GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Sirolimus Tablets 0.5mg
B. Sirolimus Tablets 1mg
C. Sirolimus Tablets 2mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Sirolimus Tablets 0.5mg
Each film-coated tablet contains:
Sirolimus……………………..0.5mg
Excipients…………………………q.s.
Colour: Iron Oxide Red


B. Sirolimus Tablets 1mg
Each film-coated tablet contains:
Sirolimus………………………….1mg
Excipients…………………………..q.s.
Colour: Titanium Dioxide IP

C. Sirolimus Tablets 2mg
Each film-coated tablet contains:
Sirolimus………………………….2mg
Excipients……………………………q.s.
Colour: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

Sirolimus is used together with other medicines to prevent the body from rejecting a transplanted kidney. It belongs to a group of medicines known as immunosuppressive agents. When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a Nephrologist only.

STORAGE & DOSAGE:

STORAGE: Store below 30°C.
Preserve in tight container.
Keep in cool & dry place. Protect from Light.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read enclosed leaflet before use.
DOSAGE: AS Directed by The Physician.

Sirolimus Tablets 0.5mg Technical Specification:

Product Name:Sirolimus Tablets 0.5mg
Brand Name:SIRLOTAJ
Strength:0.5mg, 1mg, 2mg
Dosage Form:Film-coated Oral Tablets
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: Sirolimus is used in combination with other medications to prevent rejection of kidney transplants. Sirolimus is in a class of medications called immunosuppressants. It works by suppressing the body’s immune system.
Storage:Store below 30 °C. Preserve in tight container. Keep in cool& Dry place. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Sirolimus Tablets 0.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Sirolimus Tablets 0.5mg
    Each film-coated tablet contains:

    Sirolimus……………………..0.5mg
    Excipients…………………………q.s.
    Colour: Iron Oxide Red

THERAPEUTIC INDICATIONS:

Sirolimus is used together with other medicines to prevent the body from rejecting a transplanted kidney. It belongs to a group of medicines known as immunosuppressive agents. When a patient receives an organ transplant, the body’s white blood cells will try to get rid of (reject) the transplanted organ.

CAUTION & SCHEDULE:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Keep medicine out of reach of children.
Read enclosed leaflet before use.

SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a Nephrologist only.

STORAGE & DOSAGE:

STORAGE: Store below 30°C. Preserve in tight container. Keep in cool & dry place. Protect from Light.

Dosage: As Directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharma emerges as the preferred choice for Sirolimus Tablets for several compelling reasons. First and foremost, the company’s commitment to stringent quality assurance processes ensures that their Sirolimus Tablets meet international quality standards, prioritizing the safety of patients. With a wealth of experience in the pharmaceutical industry, Taj Pharma has a proven track record in manufacturing and distributing high-quality medications, including Sirolimus Tablets. Importantly, they maintain an affordable pricing strategy, making Sirolimus treatment accessible to a wider population. Taj Pharma’s global reach ensures that patients and healthcare providers worldwide have easy access to Sirolimus Tablets. Moreover, their customer-centric approach offers support and resources throughout the treatment journey. The company’s dedication to innovation and compliance with ethical and regulatory standards further strengthens their position as a reliable choice for Sirolimus Tablets. By choosing Taj Pharma, patients and healthcare professionals can be confident in the quality, affordability, and commitment to health and well-being.

Choose Taj Pharma for Sirolimus Tablets and experience the assurance of top-notch quality, affordability, and a customer-focused approach. Your health and well-being are our priorities.

What is Sirolimus Tablets and its use?

