ONGLYZA TABLET 2.5MG

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

SAXAGLIPTIN HYDROCHLORIDE

Tilgjengelig fra:

ASTRAZENECA SDN. BHD.

INN (International Name):

SAXAGLIPTIN HYDROCHLORIDE

Enheter i pakken:

28Tablet Tablets

Produsert av:

AstraZeneca Pharmaceuticals LP.

Informasjon til brukeren

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ONGLYZA
® TABLET
SAXAGLIPTIN (2.5 MG & 5 MG)
1
WHAT IS IN THIS LEAFLET
1.
What ONGLYZA is used for
2.
How ONGLYZA works
3.
Before you use ONGLYZA
4.
How to use ONGLYZA
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
ONGLYZA
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT IS ONGLYZA USED FOR
ONGLYZA is a prescription
medicine used with diet and
exercise to control high blood
sugar (hyperglycemia) in adults
with type 2 diabetes.
_What is type 2 diabetes? _
Type 2 diabetes is a condition in
which your body does not make
enough insulin, and the insulin that
your body produces does not work
as well as it should. Your body can
also make too much sugar. When
this happens, sugar (glucose)
builds up in the blood. This can
lead to serious medical problems.
The main goal of treating diabetes
is to lower your blood sugar so that
it is as close to normal as possible.
High blood sugar can be lowered
by diet and exercise, and by certain
medicines when necessary.
HOW ONGLYZA WORKS
•
ONGLYZA lowers blood sugar
by helping the body increase the
level of insulin after meals.
•
ONGLYZA is unlikely to cause
your blood sugar to be lowered
to a dangerous level
(hypoglycemia) because it does
not work well when your blood
sugar is low. However,
hypoglycemia may still occur
with ONGLYZA. Your risk for
getting hypoglycemia is higher
if you take ONGLYZA with
some other diabetes medicines,
such as a sulfonylurea or insulin.
BEFORE YOU USE ONGLYZA
-
_When you must not use it _
_ _
DO NOT TAKE ONGLYZA IF YOU:
•
are allergic to any ingredients in
ONGLYZA. See the end of this
Patient Information Leaflet for a
complete list of ingredients in
ONGLYZA. Symptoms of a
serious allergic reaction to
ONGLYZA may include
:
-
swelling of your face, lips,
throat, and other areas on your
skin
-
difficulty with swallowing or
breathing
-
raised, red areas on your skin
(hives)
-
skin rash, itching, flaking, or
peeling
If you have these s

Preparatomtale

ONGLYZA
®
saxagliptin tablets
INDICATIONS AND USAGE
_ _
MONOTHERAPY AND COMBINATION THERAPY
_ _
ONGLYZA is indicated as an adjunct to diet and exercise to improve
glycemic control in adults
with type 2 diabetes mellitus [see
_Clinical Studies_
].
_ _
LIMITATION OF USE
ONGLYZA is not indicated for the treatment of type 1 diabetes mellitus
or diabetic ketoacidosis,
as it would not be effective in these settings.
DOSAGE AND ADMINISTRATION
_ _
RECOMMENDED DOSAGE
The recommended dosage of ONGLYZA is 2.5 mg or 5 mg once daily taken
regardless of meals.
ONGLYZA tablets must not be split or cut.
_ _
DOSAGE IN PATIENTS WITH RENAL IMPAIRMENT
No dosage adjustment for ONGLYZA is recommended for patients with eGFR
≥45 mL/min/1.73
m
2
.
The dosage of ONGLYZA is 2.5 mg once daily (regardless of meals) for
patients with eGFR <45
mL/min/1.73 m
2
(which includes a subset of moderate or severe renal impairment, or
with end-
stage renal disease (ESRD) requiring hemodialysis)
[see
_Clinical Pharmacology _
and
_Clinical _
_Studies_
]
. ONGLYZA should be administered following hemodialysis. ONGLYZA has
not been
studied in patients undergoing peritoneal dialysis.
Because the dosage of ONGLYZA should be limited to 2.5 mg based upon
renal function,
assessment of renal function is recommended prior to initiation of
ONGLYZA and periodically
thereafter.
DOSAGE ADJUSTMENT WITH CONCOMITANT USE OF STRONG CYP3A4/5 INHIBITORS
The dosage of ONGLYZA is 2.5 mg once daily when coadministered with
strong cytochrome
P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir,
clarithromycin, indinavir,
itraconazole,
nefazodone,
nelfinavir,
ritonavir,
saquinavir,
and
telithromycin)
[see
_Drug _
_Interactions_
and
_Clinical Pharmacology_
].
CONCOMITANT USE WITH AN INSULIN SECRETAGOGUE (E.G., SULFONYLUREA) OR
WITH INSULIN
When ONGLYZA is used in combination with an insulin secretagogue
(e.g., sulfonylurea) or
with insulin, a lower dose of the insulin secretagogue or insulin may
be required to minimize the
risk of hypoglycemia [see
_Warnings and Pr