Maxtrex 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methotrexate

Available from:

Pfizer Ltd

ATC code:

L04AX03

INN (International Name):

Methotrexate

Dosage:

2.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010300; GTIN: 5012882008239 5013457011654

Patient Information leaflet

The doctor may also decide to run other liver tests, some of
these may be images of your liver and others may need a
small sample of tissue taken from the liver in order to examine
it more closely. Your doctor may also check to see if you have
tuberculosis and they may X-ray your chest or perform a lung
function test.
During the treatment:
Your doctor may perform the following examinations:
-
examination of the oral cavity and the pharynx for changes
in the mucous membrane such as inflammation or ulceration
-
blood tests/ blood count with number of blood cells and
measurement of serum methotrexate levels
-
blood test to monitor liver function
-
imaging tests to monitor liver condition
-
small sample of tissue taken from the liver in order to
examine it more closely
-
blood test to monitor kidney function
-
respiratory tract monitoring and, if necessary, lung function
test
It is very important that you appear for these scheduled
examinations.
If the results of any of these tests are conspicuous, your doctor
will adjust your treatment accordingly.
Elderly patients
Elderly patients under treatment with methotrexate should be
monitored closely by a physician so that possible side effects
can be detected as early as possible. Age-related impairment
of liver and kidney function as well as low body reserves of the
vitamin folic acid in old age require a relatively low dosage of
methotrexate.
Other medicines and Maxtrex Tablets
Tell your doctor or pharmacists if you are taking, have recently
taken, or might take any other medicines. This includes the
following medicines, as the effect of Maxtex Tablets may be
altered when they are taken at the same time:
•
vaccinations / live virus vaccines
•
ibuprofen, indomethacin (NSAID’s, non-steroidal
anti-inflammatory drugs) which are used for pain or
inflammation
•
aspirin or similar medicines (known as salicylates)
•
diuretics (water tablets)
•
medicines used/taken for diabetes
•
antibiotics (used to treat bacterial infections e.g.
chloramphenicol, penicillin, sulfo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Maxtrex Tablets 2.5 mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains methotrexate 2.5 mg.
Excipient with known effect:
Each tablet contains 42.0mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Round, uncoated, convex deep yellow tablets marked with 'M2.5' on one
side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Methotrexate is a folic acid antagonist and is classified as an
antimetabolite
cytotoxic agent.
Methotrexate is used in the treatment of adults with severe, active,
classical or
definite
rheumatoid arthritis who are unresponsive or intolerant to
conventional
therapy.
Methotrexate has also been used in the treatment of severe,
uncontrolled
psoriasis, which is
not responsive to other therapy.
Methotrexate has been used to produce regression in a wide range of
neoplastic conditions
including acute leukaemias, non-Hodgkin’s lymphoma, soft-tissue and
osteogenic sarcomas,
and solid tumours particularly breast, lung, head and neck, bladder,
cervical,
ovarian, and
testicular carcinoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Methotrexate should only be prescribed by physicians with expertise in
the use of
methotrexate and a full understanding of the risks of methotrexate
therapy.
The prescriber should ensure that patients or their carers will be
able to comply with
the once weekly regimen.
Dosage for Cancer Treatment
WARNING
The dose must be adjusted carefully depending on the body surface area
if
methotrexate is used for the treatment of neoplastic diseases.
Fatal cases of intoxication have been reported after administration of
incorrectly
calculated doses. Health care professionals and patients should be
fully informed
about toxic effects.
Oral administration
A test dose of 5 - 10 mg parenterally is recommended, one week prior
to therapy to
detect idiosyncratic adverse events. Low doses not exceeding 30 mg/m
2
on five
successive days. Thereafter an interval of