METHOTREXATE- methotrexate sodium tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

methotrexate sodium (UNII: 3IG1E710ZN) (methotrexate - UNII:YL5FZ2Y5U1)

Dostopno od:

Rebel Distributors Corp

INN (mednarodno ime):

methotrexate sodium

Sestava:

methotrexate 2.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Methotrexate tablets are indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. 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 affecting immune responses. Methotrexate tablets are indicated in the management of selected adults with severe

Povzetek izdelek:

Methotrexate Tablets, USP contain an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate. Dispense with a child-resistant closure in a well-closed container as defined in the USP. Store at controlled room temperature 15°-30°C (59°-86°F) [See USP]. Protect from light.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

METHOTREXATE- METHOTREXATE SODIUM TABLET
REBEL DISTRIBUTORS CORP
----------
METHOTREXATE TABLETS, USP
RX ONLY
REVISED MARCH 2002
1005720109
WARNINGS:
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 nonsteroidal
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, Hepatic.)
5.Methotrexate-induced lung disease is a potentially dangerous lesion,
which may occur acutely
at any time during therapy and which has been report