Mycophenolate Mofetil Capsules IP 250mg Technical Specification:

Product Name:Mycophenolate Mofetil Capsules IP 250mg
Brand Name:MOZZARCEPT
Strength:250mg, 500mg
Dosage Form:Capsules (Hard gelatin)
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: Mycophenolate belongs to a group of medicines known as immunosuppressive agents. It is used with other medicines (eg, cyclosporine, steroid medicine) to lower the body’s natural immunity in patients who receive organ transplants (eg, kidney, heart, or liver).
Storage:Store below 30 °C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Mycophenolate Mofetil Capsules IP 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Mycophenolate Mofetil Capsules IP 250mg
    Each hard gelatin Capsule contains:
    Mycophenolate Mofetil IP ………………250mg
    Excipients ……………………………………… q.s.
    Approved colours used in empty capsule shells.

THERAPEUTIC INDICATIONS:

Mycophenolate is used with other medications to help prevent the body from rejecting kidney transplants. Mycophenolate is in a class of medications called immunosuppressive agents. It works by weakening the body’s immune system so it will not attack and reject the transplanted organ.

CAUTION & SCHEDULE:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
SCHEDULE: SCHEDULE H DRUG-WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A registered medical practitioner.
Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light.
Dosage: As directed by the Physician.
NOTE: Take this medicine on an empty stomach.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a renowned pharmaceutical company known for its exceptional qualities that make it a preferred choice for Mycophenolate Mofetil Capsules. One of its notable strengths is its unwavering commitment to maintaining the highest standards of quality in pharmaceutical manufacturing. This commitment ensures the safety, efficacy, and reliability of Mycophenolate Mofetil Capsules, instilling confidence in both healthcare providers and patients who rely on these medications. Taj Pharmaceuticals boasts a global presence, with a well-established distribution network that reaches patients and healthcare providers in diverse regions. This extensive reach ensures the accessibility of Mycophenolate Mofetil Capsules and other essential medications, regardless of geographic location. This international accessibility elevates patient care to a global level, guaranteeing that crucial medications are readily available when needed. Another hallmark of Taj Pharmaceuticals is its unwavering dedication to regulatory compliance. The company adheres to stringent regulatory guidelines and implements robust quality control procedures. This commitment ensures that Mycophenolate Mofetil Capsules meet the rigorous standards set by regulatory authorities, offering peace of mind to healthcare professionals and patients who rely on these medications. Taj Pharmaceuticals also invests significantly in research and development (R&D), contributing to pharmaceutical innovation. This commitment to R&D may lead to the development of more advanced formulations of medications like Mycophenolate Mofetil Capsules, enhancing their effectiveness and patient outcomes. Affordability is another critical aspect of Taj Pharmaceuticals’ approach. The company may offer competitive pricing options, making Mycophenolate Mofetil Capsules more accessible and affordable for patients. This aligns with the goal of ensuring that essential medications are within reach of all individuals without imposing financial barriers. Taj Pharmaceuticals’ patient-centric approach sets it apart as well. The company places a strong emphasis on patient well-being and safety, a vital consideration for medications like Mycophenolate Mofetil Capsules, which are often prescribed to prevent organ rejection in transplant patients. Taj Pharmaceuticals’ commitment to patient safety reinforces the trust placed in its products by healthcare providers and patients, ultimately contributing to improved patient care and outcomes on a global scale. In essence, Taj Pharmaceuticals’ dedication to quality, regulatory compliance, global reach, research and development, affordability, and patient safety positions it as a trusted and reputable choice for healthcare providers seeking a reliable supplier for Mycophenolate Mofetil Capsules and other pharmaceuticals. Their commitment to enhancing patient care and treatment outcomes underscores their significance in the pharmaceutical industry.

What is Mycophenolate Mofetil Capsules and its uses:

Mycophenolate Mofetil Capsules are a medication used in the field of transplant medicine and immunosuppression. Here’s a closer look at Mycophenolate Mofetil Capsules and their uses:

  • Active Ingredient: Mycophenolate Mofetil is the active ingredient in these capsules.
  • Immunosuppressive Medication: Mycophenolate Mofetil is classified as an immunosuppressant. It is primarily used to suppress or weaken the immune system’s activity. This is particularly important in certain medical situations.
  • Prevention of Organ Rejection: Mycophenolate Mofetil Capsules are commonly prescribed to individuals who have undergone organ transplantation, such as kidney, heart, liver, or lung transplant recipients. The medication helps prevent the recipient’s immune system from rejecting the transplanted organ.
  • Mechanism of Action: Mycophenolate Mofetil works by inhibiting the proliferation of specific immune cells, particularly T and B lymphocytes. These cells are responsible for immune responses, including those that can lead to the rejection of a transplanted organ.
  • Maintenance Therapy: Mycophenolate Mofetil is often used as part of a long-term maintenance therapy regimen for transplant recipients. It is typically taken in combination with other immunosuppressive medications to achieve optimal results.
  • Autoimmune Diseases: In addition to transplant medicine, Mycophenolate Mofetil may also be used to manage certain autoimmune diseases, such as lupus nephritis and certain forms of vasculitis. In these conditions, the medication helps to suppress the immune system’s abnormal activity that contributes to the disease.
  • Dosage and Administration: The dosage of Mycophenolate Mofetil Capsules is determined by a healthcare provider based on the patient’s specific needs. It is crucial to follow the prescribed dosage and administration instructions meticulously.
  • Monitoring: Patients taking Mycophenolate Mofetil often require regular monitoring of their immune function, organ function, and blood cell counts to ensure that the medication is effectively preventing rejection while minimizing potential side effects.

