Puri-nethol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Mercaptopurine monohydrate 50mg; Mercaptopurine monohydrate 50mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Mercaptopurine monohydrate 50 mg

Dosage:

50 mg

Pharmaceutical form:

Tablet

Composition:

Active: Mercaptopurine monohydrate 50mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Stearic acid Active: Mercaptopurine monohydrate 50mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Stearic acid

Units in package:

Bottle, glass, 25 tablet pack, 25 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Zhejiang Cheng Yi Pharmaceutical Co Ltd

Therapeutic indications:

PURI-NETHOL is indicated for the treatment of acute leukaemia. It may be utilised in remission induction and is particularly indicated for maintenance therapy in: · acute lymphoblastic leukaemia; · acute myelogenous leukaemia.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, brown glass with a 24 mm screw cap (inner shell of polypropylene, outer shell HDPE). - 25 tablets - 60 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1969-12-31

Patient Information leaflet

PURI-NETHOL (NZ) – Consumer Medicine Information
Page 1 of 4
PURI-NETHOL
®
_mercaptopurine tablets 50 mg _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PURI-NETHOL
tablets. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you taking
PURI-NETHOL against the risks
this medicine could have for you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT PURI-NETHOL IS
USED FOR
PURI-NETHOL contains the active
ingredient mercaptopurine which
belongs to a group of medicines
called anti-neoplastic agents. Within
this group, PURI-NETHOL belongs
to a class of medicines called
purine antimetabolites. These
medicines are used to treat blood
cancers.
PURI-NETHOL is used to treat
acute promyelocytic leukaemia
(APL)/ acute myeloid leukaemia M3
(AML M3) and acute lymphoblastic
leukaemia (ALL). These are
different types of cancer affecting
the blood. In people with blood
cancer, abnormal blood cells are
formed in the bone marrow which
multiplies uncontrollably, crowding
out and interfering with the vital
functions of normal healthy blood
cells.
PURI-NETHOL is often given in
combination with other medicines
used to treat cancer of the blood.
It works by interfering with the
function of the bone marrow and
reducing the number of abnormal
blood cells which are causing your
illness.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PURI-
NETHOL HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed
this medicine for another purpose.
PURI-NETHOL is available only
with a doctor’s prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE IT IF:

you have ever had an allergic
reaction before to
mercaptopurine or to any of the
ingredients in PURI-NETHOL
listed at the end of this leaflet
�

Summary of Product characteristics

PURI-NETHOL – Data Sheet
Page 1 of 17
NEW ZEALAND DATA SHEET
1.
PURI-NETHOL TABLETS (MERCAPTOPURINE 50 MG)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Purinethol 50 mg Tablets: Each tablet contains 50 mg mercaptopurine
BP.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pale yellow, round, biconvex tablets, marked PT above the line and 50
below the line on one side and plain on the other.
Please note that the tablets should not be taken in divided doses.
Breaking the tablets across the score line is to enable swallowing
only.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of acute leukaemia in adults, adolescents and children. It
may be utilised in:
Acute lymphoblastic leukaemia (ALL)
Acute promyelocytic leukaemia (APL)/Acute myeloid leukaemia M3
(AML M3).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE IN ADULTS AND CHILDREN
For adults and children, the usual dose is 2.5 mg/kg bodyweight per
day, or 50-75 mg/m2 body surface area per day, but the dose and
duration of administration depend on the nature and dosage of other
cytotoxic agents given in conjunction with PURI-NETHOL.
The dosage should be carefully adjusted to suit the individual patient
and in
accordance with the employed treatment protocol. 6-mercaptopurine has
been used in various combination therapy schedules for acute leukaemia
and the literature and current treatment guidelines
should be consulted for
details.
Studies carried out in children with acute lymphoblastic leukemia
suggested that administration of mercaptopurine in the evening lowered
the risk of relapse compared with morning administration.
Children considered to be overweight may require doses at the higher
end of the dose range and therefore close monitoring of response to
treatment is recommended (see section 5.2, Pharmacokinetic properties:
Special patient populations; Overweight children).
PURI-NETHOL – Data Sheet
Page 2 of 17
DOSAGE IN THE ELDERLY
It is advisable to monitor renal and hepatic function in these
patients,
and if there is any impa