Methotrexate Injection BP 7.5mg/ml Technical Specification:

Product Name:Methotrexate Injection BP 7.5mg/ml
Brand Name:Methotrexate
Strength:7.5mg/ml, 15mg/ml, 20mg/ml, 25mg/ml, 50mg/2ml – Ampoule,
5mg/ml (15mg/3ml), 25mg/ml (50mg/2ml, 250mg/10ml, 500mg/20ml, 1gm/40ml), 100mg/ml (500mg/5ml, 1000mg/10ml) – Vial
Dosage Form:Liquid Injection
Packing:SINGLE USE
Route of Administration:For I.M./I.A./ I.V. use
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 vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Methotrexate Injection BP 7.5mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Methotrexate Injection BP 7.5mg/ml
    Each ml contains:
    Methotrexate BP………………7.5mg
    Excipients………………………..q.s.
    Water for Injection BP………q.s.
    Contains no preservatives.

THERAPEUTIC 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.

PACKING:

Vial

  • 5mg/ml (15mg/3ml)
  • 25mg/ml (50mg/2ml, 250mg/10ml, 500mg/20ml, 1gm/40ml)
  • 100mg/ml (500mg/5ml, 1000mg/10ml)

Ampoule

  • 5mg/ml
  • 15mg/ml
  • 20mg/ml
  • 25mg/ml
  • 50mg/2ml

DIRECTION OF USE:

Methotrexate Injection may be given by the intramuscular, intravenous, intraarterial or intrathecal routes.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.

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

WARNINGS AND PRECAUTIONS

Methotrexate should be administered only under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Special care should be taken when methotrexate is co-administered with non-steroidal anti-inflammatory drugs (NSAIDs). Severe side effects including fatalities (after high doses of methotrexate) have been reported. Consumption of alcohol even in low doses should be avoided. The patient should be informed about possible risks (side effects). Contraindications and precautions for use must be strictly observed because of possible severe (under particular circumstances lethal) toxic reactions. Plasma concentration of methotrexate

  • Higher than 1-2 times 10-5 mol/I (24 hours after initiating methotrexate therapy)
  • Twice 10-6 mol/1 (48 hours after initiating methotrexate therapy)
  • 10-7 mol/I (72 hours after initiating methotrexate therapy) indicate an increased risk of intoxication (myelosuppression, mucositis) and require a long-lasting and high dose of calcium folinate rescue therapy.

Intermediate dose of methotrexate therapy:

500-1000 mg/m2 IV infusion over 36-42 h; calcium folinate rescue required, given at 2-3 weeks intervals High-dose methotrexate therapy – calcium folinate rescue required:1-12 gm/m2 IV over 1-6 hours, given at 1-3 weeks intervals

METHOTREXATE 1000 MG – CONCENTRATE FOR INFUSION HAS TO BE DILUTED WITH STANDARD SOLUTIONS FOR INFUSIONS BEFORE ADMINISTRATION ACCORDING TO THERAPY PROTOCOL AND DURATION OF INFUSION. USE 5% GLUCOSE SOLUTION, RINGER’S LACTATE OR PHYSIOLOGICAL SALINE SOLUTION.

GENERALLY, 1-2% METHOTREXATE SOLUTION IS ADMINISTERED.

Do not use after the expiry date stated on the label.

After dilution, the product should be used within 24 hours if stored at 2-8°C.

Contains no preservatives.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard unused portion.

Keep in a safe place out of the reach of children.

STORAGE & DOSAGE:

Storage: Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.

Dosage: As directed by the Oncologist. Please refer accompanying package insert for detailed dosage, directions for use and precautions.

Why choose Taj Pharma as Methotrexate Injection Manufacturers?

Choosing Taj Pharma as your Methotrexate Injection Manufacturers in India has several benefits. Here are some reasons why you should consider Taj Pharma:

Quality

Taj Pharma adheres to the highest quality standards, ensuring that all of our products are safe and effective for use. Our anticancer manufacturing facilities are equipped with state of the art technology, and our team of experts ensures that each batch of Methotrexate Injection meets strict quality control standards.

Expertise:

Taj Pharma has extensive experience in the pharmaceutical industry, and our team of experts has a deep understanding of the manufacturing process for anticancer like Methotrexate Injection. We have a dedicated research and development team that constantly works towards improving the quality and efficacy of our products.

Competitive pricing:

Taj Pharma offers competitive pricing for our Methotrexate Injection, making it an affordable option for patients and healthcare providers.

In conclusion, if you’re searching for a reliable and trustworthy manufacturer of Methotrexate Injection, then Taj Pharma is the perfect choice for you. Their commitment to quality and competitive pricing makes them stand out from the rest. With their state of-the-art facilities and experienced team, they have earned a reputation for providing high-quality products that meet the needs of healthcare professionals worldwide. By choosing Taj Pharma as your supplier of Methotrexate Injection, you can rest assured that you are getting a product that has been manufactured with precision and care. So why wait? Contact Taj Pharma today to place your order!

