METHOTREXATE TABLET 2.5 mg

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

METHOTREXATE

Disponibil de la:

PFIZER PRIVATE LIMITED

Codul ATC:

L01BA01

Dozare:

2.500 mg

Forma farmaceutică:

TABLET

Compoziție:

METHOTREXATE 2.500 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

Prescription Only

Produs de:

Excella GmbH & Co. KG

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

1988-04-06

Prospect

METHOTREXATE TABLETS
TABLE OF CONTENT
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information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
METHOTREXATE
TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Methotrexate 2.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains methotrexate sodium equivalent to 2.5 mg
methotrexate.
3.
PHARMACEUTICAL FORM
Tablets for oral administration.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ANTI-NEOPLASTIC CHEMOTHERAPY
Methotrexate is indicated for the treatment of gestational
choriocarcinoma, and in patients with
chorioadenoma destruens and hydatidiform mole.
Methotrexate is indicated for the palliation of acute lymphocytic
leukemia. It is also indicated
in the treatment and prophylaxis of meningeal leukemia. Greatest
effect has been observed in
palliation of acute lymphoblastic (stem-cell) leukemias in children.
In combination with other
anticancer drugs or suitable agents methotrexate may be used for
induction of remission, but it
is most commonly used, as described in the literature, in the
maintenance of induced
remissions.
Methotrexate may be used alone or in combination with other anticancer
agents in the
management of breast cancer, epidermoid cancers of the head and neck,
and lung cancer,
particularly squamous cells and small cell types.
Methotrexate is also effective in the treatment of the advanced stages
(III and IV, Peters Staging
System) of lymphosarcoma, particularly in those cases in children; and
in advanced cases of
mycosis fungoides.
PSORIASIS CHEMOTHERAPY
(See
_ _
section
_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE_
)
Because of high risk attending its use. Methotrexate is only indicated
in the symptomatic
control of severe, recalcitrant, disabling psoriasis which 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.
_ _
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral dosage forms of methotrexate sh