METHOTREXATE injection

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

METHOTREXATE (UNII: YL5FZ2Y5U1) (METHOTREXATE - UNII:YL5FZ2Y5U1)

Commercializzato da:

Pfizer Laboratories Div Pfizer Inc.

INN (Nome Internazionale):

METHOTREXATE

Composizione:

METHOTREXATE 25 mg in 1 mL

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

METHOTREXATE- METHOTREXATE INJECTION
PFIZER LABORATORIES DIV PFIZER INC.
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METHOTREXATE INJECTION, USP 40 ML
RX ONLY
WARNINGS
METHOTREXATE SHOULD BE USED ONLY BY PHYSICIANS WHOSE
KNOWLEDGE AND EXPERIENCE INCLUDE THE USE OF ANTIMETABOLITE
THERAPY. BECAUSE OF THE POSSIBILITY 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 NOT BEEN 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
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.
3. Unexpectedly severe (sometimes fatal) bone marrow suppression,
aplastic anemia, and
gastroint