Mercaptopurine Tablets USP 50mg Technical Specification:

Product Name:Mercaptopurine Tablets USP 50mg
Brand Name:Mercaptopurine
Strength:10mg, 50mg
Dosage Form:uncoated Tablet
Packing:10s, 25s, 30s, 60s, 250s
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: Mercaptopurine is used in combination with other medicines as maintenance treatment of acute lymphoblastic leukemia. It belongs to the group of medicines known as antimetabolites. Mercaptopurine interferes with the growth of cancer cells, which are eventually destroyed.
Storage:Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Mercaptopurine Tablets USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Mercaptopurine Tablets USP 50mg
    Each uncoated tablet contains:
    Mercaptopurine USP..………….50mg
    Excipients……………………………..q.s.
    Colours: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

Mercaptopurine is used in combination with other medicines as maintenance treatment of acute lymphoblastic leukemia. It belongs to the group of medicines known as antimetabolites. Mercaptopurine interferes with the growth of cancer cells, which are eventually destroyed.

CAUTION & WARNING:

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

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.

Do not take in larger doses or more frequently or for a longer time than specifically directed by the physician. Periodic blood counts are necessary to determine proper dose and to avoid ill effects.

Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure.

Keep container tightly closed.

Keep out of reach and sight of children.

Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° 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?

I’m not aware of any specific information regarding Taj Pharmaceuticals and Mercaptopurine Tablets USP beyond my knowledge cutoff date in September 2021. However, I can provide some general information about why individuals or healthcare providers might choose a particular pharmaceutical company for a medication like Mercaptopurine Tablets USP:

  • Reputation and Quality: Pharmaceutical companies with a strong reputation for quality and safety are often preferred. The track record of a company in producing reliable and effective medications can influence the choice of supplier.
  • Regulatory Compliance: Companies that adhere to strict regulatory standards and have a history of passing inspections by relevant health authorities (such as the FDA in the United States) are typically considered more reliable sources for pharmaceuticals.
  • Availability and Supply Chain: The ability of a pharmaceutical company to consistently supply medications, meet demand, and maintain a stable supply chain is crucial. Consistent availability of Mercaptopurine Tablets is essential for patients who rely on this medication for their health.
  • Pricing and Cost: The cost of medications can vary among different pharmaceutical manufacturers. Healthcare providers and patients may consider pricing when choosing a specific supplier, especially if there are generic alternatives available.
  • Formulation and Dosage Strengths: Different pharmaceutical companies may offer variations in the formulation or dosage strengths of a medication. Providers may choose a specific manufacturer based on the available options that best meet their patient’s needs.
  • Geographic Availability: The availability of specific pharmaceutical brands can vary by region and country. Some healthcare providers may have easier access to products from certain manufacturers based on their location.
  • Patient Preferences: In some cases, patients may have preferences for a particular brand or manufacturer based on their past experiences or sensitivities to specific formulations or excipients.

It’s important to note that healthcare providers, including doctors and pharmacists, often consider a combination of these factors when choosing a pharmaceutical supplier for a specific medication like Mercaptopurine Tablets USP. Additionally, regulations and the pharmaceutical landscape can change over time, so it’s essential to consult up-to-date sources and guidance when making decisions related to pharmaceutical products.

What are Mercaptopurine Tablets and its uses:

Mercaptopurine, often sold under the brand name Purinethol among others, is a medication that belongs to a class of drugs known as antimetabolites. It is primarily used to treat certain types of cancer and autoimmune conditions. Here are some of its main uses:

  • Leukemia: Mercaptopurine is commonly used in the treatment of acute lymphoblastic leukemia (ALL), a type of cancer that affects the white blood cells. It is often used in combination with other chemotherapy drugs to suppress the growth of cancer cells.
  • Inflammatory Bowel Disease (IBD): Mercaptopurine can also be used to manage certain autoimmune conditions, particularly Crohn’s disease and ulcerative colitis. It helps reduce inflammation in the intestines and can be used as a maintenance therapy to prevent flare-ups.
  • Rheumatoid Arthritis: In some cases, mercaptopurine may be prescribed for rheumatoid arthritis when other treatments have not been effective. It helps suppress the immune system’s abnormal response that leads to joint inflammation.
  • Autoimmune Hepatitis: Mercaptopurine can be used to treat autoimmune hepatitis, a condition where the body’s immune system mistakenly attacks the liver.
  • Dermatomyositis: This medication may also be used to treat dermatomyositis, an inflammatory muscle disease.

