MERCAPTOPURINE-LINK mercaptopurine monohydrate 50 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mercaptopurine monohydrate, Quantity: 50 mg

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: pregelatinised maize starch; stearic acid; maize starch; magnesium stearate; lactose

Administration route:

Oral

Units in package:

25 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of acute leukaemia. It is of value in remission induction and is particularly indicated for maintenance therapy in acute lymphoblastic leukaemia and acute myelogenous leukaemia.,MERCAPTOPURINE-LINK is also used in the treatment of chronic granulocytic leukaemia.

Product summary:

Visual Identification: Round yellowish tablets, scored on one side.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2019-06-14

Patient Information leaflet

MERCAPTOPURINE-LINK®
1
MERCAPTOPURINE-LINK®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING MERCAPTOPURINE-LINK?
MERCAPTOPURINE-LINK contains the active ingredient mercaptopurine
monohydrate. MERCAPTOPURINE-LINK is used to treat
acute leukaemia, a cancer of certain blood cells.
For more information, see Section 1. Why am I using
MERCAPTOPURINE-LINK? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MERCAPTOPURINE-LINK?
Do not use if you have ever had an allergic reaction to
MERCAPTOPURINE-LINK, the active ingredient mercaptopurine, or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS OR TAKE
ANY OTHER MEDICINES. DO NOT TAKE MERCAPTOPURINE-
LINK IF YOU ARE PLANNING TO BECOME PREGNANT OR FATHER A CHILD, OR IF
YOU ARE ALREADY PREGNANT OR BREASTFEEDING UNTIL YOU HAVE
DISCUSSED THE RISK AND BENEFITS WITH YOUR DOCTOR.
TELL YOUR DOCTOR IF YOU ARE ALLERGIC TO AZATHIOPRINE, A MEDICINE USED
TO SUPPRESS THE IMMUNE SYSTEM.
For more information, see Section 2. What should I know before I use
MERCAPTOPURINE-LINK? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MERCAPTOPURINE-LINK 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 USE MERCAPTOPURINE-LINK?
•
TAKE MERCAPTOPURINE-LINK EXACTLY AS DIRECTED BY YOUR DOCTOR.
Your doctor will decide what dose and for how long you will be taking
MERCAPTOPURINE-LINK depending on factors such as
your age and weight, medical condition, whether you are taking any
other medications, and your response to treatment.
More instructions can be found in Section 4. How do I use
MERCAPTOPURINE-LINK? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MERCAPTOPURINE-LINK?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
MER

Summary of Product characteristics

MERCAPTOPURINE-LINK_ Product Information (PI) V3
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
MERCAPTOPURINE-LINK
(MERCAPTOPURINE MONOHYDRATE) TABLETS
1.
NAME OF THE MEDICINE
mercaptopurine monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MERCAPTOPURINE-LINK tablets contain 50 mg mercaptopurine monohydrate.
Mercaptopurine monohydrate is odourless or practically odourless,
yellow crystalline powder,
with a solubility of 0.26 mg/mL in water at 37⁰C.
Contains anhydrous lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Tablets, uncoated and scored on one side. The score line is not
intended for breaking the
tablet.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Treatment of acute leukaemia. It is of value in remission induction
and is particularly
indicated for maintenance therapy in acute lymphoblastic leukaemia and
acute myelogenous
leukaemia.
MERCAPTOPURINE-LINK is also used in the treatment of chronic
granulocytic leukaemia.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN
For adults and children the usual dose is 2.5 mg/kg bodyweight/day,
but the dose and
duration of administration depend on the nature and dosage of other
cytotoxic agents given
in conjunction with MERCAPTOPURINE-LINK.
The dosage should be carefully adjusted to suit the individual
patient.
MERCAPTOPURINE-LINK has been used in various combination therapy
schedules for
acute leukaemia and the literature should be consulted for details.
When allopurinol and mercaptopurine monohydrate are administered
concomitantly it is
essential that only a quarter of the usual dose of mercaptopurine
monohydrate is given since
allopurinol decreases the rate of catabolism of mercaptopurine
monohydrate.
ELDERLY
No specific studies have been carried out in the elderly. However, it
is advisable to monitor
renal and hepatic function in these patients, and if there is any
impairment, consideration
should be given to reduce the MERCAPTOPURINE-LINK dosage.
MERCAPTOPURINE-LINK_ Product Information (PI)