Capreomycin for Injection USP 500mg Technical Specification:

Product Name:Capreomycin for Injection USP 500mg
Brand Name:Capretaj
Strength:500mg, 750mg, 1000mg
Dosage Form:Dry Powder Injection (Sterile) *Preservative Free
Packing:1 Vial + 1 Ampule + WFI Tray (Single use only)
Route of Administration:For Intravenous Infusion 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:Antibiotic, Antitubercular, Anti Tuberculosis (TB)
Indication: Capreomycin is an injectable broad-spectrum antibiotic used in the therapy of drug resistant tuberculosis as a second line agent, always in combination with other antituberculosis drugs. Capreomycin has not been linked to cases of clinically apparent liver disease.
Storage:Store at 20°C to 25°C; excursion permitted to 15°C to 30°C. [See USP Controlled Room Temperature].

GENERIC NAME OF MEDICINAL PRODUCT:

  • Capreomycin for Injection USP (500mg) (Capretaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Capreomycin for Injection USP (500mg)
    Composition:
    Each vial contains:
    Sterile Capreomycin Sulphate USP
    Equivalent to
    Capreomycin………………………500mg
    Sterile Water for Injection BP…………5ml

 THERAPEUTIC INDICATIONS:

Capreomycin is an injectable broad-spectrum antibiotic used in the therapy of drug resistant tuberculosis as a second line agent, always in combination with other antituberculosis drugs. Capreomycin has not been linked to cases of clinically apparent liver disease.

DIRECTION OF USE:

Withdraw 2ml of sterile water for injection* BP from the supplied pack and dissolved the contents of pack and dissolved the contents of vial immediately before use.

Discard remaining WFI

The reconstituted solution may be stored for 48 hours at room temperature and up to 14 days under refrigeration.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after reconstitution, please do not use the solution.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

WARNING: Capreomycin can harm your kidneys or damage the nerve that controls your hearing. Before you use capreomycin, tell your doctor about all your medical conditions and any medicines you are using.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C; excursion permitted to 15°C to 30°C. [See USP Controlled Room Temperature].

Keep out of the reach of children.

Dosage: As directed by Physician.

Why Taj Pharmaceuticals?

At Taj Pharmaceuticals, our legacy of pharmaceutical excellence spans decades, establishing us as a trusted and preferred source for essential medications like Capreomycin for Injection. We prioritize the well-being of patients above all else and are dedicated to upholding the highest standards of pharmaceutical manufacturing and quality control.

Our state-of-the-art manufacturing facilities are equipped with cutting-edge technology, adhering to stringent regulatory guidelines to ensure that every product we offer meets the most demanding quality benchmarks. This commitment to quality extends to every step of the production process, from sourcing raw materials to the final packaging of medications.

We understand the critical role that medications like Capreomycin play in the treatment of serious infections, including drug-resistant tuberculosis. Timely and reliable access to such medications is paramount in the fight against these diseases. Taj Pharmaceuticals is dedicated to providing a consistent and dependable supply of Capreomycin, supporting healthcare professionals in their efforts to combat infectious diseases and improve patient outcomes.

Our commitment to improving global healthcare extends beyond manufacturing medications. We actively engage in research and development endeavors to explore innovative solutions for unmet medical needs. Taj Pharmaceuticals strives to make a meaningful contribution to healthcare by advancing treatment options and ultimately promoting better health and well-being for individuals around the world.

By choosing Taj Pharmaceuticals, you align with a pharmaceutical partner that not only prioritizes quality and reliability but also shares your dedication to improving healthcare outcomes. We stand as a beacon of trust, offering dependable pharmaceutical solutions that healthcare professionals and patients can rely on with confidence.

What is Capreomycin for Injection and its uses:

Capreomycin for Injection stands as a vital medication in the realm of infectious disease treatment, with its primary and critical application centered on the management of tuberculosis (TB). This antibiotic belongs to the aminoglycoside class and is specifically designed to tackle bacterial infections caused by Mycobacterium tuberculosis, the notorious bacterium responsible for TB.

At the forefront of its utility is its effectiveness in combatting drug-resistant tuberculosis (DR-TB), a formidable challenge in the field of infectious diseases. In cases where the standard first-line TB medications prove insufficient due to bacterial resistance, Capreomycin steps in as a potent second-line option. It plays a pivotal role in multidrug regimens designed to address TB strains that have developed resistance to common antibiotics, offering renewed hope for patients facing this resilient foe.