It’s important to note that Mycophenolate Mofetil Capsules should only be used under the guidance and supervision of a healthcare provider, especially in transplant recipients who require precise immunosuppressive therapy to maintain the health and viability of their transplanted organs. Patients should adhere to their prescribed treatment regimen and attend regular follow-up appointments to assess the medication’s effectiveness and address any potential side effects or complications.

How do Mycophenolate Mofetil Capsules work?

Mycophenolate Mofetil Capsules work by suppressing the immune system’s activity, specifically targeting certain immune cells responsible for initiating immune responses. This immunosuppressive action is essential in preventing organ rejection and managing autoimmune diseases. Here’s how Mycophenolate Mofetil works:

  • Inhibition of Immune Cell Proliferation: Mycophenolate Mofetil inhibits the proliferation (multiplication) of immune cells known as lymphocytes, which include T cells and B cells. These lymphocytes play a crucial role in the immune response and can contribute to the rejection of transplanted organs in transplant recipients and the inflammation associated with autoimmune diseases.
  • Targeting Purine Synthesis: Mycophenolate Mofetil interferes with the synthesis of purines, which are building blocks of DNA and RNA, within lymphocytes. Purines are essential for the replication of these immune cells. By blocking purine synthesis, Mycophenolate Mofetil inhibits the production of new lymphocytes.
  • Suppression of Immune Response: As a result of Mycophenolate Mofetil’s actions, the overall immune response is dampened. The reduction in the number of active immune cells and their ability to proliferate limits their capacity to attack and damage transplanted organs or contribute to autoimmune disease flares.
  • Prevention of Organ Rejection: In transplant recipients, Mycophenolate Mofetil plays a critical role in preventing organ rejection. By suppressing the immune system, it reduces the risk of the recipient’s immune system identifying the transplanted organ as foreign and initiating an immune response against it.
  • Management of Autoimmune Diseases: Mycophenolate Mofetil is also used to manage certain autoimmune diseases where the immune system mistakenly attacks the body’s own tissues. By curbing the overactive immune response, it helps control the inflammation and tissue damage seen in conditions like lupus nephritis and certain vasculitides.
  • Complementary Therapy: Mycophenolate Mofetil is often used in combination with other immunosuppressive medications, such as calcineurin inhibitors and corticosteroids, to achieve a synergistic effect in preventing organ rejection or managing autoimmune diseases.

It’s important to note that Mycophenolate Mofetil Capsules should only be used under the guidance and supervision of a healthcare provider, as the balance of immunosuppression needs to be carefully tailored to each patient’s specific medical condition and needs. Patients taking Mycophenolate Mofetil should follow their prescribed treatment regimen and attend regular medical check-ups to ensure the medication is effectively achieving its immunosuppressive goals while minimizing potential side effects or complications.

Benefits of Mycophenolate Mofetil Capsules:

  • Prevention of Organ Rejection: One of the primary benefits of Mycophenolate Mofetil Capsules is their role in preventing organ rejection in transplant recipients. By suppressing the immune system’s response, the medication helps ensure that the recipient’s body does not attack and reject the transplanted organ, such as a kidney, heart, liver, or lung.
  • Effective Immunosuppression: Mycophenolate Mofetil is known for its effectiveness in suppressing the immune system’s activity, specifically targeting immune cells responsible for initiating immune responses. This immunosuppressive action is crucial in maintaining the viability of transplanted organs.
  • Management of Autoimmune Diseases: Mycophenolate Mofetil is also used to manage certain autoimmune diseases, such as lupus nephritis and vasculitides. In these conditions, it helps control the overactive immune response that leads to inflammation and tissue damage.
  • Complementary Therapy: Mycophenolate Mofetil is often used in combination with other immunosuppressive medications, such as calcineurin inhibitors and corticosteroids, to achieve a synergistic effect in preventing organ rejection or managing autoimmune diseases. This combination therapy can be highly effective in achieving the desired therapeutic outcomes.

