GENERIC NAME OF MEDICINAL PRODUCT:

A. Colistimethate Sodium for Injection IP 0.5MIU
B. Colistimethate Sodium for Injection IP 1MIU
C. Colistimethate Sodium for Injection IP 2MIU
D. Colistimethate Sodium for Injection IP 3MIU
E. Colistimethate Sodium for Injection IP 4.5MIU
F. Colistimethate Sodium for Injection IP 5MIU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Colistimethate Sodium for Injection IP 0.5MIU
a) Each vial contains:
Colistimethate Sodium IP…..5,00,000 IU
(IU: International Units)
As sterile powder for reconstitution
Excipients…………………………...q.s.
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml


2. Colistimethate Sodium for Injection IP 1MIU
a) Each vial contains:
Colistimethate Sodium IP…..10,00,000 IU
(IU: International Units)
As sterile powder for reconstitution
Excipients…………………………...q.s.
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml

3. Colistimethate Sodium for Injection IP 2MIU
a) Each vial contains:
Colistimethate Sodium IP…..20,00,000 IU
(IU: International Units)
As sterile powder for reconstitution
Excipients…………………………...q.s.
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml

4. Colistimethate Sodium for Injection IP 3MIU
a) Each vial contains:
Colistimethate Sodium IP…..30,00,000 IU
(IU: International Units)
As sterile powder for reconstitution
Excipients…………………………...q.s.
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml

5. Colistimethate Sodium for Injection IP 4.5MIU
a) Each vial contains:
Colistimethate Sodium IP…..45,00,000 IU
(IU: International Units)
As sterile powder for reconstitution
Excipients…………………………...q.s.
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml

6. Colistimethate Sodium for Injection IP 5MIU
a) Each vial contains:
Colistimethate Sodium IP…..50,00,000 IU
(IU: International Units)
As sterile powder for reconstitution
Excipients…………………………...q.s.
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml

THERAPEUTIC INDICATION:

Colistimethate injection is used to treat certain infections caused by bacteria. Colistimethate injection is in a class of medications called antibiotics. It works by killing bacteria.

DIRECTION OF USE:

Dissolve the contents in Sterile Water for Injection I.P.10ml
The reconstituted solution should be used immediately after the preparation.
Read enclosed leaflet before reconstitution and use.

CAUTION AND SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
Not to be used in food producing animals, poultry, aqua farming and animal feed supplement.
WFI IP Ampule is not manufactured by us.
*Not to be sold without water for injection.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C.
Protect from light and moisture.
Do not freeze.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
DOSAGE: As directed by the Physician.

Colistimethate Sodium for Injection I.P. 0.5MIU Technical Specification:

Product Name:Colistimethate Sodium for Injection I.P. 0.5MIU
Brand Name:COLISTIN
Strength:0.5MIU(300mg) (5,00,000 IU),
1MIU(600mg) (10,00,000 IU),
2MIU(1200mg) (20,00,000 IU),
3MIU(1800mg) (30,00,000 IU),
4.5MIU(2700mg) (45,00,000 IU),
5MIU(3000mg) (50,00,000 IU)
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:1 Single Dose Vial + WFI Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Anti-Infective, Antibacterial, Antibiotics (polymyxin)
Indication: Colistimethate injection is used to treat certain infections caused by bacteria. Colistimethate injection is in a class of medications called antibiotics. It works by killing bacteria.
Storage:Store below 25°C. Protect from light and moisture. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Colistimethate Sodium for Injection IP 0.5MIU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Colistimethate Sodium for Injection IP 0.5MIU
    a. Each vial contains:
    Colistimethate Sodium IP…..5,00,000 IU
    (IU: International Units)
    As sterile powder for reconstitution
    Excipients……………………..q.s
    b. This pack is also contains:
    One FFS ampule of Sterile Water for Injection IP…….10ml

THERAPEUTIC INDICATION:

Colistimethate injection is used to treat certain infections caused by bacteria. Colistimethate injection is in a class of medications called antibiotics. It works by killing bacteria.

DIRECTION OF USE:

Dissolve the contents in Sterile Water for Injection I.P.10ml
The reconstituted solution should be used immediately after the preparation.
Read enclosed leaflet before reconstitution and use.

CAUTION AND SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, Please do not use the solution.

Not to be used in food producing animals, poultry, aqua farming and animal feed supplement.

WFI IP Ampule is not manufactured by us.
*Not to be sold without water for injection.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.

NOTE: WFI IP Ampule is not manufactured by us.

SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C. Protect from light and moisture. Do not freeze.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

DOSAGE: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals emerges as the premier choice for Colistimethate Sodium for Injection, driven by a legacy of pharmaceutical excellence and innovation. With a steadfast commitment to pharmaceutical expertise, Taj Pharmaceuticals leverages its extensive industry experience to produce Colistimethate Sodium of the highest quality. Rigorous quality controls are applied in state-of-the-art manufacturing facilities to ensure that each vial meets stringent safety and efficacy standards. Taj Pharmaceuticals places innovation at the core of its operations, investing in cutting-edge technologies and research to advance healthcare solutions. With a global reach, the company extends access to Colistimethate Sodium worldwide, contributing to elevated healthcare standards on a global scale. Regulatory compliance is paramount, as demonstrated by certifications like ISO and WHO-GMP. Taj Pharmaceuticals places patient well-being at the forefront, offering customized solutions and competitive pricing to enhance healthcare accessibility. With responsive customer support, Taj Pharmaceuticals stands as the trusted partner for healthcare professionals and patients seeking uncompromising quality in Colistimethate Sodium for Injection. Trust Taj Pharmaceuticals for your pharmaceutical needs.

What is Colistimethate Sodium for Injection and its uses:

Colistimethate Sodium for Injection is a crucial medication containing the active ingredient colistimethate sodium, classified as an antibiotic. This medication is predominantly employed in the treatment of bacterial infections, particularly those caused by notoriously drug-resistant strains of Gram-negative bacteria. Its applications are particularly vital in cases where conventional antibiotics have proven ineffective due to antibiotic resistance.

One of the primary areas of use for Colistimethate Sodium is in combatting multidrug-resistant infections, where bacteria like Pseudomonas aeruginosa, Klebsiella pneumoniae, and Acinetobacter baumannii have developed resistance to multiple antibiotics. As a last-resort treatment, Colistimethate Sodium plays a pivotal role in addressing these severe and challenging infections.

In cases of respiratory infections, including pneumonia, where drug-resistant bacteria are implicated, Colistimethate Sodium can be administered either through inhalation or intravenous means. This application underscores its significance in managing infections of the respiratory tract.

The medication also extends its utility to tackling drug-resistant bacteria responsible for urinary tract infections, offering a potential lifeline when other antibiotics falter. Furthermore, it is occasionally considered for individuals with cystic fibrosis dealing with lung infections caused by drug-resistant pathogens, with inhaled forms providing a valuable treatment option.

In exceptional circumstances, Colistimethate Sodium may be used in the treatment of bacterial meningitis caused by susceptible organisms. Additionally, it finds a role in infection prophylaxis, serving to prevent infections, particularly in patients with compromised immune systems or those undergoing specific medical procedures.

It’s critical to emphasize that Colistimethate Sodium is considered a potent antibiotic with a limited spectrum of activity, primarily effective against Gram-negative bacteria. Its use is reserved for severe infections when other treatment avenues have been exhausted or are ineffective, reflecting the importance of prudent antibiotic use in the face of rising antibiotic resistance. Consequently, the decision to employ Colistimethate Sodium should be made by healthcare providers, taking into account the specific bacterial strain causing the infection and the patient’s medical condition.

How does Colistimethate Sodium for Injection Work:

Colistimethate Sodium for Injection operates through a distinctive mechanism to combat bacterial infections, particularly those caused by drug-resistant Gram-negative bacteria. At the heart of its action is the active ingredient colistin, a polymyxin antibiotic. Its mode of action unfolds in several crucial steps.

Firstly, upon administration, colistin engages with the outer membrane of the Gram-negative bacteria, forming an interaction that sets the stage for its action. This outer membrane acts as a protective shield encasing the bacterial cell.

Once colistin has firmly attached itself to the bacterial cell membrane, it initiates a critical process—increasing the permeability of the membrane. This process disrupts the membrane’s structural integrity, rendering it more porous and vulnerable.

As the permeability of the bacterial cell membrane escalates, it triggers a cascade of events. Vital cellular components, including ions and molecules, begin to leak out of the bacterial cell. This leakage severely hampers the bacterium’s normal functioning.

Ultimately, this relentless disruption culminates in the demise of the bacterial cell. The combined effects of membrane destabilization and the loss of essential cellular contents result in bacterial cell death. In essence, Colistimethate Sodium acts as a bactericidal agent, bringing about the demise of Gram-negative bacteria.

It is imperative to recognize that the efficacy of Colistimethate Sodium is chiefly confined to Gram-negative bacteria, reflecting its narrow spectrum of activity. This antibiotic is strategically reserved for situations where antibiotic resistance poses a significant challenge, serving as a last-resort treatment option for severe and life-threatening infections caused by these resilient bacteria. Decisions regarding the use of Colistimethate Sodium should be made by healthcare providers who can assess its suitability based on the specific bacterial infection and the patient’s medical condition.

