ZYDENA 200 TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

UDENAFIL

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

UDENAFIL

Unit dalam pakej:

2 Tablet Tablets; 4Tablet Tablets

Dikeluarkan oleh:

Dong-A ST Co., Ltd

Risalah maklumat

ZYDENA
®
TABLET
Udenafil (100mg, 200mg)
_Consumer Medication Information Leaflet (RiMUP)_
1
WHAT IS IN THIS LEAFLET
1.
What Zydena
®
Tablet is used for
2.
How Zydena
®
Tablet works
3.
Before you use Zydena
®
Tablet
4.
How to use Zydena
®
Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Zydena
®
Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
1. WHAT ZYDENA® TABLET IS USED FOR
Zydena
®
Tab.
is
used
to
treat
conditions of erectile dysfunction.
2. HOW ZYDENA® TABLET WORKS
Zydena
®
Tab. contains one type of
medicine called Udenafil. It is a type
of PDE5 inhibitor. In order for
Udenafil to be effective, sexual
stimulation is required.
Zydena
®
Tab. works by relaxing
penile arteries. This causes increase in
penile blood flow to enhance erectile
function.
3. BEFORE YOU USE ZYDENA® TABLET
When you must not use it
1)
If you have_ hypersensitivity_ to any
component of the tablet.
2)
If
you
receive
regular
or
intermittent
nitrate
nitrate/nitric
oxide (NO) donor drugs.
3)
If
you are
not
recommended to
have
sexual
activity
due
to
cardiovascular diseases.
4)
If you have had stroke, myocardial
infarction (MI) or have a history of
coronary
artery
bypass
surgery
within the last 6 months.
5)
If
you
have
hypotension,
uncontrolled
hypertension
or
uncontrolled arrhythmias which is
irregular heartbeat.
6)
If
you
have
hereditary
degenerative retinal disorders.
7)
If you have severe liver failure or
renal failure.
8)
If
you
are
administering
potent
cytochrome
CYP450
3A4
inhibitors such as clarithromycin,
erythromycin,
diltiazem,
itraconazole,
ketoconazole,
ritonavir,
verapamil,
goldenseal
and grapefruit.
9)
If
you are using other
treatments
for erectile dysfunction.
10)
If
you
have
congenital
QT
prolongation syndrome, or you are
taking drugs that
increase the QT
interval.
11)
If you are under 18 years of age.
12)
Because
this
medicine
contains
lactose,
if
you
have
genetic
problems
such
as
galactose
intolerance,
Lapp
lactase
deficiency,
or
glucose-g

Ciri produk

PRESENTATION
ZYDENA 100 mg tablets are pale orange, film-coated oval tablets,
marked 100 on one side and Z | Y on the other.
ZYDENA 200 mg tablets are pale orange, film-coated oval tablets,
marked 200 on one side and Z | Y on the other.
In addition to udenafil, each ZYDENA tablet contains the following
inactive ingredients: lactose, corn starch, light anhydrous
silicis acid, low substituted hydroxypropyl cellulose, hydroxypropyl
cellulose, talc, magnesium stearate, hydroxypropyl methyl
cellulose 2910, titanium dioxide, al lake yellow 5.
ZYDENA tablets are presented in blister packs of 2 tablets or 4
tablets per box.
PHARMACOLOGY
ZYDENA, an oral therapy for the treatment of erectile dysfunction
(ED), is a pyrazolopyrimidinone class and a selective inhibitor
of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase
type 5 (PDE5) of the corpus cavernosum, which induce
potent penile erection.
ZYDENA demonstrated 88.5% improvement in patients with ED. Based on
the results from the phase III trial performed
in 13 Korean centers, involving 270 ED patients, ZYDENA showed 81.5%
and 88.5% improvement in Global Assessment
Questionnaire (GAQ) scores at doses of 100 and 200 mg, respectively,
compared to placebo.
ZYDENA has an optimal duration of action of up to 8-12 hours. Clinical
pharmacodynamic study showed that the time to
maximum concentration (Tmax) and half-life (TI/2) of ZYDENA are
approximately 1 hour and 10-12 hours, respectively. The
ability to maintain an erection sufficient for a successful
intercourse (SEP3) at 8-12 hours after taking ZYDENA (100 mg) was
significantly superior to placebo in phase III study.
The efficacy and safety of ZYDENA are satisfactory in all the phase I,
II, and III studies. ZYDENA is an oral therapy for the
treatment of ED, which completed the clinical trial processes in
Korea. The major adverse events are flushing, nasal congestion,
headache, and dyspepsia. However, most adverse events were temporal
and mild in severity.
Moreover, these adverse events soon resolved without trea