TREXAN TABLET 2.5MG

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

METHOTREXATE

Verfügbar ab:

ORION PHARMA (SG) PTE. LTD.

ATC-Code:

L01BA01

Dosierung:

2.5 mg

Darreichungsform:

TABLET

Zusammensetzung:

METHOTREXATE 2.5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

Prescription Only

Hergestellt von:

Orion Corporation, Orion Pharma

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

1988-04-05

Fachinformation

145490-3
TREXAN TABLET 2.5MG
WARNING
Methotrexate must only be used by physicians
experienced in anti-metabolite chemother
-
apy,
or in the case of non-oncological
condi-
tions, 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
psoria
-
sis
and rheumatoid arthritis,
methotrexate
should be restricted to severe,
recalcitrant,
disabling disease which is not adequately re-
sponsive 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
fibro
-
sis have been reported. Since changes may oc-
cur without previous signs of
gastro-intesti-
nal or haematological toxicity,
it is imperative
that hepatic function be determined prior to
initiation of treatment and monitored regular-
ly throughout therapy. Special caution is indi-
cated in the presence of liver damage or im-
paired hepatic function.
Concomitant use of
other drugs with hepatotoxic potential and al-
cohol should be avoided.
3.
Malignant lymphomas,
which may regress
following withdrawal
of
methotrexate,
may
occur
in patients receiving low-dose meth
-
otrexate and,
thus,
may not require cytotox-
ic treatment.
Discontinue methotrexate first
and, if the lymphoma does not regress, appro-
priate treatment should be instituted.
4. Potentially fatal opportunistic infections, es-
pecially_ 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 pr