METHOTREXATE sodium injection solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Fresenius Kabi USA, LLC

INN (nemzetközi neve):

METHOTREXATE SODIUM

Összetétel:

METHOTREXATE 25 mg in 1 mL

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

METHOTREXATE - METHOTREXATE SODIUM INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
METHOTREXATE INJECTION USP
(PRESERVATIVE FREE)
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
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.
Unexpectedly severe (sometimes fatal) bone marrow suppression,
aplastic anemia, and
gastrointestinal toxicity have been reported with concomitant
administration of methotrexate
(usually in high dosage) along wi