GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Imatinib Mesylate Tablets 100mg
b) Imatinib Mesylate Tablets 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Imatinib Mesylate Tablets 100mg
Imatinib Mesylate Equivalent to
Imatinib………………………..100mg
Excipients……………………..q.s.
Colours: Iron Oxide of Yellow

b) Imatinib Mesylate Tablets 400mg
Imatinib Mesylate Equivalent to
Imatinib…………………………400mg
Excipients………………………q.s.
Colours: Iron Oxide of Red


THERAPEUTIC INDICATIONS:

Imatinib mesylate is approved to treat: Acute lymphoblastic leukemia in adults and children that is Philadelphia chromosome positive. In adults, it is used for disease that has recurred (come back) or is refractory (does not respond to treatment).

CAUTION & WARNING:

Imatinib mesylate is approved to treat: Acute lymphoblastic leukemia in adults and children that is Philadelphia chromosome positive. In adults, it is used for disease that has recurred (come back) or is refractory (does not respond to treatment).

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Protect from moisture.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.

Imatinib Mesylate Tablets 400mg Technical Specification:

Product Name:Imatinib Mesylate Tablets 400mg
Brand Name:Generic
Strength:100mg, 400mg
Dosage Form:Tablets
Packing:6s, 10s, 30s
Route of Administration:For Oral Use 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:Anti-Cancer
Indication: Imatinib mesylate is approved to treat: Acute lymphoblastic leukemia in adults and children that is Philadelphia chromosome positive. In adults, it is used for disease that has recurred (come back) or is refractory (does not respond to treatment).
Storage:Store at 20°C to 25°C (68° F to 77° F) [see USP Controlled Room Temperature]. Protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Imatinib Mesylate Tablets 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Imatinib Mesylate Tablets 400mg
    Imatinib Mesylate Equivalent to
    Imatinib………………………..400mg
    Excipients……………………..q.s.
    Colours: Iron Oxide of Red

THERAPEUTIC INDICATIONS:

Imatinib mesylate is approved to treat: Acute lymphoblastic leukemia in adults and children that is Philadelphia chromosome positive. In adults, it is used for disease that has recurred (come back) or is refractory (does not respond to treatment).

CAUTION & WARNING:

Warning: Cytotoxic Agent: To be sold by retail on the prescription of a Registered Medical Practitioner (Oncologist)

Caution: It is dangerous to take this preparation except under medical supervision.

Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer specialist only.

Swallow complete tablet, do not crush or chew.

Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Protect from moisture.

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

Why Taj Pharmaceuticals?

At TAJ Pharma, our commitment to your well-being goes beyond pharmaceuticals; it’s a promise of reliability, innovation, and unwavering support. Imatinib Mesylate Tablets, meticulously crafted by our experts, are a testament to our dedication to combating life-threatening diseases. With a focus on patient-centric care, we provide a ray of hope for those battling leukemia, gastrointestinal stromal tumors (GIST), and related conditions.

Our state-of-the-art facilities and stringent quality control measures ensure that every Imatinib Mesylate Tablet meets the highest industry standards. We understand the significance of these medications in your treatment journey, which is why we leave no stone unturned in delivering products you can trust. Choose TAJ Pharma as your healthcare partner, and join countless individuals who have found solace and healing in our pharmaceutical solutions. Your health is our priority, and we are here to empower you on your path to recovery. Discover the TAJ Pharma difference today, and experience healthcare with a personal touch.

What is Imatinib Mesylate Tablets and its use?

Imatinib Mesylate Tablets are a pharmaceutical medication that contains the active ingredient imatinib mesylate. Imatinib is a tyrosine kinase inhibitor, which means it works by blocking specific enzymes (kinases) involved in the growth and proliferation of cancer cells. Here’s an overview of its use:

Indications and Uses:

Imatinib Mesylate Tablets are primarily used for the treatment of certain types of cancer and related conditions, including:

  • Chronic Myeloid Leukemia (CML): Imatinib is a first-line treatment for CML, a type of leukemia characterized by the overproduction of abnormal white blood cells. It is highly effective in inhibiting the growth of CML cells and can lead to remission in many cases.
  • Acute Lymphoblastic Leukemia (ALL): Imatinib may be used in combination with other medications for the treatment of Philadelphia chromosome-positive (Ph+) ALL, a subtype of acute lymphoblastic leukemia.
  • Gastrointestinal Stromal Tumors (GIST): Imatinib is also used to treat GIST, a rare type of cancer that typically occurs in the stomach or small intestine. It has been a groundbreaking therapy for this condition.
  • Dermatofibrosarcoma Protuberans (DFSP): In some cases, Imatinib may be used to treat DFSP, a rare type of skin cancer.
  • Hypereosinophilic Syndrome (HES) and Systemic Mastocytosis: Imatinib is used to manage these rare blood disorders.
  • Other Rare Conditions: In certain cases, Imatinib may be considered for the treatment of other rare diseases, such as aggressive systemic mastocytosis and myelodysplastic/myeloproliferative diseases.

Imatinib is a targeted therapy that has revolutionized the treatment of certain cancers by specifically inhibiting the abnormal signals that drive the growth of cancer cells. While it can be highly effective, it may also be associated with side effects, and patients should be closely monitored during treatment. Individual treatment plans and potential side effects should be discussed with a healthcare provider.

How does Imatinib Mesylate Tablets work?