Benefits and Side Effects of Colistimethate Sodium for Injection:

Colistimethate sodium, administered through intravenous or intramuscular injections, is a potent antibiotic reserved for treating serious bacterial infections, particularly those caused by multidrug-resistant gram-negative bacteria. It serves as a last-resort treatment when other antibiotics prove ineffective due to resistance. Colistimethate sodium’s broad-spectrum effectiveness makes it valuable in addressing infections caused by a range of resistant pathogens, including Pseudomonas aeruginosa and Acinetobacter baumannii, often occurring in life-threatening conditions such as pneumonia, sepsis, and urinary tract infections.

Despite its effectiveness, colistimethate sodium is associated with several potential side effects that necessitate careful monitoring and consideration. Chief among these is nephrotoxicity, which can lead to kidney damage. Patients receiving the medication must have their kidney function closely assessed throughout treatment. Neurotoxicity is another concern, with symptoms like confusion and muscle weakness occasionally occurring. Respiratory side effects, such as shortness of breath and cough, can manifest when the medication is inhaled for lung infections.

Gastrointestinal disturbances like nausea, vomiting, and diarrhea may also occur, along with allergic reactions, ranging from mild skin rashes to severe anaphylactic responses. Vigilance is essential for identifying and managing these reactions promptly. Colistimethate sodium use may lead to superinfections, as it can disrupt the body’s normal microbial balance. Furthermore, ototoxicity, which can result in hearing loss or balance problems, though less common, is a potential side effect.

Lastly, prolonged or inappropriate use of colistimethate sodium may contribute to the development of antibiotic resistance, underscoring the importance of prudent prescribing and close patient monitoring. Healthcare professionals must weigh the benefits and risks carefully when considering this medication, reserving it for severe infections where no alternative treatments are available. Patients should receive colistimethate sodium under the guidance of experienced healthcare providers who can monitor them closely for side effects and adjust treatment as needed.

Frequently Asked Questions About Colistimethate Sodium for Injection:

Certainly, here are some frequently asked questions about colistimethate sodium for injection, along with their answers:

  1. What is colistimethate sodium used for?

Colistimethate sodium is primarily used to treat serious bacterial infections caused by multidrugresistant gramnegative bacteria. It is often considered a lastresort antibiotic when other treatments have failed.

  1. How is colistimethate sodium administered?

Colistimethate sodium is typically administered by injection, either intravenously (IV) or intramuscularly (IM). The specific method of administration depends on the type and severity of the infection.

  1. What are the common brand names for colistimethate sodium?

Colistimethate sodium is available under various brand names, including ColyMycin M, ColyMycin S, and Colomycin, among others.

  1. What are the potential side effects of colistimethate sodium?

Common side effects may include nephrotoxicity (kidney damage), neurotoxicity (nervous system damage), gastrointestinal disturbances, respiratory issues, and allergic reactions. It can also lead to superinfections and, rarely, ototoxicity (ear damage).

  1. How is kidney function monitored during colistimethate sodium treatment?

Patients receiving colistimethate sodium should have their kidney function closely monitored through regular blood tests. If signs of kidney problems occur, dosage adjustments or discontinuation may be necessary.

  1. Can colistimethate sodium be used during pregnancy or breastfeeding?

It should be used during pregnancy or breastfeeding only if the potential benefits outweigh the risks. Healthcare providers should carefully evaluate the situation and consider alternative treatments whenever possible.

  1. Is colistimethate sodium effective against all types of bacteria?

No, colistimethate sodium primarily targets gramnegative bacteria. It is not effective against grampositive bacteria or certain types of infections.

  1. Is resistance a concern with colistimethate sodium use?

Yes, the overuse or misuse of colistimethate sodium can contribute to the development of antibiotic resistance. Therefore, it should be reserved for cases where no other effective treatments are available.

  1. Can colistimethate sodium be used in children?

Colistimethate sodium can be used in children, but dosages and treatment plans must be carefully tailored to their age and weight. Pediatric dosing should be determined by a healthcare provider.

  1. How long should colistimethate sodium treatment last?

The duration of treatment with colistimethate sodium depends on the type and severity of the infection. Treatment is typically continued until the infection is fully resolved, as determined by a healthcare provider.

Patients and healthcare providers should engage in open communication regarding the use of colistimethate sodium, its potential side effects, and the overall treatment plan to ensure the best possible outcomes while minimizing risks.

colistimethate sodium for injection Exporters; We can cater to export business queries from the following geographies. We are exporting our colistimethate sodium 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

colistimethate sodium 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 colistimethate sodium 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