METHOBLASTIN methotrexate 2.5mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methotrexate, Quantity: 2.5 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; maize starch; lactose monohydrate; polysorbate 80; microcrystalline cellulose; pregelatinised maize starch

Administration route:

Oral

Units in package:

30

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ANTINEOPLASTIC CHEMOTHERAPY: Treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. Palliation of acute and subacute lymphocytic leukaemia. Greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. In combination with corticosteroids, methotrexate may be used for induction of remission. The drug is now most commonly used for the maintenance of induced remissions. Methoblastin is also effective in the treatment of the advanced stages (III and IV, Peters Staging System) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. PSORIASIS CHEMOTHERAPY: (See WARNINGS box and Precautions). Because of the high risk attending to its use, Methoblastin 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 consultations. RHEUMATOID ARTHRITIS CHEMOTHERAPY: (See WARNINGS box and Precautions). Management of severe, recalcitrant, active rheumatoid arthritis in adults not responding to, or intolerant of, an adequate trial of NSAIDs and one or more disease modifying drugs. Aspirin, NSAIDs and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylate has not been fully explored. (See Precautions, Interactions with other drugs). Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine or cytotoxic agents has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.

Product summary:

Visual Identification: Yellow, round, biconvex, uncoated tablets engraved M 2.5 on one side and blank on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

1991-09-23

Patient Information leaflet

METHOBLASTIN
®
M
E
T
H
O
B
L
A
S
T
I
N
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before taking this medicine.
1.
WHY AM I TAKING METHOBLASTIN?
Methoblastin contains the active ingredient methotrexate. Methoblastin
is used to treat certain types of cancers, severe psoriasis or
rheumatoid arthrtis when the condition does not improve with other
medicines.
For more information, see Section 1. Why am I taking Methoblastin? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE METHOBLASTIN?
Do not take if you have ever had an allergic reaction to Methoblastin
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding.
For more information, see Section 2. What should I know before I take
Methoblastin? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Methoblastin and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE METHOBLASTIN?
The dose of medicine given to you will depend on the condition being
treated, your medical condition, your age, your size and how
well your kidneys and liver are working. More instructions can be
found in Section 4. How do I take Methoblastin? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING METHOBLASTIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
Methoblastin.
•
You and your partner must use a reliable method of contraception
(birth control pills or condom) while
taking Methoblastin and for at least 6 months after you stop
treatment.
•
Discuss with your doctor how much water or fluids you should have as
not enough fluid intake can
increase th

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
METHOBLASTIN
® (METHOTREXATE)
WARNINGS
Methotrexate must be used only by physicians experienced in
antimetabolite chemotherapy, or
in the case of non-oncological conditions, by a specialist physician.
Because of the possibility of fatal or severe toxic reactions, the
patient should be fully informed
by the physician of the risks involved and should be under his
constant supervision.
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, but only when the diagnosis has been established by biopsy
and/or after appropriate
consultation.
POTENTIAL OF FATAL TOXICITY FROM DOSING ERRORS
Both the physician and the pharmacist should emphasise to the patient
the importance of the
weekly dosing regimen: mistaken daily use may cause serious and
sometimes life-threatening
or fatal toxicity (see Section 4.2 and 4.4, 4.9). For the same reason
great care should be taken
with dispensing to ensure the correct tablet strength of Methoblastin
is given to the patient.
Methoblastin is available as 2.5 mg and 10 mg tablets.
ORGAN SYSTEM TOXICITY
_GASTROINTESTINAL _
Diarrhoea and ulcerative stomatitis are frequent toxic effects and
require interruption of
therapy; otherwise, haemorrhage enteritis and death from intestinal
perforation may occur.
Gastrointestinal toxicity has been reported with concomitant
administration of methotrexate
(usually in high doses) along with nonsteroidal anti-inflammatory
agents (NSAIDs).
_HAEMATOLOGICAL _
Methotrexate may produce marked depression of bone marrow, anaemia,
aplastic anaemia,
leucopenia, neutropenia, thrombocytopenia and bleeding.
Unexpectedly severe (sometimes fatal) marrow suppression and aplastic
anaemia have been
reported with concomitant administration of methotrexate (usually in
high doses) along with