METHOTREXATE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

REMEDYREPACK INC.

INN (Nama Internasional):

METHOTREXATE SODIUM

Komposisi:

METHOTREXATE 2.5 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

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 67253-320-36 - bottle of 36 count  NDC 67253-320-10 - bottle of 100 count Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Status otorisasi:

New Drug Application

Karakteristik produk

METHOTREXATE- METHOTREXATE TABLET
REMEDYREPACK 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 d