Methotrexate Tablets USP 5mg Technical Specification:

Product Name:Methotrexate Tablets USP 5mg
Brand Name:Methotrexate
Strength:2.5mg, 5mg, 7.5mg, 10mg, 15mg
Dosage Form:uncoated Tablet
Packing:4s, 100s
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: Methotrexate injection is used alone or together with other medicines to treat several types of cancer such as breast, head and neck, lung, blood, bone, lymph node, and uterus cancers.
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].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Methotrexate Tablets USP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Methotrexate Tablets USP 5mg
    Each uncoated tablet contains:
    Methotrexate Sodium equivalent to
    Methotrexate…………………..5 mg
    Excipients…………………………q.s.

THERAPEUTIC INDICATIONS:

Methotrexate injection is used alone or together with other medicines to treat several types of cancer such as breast, head and neck, lung, blood, bone, lymph node, and uterus cancers.

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.

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

Caution Pharmacist: Because of its potential to cause severe toxicity. Methotrexate therapy requires close supervision of the patient by the physician.

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].

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

Why Taj Pharmaceuticals?

Choosing a pharmaceutical company for Methotrexate tablets, a prescription medication used to treat various conditions like rheumatoid arthritis and cancer, involves several critical considerations. One such company is Taj Pharmaceuticals, based in India. However, the choice of the manufacturer should be based on several factors, including quality, regulatory compliance, prescription guidance, cost, availability, patient feedback, and consultation with healthcare providers. Firstly, quality and regulatory compliance are paramount when selecting a pharmaceutical company for Methotrexate. It’s essential to ensure that the manufacturer adheres to high-quality standards and follows regulatory guidelines to guarantee the safety and efficacy of the medication. Secondly, Methotrexate is a prescription medication, and it is vital to align your choice of manufacturer with your healthcare provider’s recommendations and prescription. Your healthcare provider’s expertise plays a crucial role in determining the most suitable brand or generic form of Methotrexate for your specific medical condition. Price and accessibility are also significant factors to consider. Different manufacturers may offer varying prices for the same medication. Therefore, it’s essential to consider your budget and insurance coverage when making your choice.

Additionally, the availability of Methotrexate is critical, particularly for those with chronic conditions. Ensure that the chosen manufacturer has a reliable supply chain so that the medication is readily available when needed. Patient reviews and feedback can provide valuable insights into the experiences of others who have used a specific brand of Methotrexate tablets. These insights can help you make an informed decision. Ultimately, the decision should be made in consultation with your healthcare provider. They can consider your specific medical history, the form of Methotrexate that best suits your condition (tablet, injection, etc.), and any potential drug interactions. Lastly, Methotrexate may be available as both a generic and brand-name medication. Your healthcare provider can help you determine if the generic version is suitable for your treatment or if a specific brand is recommended based on your individual needs and circumstances. In conclusion, when choosing a pharmaceutical company for Methotrexate tablets, it’s crucial to consider factors such as quality, prescription guidance, cost, availability, patient feedback, and consultation with healthcare providers to ensure that you receive the most appropriate and effective treatment for your specific condition.

What is Methotrexate tablets and its uses:

Methotrexate is a medication that comes in various forms, including tablets, and it is commonly used for several medical purposes. Here’s an overview of Methotrexate tablets and their uses:

Uses of Methotrexate Tablets:

  • Cancer Treatment: Methotrexate is used in chemotherapy to treat various types of cancer, including leukemia, lymphoma, and certain solid tumors. It works by interfering with the growth and division of cancer cells.
  • Rheumatoid Arthritis: Methotrexate is a disease-modifying antirheumatic drug (DMARD) used to treat rheumatoid arthritis. It helps reduce inflammation and slow down the progression of joint damage in this autoimmune disease.
  • Psoriasis: Methotrexate tablets are used to treat severe psoriasis, a skin condition characterized by red, scaly patches on the skin. It helps to control skin cell overproduction and reduce inflammation associated with psoriasis.
  • Autoimmune Disorders: Methotrexate is also used to manage other autoimmune disorders such as lupus (systemic lupus erythematosus) and certain types of vasculitis. It helps suppress the overactive immune response that characterizes these conditions.
  • Ectopic Pregnancy: In some cases, Methotrexate may be used to treat ectopic pregnancies, a potentially life-threatening condition where a fertilized egg implants outside the uterus.
  • Crohn’s Disease: Methotrexate may be prescribed for the treatment of Crohn’s disease, a type of inflammatory bowel disease, in some cases.
  • Juvenile Idiopathic Arthritis (JIA): Methotrexate is used to manage JIA, a chronic inflammatory condition that affects children and adolescents.

It’s important to note that Methotrexate is a powerful medication with potential side effects and risks. The dosage and administration of Methotrexate should be carefully monitored and managed by a healthcare provider. Patients taking Methotrexate typically require regular blood tests to monitor for any adverse effects on the liver, kidneys, and blood cells.

