METHOTREXATE- methotrexate sodium injection, powder, lyophilized, for solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Fresenius Kabi USA, LLC

INN (mednarodno ime):

METHOTREXATE SODIUM

Sestava:

METHOTREXATE 1 g

Pot uporabe:

INTRAMUSCULAR

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 resectio

Povzetek izdelek:

Methotrexate for Injection, USP, Lyophilized, Preservative Free, for Single Use Only .  Each 1 g vial of lyophilized powder contains methotrexate sodium equivalent to 1 g methotrexate. Store at 20° to 25°C (68° to 77°F)  [see USP Controlled Room Temperature].  PROTECT FROM LIGHT.  Retain in carton until time of use.  Discard unused portion.  The container closure is not made with natural rubber latex. See package insert for routes of administration.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

METHOTREXATE - METHOTREXATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
FRESENIUS KABI USA, LLC
----------
METHOTREXATE FOR INJECTION, USP
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 dosag