Why Taj Pharmaceuticals?

When it comes to Methotrexate Injection BP, Taj Pharma is your trusted ally in healthcare. Our unwavering commitment to your health and well-being is reflected in every vial of Methotrexate we produce. With state-of-the-art manufacturing facilities and rigorous quality control, we ensure that you receive the highest quality medication to manage conditions like cancer, rheumatoid arthritis, and psoriasis.

At Taj Pharma, we understand the importance of precision in healthcare. Our Methotrexate Injection BP is meticulously crafted, reflecting our dedication to providing effective treatment options. Whether you are a healthcare professional seeking reliable medication or a patient looking for the best care, Taj Pharma’s legacy of pharmaceutical excellence is here to support you. Choose Taj Pharma and experience a healthcare partnership rooted in trust, innovation, and a shared commitment to a healthier, brighter future. Your health is our priority, and we are here to serve you. Explore the Taj Pharma difference today.

What is Methotrexate Injection BP and its use?

Methotrexate Injection BP is a pharmaceutical product that contains the active ingredient methotrexate. Methotrexate is a potent medication that has various medical uses. Here’s an overview of its use:

Indications and Uses:

  • Cancer Treatment: Methotrexate is widely used in chemotherapy to treat various types of cancer, including leukemia, lymphoma, and solid tumors like breast, lung, and head and neck cancers. It works by inhibiting the growth of cancer cells and suppressing their ability to multiply.
  • Rheumatoid Arthritis: Methotrexate is a disease-modifying antirheumatic drug (DMARD) commonly prescribed to manage rheumatoid arthritis. It helps reduce inflammation and slow down the progression of the disease, relieving pain and preserving joint function.
  • Psoriasis: Methotrexate is used to treat severe cases of psoriasis, a chronic skin condition characterized by the rapid growth of skin cells. It helps to slow down skin cell growth and alleviate the symptoms of psoriasis.
  • Autoimmune Diseases: Methotrexate can be prescribed for various autoimmune diseases such as systemic lupus erythematosus (SLE) and inflammatory bowel disease (Crohn’s disease and ulcerative colitis) to reduce inflammation and suppress the immune system.
  • Ectopic Pregnancy: In cases of an ectopic pregnancy (a pregnancy outside the uterus), Methotrexate may be used to terminate the pregnancy, particularly when it is detected early and surgery is not required.
  • Other Conditions: Methotrexate can also be used in the treatment of certain other conditions, including severe forms of juvenile idiopathic arthritis, sarcoidosis, and some types of vasculitis.

Methotrexate is a versatile medication that can be administered orally, intravenously, or via injection, depending on the specific condition being treated and the patient’s individual needs. The dosage and duration of treatment vary widely based on the diagnosis and the healthcare provider’s recommendations.

How does Methotrexate Injection BP Work?

Methotrexate Injection BP works primarily by interfering with the growth and replication of rapidly dividing cells, which includes cancer cells and cells involved in inflammatory and autoimmune processes. Here’s how Methotrexate functions:

  • Folate Inhibition: Methotrexate is structurally similar to folic acid, a vitamin necessary for cell growth and division. It competes with folic acid for binding to an enzyme called dihydrofolate reductase. By doing so, it inhibits the conversion of folic acid to its active form, which is essential for the synthesis of DNA and RNA, crucial components for cell proliferation.
  • Cell Cycle Disruption: By disrupting folate metabolism, Methotrexate interferes with the cell cycle, preventing cells from progressing through various stages of division. This particularly affects rapidly dividing cells, such as cancer cells, which are more sensitive to the disruption.
  • Immune Suppression: In autoimmune conditions like rheumatoid arthritis and psoriasis, Methotrexate works by suppressing the overactive immune response. It reduces the production of inflammatory chemicals called cytokines and inhibits the activity of immune cells involved in the inflammatory process.
  • Cancer Cell Destruction: In cancer treatment, Methotrexate not only inhibits the growth of cancer cells but also induces cell death (apoptosis) in some cases. It can target both cancerous and non-cancerous cells, but cancer cells, which often have higher rates of division, are more susceptible to its effects.
  • Maintenance Therapy: In some cases, Methotrexate is used as a maintenance therapy to control the underlying disease, such as in rheumatoid arthritis or autoimmune diseases. This helps manage symptoms and reduce the frequency of flare-ups.

Methotrexate’s precise mechanism of action may vary depending on the specific condition being treated, and the dosage and treatment duration are carefully adjusted by healthcare providers to balance its therapeutic benefits with potential side effects. Patients taking Methotrexate should be closely monitored to ensure its effectiveness and safety throughout their treatment.