How do Methotrexate Tablets work?

Methotrexate tablets work by interfering with the growth and division of cells, particularly rapidly dividing cells. This property makes Methotrexate useful for treating various medical conditions, including cancer, autoimmune diseases, and inflammatory conditions. Here’s how Methotrexate tablets work:

  • Inhibition of Folate Metabolism: Methotrexate is structurally similar to folic acid, which is an essential B-vitamin necessary for cell division and the production of DNA and RNA. Methotrexate works by inhibiting dihydrofolate reductase, an enzyme involved in the conversion of folic acid to its active form, tetrahydrofolate. By blocking this enzyme, Methotrexate disrupts the synthesis of DNA, RNA, and proteins in cells.
  • Anti-Inflammatory Effects: In autoimmune diseases and inflammatory conditions like rheumatoid arthritis, Methotrexate is thought to have additional anti-inflammatory effects. It can reduce the production of inflammatory cytokines (chemical messengers) and the activation of immune cells, particularly T-cells. By dampening the immune response, Methotrexate helps alleviate symptoms and slow down the progression of the disease.
  • Cancer Treatment: In cancer treatment, Methotrexate’s primary action is to inhibit the growth and division of cancer cells. Cancer cells are often rapidly dividing, and they require a constant supply of DNA and RNA for this process. Methotrexate disrupts these essential processes, leading to the death of cancer cells or slowing down their growth. It is commonly used in combination with other chemotherapy drugs to target cancer cells more effectively.
  • Psoriasis and Skin Conditions: In the case of severe psoriasis and certain skin conditions, Methotrexate is believed to work by reducing the production of skin cells. Psoriasis involves the overproduction of skin cells, leading to the formation of scales and plaques. Methotrexate helps normalize the skin cell turnover rate and reduce inflammation in the skin.

It’s important to note that Methotrexate affects not only the target cells but also normal, healthy cells that rapidly divide, such as those in the bone marrow, digestive tract, and hair follicles. This can lead to side effects, and it’s why Methotrexate use is carefully monitored by healthcare providers. Regular blood tests are often conducted to check for any adverse effects on blood cell counts, liver function, and kidney function. The specific mechanism of action and the intended therapeutic effect of Methotrexate can vary depending on the medical condition for which it is prescribed. Therefore, it’s crucial to use Methotrexate under the supervision and guidance of a healthcare professional who can tailor the treatment to the individual’s needs and monitor for potential side effects.

Benefits And Side Effects of Methotrexate Tablets:

Methotrexate tablets can offer significant benefits for individuals with various medical conditions, but they also come with potential side effects. It’s essential to understand both the benefits and risks when considering Methotrexate treatment. Here’s an overview:

Benefits of Methotrexate Tablets:

  • Treatment of Rheumatoid Arthritis (RA): Methotrexate is a commonly prescribed disease-modifying antirheumatic drug (DMARD) for RA. It can help reduce joint pain, inflammation, and slow down joint damage progression. Many people with RA find relief and improved joint function with Methotrexate.
  • Cancer Treatment: Methotrexate is used as part of chemotherapy regimens to treat various types of cancer, including leukemia, lymphoma, and certain solid tumors. It inhibits the growth and division of cancer cells, leading to the destruction of malignant cells.
  • Psoriasis Management: Methotrexate is effective in treating severe psoriasis, a skin condition characterized by red, scaly patches. It helps reduce the excessive skin cell growth and can provide relief from the symptoms of psoriasis.
  • Autoimmune Disease Management: Methotrexate is used to manage various autoimmune diseases, including systemic lupus erythematosus (lupus) and certain types of vasculitis. It helps suppress the overactive immune response that characterizes these conditions.
  • Juvenile Idiopathic Arthritis (JIA): Methotrexate is used to treat JIA in children and adolescents. It can help reduce joint inflammation and improve the quality of life for young patients.

Side Effects of Methotrexate Tablets:

  • Nausea and Vomiting: Nausea and vomiting are common side effects of Methotrexate. Taking the medication with food or using anti-nausea medications can help mitigate these symptoms.
  • Fatigue: Some people may experience fatigue or a sense of tiredness while taking Methotrexate.
  • Liver Toxicity: Methotrexate can affect the liver, potentially leading to elevated liver enzymes. Regular liver function monitoring is essential during treatment.
  • Bone Marrow Suppression: Methotrexate can reduce the production of blood cells in the bone marrow, leading to an increased risk of anemia, leukopenia (low white blood cell count), and thrombocytopenia (low platelet count).
  • Gastrointestinal Issues: Methotrexate can cause gastrointestinal symptoms such as diarrhea, abdominal pain, and mouth sores.
  • Lung Problems: Rarely, Methotrexate may lead to lung problems, such as interstitial lung disease. If you experience breathing difficulties or persistent cough, seek medical attention.
  • Infection Risk: Methotrexate suppresses the immune system, increasing the risk of infections. If you develop signs of infection (fever, chills, cough, etc.), notify your healthcare provider promptly.
  • Risk to Pregnancy: Methotrexate can harm a developing fetus and is contraindicated during pregnancy. Effective contraception is essential for those of childbearing age.
  • Hair Loss: Some individuals may experience hair loss while taking Methotrexate.
  • Increased Sensitivity to Sunlight: Methotrexate can make the skin more sensitive to sunlight. Sun protection measures are advisable.

