METHOTREXATE SODIUM- 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:

Sandoz Inc

INN (שם בינלאומי):

Methotrexate Sodium

הרכב:

Methotrexate 25 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

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 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

leaflet_short:

Methotrexate Injection, USP, Isotonic Liquid (preservative free) for Single Use Only is supplied in a single-dose vial containing 25 mg/mL of methotrexate as the base in the following package strengths: NDC 66758-040-02 50 mg in 2 mL (packaged in 10's) NDC 66758-040-08 250 mg in 10 mL (packaged in 10's) NDC 66758-041-01 1 gram in 40 mL (individually packaged) Store at USP controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). See USP controlled room temperature. Protect from light. For Sandoz Inc. Customer Service call , 1-800-525-8747. ‡LEUCOVORIN RESCUE SCHEDULES FOLLOWING TREATMENT WITH HIGHER DOSES OF METHOTREXATE Clinical Situation Laboratory Findings Leucovorin Dosage and Duration Normal Methotrexate Elimination Serum methotrexate level approximately 10 micromolar at 24 hours after administration, 1 micromolar at 48 hours, and less than 0.2 micromolar at 72 hours. 15 mg PO, IM, or IV q 6 hours for 60 hours (10 doses starting at 24 hours after start of methotrexate infusion). Delayed Late Methotrexate Elimination Serum methotrexate level remaining above 0.2 micromolar at 72 hours, and more than 0.05 micromolar at 96 hours after administration. Continue 15 mg PO, IM, or IV q six hours, until methotrexate level is less than 0.05 micromolar. Delayed Early Methotrexate Elimination and/or Evidence of Acute Renal Injury Serum methotrexate level of 50 micromolar or more at 24 hours, or 5 micromolar or more at 48 hours after administration, OR; a 100% or greater increase in serum creatinine level at 24 hours after methotrexate administration, (e.g., an increase from 0.5 mg/dL to a level of 1 mg/dL or more). 150 mg IV q three hours, until methotrexate level is less than 1 micromolar; then 15 mg IV q three hours until methotrexate level is less than 0.05 micromolar.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

METHOTREXATE SODIUM- METHOTREXATE SODIUM INJECTION, SOLUTION
SANDOZ INC
----------
METHOTREXATE INJECTION, USP
RX ONLY
WARNINGS
METHOTREXATE SHOULD BE USED ONLY BY PHYSICIANS WHOSE KNOWLEDGE
AND EXPERIENCE INCLUDE THE USE OF ANTIMETABOLITE THERAPY.
BECAUSE OF THE POSSIBLITY 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 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 NOTBEEN
ESTABLISHED. METHOTREXATE FORMULATIONS AND DILUENTS CONTAINING
PRESERVATIVES MUST NOT BE USED FOR INTRATHECAL OR HIGH DOSE
METHOTREXATE THERAPY.
1. 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].
2. Methotrexate elimination is reduced in patients with impaired renal
function, ascites, or pleural
effusions. Such patients require especially careful monitoring for
toxicity, and require dose
reduction or, in some cases, discontinuation of methotrexate
administration.
3. Unexpectedly severe (sometimes fatal) bone marrow suppression,
aplastic anemia, and
gastrointestinal tox