Common Side Effects of Mycophenolate Mofetil Capsules:

  • Gastrointestinal Symptoms: Gastrointestinal side effects are common and can include nausea, vomiting, diarrhea, abdominal pain, and indigestion. These symptoms can be mild to moderate and may improve over time as the body adjusts to the medication.
  • 2. Bone Marrow Suppression: Mycophenolate Mofetil may lead to bone marrow suppression, resulting in a decrease in the production of blood cells, including red blood cells, white blood cells, and platelets. This can increase the risk of anemia, infections, and bleeding.
  • Increased Susceptibility to Infections: Due to its immunosuppressive properties, Mycophenolate Mofetil may increase the risk of infections. Patients should be vigilant about hygiene and report any signs of infection to their healthcare provider promptly.
  • Other Potential Side Effects: Less common side effects can include headache, dizziness, high blood pressure, and skin rashes. Some patients may also experience changes in blood levels of liver enzymes.
  • Teratogenicity: Mycophenolate Mofetil is known to be teratogenic, meaning it can cause birth defects in fetuses. Women of childbearing age should use effective contraception during treatment and for a period after discontinuing the medication to avoid pregnancy-related risks.

It’s important to note that not all patients will experience these side effects, and many individuals tolerate Mycophenolate Mofetil well. Patients should communicate any side effects to their healthcare provider promptly, as adjustments to the treatment plan may be necessary. The benefits of Mycophenolate Mofetil in preventing organ rejection or managing autoimmune diseases often outweigh the potential side effects when used under medical supervision. Patients should follow their prescribed treatment regimen and attend regular medical check-ups for close monitoring of their condition.

Frequently Asked Questions About Mycophenolate Mofetil Capsules:

Mycophenolate mofetil is a medication commonly used in transplant patients to prevent rejection of the transplanted organ. Here are some frequently asked questions (FAQs) about mycophenolate mofetil capsules:

  1. What is Mycophenolate Mofetil Capsules?

Mycophenolate mofetil is an immunosuppressive medication used to prevent the body from rejecting a transplanted organ, such as a kidney, heart, or liver.

  1. How does Mycophenolate Mofetil work?

Mycophenolate mofetil works by suppressing the immune system’s response to the transplanted organ. It inhibits the proliferation of immune cells, such as T and B cells, which are responsible for organ rejection.

  1. What conditions is Mycophenolate Mofetil used to treat?

Mycophenolate mofetil is primarily used to prevent organ rejection in transplant recipients. It is also used in some autoimmune disorders, such as lupus and rheumatoid arthritis.

  1. How should I take Mycophenolate Mofetil capsules?

Follow your healthcare provider’s instructions carefully. Generally, it is taken orally with or without food. Do not crush or chew the capsules; swallow them whole with water.

  1. What are the common side effects of Mycophenolate Mofetil?

Common side effects may include nausea, vomiting, diarrhea, headache, and stomach upset. Contact your doctor if these side effects persist or worsen.

  1. Are there any serious side effects I should be aware of?

Yes, there are potential serious side effects, including a decreased white blood cell count, increased risk of infections, and gastrointestinal bleeding. It’s important to report any unusual symptoms to your healthcare provider.

  1. Can I drink alcohol while taking Mycophenolate Mofetil?

Alcohol can interact with this medication and may increase the risk of side effects. It’s generally advisable to limit or avoid alcohol consumption while taking Mycophenolate Mofetil.

  1. Can I become pregnant or father a child while taking Mycophenolate Mofetil?

Mycophenolate Mofetil can be harmful to a developing fetus and may cause birth defects. If you are of childbearing age, use effective contraception and discuss family planning with your healthcare provider.

  1. Can I take other medications with Mycophenolate Mofetil?

Inform your doctor about all medications and supplements you are taking. Some drugs may interact with Mycophenolate Mofetil and affect its effectiveness or increase the risk of side effects.

  1. How long will I need to take Mycophenolate Mofetil?

The duration of treatment depends on your specific medical condition and transplant. Your healthcare provider will determine the appropriate length of therapy.

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

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 one and continue with your regular dosing schedule.

Always consult your healthcare provider or pharmacist for personalized information and guidance regarding Mycophenolate Mofetil capsules, as individual circumstances and medical conditions may vary.

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

Mycophenolate Mofetil 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 Mycophenolate Mofetil 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

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Mycophenolate Mofetil Capsules IP 250mg
B. Mycophenolate Mofetil Capsules IP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Mycophenolate Mofetil Capsules IP 250mg
Each hard gelatin Capsule contains:
Mycophenolate Mofetil IP ……………...250mg
Excipients ……………………………………... q.s.
Approved colours used in empty capsule shells.


B. Mycophenolate Mofetil Capsules IP 500mg
Each hard gelatin Capsule contains:
Mycophenolate Mofetil IP ………………...500mg
Excipients …………………………………………. q.s.
Approved colours used in empty capsule shells.

THERAPEUTIC INDICATIONS:

Mycophenolate is used with other medications to help prevent the body from rejecting kidney transplants. Mycophenolate is in a class of medications called immunosuppressive agents. It works by weakening the body's immune system so it will not attack and reject the transplanted organ.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
SCHEDULE: SCHEDULE H DRUG-WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light.
Dosage: As directed by the Physician.
NOTE: Take this medicine on an empty stomach.