Benefits of Methotrexate Injection BP:

  • Cancer Treatment: Methotrexate Injection BP is a potent chemotherapy medication used to treat various types of cancer, including leukemia, lymphoma, and solid tumors. It can be highly effective in inducing remission or controlling the growth of cancer cells.
  • Rheumatoid Arthritis Management: Methotrexate is a commonly prescribed disease-modifying antirheumatic drug (DMARD) for rheumatoid arthritis. It helps reduce inflammation, alleviate pain, slow disease progression, and preserve joint function.
  • Psoriasis Control: In cases of severe psoriasis, Methotrexate can effectively slow down the rapid growth of skin cells, reducing the severity and symptoms of this chronic skin condition.
  • Autoimmune Disease Management: Methotrexate is used to manage various autoimmune diseases like systemic lupus erythematosus (SLE), inflammatory bowel disease, and some types of vasculitis by suppressing an overactive immune response.
  • Ectopic Pregnancy Treatment: Methotrexate can be an alternative to surgery for treating early ectopic pregnancies, offering a less invasive option for termination.

Side Effects of Methotrexate Injection BP:

  • Gastrointestinal Disturbances: Common side effects include nausea, vomiting, diarrhea, and mouth sores. These symptoms can often be managed with supportive care or dose adjustments.
  • Low Blood Cell Counts: Methotrexate can suppress bone marrow function, leading to low white blood cell, red blood cell, and platelet counts. This may increase the risk of infections, anemia, and bleeding.
  • Liver Toxicity: Methotrexate can affect liver function, potentially leading to elevated liver enzymes. Regular liver function monitoring is necessary during treatment.
  • Pulmonary Issues: In rare cases, Methotrexate can cause lung problems, such as interstitial pneumonitis, which may present as cough and shortness of breath.
  • Folic Acid Deficiency: Methotrexate interferes with folic acid metabolism, which can result in folic acid deficiency. Patients are often prescribed folic acid supplements to mitigate this side effect.
  • Hair Loss: Hair thinning or loss may occur but is usually temporary and reversible once treatment is discontinued.
  • Skin Sensitivity: Some patients may experience increased sensitivity to sunlight while taking Methotrexate.
  • Renal Toxicity: Methotrexate can affect kidney function, so kidney function should also be monitored during treatment.
  • Mood Changes: In some cases, Methotrexate may cause mood changes or depression.
  • Potential Birth Defects: Methotrexate is contraindicated during pregnancy due to the risk of severe birth defects if taken during pregnancy.

It’s crucial to recognize that the benefits of Methotrexate often outweigh the risks in many clinical scenarios. The medication should be administered and monitored by a healthcare provider experienced in its use, and patients should be informed about potential side effects and undergo regular check-ups to ensure safe and effective treatment. Individual responses to Methotrexate can vary, and healthcare providers can make adjustments as needed to manage side effects and optimize treatment outcomes.

Frequently asked questions about Methotrexate Injection BP:

  1. What is Methotrexate Injection BP, and how does it work?

Methotrexate Injection BP is a medication used for cancer treatment, autoimmune diseases, and inflammatory conditions. It works by inhibiting the growth of rapidly dividing cells and suppressing the immune system in autoimmune diseases.

  1. What conditions are treated with Methotrexate Injection BP?

Methotrexate is used to treat various conditions, including cancer (leukemia, lymphoma, solid tumors), rheumatoid arthritis, psoriasis, and autoimmune diseases like lupus and inflammatory bowel disease.

  1. How is Methotrexate Injection BP administered?

Methotrexate can be administered intravenously or subcutaneously (under the skin). The injection is typically given by a healthcare provider in a clinical setting.

  1. Are there any precautions I should take while on Methotrexate?

Patients taking Methotrexate should avoid alcohol, as it can increase the risk of liver toxicity. Additionally, it’s crucial to use effective contraception during treatment, as Methotrexate can cause birth defects.

  1. What should I do if I miss a dose of Methotrexate Injection BP?

If you miss a dose, consult your healthcare provider for guidance. In some cases, the dose may be taken later or skipped, depending on the circumstances.

  1. Can I take other medications or supplements while on Methotrexate?

Methotrexate can interact with various medications and supplements. It’s essential to inform your healthcare provider about all medications and supplements you are taking to avoid potential interactions.

  1. Are there any common side effects of Methotrexate Injection BP?

Common side effects may include nausea, vomiting, diarrhea, mouth sores, and fatigue. Regular blood tests are often performed to monitor for potential side effects.

  1. How long will I need to take Methotrexate Injection BP?

The duration of treatment with Methotrexate varies depending on the condition being treated and the patient’s response. Your healthcare provider will determine the appropriate treatment duration.

