METHOTREXATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE, Inc.

INN (International Name):

METHOTREXATE SODIUM

Composition:

METHOTREXATE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methotrexate tablets are 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. Methotrexate tablets are 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 af

Product summary:

Methotrexate Tablets USP contain an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate. 2.5 mg: Yellow, oval-shaped, scored tablet. Debossed with stylized b/572 on one side. Available in bottles of 100   NDC 42291-594-01 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHOTREXATE- METHOTREXATE TABLET
AVKARE, INC.
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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):
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.
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 ap