post-title portfolio-title Tacrolimus Capsules USP 1mg 2023-02-24 08:30:47 no no

Tacrolimus Capsules USP 1mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Tacrolimus Capsules USP 0.5mg
B) Tacrolimus Capsules USP 1mg
C) Tacrolimus Capsules USP 2mg
D) Tacrolimus Capsules USP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Tacrolimus Capsules USP 0.5mg
Each hard gelatin Capsule contains:
Tacrolimus Monohydrate
Equivalent to Tacrolimus USP……………0.5mg
Excipients…………………………………………q.s.
Approved colours used in capsule shell.

B) Tacrolimus Capsules USP 1mg
Each hard gelatin Capsule contains:
Tacrolimus Monohydrate
Equivalent to Tacrolimus USP…………1mg
Excipients……………………………………….q.s.
Approved colours used in capsule shell.

C) Tacrolimus Capsules USP 2mg
Each hard gelatin Capsule contains:
Tacrolimus Monohydrate
Equivalent to Tacrolimus USP…………2mg
Excipients……………………………………….q.s.
Approved colours used in capsule shell.

D) Tacrolimus Capsules USP 5mg
Each hard gelatin Capsule contains:
Tacrolimus Monohydrate
Equivalent to Tacrolimus USP…………5mg
Excipients……………………………………….q.s.
Approved colours used in capsule shell.

THERAPEUTIC INDICATIONS:

Tacrolimus is used together with other medicines to prevent the body from rejecting a transplanted organ (eg, kidney, liver, heart, or lung). This medicine may be used with steroids, azathioprine, basiliximab, or mycophenolate mofetil. Tacrolimus belongs to a group of medicines known as immunosuppressive agents.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Nephrologist.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Protect from light and moisture.
Dosage: As directed by the Nephrologist.
Attach dispensing label as per end country.

Tacrolimus Capsules USP 1mg Technical Specification:

Product Name:Tacrolimus Capsules USP
Brand Name:Generics
Strength:0.5mg, 1mg, 2mg, 5mg
Dosage Form:Capsules(Hard gelatin)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Immunosuppressants
Indication: Tacrolimus is an immunosuppressive drug. After allogeneic organ transplant, the risk of organ rejection is moderate.
Storage:Store at 20° to 25°C (68° to 77°F). Protect from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Tacrolimus Capsules USP 0.5mg
  • Tacrolimus Capsules USP 1mg
  • Tacrolimus Capsules USP 2mg
  • Tacrolimus Capsules USP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Tacrolimus Capsules USP 0.5mg
    Each hard gelatin Capsule contains:
    Tacrolimus Monohydrate
    Equivalent to Tacrolimus USP……………0.5mg
    Excipients…………………………………………q.s.
    Approved colours used in capsule shell.
  • Tacrolimus Capsules USP 1mg
    Each hard gelatin Capsule contains:
    Tacrolimus Monohydrate
    Equivalent to Tacrolimus USP…………1mg
    Excipients……………………………………….q.s.
    Approved colours used in capsule shell.
  • Tacrolimus Capsules USP 2mg
    Each hard gelatin Capsule contains:
    Tacrolimus Monohydrate
    Equivalent to Tacrolimus USP…………2mg
    Excipients……………………………………….q.s.
    Approved colours used in capsule shell.
  • Tacrolimus Capsules USP 5mg
    Each hard gelatin Capsule contains:
    Tacrolimus Monohydrate
    Equivalent to Tacrolimus USP…………5mg
    Excipients……………………………………….q.s.
    Approved colours used in capsule shell.

THERAPEUTIC INDICATIONS:

Tacrolimus is used together with other medicines to prevent the body from rejecting a transplanted organ (eg, kidney, liver, heart, or lung). This medicine may be used with steroids, azathioprine, basiliximab, or mycophenolate mofetil. Tacrolimus belongs to a group of medicines known as immunosuppressive agents.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Nephrologist.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Protect from light and moisture.
Dosage: As directed by the Nephrologist.
Attach dispensing label as per end country.

Why Taj Pharmaceuticals?

Certainly, here’s an expanded version of why you should choose Taj Pharmaceuticals for Tacrolimus Capsules USP:

Quality Assurance and Safety: At Taj Pharmaceuticals, quality is the cornerstone of our operations. We prioritize your safety and well-being by adhering to stringent quality control standards. Our commitment to producing high-quality medications ensures that Tacrolimus Capsules USP meet the highest industry standards, providing you with peace of mind regarding their safety and efficacy.

Proven Efficacy: Tacrolimus Capsules USP are meticulously designed for therapeutic effectiveness. Our extensive research and development efforts guarantee that our medications, including Tacrolimus Capsules, deliver the desired therapeutic outcomes. We are dedicated to providing you with reliable and effective treatment options.

