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Methotrexate

Generic Name
Methotrexate
Brand Names
Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo
Drug Type
Small Molecule
Chemical Formula
C20H22N8O5
CAS Number
59-05-2
Unique Ingredient Identifier
YL5FZ2Y5U1

Overview

Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division. Because of these effects, methotrexate is often used to treat inflammation caused by arthritis or to control cell division in neoplastic diseases such as breast cancer and non-Hodgkin's lymphoma. Due to the toxic effects of methotrexate, it is indicated for treatment of some forms of arthritis and severe psoriasis only if first line treatment has failed or patients are intolerant of those treatments. Methotrexate was granted FDA approval on 7 December 1953.

Background

Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division. Because of these effects, methotrexate is often used to treat inflammation caused by arthritis or to control cell division in neoplastic diseases such as breast cancer and non-Hodgkin's lymphoma. Due to the toxic effects of methotrexate, it is indicated for treatment of some forms of arthritis and severe psoriasis only if first line treatment has failed or patients are intolerant of those treatments. Methotrexate was granted FDA approval on 7 December 1953.

Indication

Methotrexate oral solution is indicated for pediatric acute lymphoblastic leukemia and pediatric polyarticular juvenile idiopathic arthritis. Methotrexate injections for subcutaneous use are indicated for severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe, recalcitrant, disabling psoriasis. Other formulations are indicated to treat gestational choriocarcinoma, chorioadenoma destruens, hydatiform mole, breast cancer, epidermoid cancer of the head and neck, advanced mycosis fungoides, lung cancer, and advanced non-Hodgkin's lymphoma. It is also used in the maintenance of acute lymphocytic leukemia. Methotrexate is also given before treatment with leucovorin to prolong relapse-free survival following surgical removal of a tumour in non-metastatic osteosarcoma.

Associated Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Promyelocytic Leukemia
  • Bladder Cancer
  • Breast Cancer
  • Central Nervous System Lymphoma
  • Crohn's Disease (CD)
  • Dermatomyositis (DM)
  • Extrauterine Pregnancy
  • Gestational Trophoblastic Neoplasia
  • Graft-versus-host Disease (GVHD)
  • Meningeal leukemia
  • Multiple Sclerosis
  • Mycosis Fungoides (MF)
  • Non-Hodgkin's Lymphoma (NHL)
  • Non-Hodgkin's Lymphoma, Relapsed
  • Osteosarcoma
  • Polyarticular Juvenile Idiopathic Arthritis
  • Polymyositis
  • Rheumatoid Arthritis
  • Soft Tissue Sarcoma
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Systemic Lupus Erythematosus
  • Uveitis
  • Nonleukemic meningeal cancer
  • Refractory Non-Hodgkin's lymphoma
  • Refractory Takayasu arteritis
  • Severe Psoriasis

FDA Approved Products

Methotrexate
Manufacturer:AvPAK
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2024/01/09
NDC:50268-527
Methotrexate
Manufacturer:Hospira, Inc.
Route:INTRAMUSCULAR, INTRAVENOUS, INTRATHECAL, SUBCUTANEOUS
Strength:25 mg in 1 mL
Approved: 2023/12/11
NDC:61703-124
Methotrexate
Manufacturer:REMEDYREPACK INC.
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2024/03/27
NDC:70518-3672
Methotrexate
Manufacturer:Hospira, Inc.
Route:INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Strength:25 mg in 1 mL
Approved: 2021/06/01
NDC:61703-350
Methotrexate
Manufacturer:Zydus Lifesciences Limited
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2022/10/31
NDC:70771-1058

Singapore Approved Products

MEREX 2.5-METHOTREXATE TABLETS USP 2.5 mg
Manufacturer:Intas Pharmaceuticals Limited
Form:TABLET
Strength:2.5 mg
Online:Yes
Approved: 2023/03/13
Approval:SIN16737P
TREXAN TABLET 2.5MG
Manufacturer:Orion Corporation, Orion Pharma
Form:TABLET
Strength:2.5 mg
Online:Yes
Approved: 1988/04/05
Approval:SIN00241P
DBL METHOTREXATE INJECTION BP 50 mg/2 ml (WITHOUT PRESERVATIVE)
Manufacturer:Hospira Australia Pty Ltd
Form:INJECTION
Strength:50 mg/2 ml
Online:Yes
Approved: 1988/05/04
Approval:SIN00758P
EMTHEXATE 2.5 TABLET 2.5 mg
Manufacturer:TEVA CZECH INDUSTRIES S.R.O
Form:TABLET
Strength:2.5 mg
Online:Yes
Approved: 2003/08/30
Approval:SIN12414P
Methotrexate Injection BP 50mg in 2ml
Manufacturer:Pfizer (Perth) Pty Ltd
Form:INJECTION
Strength:50mg/2ml
Online:Yes
Approved: 2012/06/11
Approval:SIN14155P

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