METHOTREXATE SODIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

GenPak Solutions LLC

INN (International Name):

METHOTREXATE SODIUM

Composition:

METHOTREXATE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE Neoplastic Disease Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destuens and hydatidiform mole. Methotrexate is used in maintenance therapy in combination with other chemotherapeutic agents. 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. Psoriasis Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important that a psoriasis "flare" is not due to an undiagnosed concomitant disea

Product summary:

HOW SUPPLIED Oral: Description Methotrexate Tablets, USP contain a certain amount of methotrexate sodium equivalent to 2.5 mg of methotrexate and are round, convex, yellow tablets, scored in half on one side, engraved with M above the score, and 1 below. NDC 67253-320-36 - bottle of 36 count NDC 67253-320-10-bottle of 100 count

Authorization status:

New Drug Application

Summary of Product characteristics

METHOTREXATE SODIUM - METHOTREXATE SODIUM TABLET
GENPAK SOLUTIONS LLC
----------
WARNINGS
WARNINGS
METHOTREXATE SHOULD BE USED ONLY BY PHYSICIANS WHOSE KNOWLEDGE
AND EXPERIENCE INCLUDE THE USE OF ANTIMETABOLITE THERAPY BECAUSE OF
THE POSSIBILITY OF SERIOUS REACTIONS (WHICH CAN BE FATAL):
METHOTREXATE SHOULD BE USED ONLY IN LIFE THREATING NEOPLASTIC
DISEASE, 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 PHYSICIANS OF THE RISKS INVOLVED
AND BE UNDER A PHYSICIANS CARE THROUGHOUT THERAPY.
1. Methotrexate has been reported to cause fatal 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 out-weigh 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, ascities, 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
gastrointestinal toxicity have been reported with concomitant
administration of methotrexate
(usually in high dosage) along with some non-steroidal
4. Methotrexate causes hepatotoxicity, fibrosis and cirrhosis, but
generally only after prolonged
use. Acutely, liver enzyme elevations are frequently seen. These are
usually transient and
asymptomatic, and also do not appear predictive of subsequent hepatic
disease. Liver biopsy after
susta