  1. Can I continue Methotrexate treatment if I plan to become pregnant or am breastfeeding?

Methotrexate is contraindicated during pregnancy due to the risk of birth defects. It should not be used while breastfeeding. If you plan to become pregnant, consult your healthcare provider to discuss alternative treatments.

  1. Is it safe to receive vaccinations while on Methotrexate?

Live vaccines are generally avoided while taking Methotrexate, as they may pose a risk of infection. Consult your healthcare provider about vaccination recommendations.

As Methotrexate Injection BP Exporters; We can cater to export business queries from the following geographies. We are exporting our Methotrexate Injection BP 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 Injection BP 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 Injection BP, 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 Injection BP 5mg/ml (15mg/3ml)
b) Methotrexate Injection BP 25mg/ml (50mg/2ml, 250mg/10ml, 500mg/20ml,1gm/40ml)
c) Methotrexate Injection BP 100mg/ml (500mg/5ml, 1000mg/10ml)
d) Methotrexate Injection BP 7.5mg/ml
e) Methotrexate Injection BP 15mg/ml
f) Methotrexate Injection BP 20mg/ml
g) Methotrexate Injection BP 25mg/ml (25mg/ml, 50mg/2ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Methotrexate Injection BP 5mg/ml (15mg/3ml)
Each ml contains:
Methotrexate BP………………5mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

b) Methotrexate Injection BP 25mg/ml (50mg/2ml, 250mg/10ml, 500mg/20ml,1gm/40ml)
Each ml contains:
Methotrexate BP………………25mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

c) Methotrexate Injection BP 100mg/ml (500mg/5ml, 1000mg/10ml)
Each ml contains:
Methotrexate BP………………100mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

d) Methotrexate Injection BP 7.5mg/ml
Each ml contains:
Methotrexate BP………………7.5mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

e) Methotrexate Injection BP 15mg/ml
Each ml contains:
Methotrexate BP………………15mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

f) Methotrexate Injection BP 20mg/ml
Each ml contains:
Methotrexate BP………………20mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

g) Methotrexate Injection BP 25mg/ml (25mg/ml, 50mg/2ml)
Each ml contains:
Methotrexate BP………………20mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

THERAPEUTIC 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.

PACKING:

Vial
1) 5mg/ml (15mg/3ml)
2) 25mg/ml (50mg/2ml, 250mg/10ml, 500mg/20ml, 1gm/40ml)
3) 100mg/ml (500mg/5ml, 1000mg/10ml)

Ampoule
1) 7.5mg/ml
2) 15mg/ml
3) 20mg/ml
4) 25mg/ml
5) 50mg/2ml

DIRECTION OF USE:

Methotrexate Injection may be given by the intramuscular, intravenous, intraarterial or intrathecal routes.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNINGS AND PRECAUTIONS
Methotrexate should be administered only under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Special care should be taken when methotrexate is co-administered with non-steroidal anti-inflammatory drugs (NSAIDs). Severe side effects including fatalities (after high doses of methotrexate) have been reported. Consumption of alcohol even in low doses should be avoided. The patient should be informed about possible risks (side effects). Contraindications and precautions for use must be strictly observed because of possible severe (under particular circumstances lethal) toxic reactions. Plasma concentration of methotrexate
• Higher than 1-2 times 10-5 mol/I (24 hours after initiating methotrexate therapy)
• Twice 10-6 mol/1 (48 hours after initiating methotrexate therapy)
• 10-7 mol/I (72 hours after initiating methotrexate therapy) indicate an increased risk of intoxication (myelosuppression, mucositis) and require a long -lasting and high dose of calcium folinate rescue therapy.
Intermediate dose of methotrexate therapy:
500-1000 mg/m2 IV infusion over 36-42 h; calcium folinate rescue required, given at 2-3 weeks intervals High-dose methotrexate therapy - calcium folinate rescue required:1-12 gm/m2 IV over 1-6 hours, given at 1-3 weeks intervals
METHOTREXATE 1000 MG - CONCENTRATE FOR INFUSION HAS TO BE DILUTED WITH STANDARD SOLUTIONS FOR INFUSIONS BEFORE ADMINISTRATION ACCORDING TO THERAPY PROTOCOL AND DURATION OF INFUSION. USE 5% GLUCOSE SOLUTION, RINGER'S LACTATE OR PHYSIOLOGICAL SALINE SOLUTION.
GENERALLY, 1-2% METHOTREXATE SOLUTION IS ADMINISTERED.
Do not use after the expiry date stated on the label.
After dilution, the product should be used within 24 hours if stored at 2-8°C.
Contains no preservatives.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.
Keep in a safe place out of the reach of children.

STORAGE & DOSAGE:

Storage: Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.
Dosage: As directed by the Oncologist. Please refer accompanying package insert for detailed dosage, directions for use and precautions.