国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
UDENAFIL
PAHANG PHARMACY SDN. BHD.
UDENAFIL
2 Tablet Tablets; 4Tablet Tablets
Dong-A ST Co., Ltd
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 阅读完整的文件
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 阅读完整的文件