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Polymyxin B for Injection product in 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

Polymyxin 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 Polymyxin 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
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

(A) Polymyxin B for Injection USP 7,50,000 Units
(B) Polymyxin B for Injection USP 5,00,000 Units

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Polymyxin B for Injection USP 7,50,000 Units
a) Each vial Contains:
Polymyxin B Sulphate USP
equivalent to Polymyxin B……… 7,50,000 Units
b) Excipients…………………q.s.

B) Polymyxin B for Injection USP 5,00,000 Units
a) Each vial Contains:
Polymyxin B Sulphate USP
equivalent to Polymyxin B……… 5,00,000 Units
b) Excipients…………………q.s.


THERAPEUTIC INDICATIONS:

Polymyxin B and trimethoprim combination is used to treat eye infections, including acute bacterial conjunctivitis and blepharoconjunctivitis. Polymyxin B and trimethoprim belong to the class of medicines known as antibiotics. They work by killing the bacteria or preventing their growth.

DIRECTION OF USE:

TO BE USED IMMEDIATELY AFTER RECONSTITUTION
INTRAVENOUS: Dissolve 500,000 polymyxin B units in 300 to 500 ml solutions for parenteral 5% Dextrose Injection for continuous drip.
INTRAMUSCULAR: Dissolve 500,000 polymyxin B units in 2 ml. Sterile Water for Injection or 0.9% Sodium Chloride Injection.
INTRATHECAL: Dissolve 500,000 polymyxin B units in 10 mL 0.9 % Sodium Chloride Injection USP for 50,000 units per ml. dosage unit.

CAUTION & WARNING:

CAUTION: Not recommended routinely because of severe pain at injection sites, particularly in infants and children.
When this drug is given intramuscularly, intravenously or intrathecally, it should be given only to hospitalized patients so as to provide constant supervision by a physician.
Discard unused portion.
WARNING: To be sold by the retail on the prescription of a registered medical practitioner only.

STORAGE & DOSAGE:

Storage: Protect from light and moisture, store below 2°-8°C.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
FOR USAGE & RECONSTITUTION REFER LEAFLET
Dosage: As directed by Physician.