ZYDENA 100 TABLET

País: Malasia

Idioma: inglés

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

Ingredientes activos:

UDENAFIL

Disponible desde:

PAHANG PHARMACY SDN. BHD.

Designación común internacional (DCI):

UDENAFIL

Unidades en paquete:

2 Tablet Tablets; 4Tablet Tablets

Fabricado por:

Dong-A ST Co., Ltd

Información para el usuario

PATIENT INFORMATION
ZYDENA
(UDENAFIL)
TABLET
Read this important information before you start taking ZYDENA and
each time you get a refill.
There may be new information. You may also find it helpful to share
this information with your
partner. You and your doctor should talk about ZYDENA when you start
taking it and at regular
checkups. If you do not understand the information, or have questions,
talk to your doctor or
pharmacist.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ZYDENA?
ZYDENA CAN CAUSE YOUR BLOOD PRESSURE TO DROP SUDDENLY TO AN UNSAFE
LEVEL IF IT IS TAKEN
WITH CERTAIN OTHER MEDICINES. You could get dizzy, faint, or have a
heart attack or stroke.
DO NOT TAKE ZYDENA IF YOU:
-
TAKE ANY MEDICINES CALLED “NITRATES.”
-
USE RECREATIONAL DRUGS CALLED “POPPERS” LIKE AMYL NITRITE AND
BUTYL NITRITE.
TELL ALL OF YOUR DOCTORS THAT YOU TAKE ZYDENA. If you need emergency
medical care for a heart
problem, it will be important for your doctor to know when you last
took ZYDENA.
WHAT IS ZYDENA?
ZYDENA is a prescription medicine taken orally for the treatment of
erectile dysfunction (ED) in
men.
ED is a condition where the penis does not fill with enough blood to
harden and expand when a
man is sexually excited, or when he cannot keep an erection. A man who
has trouble getting or
keeping an erection should see his doctor for help if the condition
bothers him. ZYDENA helps
increase blood flow to the penis and may help men with ED get and keep
an erection satisfactory
for sexual activity.
ZYDENA DOES NOT:
•
cure ED
•
increase man’s sexual desire
•
protect the user or his partner from sexually transmitted diseases,
including HIV. Speak
to your doctor about ways to guard against sexually transmitted
diseases
•
serve as a male form of birth control
ZYDENA is only for men with ED. ZYDENA is not for women or children.
ZYDENA must be used
only under a doctor’s care.
HOW DOES ZYDENA WORK?
When a man is sexually excited, his body’s normal physical response
is to increase blood flow to
his peni

Ficha técnica

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 appr\
oximately 1 hour and 10-12 hours, respectively. The
ability to maintain an erection sufficient for a successful intercours\
e (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 with