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Basic Drug Info
Drug Name:Methotrexate
Manufacturer:GeneraMedix Inc
Other Info:



Clinical Trials:


Indications and Usage

Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole.In acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents.

Methotrexate is also indicated in the treatment of meningeal leukemia.Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types.

Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin’s lymphomas.Methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor.
Gestational Choriocarcinoma -- A rare, highly malignant, epithelial tumor that develops from a hydatidiform mole (50%), following abortion (25%), or during normal pregnancy (22%). Histologically, choriocarcinomas consist of invasive and anaplastic trophoblastic tissue composed of cytotrophoblastic and syncytiotrophoblastic cells, secretion of human chorionic gonadotropin, and abundant vascularity. Because of rapid growth and a high propensity for hemorrhage, this neoplasm often constitutes a medical emergency. --2004

Invasive Hydatidiform Mole -- A uterine tumor derived from persistent gestational TROPHOBLASTS, most likely after a molar pregnancy (HYDATIDIFORM MOLE). Invasive hyadatiform mole develops in about 15% of patients after evacuation of a complete mole and less frequently after other types of gestation. It may perforate the MYOMETRIUM and erode uterine vessels causing hemorrhage.

Hydatidiform Mole -- Trophoblastic hyperplasia associated with normal gestation, or molar pregnancy. It is characterized by the swelling of the CHORIONIC VILLI and elevated human CHORIONIC GONADOTROPIN. Hydatidiform moles or molar pregnancy may be categorized as complete or partial based on their gross morphology, histopathology, and karyotype.

Acute lymphocytic leukemia -- acute leukemia in which lymphoblasts and their progenitor cells predominate; the most common childhood cancer and accounts for 20 percent of adult acute leukemia; common ALL antigen (CALLA) expressed in most cases.

Precursor Cell Lymphoblastic Leukemia Lymphoma -- A neoplasm characterized by abnormalities of the lymphoid cell precursors leading to excessive lymphoblasts in the marrow and other organs. It is the most common cancer in children and accounts for the vast majority of all childhood leukemias.

Breast Carcinoma -- (brest KAN-ser) Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

Malignant neoplasm of breast -- A primary or metastatic malignant neoplasm involving the breast. The vast majority of cases are carcinomas arising from the breast parenchyma or the nipple. Malignant breast neoplasms occur more frequently in females than in males. -- 2003

Malignant Neoplasms -- A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread through the bloodstream and lymphatic system to other parts of the body.

Lymphoma, T-Cell, Cutaneous -- A group of lymphomas exhibiting clonal expansion of malignant T-lymphocytes arrested at varying stages of differentiation as well as malignant infiltration of the skin. MYCOSIS FUNGOIDES; SEZARY SYNDROME; LYMPHOMATOID PAPULOSIS; and PRIMARY CUTANEOUS ANAPLASTIC LYMPHOMA are the best characterized of these disorders.

Carcinoma of lung -- A carcinoma originating in the lung. Lung carcinomas usually arise from the epithelium that lines the bronchial tree (bronchogenic carcinomas), and are classified as small cell or non-small cell carcinomas. Non-small cell lung carcinomas are usually adenocarcinomas, squamous cell carcinomas, or large cell carcinomas. Metastatic carcinomas to the lung are also common, and can be difficult to distinguish from primary tumors.

Malignant neoplasm of lung -- A primary or metastatic malignant neoplasm involving the lung

Lymphoma, Non-Hodgkin's -- Any of a group of malignant tumors of lymphoid tissue that differ from HODGKIN DISEASE, being more heterogeneous with respect to malignant cell lineage, clinical course, prognosis, and therapy. The only common feature among these tumors is the absence of giant REED-STERNBERG CELLS, a characteristic of Hodgkin's disease.

Recurrent disease -- The return of signs and symptoms of cancer after a period of improvement.

Metastatic Osteosarcoma -- An osteosarcoma which has spread to another anatomical site.

Primary Neoplasm -- The original tumor.

Contraindications

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 PRECAUTIONS) 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 Boxed WARNINGS).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.
Fetal Death -- Death of the developing young in utero. BIRTH of a dead FETUS is STILLBIRTH.

Teratogenic Effect --

Psoriasis -- A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.

Rheumatoid Arthritis -- A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.

Neoplasms -- New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.

Alcoholic Liver Diseases -- Liver diseases associated with ALCOHOLISM. It usually refers to the coexistence of two or more subentities, i.e., ALCOHOLIC FATTY LIVER; ALCOHOLIC HEPATITIS; and ALCOHOLIC CIRRHOSIS.

Unspecified immunity deficiency -- Syndromes in which there is a deficiency or defect in the mechanisms of immunity, either cellular or humoral.

Hematological Disease -- Disorders of the blood and blood forming tissues.

Bone marrow depression --

Leukopenia -- reduction in the number of leukocytes in the blood, the count being 5000 per cubic millimeter or less.

Thrombocytopenia -- A subnormal level of BLOOD PLATELETS.

Anemia -- A reduction in the number of circulating erythrocytes or in the quantity of hemoglobin.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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

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