It’s crucial to work closely with a healthcare provider when using Methotrexate. They will monitor your condition, adjust the dosage as needed, and address any side effects. The potential benefits of Methotrexate in managing your specific condition should be weighed against the potential risks, and your healthcare provider can help you make informed decisions about your treatment.

Frequently Asked Questions About Methotrexate Tablets:

Certainly, here are some frequently asked questions (FAQs) about Methotrexate tablets:

  1. What are Methotrexate tablets, and what are they used for?

Methotrexate tablets are a medication used to treat a variety of medical conditions, including rheumatoid arthritis, psoriasis, certain types of cancer, autoimmune diseases, and inflammatory conditions.

  1. How do Methotrexate tablets work?

Methotrexate works by interfering with the growth and division of cells, particularly rapidly dividing cells. It inhibits the synthesis of DNA, RNA, and proteins in cells, making it effective for treating conditions where cell overgrowth or an overactive immune system is a problem.

  1. Is Methotrexate a chemotherapy drug?

Yes, Methotrexate is used in chemotherapy to treat certain types of cancer. It is administered at lower doses for noncancerous conditions like rheumatoid arthritis and psoriasis.

  1. What are the common side effects of Methotrexate tablets?

Common side effects may include nausea, vomiting, fatigue, mouth sores, diarrhea, and increased sensitivity to sunlight. Some individuals may experience hair loss as well.

  1. Are there serious side effects associated with Methotrexate?

Yes, Methotrexate can have serious side effects, including liver toxicity, bone marrow suppression, lung problems, increased risk of infections, and birth defects if taken during pregnancy.

  1. How should I take Methotrexate tablets?

Follow your healthcare provider’s instructions carefully. Methotrexate is usually taken once a week, and it may be taken with or without food. It is important not to crush or chew the tablets but to swallow them whole with water.

  1. Can I drink alcohol while taking Methotrexate?

Alcohol can increase the risk of liver problems when taken with Methotrexate. It’s generally advisable to limit or avoid alcohol consumption during Methotrexate treatment.

  1. Is Methotrexate safe during pregnancy and breastfeeding?

Methotrexate is contraindicated during pregnancy as it can cause birth defects. It is also not recommended while breastfeeding due to potential risks to the infant.

  1. Do I need regular monitoring while taking Methotrexate?

Yes, regular monitoring is essential while taking Methotrexate. This typically includes blood tests to check liver function, blood cell counts, and markers of inflammation.

  1. Can Methotrexate be used in children?

Methotrexate can be prescribed for certain conditions in children, such as juvenile idiopathic arthritis and certain cancers. Paediatric dosages are adjusted based on the child’s weight and condition.

  1. Can I take other medications with Methotrexate?

Inform your healthcare provider about all medications, including over-the-counter drugs and supplements, that you are taking. Some medications can interact with Methotrexate and may need dosage adjustments or close monitoring.

These are general FAQs about Methotrexate tablets. However, it’s crucial to consult with your healthcare provider or pharmacist for personalized information and guidance based on your specific medical condition and needs.

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

Methotrexate 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 Methotrexate 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) Methotrexate Tablets USP 2.5mg
b) Methotrexate Tablets USP 5mg
c) Methotrexate Tablets USP 7.5mg
d) Methotrexate Tablets USP 10mg
e) Methotrexate Tablets USP 15mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Methotrexate Tablets USP 2.5mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..2.5 mg
Excipients…………………………q.s.

b) Methotrexate Tablets USP 5mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate.………..………..5 mg
Excipients…………………………q.s.

c) Methotrexate Tablets USP 7.5mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..7.5 mg
Excipients…………………………q.s.

d) Methotrexate Tablets USP 10mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..10 mg
Excipients…………………………q.s.

e) Methotrexate Tablets USP 15mg
Each uncoated tablet contains:
Methotrexate Sodium equivalent to
Methotrexate…………………..15 mg
Excipients…………………………q.s.

THERAPEUTIC INDICATIONS:

Methotrexate injection is used alone or together with other medicines to treat several types of cancer such as breast, head and neck, lung, blood, bone, lymph node, and uterus cancers.

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.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Caution Pharmacist: Because of its potential to cause severe toxicity. Methotrexate therapy requires close supervision of the patient by the physician.
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].
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.