Zydena

Zydena

Manufacturer:

Dong-A

Distributor:

Pahang Pharmacy
Concise Prescribing Info
Contents
Udenafil
Indications/Uses
Dosage/Direction for Use
Adult & elderly Initially 100 mg once daily approx 30 min-12 hr before sexual activity, may be increased to 200 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Men for whom sexual intercourse is inadvisable due to severe CV disease. Hypotension (BP <90/50 mmHg), HTN (BP >170/100 mmHg), recent history of stroke, cerebral hemorrhage or MI; known hereditary degenerative retinal disorders eg, retinitis pigmentosa. Not recommended in patients w/ previous non-arteritic anterior ischemic optic neuropathy, congenital QT prolongation syndrome. Concomitant use w/ nitric oxide donors, organic nitrates or nitrites, guanylate cyclase stimulator (eg, riociguat), glyceryl trinitrate, isosorbide salts, Na nitroprusside, amyl nitrite, nicorandil, drugs prolonging QT interval. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Severe hepatic or renal failure. Childn <18 yr.
Special Precautions
Discontinue use if sudden vision or hearing loss or deafness occurs. Not to be used as aphrodisiac nor sexual stimulant. CV status; left ventricular outflow obstruction (eg, aortic stenosis, hyperthrophic obstructive cardiomyopathy), severely impaired autonomic BP control; anatomical penis deformation or conditions predisposing to priapism eg, sickle cell anaemia, multiple myeloma or leukemia. May affect ability to drive & operate machines. Severe hepatic or renal impairment. Not indicated for use in newborn, childn <18 yr or women.
Adverse Reactions
Flushing. Headache; eye discomfort; nasal congestion.
Drug Interactions
Increased plasma conc by CYP450 inhibitors eg, ketoconazole, itraconazole, ritonavir, indinavir, cimetidine, erythromycin, grapefruit juice. Decreased plasma conc by CYP450 inducers eg, dexamethasone, rifampin, anticonvulsants eg, carbamazepine, phenytoin, phenobarb. Increased heart rate, decreased BP, dizziness, myalgia & orthostatic syndrome w/ alcohol. Lowered BP w/ nitroglycerine, amlodipine besylate. Decreased mean standing systolic BP w/ tamsulosin. Symptomatic hypotension w/ α-blockers. Increased Cmax & AUC w/ ketoconazole, omeprazole.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BE11 - udenafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Zydena FC tab 100 mg
Packing/Price
4's
Form
Zydena FC tab 200 mg
Packing/Price
4's
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