Crucially, Capreomycin doesn’t operate in isolation. It is rarely used as a standalone treatment but rather as an integral part of combination therapy. When administered alongside other antibiotics, such as fluoroquinolones and other second-line TB drugs, it contributes to the creation of a comprehensive and highly effective treatment plan. This combination approach is central to tackling drug-resistant TB, ensuring that multiple fronts are engaged in the battle against the disease.

While Capreomycin may find occasional use in treating other serious bacterial infections that resist other antibiotics, its primary mission remains firmly fixed on TB treatment. It plays a pivotal role in addressing one of the world’s most significant infectious disease challenges, offering a lifeline to patients dealing with drug-resistant TB strains. Its use, however, demands careful monitoring by healthcare professionals to ensure precise dosing and to minimize the risk of antibiotic resistance. The importance of vigilance regarding potential side effects and patient responses cannot be overstated, underscoring the significance of meticulous healthcare management during Capreomycin treatment.

How does Capreomycin for Injection Work:

Capreomycin for Injection is a powerful antibiotic specifically engineered to combat bacterial infections, most notably tuberculosis (TB) caused by Mycobacterium tuberculosis. Its mechanism of action is intricate and precise, focusing on disrupting the bacterial protein synthesis process. By binding to the bacterial ribosomes responsible for protein production, Capreomycin intervenes in the crucial translation process. This stage is essential for the creation of proteins necessary for bacterial growth and survival. Through its interference, Capreomycin effectively halts the production of these vital components, leading to the demise of the bacterium.

Unlike some antibiotics that merely inhibit bacterial growth, Capreomycin exerts a bactericidal effect, actively killing the bacteria. This distinguishes it as a potent weapon in the fight against infections caused by Mycobacterium tuberculosis. Additionally, Capreomycin is often employed in combination with other antibiotics, a synergistic approach that targets different facets of bacterial growth. This combination therapy is particularly pivotal in cases of drug-resistant TB, where the effectiveness of standard treatments is limited.

It’s worth emphasizing that Capreomycin’s efficacy is primarily directed towards Mycobacterium tuberculosis and certain closely related bacterial species. This precision, coupled with its synergistic use in combination therapies, positions Capreomycin as a crucial tool in the battle against TB, especially in cases of drug-resistant strains. Through its targeted mechanism of action and strategic integration into treatment regimens, Capreomycin significantly enhances the prospects for successful outcomes in patients grappling with this challenging and persistent infectious disease.

Benefits of Capreomycin for Injection:

Capreomycin for Injection stands as a beacon of hope for patients grappling with drug-resistant tuberculosis (DR-TB). Its primary advantage lies in its remarkable effectiveness in treating cases where standard first-line TB medications fall short due to drug resistance. Capreomycin plays a pivotal role in multidrug regimens, offering a lifeline to individuals facing TB strains that have developed resistance to common antibiotics. This antibiotic significantly enhances treatment outcomes, leading to better response rates and an increased likelihood of reducing the bacterial load.

Furthermore, Capreomycin acts as a safeguard against TB recurrence. For patients who have encountered challenges with drug-resistant TB in the past, its inclusion in treatment regimens provides an additional layer of protection, reducing the risk of relapse. Its status as a lifesaving antibiotic cannot be overstated, especially for those with limited treatment options due to drug-resistant TB. Capreomycin stands as a critical intervention in the battle against this formidable infectious disease, offering renewed hope and improved prospects for recovery.

Side Effects of Capreomycin for Injection:

While Capreomycin is a powerful ally in the fight against drug-resistant TB, it is not without its potential side effects. One of the significant concerns is ototoxicity, a condition that could lead to damage to the hearing and balance mechanisms in the inner ear. To monitor any signs of hearing loss, patients receiving Capreomycin should undergo regular hearing tests.

Additionally, Capreomycin may affect kidney function, potentially leading to kidney toxicity. This underlines the importance of regular monitoring of kidney function during treatment to detect any abnormalities and intervene promptly. Some patients may also experience injection site reactions, such as pain, redness, or irritation. Proper injection techniques and site rotation can help minimize these reactions.

Nausea and vomiting are common side effects of Capreomycin. These symptoms, however, can be effectively managed with anti-nausea medications. It’s crucial to note that, in some cases, Capreomycin may lead to kidney dysfunction. Regular monitoring of kidney function is imperative during treatment to detect and manage any kidney-related issues that may arise.

While rare, severe allergic reactions to Capreomycin can occur. These reactions may manifest as symptoms like rash, itching, swelling, severe dizziness, or difficulty breathing. Immediate medical attention is imperative if such reactions occur. In conclusion, Capreomycin is a potent antibiotic offering significant benefits in the treatment of drug-resistant TB. However, its use requires close monitoring by healthcare professionals to minimize potential side effects and ensure that patients receive the maximum benefit from this lifesaving medication. Patients receiving Capreomycin should have a comprehensive treatment plan tailored to their specific needs, along with a thorough understanding of potential side effects and their management.

