METHOTREXATE ORION TABLETS 2.5 MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Methotrexate disodium eqv Methotrexate

Available from:

ORION PHARMA (SG) PTE. LTD.

ATC code:

L01BA01

Pharmaceutical form:

TABLET

Composition:

Methotrexate disodium eqv Methotrexate 2.5mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Orion Corporation, Orion Pharma

Authorization status:

ACTIVE

Authorization date:

2021-12-09

Summary of Product characteristics

METHOTREXATE ORION TABLET 2.5MG
WARNING
Methotrexate
must
only
be
used
by
physicians
experienced
in
anti-metabolite
chemotherapy, or in the case of non-oncological conditions, by a
specialist physician.
Patients should be fully informed of the risk of fatal or severe toxic
reactions involved with
the administration of methotrexate and should be under constant
supervision of the
physician.
Deaths have been reported with the use of methotrexate. In the
treatment of psoriasis and
rheumatoid arthritis, methotrexate should be restricted to severe,
recalcitrant, disabling
disease which is not adequately responsive to other forms of therapy
and only when the
diagnosis has been established, by biopsy and/or after consultation.
1. Methotrexate may produce depression of the bone marrow, anaemia,
aplastic anaemia,
leucopenia, neutropenia, thrombocytopenia and bleeding.
2. At high or prolonged doses, methotrexate may be hepatotoxic. Liver
atrophy, necrosis,
cirrhosis, fatty changes and periportal fibrosis have been reported.
Since changes may
occur without previous signs of gastro-intestinal or haematological
toxicity, it is imperative
that hepatic function be determined prior to initiation of treatment
and monitored
regularly throughout therapy. Special caution is indicated in the
presence of liver damage
or impaired hepatic function. Concomitant use of other drugs with
hepatotoxic potential
and alcohol should be avoided.
3. Malignant lymphomas, which may regress following withdrawal of
methotrexate, may
occur in patients receiving low-dose methotrexate and, thus, may not
require cytotoxic
treatment.
Discontinue
methotrexate
first
and,
if
the
lymphoma
does
not
regress,
appropriate treatment should be instituted.
4. Potentially fatal opportunistic infections, especially _
Pneumocystis carinii _ pneumonia,
may occur with methotrexate therapy.
5. USE IN PREGNANCY Methotrexate has caused foetal death and/or
congenital anomalies. It
should not be used in pregnant women or in those who might become
pregnant unless the
potential b