METHOTREXATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

METHOTREXATE SODIUM

Composition:

METHOTREXATE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Neoplastic Diseases Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorio-adenoma destruens 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 to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affec

Product summary:

Oral: Description Methotrexate Tablets, USP contain an 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 42254-110-30 - -bottle of 30 count Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]

Authorization status:

New Drug Application

Summary of Product characteristics

METHOTREXATE- METHOTREXATE TABLET
REBEL DISTRIBUTORS CORP
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METHOTREXATE TABLETS, USP
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):
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,
aplastic anemia, and
gastrointestinal toxicity have been reported with concomitant
administration of methotrexate
(usually in high dosage) along with some non-steroidal
anti-inflammatory drugs (NSAIDs).
(See PRECAUTIONS, DRUG INTERACTIONS.)
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 sustained use often shows histologic changes, and fibrosis and
cirrhosis have been
reported; these latter lesions may not be preceded by symptoms or
abnormal liver function
tests in the psoriasis population. For this reason, periodic liver
biopsies are usually
recommended for psoriatic patients who are under long-term treatment.
Persistent
abnormalities in liver function tests may precede appearance of
fibrosis or cirrhosis in the
rheumatoid arthritis population. (See PRECAUTIONS, ORGAN SYSTEM
TOXICITY, _