METHOTREXATE injection solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Hospira, Inc.

DCI (Denominação Comum Internacional):

METHOTREXATE SODIUM

Composição:

METHOTREXATE 25 mg in 1 mL

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

New Drug Application

Características técnicas

METHOTREXATE- METHOTREXATE INJECTION, SOLUTION
HOSPIRA, INC.
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METHOTREXATE INJECTION, USP
Rx only
WARNINGS
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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 hi