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ZYDENA

Prepared by :
Cheok Ken Yew
Caren Chan Sook Yeen
Lai Shu Mei
Mabel Cheong Sook Ling
Pugunes Selvam
Zydena® [film-coated tab]
Udenafil
Manufacturer : Dong-A Pharmaceutical Co.,
Ltd.  ( a Korean pharmaceutical company )
Distributor: Pahang Pharmacy
Drug for Erectile Dysfunction
Over 80% of seniors suffering from erectile
dysfunction and premature ejaculation
A quarter of men are reported with signs of
PE and ED in their early twenties!
Zydena is a newly approved prescribed
medication primarily addresses to PE and
ED by the Malaysian Heath Ministry since
May 2010.
Presentation/Packing:
Zydena film-coatedtablet
Zydena 100 mg x 4's (USD 100)
Zydena 200 mg x 4's

Udenafil comes in oval shaped tablets, film-coated light-


pink color with light-yellow shade. There are imprinted
symbol "100" on one side and symbols  "Z" and "Y" on
another

No serious side effects reported and is claimed to be free


from any adverse effects such as back pain, hazy vision;
but mild side effects were reported such as facial
flushing and headaches.
Dosage
Adult & elderly: Initially, 100 mg once
daily taken approx 30 mins-12 hr before
sexual activity. Dose may be increased to
200 mg
May be taken with or without food
MOA of Zydena
Inhibitsthe cGMP specific
phosphodiesterase type 5 (PDE5) which is
responsible for degeneration of cGMP in
the corpus cavernosum located around the
penis.

Penile erection during sexual stimulation is


produced by penile blood flow caused by
the relaxation of penile arteries & corpus
cavernosal smooth muscle.
This reaction is mediated by the release of
NO from nerve terminals and endothelial
cells, which stimulates the synthesis of
cGMP in smooth muscle cells.

CGMP causes smooth muscle relaxation &


blood flow into the corpus cavernosum
• The inhibition of PDE5 by Zydena
reinforces erection by increasing the amount
of cGMP.

• Zydena improves erection & the possibility


of successful sexual intercourse.
Special precautions
Patient with increased susceptibility to
vasodilators (aortic stenosis)
Penile deformation
Sickle cell anaemia, multiple myeloma or
leukaemia
May impair ability to drive or operate
machinery.
Group B Poison
Contraindication
1. Severe hepatic impairment
2. Hypotension
3. HTN, stroke or MI
4. Degenerative retinal disorders
5. Use w/ organic nitrates
6. Neonates, children, women
7. Non-arteritic anterior ischemic optic
neuropathy (NAION)
Drug Interactions
• Nitric oxide, nitroglycerin
• Organic nitrates or nitrites
• Ketoconazole, Itraconazole, ritonavir, Indinavir,
erythromycin
• Cimetidine
• Grapefruit juice
• Dexamethasone
• Rifampin
• Anticonvulsants
• Amlodipine besylate
• α-blockers
• Omeprazole
Advantages
fast-acting
- 30 - 40min from the time of ingestion
- Tmax : 1-1.5h
- t1/2: 11-13h
improve men's sexual lives
- after 12 weeks therapy
- 92% vaginal penetration success rate
- 76% intercourse completion rate
long duration of activity
no significant inhibition of PDE-11
isozyme
- no myalgia
safe for long-term use
-no visual disturbances and backache
effective in patients with concomitant
therapy for hypertension, DM and prostate
hyperplasia
no interaction with alcohol and oily food
Disadvantages
mild to moderate facial flushing and
headache
It is not well-documented
Pharmacist Review
•It is a new drug, there isn’t enough data on its
efficacy and adverse effects.

• Not many clinical trials done.

• Only been on the market for 4 years.

• Has much shorter onset and longer duration.

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