ZYDENA

Prepared by : Cheok Ken Yew Caren Chan Sook Yeen Lai Shu Mei Mabel Cheong Sook Ling Pugunes Selvam

Zydena® [filmZydena® [film-coated tab] tab] Udenafil
Manufacturer : Dong-A Pharmaceutical Co., Ltd. ( a Korean pharmaceutical company ) Distributor: Pahang Pharmacy Drug for Erectile Dysfunction

80% of seniors suffering from erectile dysfunction and premature ejaculation y A quarter of men are reported with signs of PE and ED in their early twenties! y Zydena is a newly approved prescribed medication primarily addresses to PE and ED by the Malaysian Heath Ministry since May 2010.
y Over

Presentation/Packing: Zydena film-coated tablet 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
y Adult

& elderly: Initially, 100 mg once daily taken approx 30 mins-12 hr before sexual activity. Dose may be increased to 200 mg y May be taken with or without food

MOA of Zydena
y Inhibits

the cGMP specific phosphodiesterase type 5 (PDE5) which is responsible for degeneration of cGMP in the corpus cavernosum located around the penis.

y Penile

erection during sexual stimulation is produced by penile blood flow caused by the relaxation of penile arteries & corpus cavernosal smooth muscle.

y 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. causes smooth muscle relaxation & blood flow into the corpus cavernosum

y CGMP

‡ 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
y Patient

with increased susceptibility to vasodilators (aortic stenosis) y Penile deformation y Sickle cell anaemia, multiple myeloma or leukaemia y May impair ability to drive or operate machinery. y Group B Poison

Contraindication
1. 2. 3. 4. 5. 6. 7.

Severe hepatic impairment Hypotension HTN, stroke or MI Degenerative retinal disorders Use w/ organic nitrates Neonates, children, women 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 -blockers Omeprazole

Advantages
y fast-acting

- 30 - 40min from the time of ingestion - Tmax : 1-1.5h - t1/2: 11-13h y improve men's sexual lives - after 12 weeks therapy - 92% vaginal penetration success rate - 76% intercourse completion rate

y long

duration of activity y no significant inhibition of PDE-11 isozyme - no myalgia y safe for long-term use -no visual disturbances and backache y effective in patients with concomitant therapy for hypertension, DM and prostate hyperplasia y no interaction with alcohol and oily food

Disadvantages
y mild

to moderate facial flushing and headache y 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.

‡

‡