Daptomycin for Injection 500mg Technical Specification:

Product Name:Daptomycin for Injection 500mg
Brand Name:Generics
Strength:350mg, 500mg
Dosage Form:Lyophilized
Dry Powder for Solution for Injection/Infusion
Packing:1 Vial
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antibiotic
Indication: Daptomycin injection is used to treat certain blood infections or serious skin infections caused by bacteria in adults and children 1 year of age and older.
Storage:Store at 2°C-8°C. (in a refrigerator) Store in original package. Avoid excessive heat.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Daptomycin for Injection 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Daptomycin for Injection 500mg
    Composition:
    Each vial contains:
    Daptomycin …………………500mg
    Sodium Hydroxide………………q.s.
    (to adjust pH)

THERAPEUTIC INDICATION:

Daptomycin injection is used to treat certain blood infections or serious skin infections caused by bacteria in adults and children 1 year of age and older.

DIRECTION OF USE:

For I.V. use only.
Read the package leaflet before use for direction on reconstitution.

CAUTION AND WARNING:

CAUTION: Not to be used if the reconstituted solution contains any visible particles.
The reconstituted solution should be used immediately after preparation.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store at 2°C-8°C. (in a refrigerator) Store in original package. Avoid excessive heat.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
Read the leaflet for the shelf life of the reconstituted product.
DOSAGE: As directed by Physician.

Why Taj Pharmaceuticals?

Taj Pharma’s Daptomycin for Injection stands as the pinnacle of antibiotic innovation and patient care. Our unwavering commitment to excellence is reflected in every vial of this vital medication. With Taj Pharma, you can expect stringent quality control measures, expertly crafted formulations, and a dedication to combatting infectious diseases. At Taj Pharma, we understand the urgency of addressing serious bacterial infections. Daptomycin for Injection is a powerful tool in the fight against a range of pathogens, offering hope and healing to patients worldwide. Our commitment to affordability ensures that life-saving antibiotics remain accessible to all, prioritizing both health and financial well-being. Choose Taj Pharma for Daptomycin for Injection and experience the assurance of a trusted partner in healthcare. Your health, our responsibility.

What is Daptomycin for Injection and its Use?

Daptomycin for Injection is a powerful antibiotic medication used to treat serious bacterial infections. It belongs to a class of antibiotics known as lipopeptides and is typically administered intravenously. Here is an overview of Daptomycin and its common uses:

Common Uses of Daptomycin for Injection:

  • Skin and Soft Tissue Infections: Daptomycin is used to treat severe skin and soft tissue infections caused by Gram-positive bacteria. This includes infections like cellulitis, abscesses, and diabetic foot ulcers.
  • Bone and Joint Infections: It can also be employed to treat bone and joint infections, particularly in cases where these infections are caused by resistant strains of bacteria.
  • Bloodstream Infections (Bacteremia): Daptomycin is effective in treating bloodstream infections caused by Gram-positive bacteria, including Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA), and Enterococcus species.
  • Endocarditis: In some cases, Daptomycin may be used as part of the treatment for infective endocarditis, an infection of the heart’s inner lining and valves.
  • Pulmonary Infections: While less common, Daptomycin may also be considered for certain respiratory infections caused by resistant Gram-positive bacteria.

It’s important to note that Daptomycin should be used under the guidance of a healthcare professional who will determine the appropriate dosage and duration of treatment based on the specific bacterial infection, the patient’s medical history, and the antibiotic sensitivity of the bacteria involved. Like all antibiotics, Daptomycin should be used responsibly to minimize the risk of antibiotic resistance. Patients should follow their healthcare provider’s instructions carefully and complete the full course of treatment even if they start to feel better before it is finished.

How does Daptomycin for Injection work?

Daptomycin for Injection works by disrupting the integrity of bacterial cell membranes, leading to bacterial cell death. It is particularly effective against Gram-positive bacteria, including strains that may be resistant to other antibiotics. Here’s how Daptomycin’s mechanism of action works:

  • Cell Membrane Disruption: Bacterial cells are surrounded by a protective outer membrane that serves as a barrier to keep the cell contents intact. Daptomycin specifically targets the cell membrane of bacteria.
  • Calcium Ions Binding: Daptomycin has a unique mechanism of action. It binds to calcium ions, which are abundant in the environment surrounding bacterial cells.
  • Insertion into the Cell Membrane: When Daptomycin binds to calcium ions, it undergoes a conformational change that allows it to insert itself into the bacterial cell membrane.
  • Disruption of Membrane Integrity: Once inserted into the cell membrane, Daptomycin forms pores or channels within the membrane. These pores create disruptions in the membrane’s integrity.
  • Leakage of Cellular Contents: The disruption of the cell membrane leads to an increase in permeability, causing the bacterial cell to leak essential ions and cellular contents. This loss of integrity compromises the bacterium’s ability to maintain its structure and function.
  • Cell Death: As the bacterial cell loses its structural integrity and essential components, it cannot survive. This process ultimately results in bacterial cell death.

Daptomycin’s unique mechanism of action, targeting the bacterial cell membrane, makes it particularly effective against a wide range of Gram-positive bacteria, including strains that may be resistant to other antibiotics. This property has made Daptomycin an important treatment option for serious bacterial infections caused by these pathogens.