Sirolimus Tablets are a medication that contains the active ingredient sirolimus. Sirolimus is an immunosuppressant drug, and these tablets are used for various medical purposes, primarily in the field of transplantation and immunology. Here are some common uses of Sirolimus Tablets:

  • Organ Transplantation: Sirolimus is often prescribed to transplant recipients to prevent organ rejection. It works by suppressing the immune system’s response to the newly transplanted organ, reducing the risk of rejection.
  • Kidney Transplants: Sirolimus Tablets are frequently used in kidney transplant patients to help maintain the function of the transplanted kidney over the long term.
  • Heart Transplants: In heart transplant patients, Sirolimus may be used as part of an immunosuppressive regimen to protect the newly transplanted heart from rejection.
  • Lung Transplants: Sirolimus can also be part of the treatment plan for lung transplant recipients, helping to prevent rejection of the transplanted lungs.
  • Vascular Conditions: Sirolimus has been used in the treatment of certain vascular conditions, including the prevention of restenosis (narrowing of blood vessels) following procedures such as angioplasty and stent placement.
  • Autoimmune Disorders: In some cases, Sirolimus may be prescribed for autoimmune disorders like lupus or rheumatoid arthritis, where suppressing the immune system’s activity can help manage the disease.

Sirolimus is a potent immunosuppressant, and its use requires careful monitoring by healthcare professionals. Patients taking Sirolimus Tablets should be closely monitored for potential side effects and interactions with other medications. The dosage and duration of treatment will vary depending on the specific medical condition and individual patient factors. Always follow your healthcare provider’s instructions when taking Sirolimus Tablets or any other prescription medication.

How is Sirolimus Tablets Work?

Sirolimus tablets work by suppressing the immune system’s response. It accomplishes this primarily through its ability to inhibit a specific group of proteins known as “mammalian target of rapamycin” or mTOR. Here’s how Sirolimus works:

  • Immune System Suppression: Sirolimus is classified as an immunosuppressant medication. It interferes with the normal functioning of certain immune cells, particularly T lymphocytes (T cells). T cells are a crucial component of the immune system responsible for identifying and attacking foreign invaders, including transplanted organs.
  • Inhibition of mTOR: Sirolimus inhibits mTOR, a protein that plays a central role in regulating cell growth, proliferation, and the immune response. By blocking mTOR, Sirolimus interferes with the signaling pathways that T cells require to multiply and become activated.
  • Preventing Organ Rejection: In the context of organ transplantation, Sirolimus is used to prevent the recipient’s immune system from recognizing and attacking the transplanted organ as foreign tissue. When the immune system’s response is suppressed, the risk of organ rejection is reduced.
  • Antiproliferative Effects: Sirolimus also has antiproliferative properties, meaning it inhibits the growth and multiplication of certain cell types, including smooth muscle cells. This is why Sirolimus is sometimes used to prevent restenosis, a condition where blood vessels become narrow again after procedures like angioplasty or stent placement.
  • Anti-Inflammatory Effects: Sirolimus can also have anti-inflammatory effects, which can be beneficial in certain medical conditions where inflammation plays a role.

Sirolimus effectively suppresses the immune response, this suppression also increases the risk of infections and other potential side effects. Therefore, its use is carefully monitored in patients, and healthcare providers adjust the dosage and monitor patients for any adverse effects or signs of rejection, especially in the context of organ transplantation. Patients taking Sirolimus should follow their healthcare provider’s instructions closely and report any concerning symptoms or side effects.

Benefits of Sirolimus Tablets:

  • Preventing Organ Rejection: Sirolimus is primarily used to prevent organ rejection in transplant recipients. By suppressing the immune system’s response, it helps the body accept and tolerate the transplanted organ, improving the chances of a successful transplant.
  • Long-term Graft Survival: Sirolimus has been associated with better long-term graft (transplanted organ) survival in kidney transplant patients compared to some other immunosuppressant medications.
  • Treatment of Certain Vascular Conditions: Sirolimus has been used to reduce the risk of restenosis (narrowing of blood vessels) after procedures like angioplasty and stent placement, which can help maintain improved blood flow.
  • Potential for Use in Autoimmune Disorders: In some cases, Sirolimus may be prescribed for autoimmune disorders like lupus or rheumatoid arthritis to help manage the disease by suppressing the immune system’s activity.

