GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Tacrolimus Capsules IP 0.5mg
B. Tacrolimus Capsules IP 1mg
C. Tacrolimus Capsules IP 2mg
D. Tacrolimus Capsules IP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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


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

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

D. Tacrolimus Capsules IP 5mg
Each hard gelatin Capsule contains:
Tacrolimus IP
Equivalent to Anhydrous Tacrolimus …….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 & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A NEPHROLOGIST.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light.
Do not refrigerate.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: As directed by the Nephrologist.

Tacrolimus Capsules IP 0.5mg Technical Specification:

Product Name:Tacrolimus Capsules IP 0.5mg
Brand Name:TACROTAJ
Strength:0.5mg, 1mg, 2mg, 5mg
Dosage Form:Hard Gelatin Capsules
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Immunosuppressants
Indication: 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.
Storage:Store below 30 °C. Protect from Light. Do not refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Tacrolimus Capsules IP 0.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Tacrolimus Capsules IP 0.5mg
    Each hard gelatin Capsule contains:
    Tacrolimus IP
    Equivalent to Anhydrous Tacrolimus …….0.5mg
    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 & SHEDULE:

CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A Nephrologist.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.

STORAGE & DOSAGE:

Storage: Store below 30 °C. Protect from Light. Do not refrigerate.

Dosage: As directed by the Nephrologist.

Why Taj Pharmaceuticals?

Taj Pharma is your reliable source for Tacrolimus Capsules IP, delivering exceptional pharmaceutical solutions and unwavering commitment to patient health. Our dedication to quality and safety ensures that you receive the highest standard of care. With a legacy of excellence spanning years, Taj Pharma has established itself as a trusted name in the pharmaceutical industry. Our Tacrolimus Capsules IP exemplify our commitment to innovation and efficacy. We adhere to stringent quality control measures, ensuring that every capsule meets international standards, making them the preferred choice for healthcare professionals worldwide.

At Taj Pharma, we understand the importance of patient well-being. Our Tacrolimus Capsules IP are designed to address critical medical conditions, such as organ transplant rejection and autoimmune disorders. We prioritize patient safety and therapeutic effectiveness, making us a preferred partner for healthcare providers seeking dependable pharmaceutical solutions. Choose Taj Pharma for Tacrolimus Capsules IP and experience pharmaceutical excellence that enhances patient outcomes. Your health is our priority, and we are dedicated to delivering medication you can trust.

What is Tacrolimus Capsules IP and its use?

Tacrolimus Capsules IP, often simply referred to as Tacrolimus capsules, contain the active ingredient Tacrolimus, which is an immunosuppressant medication. Tacrolimus is primarily used to prevent the rejection of organ transplants, such as kidney, liver, heart, and lung transplants. Here’s a more detailed explanation of its uses:

  • Organ Transplantation: Tacrolimus Capsules IP are commonly prescribed to transplant recipients as part of their immunosuppressive regimen. After receiving a new organ, the body’s immune system recognizes it as foreign and may try to attack and reject it. Tacrolimus works by suppressing the immune system’s response, thereby reducing the risk of organ rejection. It is often used in combination with other immunosuppressive drugs.
  • Autoimmune Diseases: In addition to transplantation, Tacrolimus may also be prescribed for the treatment of certain autoimmune diseases. These conditions include rheumatoid arthritis, psoriasis, and severe atopic dermatitis. By suppressing the immune response, Tacrolimus can help manage the symptoms and inflammation associated with these disorders.
  • Topical Tacrolimus: Tacrolimus is also available in topical forms (ointments and creams) for the treatment of certain skin conditions like eczema (atopic dermatitis). When applied topically, it helps reduce inflammation and itching associated with these skin disorders.
  • Off-Label Uses: In some cases, healthcare providers may prescribe Tacrolimus for conditions other than those mentioned above, depending on their clinical judgment and the patient’s specific needs.

Tacrolimus is a potent medication with potential side effects and requires careful monitoring by healthcare professionals. Patients taking Tacrolimus need regular blood tests to ensure that the drug is at the right therapeutic level and to monitor for any potential side effects or complications.

How does Tacrolimus Capsules IP Work?

Tacrolimus Capsules IP work by suppressing the immune system’s response, specifically the T-cell-mediated immune response. This immunosuppressive action is crucial in preventing organ rejection in transplant recipients and managing certain autoimmune diseases. Here’s how Tacrolimus works:

  • T-Cell Inhibition: The immune system’s primary defense mechanism against foreign substances, including transplanted organs, involves T-lymphocytes (T-cells). T-cells recognize and attack foreign cells, which can include transplanted organs. Tacrolimus inhibits the activation of T-cells, making them less responsive to signals that would normally trigger an immune response.
  • Interference with Cytokines: Tacrolimus interferes with the production and release of cytokines, which are signaling molecules involved in immune responses. These cytokines play a key role in coordinating immune reactions. By reducing the production of cytokines, Tacrolimus dampens the overall immune response.
  • Preventing Inflammation: In conditions like autoimmune diseases, the immune system mistakenly attacks healthy tissues, leading to inflammation. Tacrolimus helps reduce this inflammation by inhibiting the immune response and the release of inflammatory cytokines.
  • Preventing Organ Rejection: In the context of organ transplantation, Tacrolimus is crucial for preventing the recipient’s immune system from recognizing and attacking the transplanted organ as a foreign invader. By suppressing T-cell activation and the immune response, Tacrolimus helps ensure the acceptance and long-term survival of the transplanted organ.