Affordability and Accessibility: We recognize the importance of accessible healthcare. Taj Pharmaceuticals strives to make essential medications, such as Tacrolimus Capsules USP, affordable to patients without compromising quality. Our commitment to affordability ensures that vital treatments are within reach for individuals worldwide.

Global Reach and Distribution: With a global presence, Taj Pharmaceuticals ensures that Tacrolimus Capsules USP are available to patients around the world. Our extensive distribution network is designed to reach patients wherever they reside, facilitating global healthcare access.

Customer-Centric Approach: Your satisfaction is our top priority. We take pride in providing exceptional service and support, creating a positive healthcare experience for both healthcare professionals and patients. Our customer-centric approach ensures that your needs and concerns are addressed promptly and effectively.

Environmental Responsibility: Sustainability matters to us. Taj Pharmaceuticals is committed to environmentally responsible manufacturing practices, aiming to minimize our ecological footprint. We prioritize sustainability to contribute positively to the environment.

By choosing Taj Pharmaceuticals for Tacrolimus Capsules USP, you are choosing a reliable and patient-focused healthcare partner. Our unwavering commitment to quality, safety, affordability, and customer satisfaction underscores our dedication to meeting your healthcare needs with trust and reliability. Your health and well-being are central to our mission.

What is Tacrolimus Capsules USP and its uses:

Tacrolimus Capsules USP are a medication that contains the active ingredient tacrolimus. This medication belongs to a class of drugs known as calcineurin inhibitors and is primarily used to suppress the immune system’s response. Tacrolimus is available in various forms, including capsules, and is used to prevent the rejection of organ transplants and to treat certain skin conditions. Here are its primary uses:

  1. Organ Transplantation: Tacrolimus Capsules USP are commonly used in organ transplantation, such as kidney, liver, heart, and lung transplants. They play a crucial role in preventing the recipient’s immune system from rejecting the transplanted organ. By suppressing the immune response, tacrolimus helps ensure that the transplanted organ functions effectively and remains viable.
  1. Dermatological Conditions: Tacrolimus is also prescribed in topical formulations (ointment or cream) for the treatment of certain skin conditions. It is particularly effective in cases of atopic dermatitis (eczema) and other inflammatory skin disorders. Topical tacrolimus helps reduce inflammation, itching, and redness associated with these conditions.

It’s important to note that Tacrolimus Capsules USP is typically used as an oral medication for immunosuppression in transplant recipients. The dosage and treatment plan are individualized based on factors such as the type of organ transplant, the patient’s age, and their response to the medication. Tacrolimus works by inhibiting the activation of T lymphocytes, a type of immune cell, which are involved in the rejection of transplanted organs. By dampening the immune response, the medication helps maintain the harmony between the transplanted organ and the recipient’s body. Patients prescribed Tacrolimus Capsules should be closely monitored by their healthcare provider. Regular blood tests are essential to ensure that the medication is at the appropriate therapeutic level and to detect any potential side effects or complications. The use of tacrolimus requires careful management and adherence to the prescribed treatment plan to optimize the chances of transplant success and minimize the risk of rejection.

How Do Tacrolimus Capsules USP Work?

Tacrolimus Capsules USP works by suppressing the immune system’s response, specifically by inhibiting the activation and function of T-lymphocytes, a type of immune cell. This mechanism of action is crucial for their use in preventing the rejection of transplanted organs and in treating certain skin conditions. Here’s how Tacrolimus Capsules USP works:

  • Immune System Suppression: Tacrolimus is classified as an immunosuppressant, which means it dampens the activity of the immune system. In the context of organ transplantation, the immune system of the recipient recognizes the transplanted organ as foreign and tries to attack and reject it. Tacrolimus inhibits this immune response.
  • T-lymphocyte Inhibition: T-lymphocytes, also known as T cells, are a type of white blood cell that plays a central role in immune responses. They are responsible for identifying and attacking foreign invaders, including transplanted organs. Tacrolimus specifically targets and inhibits the activation of T-lymphocytes.
  • Calcineurin Inhibition: Tacrolimus’s primary mechanism of action involves inhibiting an enzyme called calcineurin within T-lymphocytes. Calcineurin is responsible for activating T-lymphocytes, which then initiate the immune response. By inhibiting calcineurin, Tacrolimus prevents T-lymphocytes from becoming fully activated.
  • Reduced Immune Response: When T-lymphocytes are unable to become fully activated, they are less effective at initiating the immune response against the transplanted organ. This reduction in immune activity helps prevent the rejection of the transplanted organ.
  • Maintenance of Organ Function: In the context of organ transplantation, Tacrolimus helps maintain the function and viability of the transplanted organ by keeping the immune response in check. This allows the transplanted organ to integrate and function properly within the recipient’s body.