Side Effects of Sirolimus Tablets:

  • Immunosuppression: While suppressing the immune system is the desired effect, it also increases the risk of infections, which can range from mild to severe.
  • Gastrointestinal Issues: Common side effects include diarrhea, nausea, vomiting, and abdominal discomfort.
  • Skin Issues: Sirolimus can cause skin problems like rash, acne, and skin ulcers.
  • Metabolic Effects: It may lead to high cholesterol levels, high blood pressure, and elevated blood sugar levels, which can increase the risk of cardiovascular problems.
  • Renal Dysfunction: Sirolimus can affect kidney function in some patients, leading to decreased kidney function or proteinuria (protein in the urine).
  • Oral Ulcers: Some individuals may develop mouth ulcers.
  • Swelling: Swelling of the hands, feet, or ankles is another common side effect.
  • Changes in Blood Counts: Sirolimus can reduce the number of red blood cells, white blood cells, and platelets in the blood, potentially leading to anemia, leukopenia, or thrombocytopenia.
  • Lung Problems: In rare cases, Sirolimus may cause interstitial lung disease, which can lead to cough, shortness of breath, and lung scarring.
  • Wound Healing: Sirolimus can slow down the process of wound healing.

It’s essential to understand that the benefits of Sirolimus in preventing organ rejection often outweigh the risks of side effects in transplant patients. However, the use of Sirolimus should be closely monitored by healthcare providers, and patients should report any unusual or severe side effects promptly. The specific side effects and their severity can vary from person to person, and not everyone will experience all of these side effects. Your healthcare provider can help manage and address these side effects while balancing the benefits of the medication.

Frequently asked questions about Sirolimus Tablets:

  1. What is Sirolimus?

Sirolimus is an immunosuppressant medication used to prevent organ rejection in transplant recipients and to treat certain vascular conditions and autoimmune disorders.

  1. How does Sirolimus work?

Sirolimus suppresses the immune system by inhibiting a protein called mTOR, which is involved in cell growth and the immune response.

  1. In what medical conditions is Sirolimus used?

Sirolimus is primarily used to prevent organ rejection in transplant patients, but it can also be used to prevent restenosis after vascular procedures and in some autoimmune disorders.

  1. What are the common side effects of Sirolimus Tablets?

Common side effects include gastrointestinal issues (diarrhea, nausea), skin problems (rash, acne), high cholesterol, high blood pressure, and an increased risk of infections.

  1. How is Sirolimus dosage determined?

The dosage of Sirolimus is determined by a healthcare provider based on factors such as the patient’s weight, medical condition, and response to the medication.

  1. Can Sirolimus interact with other medications?

Yes, Sirolimus can interact with various medications, including some antibiotics and antifungal drugs. It’s essential to inform your healthcare provider of all the medications you are taking.

  1. How long do transplant patients typically take Sirolimus?

The duration of Sirolimus treatment can vary, but transplant patients often take it for an extended period, sometimes for the life of the transplanted organ.

  1. What precautions should transplant patients take while on Sirolimus?

Transplant patients should avoid exposure to infection, receive recommended vaccinations, and undergo regular checkups to monitor their kidney function and overall health.

  1. Can Sirolimus be taken during pregnancy or breastfeeding?

Sirolimus is generally not recommended during pregnancy or breastfeeding due to potential risks to the fetus or infant. Patients should discuss this with their healthcare provider.

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

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.

  1. Can alcohol be consumed while taking Sirolimus?

It’s best to avoid alcohol or consume it in moderation while taking Sirolimus, as alcohol can interact with the medication and potentially increase its side effects.

  1. Is Sirolimus available in generic form?

Yes, generic versions of Sirolimus are available, which may be more costeffective than brandname versions.

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

Sirolimus Tablets 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 Sirolimus Tablets, 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