Imatinib Mesylate Tablets work by inhibiting the activity of specific enzymes known as tyrosine kinases. These enzymes play a crucial role in the signaling pathways that regulate cell growth and division. Here’s how Imatinib functions:

  • Targeting Abnormal Tyrosine Kinases: In certain cancers and related conditions, there is an overexpression or mutation of tyrosine kinases, particularly those associated with the BCR-ABL gene in chronic myeloid leukemia (CML), and the KIT and PDGFRA genes in gastrointestinal stromal tumors (GIST). These abnormal kinases send continuous signals that promote uncontrolled cell proliferation.
  • Blocking the Abnormal Signals: Imatinib Mesylate is designed to specifically target and bind to these abnormal tyrosine kinases. By doing so, it inhibits their activity, preventing them from sending continuous growth signals to cancer cells.
  • Inducing Apoptosis: Imatinib also promotes programmed cell death (apoptosis) in cancer cells. It triggers a cascade of events within the cell that ultimately leads to its self-destruction.
  • Reducing Tumor Size: By interfering with the signaling pathways and promoting cell death, Imatinib can lead to a reduction in the size of tumors or even complete remission in many cases.
  • Maintenance Therapy: In chronic conditions like CML, Imatinib Mesylate Tablets are often used as maintenance therapy to keep the disease under control and prevent relapse.

Benefits of Imatinib Mesylate Tablets:

  • Effective Cancer Treatment: Imatinib is highly effective in the treatment of specific cancers, such as Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumors (GIST). It has revolutionized the management of these conditions, often leading to remission and improved quality of life for patients.
  • Targeted Therapy: Imatinib is a targeted therapy that specifically inhibits the abnormal signaling pathways in cancer cells while sparing healthy cells to a greater extent than traditional chemotherapy. This results in fewer side effects associated with treatment.
  • Long-Term Control: Imatinib is often used as a long-term or maintenance therapy, helping to keep cancer in check and prevent relapse. Many patients can maintain a good quality of life while on this medication.
  • Oral Administration: Imatinib Mesylate Tablets are taken orally, which can be more convenient for patients compared to intravenous chemotherapy.
  • Pioneer in Treatment: Imatinib was one of the first tyrosine kinase inhibitors to be developed, paving the way for the development of similar targeted therapies for various cancers.

Side Effects of Imatinib Mesylate Tablets:

  • Gastrointestinal Issues: Common side effects may include nausea, vomiting, diarrhea, and abdominal pain. These symptoms can usually be managed with medication or dietary adjustments.
  • Fluid Retention: Some patients may experience fluid retention, leading to swelling (edema) in the legs, feet, or hands.
  • Muscle Cramps: Muscle cramps or pain can occur in some individuals taking Imatinib.
  • Skin Rash: Skin rashes, including a mild to moderate rash, have been reported.
  • Fatigue: Feeling tired or fatigued is a possible side effect.
  • Low Blood Counts: Imatinib can reduce the number of blood cells produced by the bone marrow, leading to anemia, neutropenia (low white blood cell count), and thrombocytopenia (low platelet count).
  • Liver Function: It may affect liver function, resulting in elevated liver enzymes.
  • Cardiac Effects: In rare cases, Imatinib may lead to heart problems, such as congestive heart failure or changes in heart rhythm.
  • Skin and Hair Changes: Changes in skin and hair pigmentation are possible, but these are typically mild.
  • Interactions: Imatinib can interact with other medications, potentially affecting their effectiveness or causing additional side effects. Patients should inform their healthcare provider of all medications and supplements they are taking.

Frequently asked questions (FAQs) about Imatinib Mesylate Tablets:

  1. What is Imatinib Mesylate, and how does it work?

Imatinib Mesylate is a medication used to treat certain cancers. It works by blocking specific enzymes called tyrosine kinases, which are involved in the growth of cancer cells.

  1. What conditions are treated with Imatinib Mesylate Tablets?

Imatinib is primarily used to treat conditions such as Chronic Myeloid Leukemia (CML), Gastrointestinal Stromal Tumors (GIST), and some other rare cancers and blood disorders.

  1. How should I take Imatinib Mesylate Tablets?

Imatinib Mesylate Tablets are typically taken orally with a glass of water, as directed by your healthcare provider. It’s essential to follow the prescribed dosage and schedule.

  1. Are there any special considerations regarding food or timing when taking Imatinib?

Imatinib can be taken with or without food, but some patients find it more comfortable to take it with a meal. Consistency in taking the medication at the same time each day is important.

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

If you miss a dose, take it as soon as you remember. If it’s close to your next scheduled dose, skip the missed one and resume your regular dosing schedule. Do not double the dose to catch up.

  1. Are there any potential side effects of Imatinib Mesylate Tablets?

Yes, there can be side effects, including nausea, vomiting, diarrhea, fatigue, and fluid retention. However, side effects can vary among individuals, and not everyone will experience them.

  1. How long will I need to take Imatinib Mesylate Tablets?

The duration of treatment varies depending on the type and stage of cancer or condition being treated. Your healthcare provider will discuss your treatment plan and its duration with you.

  1. Can I drink alcohol while taking Imatinib?

It’s generally recommended to limit alcohol consumption while taking Imatinib, as alcohol can interact with the medication and potentially increase side effects.

  1. Can Imatinib interact with other medications I’m taking?

Yes, Imatinib can interact with certain medications, so it’s essential to inform your healthcare provider about all the medications, supplements, and overthecounter drugs you are taking.

  1. Is it safe to use Imatinib during pregnancy or while breastfeeding?

Imatinib may have potential risks during pregnancy and breastfeeding, so it’s crucial to discuss this with your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding.

  1. How often should I have followup appointments with my healthcare provider while taking Imatinib Mesylate Tablets?

Regular followup appointments are essential to monitor your response to treatment, manage side effects, and adjust your treatment plan if necessary. Your healthcare provider will determine the frequency of these visits.

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

Imatinib Mesylate 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 Imatinib Mesylate 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