Mercaptopurine works by interfering with the production of DNA and RNA in rapidly dividing cells, including cancer cells and activated immune cells. This makes it effective in treating conditions where the immune system is overactive or where cell division needs to be slowed down, such as in cancer. It’s important to note that mercaptopurine is a potent medication with potential side effects, and its use should be carefully monitored by a healthcare professional. Patients taking this medication should have regular blood tests to check for any potential adverse effects and to ensure it is being used safely and effectively for their specific condition.

Mercaptopurine, often sold under the brand name Purinethol, is a medication that belongs to the class of drugs known as antimetabolites. It is commonly used to treat certain types of cancer, particularly leukemia (such as acute lymphoblastic leukemia or ALL), as well as some autoimmune conditions like Crohn’s disease and ulcerative colitis. Mercaptopurine works by interfering with the growth and spread of abnormal cells in the body.

Benefits of Mercaptopurine Tablets:

  • Cancer Treatment: Mercaptopurine is primarily used in the treatment of certain types of leukemia, especially ALL. It helps to suppress the growth of cancer cells and improves the chances of remission and long-term survival in patients with these conditions.
  • Autoimmune Disease Management: Mercaptopurine can be effective in managing autoimmune conditions like Crohn’s disease and ulcerative colitis by reducing inflammation in the gastrointestinal tract. It is often used when other medications have not provided adequate relief.
  • Immunosuppression: In autoimmune diseases, mercaptopurine helps suppress the immune system’s overactivity, which can reduce the severity of symptoms and slow down the progression of the disease.
  • Long-Term Remission: For some patients with leukemia or autoimmune diseases, mercaptopurine can help achieve and maintain long-term remission or control of their condition.

However, it’s important to note that mercaptopurine can have side effects, and its use should be closely monitored by a healthcare provider.

Common Side Effects of Mercaptopurine Tablets:

  • Nausea and Vomiting: These are common side effects of mercaptopurine and can be managed with anti-nausea medications.
  • Bone Marrow Suppression: Mercaptopurine can lower the number of blood cells produced by the bone marrow, increasing the risk of anemia, bleeding, and infections. Regular blood tests are necessary to monitor blood cell counts.
  • Liver Toxicity: It can affect liver function, leading to elevated liver enzyme levels. Regular liver function tests are important during treatment.
  • Pancreatitis: In some cases, mercaptopurine may cause inflammation of the pancreas (pancreatitis), which can be a serious side effect.
  • Skin Rash: Skin reactions, including rashes, can occur as a side effect of this medication.
  • Increased Risk of Infections: Due to its immunosuppressive effects, mercaptopurine may increase the risk of infections.
  • Gastrointestinal Symptoms: Some people may experience diarrhea, abdominal pain, or other gastrointestinal symptoms.
  • Hair Loss: Hair thinning or loss can occur, though it is generally less common than with some other cancer treatments.

It’s important for patients taking mercaptopurine to have regular follow-up appointments with their healthcare provider to monitor for any potential side effects and to adjust the dosage as needed. In some cases, the benefits of the medication may outweigh the risks, but this should be determined on an individual basis by a healthcare professional. Always follow your healthcare provider’s instructions and report any unusual or severe side effects promptly.

Frequently Asked Questions About Mercaptopurine Tablets:

Here are some frequently asked questions (FAQs) about Mercaptopurine tablets:

  • What is Mercaptopurine?

Mercaptopurine is a medication used to treat certain types of cancer, particularly leukemia, and autoimmune conditions like Crohn’s disease and ulcerative colitis.

