Dexilant Delayed Release Capsules 30mg

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

dexlansoprazole

Dostępny od:

Takeda Malaysia Sdn Bhd

INN (International Nazwa):

dexlansoprazole

Sztuk w opakowaniu:

7 Capsules; 14 Capsules

Wyprodukowano przez:

Takeda GmbH

Ulotka dla pacjenta

_Consumer Medication Information Leaflet (RiMUP)_
DEXILANT
_ _ DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES (30MG AND 60MG)
__________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Dexilant is used for
2.
How Dexilant works
3.
Before you use Dexilant
4.
How to use Dexilant
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Dexilant
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT DEXILANT IS USED FOR
Dexilant is a prescription
medicine called a proton pump
inhibitor (PPI).
•
Dexilant is used in children
12 years and above for up
to 8 weeks to heal acid-
related damage to the lining
of the esophagus (called
erosive esophagitis or EE).
•
Dexilant is used for up to 4
months in adolescents 12-
17 years of age and 6
months in adults to
continue healing of erosive
esophagitis and relief of
heartburn.
•
Dexilant is used in children
12 years and above for 4
weeks to treat heartburn
related to symptomatic non-
erosive gastroesophageal
reflux disease (GERD).
GERD happens when acid
from your stomach enters the
tube (esophagus) that connects
your mouth to your stomach.
This may cause a burning
feeling in your chest or throat,
sour taste or burping.
In some cases, acid can damage
the lining of your esophagus.
This damage is called erosive
esophagitis or EE.
HOW DEXILANT WORKS
Dexilant reduces the amount of
acid in your stomach.
D
exilant
may help your acid-
related symptoms, but you
could still
have serious
stomach problems. Talk with
your doctor.
BEFORE YOU USE DEXILANT
-
_When you must not use it _
You should not take Dexilant if
you are allergic to
dexlansoprazole or any of the
other ingredients of this
medicine.
-
_Before you start to use it _
Before you take Dexilant, tells
your doctor if you
:
•
Have low magnesium
levels in your blood
•
have liver problems
•
have any other medical
conditions
•
Are pregnant or plan to
become pregnant. It is not
known if Dexilant can
harm your unb

Charakterystyka produktu

1
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Dexilant delayed-release Capsules 30mg
Dexilant delayed-release Capsules 60mg
2.
NAME AND STRENGTH OF ACTIVE SUBSTANCES
Dexilant is available in two dosage strengths: 30 mg and 60 mg, per
capsule. Each capsule contains
enteric-coated granules consisting of dexlansoprazole (active
ingredient) and the following excipients:
_Excipients: Sugar spheres, magnesium carbonate, sucrose,
low-substituted_ _hydroxypropyl cellulose, _
_titanium dioxide, hydroxypropyl cellulose, hypromellose 2910, talc,
methacrylic acid copolymers, _
_polyethylene glycol 8000, triethyl citrate, polysorbate 80, colloidal
silicon dioxide, hypromellose, _
_carrageenan, potassium chloride, _
_FD&C Blue No. 2 aluminum lake (Blue capsule) and black ferric oxide
(Gray capsule). _
_ _
3.
PRODUCT DESCRIPTION
30 mg delayed-release capsules are opaque, blue and gray with TAP and
“30” imprinted on the
capsule.
60 mg delayed-release capsules are opaque, blue with TAP and “60”
imprinted on the capsule.
4.
CLINICAL PHARMACOLOGY
ATC code: A02BC06
4.1
MECHANISM OF ACTION
Dexlansoprazole is a PPI that suppresses gastric acid secretion by
specific inhibition of the (H
+
,K
+
)-
ATPase in the gastric parietal cell. By acting specifically on the
proton pump, dexlansoprazole blocks
the final step of acid production.
4.2
PHARMACODYNAMICS
Antisecretory Activity
The effects of Dexilant 60 mg (n=20) or lansoprazole 30 mg (n=23) once
daily for five days on 24-hour
intragastric pH were assessed in healthy subjects in a multiple-dose
crossover study. The results are
summarized in Table 1.
TABLE 1: EFFECT ON 24-HOUR INTRAGASTRIC PH ON DAY 5 AFTER
ADMINISTRATION OF DEXILANT OR LANSOPRAZOLE IN ADULTS
DEXILANT
60 MG
LANSOPRAZOLE
30 MG
MEAN INTRAGASTRIC PH
4.55
4.13
% TIME INTRAGASTRIC PH > 4
(HOURS)
71
(17 hours)
60
(14 hours)
Serum Gastrin Effects
The effect of Dexilant on serum gastrin concentrations was evaluated
in approximately 3460 patients
in clinical trials up to 8 weeks and in 1023 patients for up to 6 to
12 months. The