Benefits of Daptomycin for Injection:

  • Broad-Spectrum Effectiveness: Daptomycin is highly effective against a wide range of Gram-positive bacteria, including those that are resistant to other antibiotics. This makes it a valuable treatment option for serious bacterial infections.
  • Effective Against Resistant Strains: Daptomycin’s unique mechanism of action, targeting the bacterial cell membrane, allows it to combat bacteria that may be resistant to other antibiotics, such as methicillin-resistant Staphylococcus aureus (MRSA).
  • Treatment of Severe Infections: Daptomycin is particularly useful for treating severe bacterial infections, including skin and soft tissue infections, bone and joint infections, bloodstream infections, and infective endocarditis.
  • Limited Development of Resistance: Due to its unique mechanism of action, the development of bacterial resistance to Daptomycin is less common compared to some other antibiotics.
  • Rapid Onset of Action: Daptomycin typically exhibits a relatively fast onset of action, allowing for prompt control of bacterial infections.

Side Effects of Daptomycin for Injection:

  • Allergic Reactions: While rare, some individuals may experience allergic reactions to Daptomycin, which can include hives, rash, itching, swelling, or difficulty breathing.
  • Injection Site Reactions: Pain, swelling, and redness at the injection site are possible side effects.
  • Gastrointestinal Disturbances: Nausea, vomiting, diarrhea, or abdominal pain may occur in some individuals.
  • Elevated Blood Enzymes: In rare cases, Daptomycin may cause an increase in certain liver enzymes, which can be detected through blood tests.
  • Muscle and Joint Pain: Some individuals may experience muscle pain or joint pain during Daptomycin treatment.
  • Changes in Blood Cell Counts: Daptomycin may cause changes in blood cell counts, which can be monitored through blood tests. This may include a decrease in white blood cell count (leukopenia) or platelet count (thrombocytopenia).
  • Potential for Kidney Toxicity: In rare cases, Daptomycin may lead to kidney-related side effects, which can be detected through blood and urine tests.

Frequently asked questions about Daptomycin for Injection:

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

  1. What is Daptomycin for Injection?

Daptomycin for Injection is an antibiotic medication used to treat severe bacterial infections, particularly those caused by Gram-positive bacteria.

  1. How does Daptomycin work?

Daptomycin disrupts the bacterial cell membrane, leading to cell death. This mechanism is effective against a wide range of bacteria, including drug resistant strains.

  1. What types of infections can Daptomycin treat?

Daptomycin is used to treat various infections, including skin and soft tissue infections, bone and joint infections, bloodstream infections (bacteremia), and infective endocarditis.

  1. Is Daptomycin effective against MRSA (Methicillin Resistant Staphylococcus aureus)?

Yes, Daptomycin is effective against MRSA and other drug resistant strains of Staphylococcus aureus.

  1. How is Daptomycin administered?

Daptomycin is typically administered as an intravenous (IV) infusion in a healthcare setting.

  1. What are the common side effects of Daptomycin?

Common side effects may include allergic reactions, injection site reactions, gastrointestinal symptoms (nausea, vomiting, diarrhea), and muscle or joint pain.

  1. Are there any serious side effects associated with Daptomycin?

While rare, serious side effects can include kidney toxicity, changes in blood cell counts, and liver enzyme elevations. It’s essential to report any unusual symptoms to your healthcare provider.

  1. Can Daptomycin be used during pregnancy or breastfeeding?

The use of Daptomycin during pregnancy or breastfeeding should be discussed with a healthcare provider to weigh potential risks and benefits.

  1. Is it safe to consume alcohol while taking Daptomycin?

Alcohol consumption should be discussed with your healthcare provider, as it may interact with medications and affect treatment outcomes.

  1. Is Daptomycin suitable for children or the elderly?

Daptomycin can be used in children and the elderly, but dosages may vary based on individual factors and should be determined by a healthcare provider.

  1. Can I stop taking Daptomycin once my symptoms improve?

It’s important to complete the full course of Daptomycin treatment, even if you start feeling better before the medication is finished. Stopping prematurely can lead to the development of antibiotic resistance.

  1. Are there any drug interactions with Daptomycin?

Daptomycin can interact with certain medications, so it’s essential to inform your healthcare provider of all the medications you are taking.

Always consult with a healthcare professional for personalized information and guidance regarding the use of Daptomycin for your specific medical condition or situation.

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

Daptomycin 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 Daptomycin 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. Daptomycin for Injection 350mg
B. Daptomycin for Injection 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Daptomycin for Injection 350mg
Composition:
Each vial contains:
Daptomycin …………………350mg
Sodium Hydroxide………………q.s.
(to adjust pH)

B. Daptomycin for Injection 500mg
Composition:
Each vial contains:
Daptomycin …………………500mg
Sodium Hydroxide………………q.s.
(to adjust pH)


THERAPEUTIC INDICATIONS:

Daptomycin injection is used to treat certain blood infections or serious skin infections caused by bacteria in adults and children 1 year of age and older.

DIRECTION OF USE:

For I.V. use only.
Read the package leaflet before use for direction on reconstitution.

CAUTION & WARNING:

CAUTION: Not to be used if the reconstituted solution contains any visible particles.
The reconstituted solution should be used immediately after preparation.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

STORAGE: Store at 2°C-8°C. (in a refrigerator) Store in original package. Avoid excessive heat.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
Read the leaflet for the shelf life of the reconstituted product.
DOSAGE: As directed by Physician.