Methotrexate Sodium (Methotrexate Sodium)

Trade Name : Methotrexate Sodium

West-Ward Pharmaceuticals Corp.

TABLET

Strength 2.5 mg/1

METHOTREXATE SODIUM Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Methotrexate Sodium (Methotrexate Sodium) which is also known as Methotrexate Sodium and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 2.5 mg/1 per ml. Read more

Methotrexate Sodium (Methotrexate Sodium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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METHOTREXATE SHOULD BE USED ONLY BY PHYSICIANS WHOSE KNOWLEDGE AND EXPERIENCE INCLUDE THE USE OF ANTIMETABOLITE THERAPY BECAUSE OF THE POSSIBILITY OF SERIOUS TOXIC REACTIONS (WHICH CAN BE FATAL):
METHOTREXATE SHOULD BE USED ONLY IN LIFE THREATENING NEOPLASTIC DISEASES, OR IN PATIENTS WITH PSORIASIS OR RHEUMATOID ARTHRITIS WITH SEVERE, RECALCITRANT, DISABLING DISEASE WHICH IS NOT ADEQUATELY RESPONSIVE TO OTHER FORMS OF THERAPY.
DEATHS HAVE BEEN REPORTED WITH THE USE OF METHOTREXATE IN THE TREATMENT OF MALIGNANCY, PSORIASIS, AND RHEUMATOID ARTHRITIS.
PATIENTS SHOULD BE CLOSELY MONITORED FOR BONE MARROW, LIVER, LUNG AND KIDNEY TOXICITIES. (See .) PATIENTS SHOULD BE INFORMED BY THEIR PHYSICIAN OF THE RISKS INVOLVED AND BE UNDER A PHYSICIANu2019S CARE THROUGHOUT THERAPY.

Methotrexate (formerly Amethopterin) is an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate is -[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is:
Methotrexate Tablets USP for oral administration are available as 2.5 mg tablets. Methotrexate Tablets USP contain an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate USP and the following inactive ingredients: lactose (anhydrous), magnesium stearate, pregelatinized starch, sodium hydroxide pellets, sodium starch glycolate and purified water.

Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of purine nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate. When cellular proliferation in malignant tissues is greater than in most normal tissues, methotrexate may impair malignant growth without irreversible damage to normal tissues.
The mechanism of action in rheumatoid arthritis is unknown; it may affect immune function. Two reports describe methotrexate inhibition of DNA precursor uptake by stimulated mononuclear cells, and another describes in animal polyarthritis partial correction by methotrexate of spleen cell hyporesponsiveness and suppressed IL 2 production. Other laboratories, however, have been unable to demonstrate similar effects. Clarification of methotrexateu2019s effect on immune activity and its relation to rheumatoid immunopathogenesis await further studies.
In patients with rheumatoid arthritis, effects of methotrexate on articular swelling and tenderness can be seen as early as 3 to 6 weeks. Although methotrexate clearly ameliorates symptoms of inflammation (pain, swelling, stiffness), there is no evidence that it induces remission of rheumatoid arthritis nor has a beneficial effect been demonstrated on bone erosions and other radiologic changes which result in impaired joint use, functional disability, and deformity.
Most studies of methotrexate in patients with rheumatoid arthritis are relatively short term (3 to 6 months). Limited data from long-term studies indicate that an initial clinical improvement is maintained for at least two years with continued therapy.
In psoriasis, the rate of production of epithelial cells in the skin is greatly increased over normal skin. This differential in proliferation rates is the basis for the use of methotrexate to control the psoriatic process.
In a 6-month, double-blind, placebo-controlled trial of 127 pediatric patients with juvenile rheumatoid arthritis (JRA) (mean age, 10.1 years; age range 2.5 to 18 years, mean duration of disease, 5.1 years) on background non-steroidal anti-inflammatory drugs (NSAIDs) and/or prednisone, methotrexate given weekly at an oral dose of 10 mg/m provided significant clinical improvement compared to placebo as measured by either the physicianu2019s global assessment, or by a patient composite (25% reduction in the articular-severity score plus improvement in parent and physician global assessments of disease activity.) Over two-thirds of the patients in this trial had polyarticular-course JRA, and the numerically greatest response was seen in this subgroup treated with 10 mg/m/wk methotrexate. The overwhelming majority of the remaining patients had systemic-course JRA. All patients were unresponsive to NSAIDs; approximately one-third were using low dose corticosteroids. Weekly methotrexate at a dose of 5 mg/m was not significantly more effective than placebo in this trial.

No data

Methotrexate can cause fetal death or teratogenic effects when administered to a pregnant woman. Methotrexate is contraindicated in pregnant women with psoriasis or rheumatoid arthritis and should be used in the treatment of neoplastic diseases only when the potential benefit outweighs the risk to the fetus. Women of childbearing potential should not be started on methotrexate until pregnancy is excluded and should be fully counseled on the serious risk to the fetus (See ) should they become pregnant while undergoing treatment. Pregnancy should be avoided if either partner is receiving methotrexate; during and for a minimum of three months after therapy for male patients, and during and for at least one ovulatory cycle after therapy for female patients. (See n )
Because of the potential for serious adverse reactions from methotrexate in breast fed infants, it is contraindicated in nursing mothers.
Patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic liver disease or other chronic liver disease should not receive methotrexate.
Patients with psoriasis or rheumatoid arthritis who have overt or laboratory evidence of immunodeficiency syndromes should not receive methotrexate.
Patients with psoriasis or rheumatoid arthritis who have preexisting blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anemia, should not receive methotrexate.
Patients with a known hypersensitivity to methotrexate should not receive the drug.

