Dexilant Delayed Release Capsules 60mg

국가: 말레이시아

언어: 영어

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

유효 성분:

dexlansoprazole

제공처:

Takeda Malaysia Sdn Bhd

INN (International Name):

dexlansoprazole

패키지 단위:

60 mg x 14 capsule Capsules; 60 mg x 28capsule Capsules; 60mg x 7 Capsules

Manufactured by:

TAKEDA PHARMACEUTICAL COMPANY LIMITED

환자 정보 전단

_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 adults:
•
for up to 8 weeks to heal
acid-related damage to the
lining of the esophagus
(called erosive esophagitis
or EE).
•
for up to 6 months to
continue healing of erosive
esophagitis and relief of
heartburn.
•
For 4 weeks to treat
heartburn related to
symptomatic non-erosive
gastroesophageal reflux
disease (GERD) in children
12 years of age or older.
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 unborn baby.
•
are breast-feeding or
planning to breast-feed.
You and your doctor
should decide if you will
t

제품 특성 요약

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 PHARM ACOLOG Y
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 product ion.
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
summa rized 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)