MEREX 2.5-METHOTREXATE TABLETS USP 2.5 mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Methotrexate disodium eqv to methotrexate

Tilgængelig fra:

ACCORD HEALTHCARE PRIVATE LIMITED

ATC-kode:

L01BA01

Lægemiddelform:

TABLET

Sammensætning:

Methotrexate disodium eqv to methotrexate 2.5 mg

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

Intas Pharmaceuticals Limited

Autorisation status:

ACTIVE

Autorisation dato:

2023-03-13

Produktets egenskaber

PACKAGE INSERT
(For the use of a Registered Medical Practitioner or a Hospital)
NAME OF THE MEDICINAL PRODUCT
MEREX 2.5 (Methotrexate Tablets USP 2.5 mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablets contains: Methotrexate disodium equivalent to
Methotrexate.....2.5 mg
For a full list of excipients, see Pharmaceutical particulars section
PHARMACEUTICAL FORM
Uncoated tablets
Pale yellow to yellow, round shaped, biconvex, uncoated tablets,
debossed on one side “HZ”
and “1” on either side of the score line and plain on other side.
Scoreline is provided in order to facilitate tablet breaking.
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,