See .
Methotrexate formulations and diluents containing preservatives must not be used for intrathecal or high dose methotrexate therapy.

No data

IN GENERAL, THE INCIDENCE AND SEVERITY OF ACUTE SIDE EFFECTS ARE RELATED TO DOSE AND FREQUENCY OF ADMINISTRATION. THE MOST SERIOUS REACTIONS ARE DISCUSSED ABOVE UNDER ORGAN SYSTEM TOXICITY IN THE PRECAUTION SECTION. THAT SECTION SHOULD ALSO BE CONSULTED WHEN LOOKING FOR INFORMATION ABOUT ADVERSE REACTIONS WITH METHOTREXATE.
The most frequently reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequently reported adverse effects are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection.
Other adverse reactions that have been reported with methotrexate are listed below by organ system. In the oncology setting, concomitant treatment and the underlying disease make specific attribution of a reaction to methotrexate difficult.
Alimentary System:
Blood and Lymphatic System Disorders:
Cardiovascular:
Central Nervous System:
Hepatobiliary
Infection:
Musculoskeletal System:
Ophthalmic:
Pulmonary System:
Skin:
Urogenital System:
Other rarer reactions related to or attributed to the use of methotrexate such as nodulosis, vasculitis, arthralgia/myalgia, loss of libido/impotence, diabetes, osteoporosis, sudden death, reversible lymphomas, tumor lysis syndrome, soft tissue necrosis and osteonecrosis. Anaphylactoid reactions have been reported.

Leucovorin is indicated to diminish the toxicity and counteract the effect of inadvertently administered overdosages of methotrexate. Leucovorin administration should begin as promptly as possible. As the time interval between methotrexate administration and leucovorin initiation increases, the effectiveness of leucovorin in counteracting toxicity decreases. Monitoring of the serum methotrexate concentration is essential in determining the optimal dose and duration of treatment with leucovorin.
In cases of massive overdosage, hydration and urinary alkalinization may be necessary to prevent the precipitation of methotrexate and/or its metabolites in the renal tubules. Generally speaking, neither hemodialysis nor peritoneal dialysis has been shown to improve methotrexate elimination. However, effective clearance of methotrexate has been reported with acute, intermittent hemodialysis using a high-flux dialyzer (Wall, SM et al: 28(6): 846-854, 1996).
In postmarketing experience, overdose with methotrexate has generally occurred with oral and intrathecal administration, although intravenous and intramuscular overdose have also been reported.
Reports of oral overdose often indicate accidental daily administration instead of weekly (single or divided doses). Symptoms commonly reported following oral overdose include those symptoms and signs reported at pharmacologic doses, particularly hematologic and gastrointestinal reaction. For example, leukopenia, thrombocytopenia, anemia, pancytopenia, bone marrow suppression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration, gastrointestinal bleeding. In some cases, no symptoms were reported. There have been reports of death following overdose. In these cases, events such as sepsis or septic shock, renal failure, and aplastic anemia were also reported.

No data

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

Methotrexate Tablets USP, 2.5 mg (contain an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate USP)
2.5 mg tablets are supplied as a yellow, round slightly biconvex tablet, scored on one side and product identification u201c54 323u201d debossed on the other side.
NDC 0054-8550-25: 10x10 Unit-Dose
NDC 0054-4550-15: Bottle of 36 Tablets
NDC 0054-4550-25: Bottle of 100 Tablets
Dispense with a child-resistant closure in a well closed container, as defined in the USP/NF.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]

Distr. by:n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10004494/09
Revised August 2018

Methotrexate (methu201d oh trexu2019 ate) Tablets USP
Rx Only
Read the Patient Instructions that come with methotrexate before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition.
What is the most important information I should know about methotrexate?
What is methotrexate?
Methotrexate is a prescription medicine used in treating certain cancers, severe rheumatoid arthritis including polyarticular juvenile rheumatoid arthritis, and severe psoriasis.
Who should not take methotrexate?
Do not take methotrexate if:
u00a0n
How should I take methotrexate?
What should I avoid while taking methotrexate?
Do not:
What are the possible or reasonably likely side effects of methotrexate?
Methotrexate can cause serious and life-threatening problems includingn- see u201cWhat is the most important information I should know about methotrexate?u201d
u00a0n
Stop taking methotrexate and call your doctor right away if you get
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Methotrexate Tablets USP?
General information about methotrexate tablets
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use methotrexate for a condition for which it was not prescribed. Do not give methotrexate to other people, even if they have the same symptoms that you have. It may harm them.
This leaflet summarizes the most important information about methotrexate. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about methotrexate that is written for healthcare professionals.
For additional information, you may contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364.
What are the ingredients in Methotrexate Tablets USP?
Active Ingredient:
Inactive Ingredients:
This Patient Information has been approved by the U.S. Food and Drug Administration.
Distr. by:n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10004494/09
Revised August 2018

NDC 0054-4550-15: Bottle of 36 Tablets
Rx only

NDC 0054-8550-25: 10x10 Unit-Dose
Rx only

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Methotrexate Sodium (Methotrexate Sodium)

Trade Name : Methotrexate Sodium

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Methotrexate Sodium (Methotrexate Sodium)

Trade Name : Methotrexate Sodium

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Browse from other international pharmaceuticals

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US NDC

Canadian DIN

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NZ Drugs

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