Frequently Asked Questions About Capreomycin for Injection:

Certainly! Here are some frequently asked questions about Capreomycin for Injection:

  1. What is Capreomycin for Injection used for?

Capreomycin for Injection is primarily used in the treatment of drug resistant tuberculosis (DRTB). It is employed when standard first line TB medications are ineffective due to drug resistance.

  1. How does Capreomycin work in treating tuberculosis?

Capreomycin disrupts the protein synthesis process in Mycobacterium tuberculosis, the bacterium causing TB. By inhibiting this vital process, Capreomycin kills the bacteria, making it effective against drug resistant TB strains.

  1. Is Capreomycin used as a standalone treatment for TB?

No, Capreomycin is typically used in combination with other antibiotics as part of a multidrug regimen. This combination therapy enhances treatment effectiveness and reduces the risk of bacterial resistance.

  1. What are the potential side effects of Capreomycin treatment?

Capreomycin can cause side effects, including ototoxicity (hearing loss and balance problems), kidney toxicity, nausea, vomiting, and injection site reactions. Severe allergic reactions are rare but possible.

  1. How is ototoxicity monitored during Capreomycin treatment?

Patients receiving Capreomycin should undergo regular hearing tests to detect any signs of hearing loss or balance issues. Any changes should be reported to healthcare providers promptly.

  1. Can Capreomycin be used in the treatment of other bacterial infections?

While Capreomycin is primarily used for TB treatment, it may find occasional use in treating other serious bacterial infections when they are unresponsive to other antibiotics.

  1. Is Capreomycin safe for pregnant or breastfeeding women?

Capreomycin should be used during pregnancy or breastfeeding only if the potential benefits outweigh the risks. Healthcare providers will carefully assess the individual circumstances and make informed decisions.

  1. What should I do if I experience side effects during Capreomycin treatment?

Patients should communicate any side effects or concerns with their healthcare provider promptly. Proper management and adjustment of the treatment plan may be necessary.

  1. How long is Capreomycin treatment typically administered for?

The duration of Capreomycin treatment can vary depending on factors like the severity of TB, individual patient responses, and the overall treatment plan. It is determined by the treating healthcare provider.

  1. Can drug interactions occur with Capreomycin?

Capreomycin may interact with other medications, so it’s essential to inform your healthcare provider about all the medications and supplements you are taking to prevent potential interactions.

These frequently asked questions provide valuable information for individuals undergoing Capreomycin treatment for drugresistant tuberculosis. However, specific concerns and inquiries should always be discussed with a healthcare professional who can provide personalized guidance based on an individual’s medical history and treatment needs.

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

Capreomycin 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 Capreomycin 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. Capreomycin for Injection USP (500mg)
B. Capreomycin for Injection USP (750mg)
C. Capreomycin for Injection USP (1000mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Capreomycin for Injection USP (500mg)
Composition:
a) Each vial contains:
Sterile Capreomycin Sulphate USP
Equivalent to
Capreomycin………………………500mg
b) Sterile Water for Injection BP…………5ml


B. Capreomycin for Injection USP (750mg)
Composition:
a) Each vial contains:
Sterile Capreomycin Sulphate USP
Equivalent to
Capreomycin………………………750mg
b) Sterile Water for Injection BP…………5ml

C. Capreomycin for Injection USP (1000mg)
Composition:
a) Each vial contains:
Sterile Capreomycin Sulphate USP
Equivalent to
Capreomycin………………………1000mg
b) Sterile Water for Injection BP…………5ml

THERAPEUTIC INDICATIONS:

Capreomycin is an injectable broad-spectrum antibiotic used in the therapy of drug resistant tuberculosis as a second line agent, always in combination with other antituberculosis drugs. Capreomycin has not been linked to cases of clinically apparent liver disease.

DIRECTION OF USE:

Withdraw 2ml of sterile water for injection* BP from the supplied pack and dissolved the contents of pack and dissolved the contents of vial immediately before use.
Discard remaining WFI
The reconstituted solution may be stored for 48 hours at room temperature and up to 14 days under refrigeration.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after reconstitution, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Capreomycin can harm your kidneys or damage the nerve that controls your hearing. Before you use capreomycin, tell your doctor about all your medical conditions and any medicines you are using.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C; excursion permitted to 15°C to 30°C. [See USP Controlled Room Temperature].
Keep out of the reach of children.
Dosage: As directed by Physician.