  • How does Mercaptopurine work?

Mercaptopurine is an antimetabolite drug that interferes with the growth and spread of abnormal cells in the body. It disrupts DNA synthesis in rapidly dividing cells, including cancer cells.

  • What are the brand names of Mercaptopurine?

Mercaptopurine is commonly sold under the brand name Purinethol.

  • What conditions are treated with Mercaptopurine?

Mercaptopurine is used primarily for the treatment of acute lymphoblastic leukemia (ALL) and some autoimmune diseases like Crohn’s disease and ulcerative colitis.

  • How is Mercaptopurine taken?

Mercaptopurine is usually taken orally in tablet form, with or without food, as directed by a healthcare provider. The dosage and frequency will depend on the specific condition being treated.

  • What are the common side effects of Mercaptopurine?

Common side effects may include nausea, vomiting, bone marrow suppression (leading to anemia, increased risk of infections, and bleeding), liver toxicity, skin rash, pancreatitis, and gastrointestinal symptoms.

  • Are there any serious side effects of Mercaptopurine?

Yes, serious side effects can include severe bone marrow suppression, severe liver problems, and an increased risk of certain infections. It’s important to have regular blood tests and medical monitoring while taking this medication.

  • Can Mercaptopurine be used during pregnancy or breastfeeding?

Mercaptopurine should be used with caution during pregnancy, and the potential benefits and risks should be discussed with a healthcare provider. It is generally not recommended during breastfeeding.

  • Can Mercaptopurine be taken with other medications?

Mercaptopurine can interact with other drugs, so it’s essential to inform your healthcare provider about all the medications you are taking, including over-the-counter drugs and supplements.

  • How long do I need to take Mercaptopurine?

The duration of Mercaptopurine treatment varies depending on the condition being treated. Some patients may take it for several months or even years, while others may require lifelong treatment for certain autoimmune diseases.

  • Can Mercaptopurine cure leukemia or autoimmune diseases?

Mercaptopurine can be a crucial part of treatment for leukemia, increasing the chances of remission and longterm survival. In autoimmune diseases, it helps manage symptoms and control the progression of the condition but may not provide a cure.

  • What should I do if I miss a dose of Mercaptopurine?

If you miss a dose, take it as soon as you remember, unless it’s close to the time for your next dose. Do not double the dose to make up for a missed one.

  • Are there any dietary restrictions while taking Mercaptopurine?

Some healthcare providers may recommend avoiding certain foods high in purines, as Mercaptopurine can affect purine metabolism. However, dietary restrictions should be discussed with your healthcare provider.

  • Can Mercaptopurine be used in children?

Yes, Mercaptopurine is often used in pediatric oncology for the treatment of leukemia, but the dosage is adjusted based on the child’s weight and condition.

  • Can I drink alcohol while taking Mercaptopurine?

It’s generally recommended to limit or avoid alcohol while taking Mercaptopurine, as alcohol can interact with the medication and increase the risk of liver problems.

Always consult your healthcare provider for personalized information and guidance regarding Mercaptopurine or any medication you are taking.

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

Mercaptopurine 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 Mercaptopurine 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

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Mercaptopurine Tablets USP 10mg
b) Mercaptopurine Tablets USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Mercaptopurine Tablets USP 10mg
Each uncoated tablet contains:
Mercaptopurine USP..………….10mg
Excipients……………………………..q.s.
Colours: Titanium Dioxide USP

b) Mercaptopurine Tablets USP 50mg
Each uncoated tablet contains:
Mercaptopurine USP…………...50mg
Excipients………………………….…q.s.
Colours: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

Mercaptopurine is used in combination with other medicines as maintenance treatment of acute lymphoblastic leukemia. It belongs to the group of medicines known as antimetabolites. Mercaptopurine interferes with the growth of cancer cells, which are eventually destroyed.

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
Do not take in larger doses or more frequently or for a longer time than specifically directed by the physician. Periodic blood counts are necessary to determine proper dose and to avoid ill effects.
Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure.
Keep container tightly closed.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° 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.