METHOTREXATE- methotrexate sodium injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

METHOTREXATE SODIUM (UNII: 3IG1E710ZN) (METHOTREXATE - UNII:YL5FZ2Y5U1)

זמין מ:

Fresenius Kabi USA, LLC

INN (שם בינלאומי):

METHOTREXATE SODIUM

הרכב:

METHOTREXATE 25 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated for use in maintenance therapy in combination with other chemotherapeutic agents.   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. Methotrexate is indicated in the symptomatic control of se

leaflet_short:

Methotrexate Injection, USP, Isotonic Liquid, Contains Preservative . Each mL contains methotrexate sodium equivalent to 25 mg methotrexate. Store at  20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. The container closure is not made with natural rubber latex.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

METHOTREXATE - METHOTREXATE SODIUM INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
METHOTREXATE INJECTION, USP
(CONTAINS PRESERVATIVE)
Rx only
WARNINGS
FOR INTRATHECAL AND HIGH-DOSE THERAPY, USE THE PRESERVATIVE-
FREE FORMULATION OF METHOTREXATE. DO NOT USE THE
PRESERVED FORMULATION FOR INTRATHECAL OR HIGH-DOSE
THERAPY BECAUSE IT CONTAINS BENZYL ALCOHOL.
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 PRECAUTIONS).
PATIENTS SHOULD BE INFORMED BY THEIR PHYSICIAN OF THE RISKS
INVOLVED AND BE UNDER A PHYSICIAN’S CARE THROUGHOUT THERAPY.
THE USE OF METHOTREXATE HIGH-DOSE REGIMENS RECOMMENDED FOR
OSTEOSARCOMA REQUIRES METICULOUS CARE (see DOSAGE AND
ADMINISTRATION). HIGH-DOSE REGIMENS FOR OTHER NEOPLASTIC
DISEASES ARE INVESTIGATIONAL AND A THERAPEUTIC ADVANTAGE HAS NOT
BEEN ESTABLISHED.
Methotrexate has been reported to cause fetal death and/or congenital
anomalies. Therefore, it is not recommended for women of childbearing
potential unless there is clear medical evidence that the benefits can
be
expected to outweigh the considered risks. Pregnant women with
psoriasis or
rheumatoid arthritis should not receive methotrexate (see
CONTRAINDICATIONS).
Methotrexate elimination is reduced in patients with impaired renal
functions,
ascites, or pleural effusions. Such patients require especially
careful monitoring
for toxicity, and require dose reduction or, in some cases,
discontinuation of
methotrexate administration.
Unexpectedly severe (sometimes fatal) bone marrow suppression,
aplastic
anemia, and gastrointestinal toxicity have been reported with
concomitant
administration of methotrexate (usually in high dosage) al