PURI-NETHOL mercaptopurine monohydrate 50mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mercaptopurine monohydrate, Quantity: 50 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; stearic acid; magnesium stearate; hydrolysed maize starch

Administration route:

Oral

Units in package:

25 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 5 March 2004: Treatment of leukemia. It is of value in remission induction and is particularly indicated for maintenance therapy in acute lymphoblastic leukemia and acute myelogenous leukemia. PURI-NETHOL is also used in the treatment of chronic granulocytic leukaemia.

Product summary:

Visual Identification: Pale yellow, round, biconvex tablets, marked PT above the line and 50 below the line on one side and plain on the other.; Container Type: Bottle; Container Material: Glass; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1991-08-02

Patient Information leaflet

PURI-NETHOL
®
1
PURI-NETHOL
®
_mercaptopurine monohydrate 50mg tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PURI-NETHOL. It
does not contain all of 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 risks of you taking PURI-
NETHOL against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PURI-NETHOL IS
USED FOR
PURI-NETHOL contains
mercaptopurine monohydrate as the
active ingredient. It belongs to a
group of medicines called cytotoxics.
PURI-NETHOL is used solely or in
combination with other medicines to
treat acute leukaemia, a cancer of
certain blood cells.
It works by interfering with the
growth of cancer cells.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PURI-
NETHOL HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is only available with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PURI-NETHOL IF YOU
HAVE EVER HAD AN ALLERGIC REACTION
TO:

Mercaptopurine monohydrate

Azathioprine

any of the tablet ingredients listed
at the end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty in breathing;
swelling of the face, lips, tongue or
any other parts of the body; rash,
itching or hives on the skin.
DO NOT TAKE PURI-NETHOL IF YOU
ARE PLANNING TO BECOME PREGNANT
OR FATHER A CHILD UNLESS YOU AND
YOUR DOCTOR HAVE DISCUSSED THE
RISKS AND BENEFITS INVOLVED.
As with all cytotoxic drugs, PURI -
NETHOL may harm eggs and sperm.
Reliable contraceptive methods must
be taken to avoid pregnancy whilst
you or your partner is taking this
medicine. Contraception is advised
for at least 3 months

Summary of Product characteristics

PURI-NETHOL_Product Information (PI) Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION (PI)
PURI-NETHOL(MERCAPTOPURINE MONOHYDRATE) TABLETS
1.
NAME OF THE MEDICINE
mercaptopurine monohydrate
2.
QUALITATIVE AND QUANITATIVE COMPOSITION
PURI-NETHOL 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 37
°
C.
Contains lactose monohydrate
For the full list of excipients, see section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
Tablets, uncoated
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.
PURI-NETHOL 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 PURI-NETHOL.
The dosage should be carefully adjusted to suit the individual
patient.
PURI-NETHOL 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 PURI-NETHOL dosage.
PURI-NETHOL_Product Information (PI) Page 2 of 12
RENAL OR HEPATIC IMPAIRMENT
Consideration should be given to reducing the dosage in patients with
impaired hepatic
or renal function