METHOTREXATE injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Physicians Total Care, Inc.

INN (International Name):

METHOTREXATE

Sammensætning:

METHOTREXATE 25 mg in 1 mL

Indgivelsesvej:

INTRA-ARTERIAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Methotrexate Injection, USP (preservative free) is supplied in a single-dose vial containing 25 mg/mL of methotrexate as the basein the following packagestrengths: NDC 54868-0173-0                                   50 mg in 2 mL (1 vial to a pouch) Store at room temperature 20° to 25°C (68° to 77°F). See USP controlled room temperature. Protect from light .

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

METHOTREXATE - METHOTREXATE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
METHOTREXATE INJECTION, USP
METHOTREXATE FOR 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 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
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,
ap