ACTOS 30MG TABLET

Negara: Malaysia

Bahasa: Inggris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

PIOGLITAZONE HYDROCHLORIDE

Tersedia dari:

CELLTRION HEALTHCARE MALAYSIA SDN. BHD.

INN (Nama Internasional):

PIOGLITAZONE HYDROCHLORIDE

Unit dalam paket:

1 x 10 Tablets; 3 x 10 Tablets

Diproduksi oleh:

Takeda Pharmaceutical Company Limited Hikari Plant

Selebaran informasi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
ACTOS TABLET
_®_
_ _
Pioglitazone hydrochloride (15mg, 30mg)
1
WHAT IS IN THIS LEAFLET
1. What Actos is used for
2. How Actos works
3. Before you use Actos
4. How to use Actos
5. While you are using it
6. Side effects
7. Storage and Disposal of Actos
8. Product Description
9. Manufacturer and Product
registration Holder
10. Date of revision
11. Serial number
WHAT ACTOS IS USED FOR
•
Actos is used as oral monotherapy
in type 2 diabetes mellitus
patients, particularly overweight
patients whom are inadequately
controlled by diet and exercise.
•
Actos is used for oral combination
treatment in type 2 diabetes
mellitus patients with insufficient
glycaemic control despite
maximal tolerated dose of oral
monotherapy with either
metformin or sulponylurea.
HOW ACTOS WORKS
Actos is a thiazolidonedione
antidiabetic agent that depends on the
presence of insulin for its mechanism
of action. It acts primarily by
decreasing insulin resistance. It
decreases insulin resistance in the
body, resulting in increased insulin-
dependent glucose disposal and
decreased hepatic glucose output.
BEFORE YOU USE ACTOS
_- When you must not use it _
Do not use Actos if you are:
a)
Hypersensitive to pioglitazone or
to any of the excipients of the
tablet
b)
Having cardiac failure or history
of cardiac failure (NYHA stages I
to IV)
c)
The patient of hepatic impairment
d)
Pregnancy and lactation
e)
A type 1 diabetes patient
_ _
_- Before you start to use it _
•
You must undergo blood tests for
liver function prior to the start of
therapy, and periodically
thereafter per clinical judgment of
the health care professional.
•
Talk to your doctor if you are
pregnant.
_ _
_- Taking other medicines _
•
Actos can be co-administered
with:
a)
Oral contraceptives
b)
Fexofenadine HCI
c)
Glipizide
d)
Digoxin
e)
Warfarin
f)
Metformin
g)
Midazolam
h)
Ranitidine HCI
i)
Nifedipine ER
j)
Ketoconazole
k)
Atorvastatin Calcium
l)
Theophylline
m)
Cytochrome P450
Tell your doctor if you are taking
any of the

Karakteristik produk

1
ACTOS

(PIOGLITAZONE HYDROCHLORIDE TABLETS)
_ _
_ACTOS_

is an oral antidiabetic agent that acts primarily by decreasing
insulin resistance.
_ACTOS_

is used in the management of type 2 diabetes mellitus (also known as
non-insulin-
dependent
diabetes
mellitus
[NIDDM]
or
adult-onset
diabetes).
Pharmacological
studies
indicate that _ACTOS_

improves sensitivity to insulin in muscle and adipose tissue and
inhibits
hepatic gluconeogenesis. _ACTOS_

improves glycemic control while reducing circulating insulin
levels.
Pioglitazone
[(+)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-]
thiazolidinedione
monohydrochloride belongs to a different chemical class and has a
different pharmacological
action
than
the
sulfonylureas,
metformin,
or the
α
-glucosidase
inhibitors. The
molecule
contains one asymmetric carbon, and the compound is synthesized and
used as the racemic
mixture. The two enantiomers of pioglitazone interconvert in vivo. No
differences were found
in the pharmacologic activity between the two enantiomers. The
structural formula is as
shown:
Pioglitazone hydrochloride is an odorless white crystalline powder
that has a molecular
formula of C
19
H
20
N
2
O
3
S.HCl and a molecular weight of 392.90 daltons. It is soluble in N,N-
dimethylformamide, slightly soluble in anhydrous ethanol, very
slightly soluble in acetone and
acetonitrile, practically insoluble in water, and insoluble in ether.
CHEMICAL NAME
(+)-5-[p-[2-(5-ethyl-2-pyridyl)ethoxy]benzyl]-2,4-thiazolidinedione
hydrochloride
COMPOSITION
_ACTOS_

15 : Each tablet contains 15 mg of pioglitazone
_ACTOS_

30 : Each tablet contains 30 mg of pioglitazone
DESCRIPTION
White to yellowish white tablet.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
_ACTOS_

is a thiazolidinedione antidiabetic agent that depends on the presence
of insulin for its
mechanism of action. _ ACTOS_

decreases insulin resistance in the periphery and in the liver
resulting in increased insulin-dependent glucose disposal and
decreased hepatic glucose
output.