It’s important to note that while Tacrolimus is effective in preventing rejection and managing autoimmune diseases, its immunosuppressive properties can also increase the risk of infections and other side effects. Therefore, patients taking Tacrolimus require careful monitoring, regular blood tests, and close medical supervision to ensure that the drug is at the right therapeutic level and to manage any potential side effects or complications. The goal is to strike a balance between suppressing the immune system enough to prevent rejection or manage autoimmune conditions while minimizing the risk of infection and other adverse effects.

Benefits and Side effects of Tacrolimus Capsules IP:

Tacrolimus Capsules IP offer several benefits in the treatment of organ transplantation and certain autoimmune conditions. However, like all medications, they also come with potential side effects. Here’s an overview of the benefits and common side effects associated with Tacrolimus:

Benefits:

  • Prevention of Organ Rejection: Tacrolimus is highly effective in preventing the rejection of transplanted organs, such as kidneys, livers, hearts, and lungs. By suppressing the immune response, it helps ensure the long-term survival of the transplanted organ.
  • Management of Autoimmune Diseases: Tacrolimus is used to manage various autoimmune conditions, including rheumatoid arthritis, psoriasis, and severe atopic dermatitis. It helps reduce inflammation and symptoms associated with these disorders.
  • Topical Treatment: When used in topical forms (ointments or creams), Tacrolimus can effectively treat skin conditions like eczema (atopic dermatitis), reducing itching and inflammation.

Side Effects:

  • Immunosuppression: While suppressing the immune system is beneficial for preventing organ rejection and managing autoimmune diseases, it also increases the risk of infections. Patients on Tacrolimus may be more susceptible to bacterial, viral, and fungal infections.
  • Kidney Function: Tacrolimus can affect kidney function, leading to conditions like nephrotoxicity. Regular monitoring of kidney function through blood tests is essential.
  • Hypertension (High Blood Pressure): Tacrolimus may cause an increase in blood pressure, which needs to be monitored and managed.
  • Neurological Effects: Some individuals may experience neurological side effects, including tremors, headaches, and difficulty sleeping (insomnia).
  • Gastrointestinal Symptoms: Nausea, vomiting, diarrhea, and abdominal discomfort are common gastrointestinal side effects associated with Tacrolimus.
  • Ski Issues: Skin-related side effects like acne, rash, and increased sensitivity to sunlight may occur.
  • Metabolic Changes: Tacrolimus can lead to metabolic changes, including increased blood glucose levels, which can be problematic for individuals with diabetes.
  • Changes in Blood Counts: It may lead to changes in blood cell counts, including a decrease in white blood cells, increasing the risk of infections.
  • Osteoporosis: Long-term use of Tacrolimus may contribute to bone density loss (osteoporosis).
  • Weight Gain: Some individuals may experience weight gain as a side effect.

It’s important to note that not everyone experiences these side effects, and their severity can vary from person to person. Healthcare providers closely monitor patients taking Tacrolimus to manage side effects, adjust the medication dosage as needed, and provide appropriate interventions when necessary.

Frequently asked questions (FAQs) about Tacrolimus Capsules IP:

  1. What is Tacrolimus Capsules IP used for?

Tacrolimus Capsules IP are primarily used to prevent organ rejection in transplant recipients and to manage certain autoimmune diseases.

  1. How does Tacrolimus Capsules IP work?

Tacrolimus suppresses the immune system’s response, specifically T- cell activation, to prevent the rejection of transplanted organs and manage autoimmune conditions.

  1. What are the common brand names for Tacrolimus Capsules IP?

Tacrolimus is available under various brand names, with Prograf and Astagraf being some common ones.

  1. How should Tacrolimus Capsules IP be taken?

Tacrolimus is typically taken orally as directed by a healthcare provider. It is crucial to follow the prescribed dosage and schedule.

  1. What are the potential side effects of Tacrolimus Capsules IP?

Common side effects include immunosuppression (increased risk of infections), kidney function changes, high blood pressure, neurological effects, gastrointestinal symptoms, and skin issues, among others.

  1. Is Tacrolimus safe during pregnancy and breastfeeding?

Tacrolimus should be used during pregnancy and breastfeeding only if the potential benefits outweigh the risks. It’s important to discuss this with a healthcare provider.

  1. Can Tacrolimus be taken with other medications?

Tacrolimus may interact with other drugs, so it’s crucial to inform your healthcare provider about all medications, supplements, and herbal products you are taking.

  1. How often should blood tests be done while taking Tacrolimus?

Regular blood tests are essential to monitor Tacrolimus levels, kidney function, and other potential side effects. The frequency of tests may vary depending on individual needs.

  1. Can I drink alcohol while taking Tacrolimus?

It’s advisable to limit or avoid alcohol consumption while on Tacrolimus, as it can interact with the medication and exacerbate certain side effects.

  1. Is there a generic version of Tacrolimus Capsules IP available?

Yes, generic versions of Tacrolimus are available, and they are often more affordable than brandname versions.

  1. How long do I need to take Tacrolimus after a transplant?

The duration of Tacrolimus treatment after a transplant varies depending on the specific transplant, individual factors, and the guidance of your healthcare provider. It may be lifelong or for a specified period.

  1. What should I do if I miss a dose of Tacrolimus?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

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