Benefits of Tacrolimus Capsules USP:

  • Prevention of Organ Rejection: One of the primary benefits of Tacrolimus Capsules USP is their effectiveness in preventing the rejection of transplanted organs, such as kidney, liver, heart, and lung transplants. By suppressing the immune response, these capsules help ensure that the transplanted organ remains functional and viable in the recipient’s body.
  • Treatment of Skin Conditions: Topical formulations of tacrolimus are used for the treatment of certain skin conditions, such as atopic dermatitis (eczema). Tacrolimus helps reduce inflammation, itching, and redness associated with these skin disorders, improving the patient’s quality of life.
  • Immunosuppressive Control: Tacrolimus is used to control the immune system’s activity in autoimmune diseases and following organ transplantation. It can help manage autoimmune conditions like rheumatoid arthritis and psoriasis by suppressing the immune system’s response to reduce inflammation and symptoms.
  • Lower Steroid Doses: In transplant patients, Tacrolimus Capsules USP may allow for the use of lower doses of corticosteroids (steroids), which can have significant side effects. This can help reduce the risk of steroid-related complications.

Common Side Effects of Tacrolimus Capsules USP:

  • Immune Suppression: While immune suppression is the desired effect in transplant patients, it can increase the risk of infections, including bacterial, viral, and fungal infections. Patients need to be vigilant about preventing and promptly treating infections.
  • Gastrointestinal Symptoms: Common side effects may include nausea, vomiting, diarrhea, and abdominal discomfort. These symptoms can be managed with proper medication and dietary adjustments.
  • Hypertension (High Blood Pressure): Tacrolimus can lead to elevated blood pressure in some patients. Regular monitoring and blood pressure management are essential.
  • Kidney Dysfunction: Kidney function may be affected in some individuals taking Tacrolimus. Regular monitoring of kidney function through blood tests is crucial.
  • Tremors and Neurological Effects: Some patients may experience tremors (shaking) or other neurological symptoms. These effects are usually mild but should be reported to the healthcare provider.
  • Increased Risk of Skin Cancer: Long-term use of Tacrolimus may slightly increase the risk of skin cancer. Patients should take precautions to protect their skin from excessive sun exposure.
  • Metabolic Changes: Tacrolimus can affect glucose metabolism and lipid profiles, potentially leading to diabetes or elevated cholesterol levels. Monitoring and lifestyle modifications may be necessary.
  • Insomnia: Difficulty sleeping (insomnia) is a possible side effect.

Frequently Asked Questions About Tacrolimus Capsules USP:

Certainly, here are some frequently asked questions (FAQs) about Tacrolimus Capsules USP:

  • What are Tacrolimus Capsules USP?

Tacrolimus Capsules USP is a medication that contains the active ingredient tacrolimus. They are used to suppress the immune system and are primarily prescribed to prevent the rejection of transplanted organs and to treat certain skin conditions.

  • How does Tacrolimus work to prevent organ rejection?

Tacrolimus suppresses the immune system by inhibiting the activation of immune cells called T lymphocytes. This helps prevent the recipient’s immune system from attacking and rejecting a transplanted organ.

  • What types of organ transplants are Tacrolimus Capsules used for?

Tacrolimus is used in various organ transplantations, including kidney, liver, heart, lung, and pancreas transplants. It is an essential component of immunosuppressive regimens in these procedures.

  • Are there different strengths or formulations of Tacrolimus available?

Yes, Tacrolimus is available in various formulations, including capsules and topical ointments or creams. The strength and formulation may vary depending on the medical condition being treated.

  • What skin conditions are treated with Tacrolimus ointment or cream?

Tacrolimus ointment or cream is commonly used to treat inflammatory skin conditions, such as atopic dermatitis (eczema) and other conditions where inflammation and itching are prominent.

  • Can Tacrolimus cause side effects?

Yes, like many medications, Tacrolimus can cause side effects. Common side effects may include gastrointestinal symptoms, hypertension, kidney dysfunction, tremors, and an increased risk of infections. It’s essential to discuss potential side effects with your healthcare provider.

  • How often should Tacrolimus blood levels be monitored?

The frequency of blood level monitoring varies among patients but is typically performed regularly, especially after transplant surgery. Monitoring helps ensure that Tacrolimus levels are within the therapeutic range.

  • Can Tacrolimus be used during pregnancy or breastfeeding?

The use of Tacrolimus during pregnancy and breastfeeding should be carefully considered and discussed with a healthcare provider. The benefits and risks must be weighed on an individual basis.

  • Is it safe to drink alcohol while taking Tacrolimus Capsules?

Alcohol consumption should be discussed with a healthcare provider. Tacrolimus may interact with alcohol, potentially affecting liver function and medication metabolism.

  • Are there any drug interactions with Tacrolimus?

Yes, Tacrolimus may interact with other medications. Patients should inform their healthcare provider about all medications, supplements, and herbal products they are taking to avoid potential interactions.

As Tacrolimus Capsules Exporters; We can cater to export business queries from the following geographies. We are exporting our Tacrolimus Capsules 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

Tacrolimus Capsules 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 Tacrolimus Capsules, 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

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