PURINETONE TABLETS 50 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MERCAPTOPURINE

Available from:

SHOEI UNIVERSAL CORPORATION PTE LTD

ATC code:

L01BB02

Dosage:

50 mg

Pharmaceutical form:

TABLET

Composition:

MERCAPTOPURINE 50 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

KOREA UNITED PHARMACEUTICAL INC

Authorization status:

ACTIVE

Authorization date:

1999-03-17

Summary of Product characteristics

PURINETONE
TABLET
MERCAPTOPURINE 50 MG
COMPOSITION
Each tablet contains
Mercaptopurine
‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
50 mg
List
of
Excipients:
Lactose
monohydrate,
Corn
starch,
Carboxymethyl
cellulose
calcium,
Hydroxypropyl cellulose, Silicon dioxide and Magnesium stearate
DESCRIPTION
Pale yellow to yellow, round tablet
INDICATIONS
Mercaptopurine is indicated for treatment or maintenance therapy in
acute leukemia, acute
lymphoblastic leukemia, and acute myelogenous leukemia.
Mercaptopurine is also used in the treatment of chronic granulocytic
leukemia.
DOSAGE AND ADMINISTRATIONS
For adults and children the usual dose is 2.5 mg/kg bodyweight per
day, but the dose and
duration of administration depend on the nature and dosage of other
cytotoxic agents given in
conjunction with Mercaptopurine. The dosage should be carefully
adjusted to suit the individual
patient. Mercaptopurine has been used in various combination therapy
schedules for acute
leukemia and the literature should be consulted for details.
Consideration should be given to
reducing the dosage in patients with impaired hepatic or renal
function. When allopurinol and
mercaptopurine are administered concomitantly it is essential that
only a quarter of the usual
dose
of
mercaptopurine
is
given
since
allopurinol
decreases
the
rate
of
catabolism
of
mercaptopurine.
CONTRAINDICATIONS
1)
Purinetone should not be used in patients who have a hypersensitivity
to mercaptopurine or
any component of the formulation.
2)
Purinetone contains lactose and should not be taken by patients with
rare hereditary
problems
of
galactose
intolerance,
the
Lapp
lactase
deficiency
or
glucose-galactose
malabsorption.
ADVERSE REACTIONS
There is no recent clinical data that can support to the onset
frequency of adverse reactions.
The onset frequency: Very frequently (
≧
1/10), frequently (
≧
1/100, <1/10), occasionally
(
≧
1/1000, <1/1000), rarely (
≧
1/10,000, <1/10,000), very rarely (<1/10,000)
1)
Unspecific tumor incl