ZYDENAPrepared by :Cheok Ken YewCaren Chan Sook YeenLai Shu MeiMabel Cheong Sook LingPugunes Selvam

Zydena® [film-coated tab]UdenafilManufacturer : Dong-A Pharmaceutical Co., Ltd.  ( a Korean pharmaceutical company )Distributor: Pahang PharmacyDrug 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-coated tabletZydena 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.

DosageAdult & 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 ZydenaInhibits the 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 deformationSickle cell anaemia, multiple

myeloma or leukaemiaMay impair ability to drive or

operate machinery.Group B Poison

Contraindication1. Severe hepatic impairment2. Hypotension3. HTN, stroke or MI 4. Degenerative retinal disorders5. Use w/ organic nitrates6. Neonates, children, women7. 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

Advantagesfast-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

Disadvantagesmild to moderate facial flushing

and headacheIt 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.