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Udziretablets(pi)2024466(resize)[2].pdf

1. Name of the medical Product:
4.6 Pregnancy and lactation
Udenafil is not indicated for use in women. 2. Qualitative and Quantitative Composition:
In the embryo fetal development study performed in rats and rabbits, only high doses of Udenafil (300 mg/kg/day and 240 mg/kg/day) showed skeletal variations and ossific retardations in fetuses. In the study for the effects of udenafil on pre- and postnatal development, Each film coated tablet contains: Udenafil 100 mg including maternal function, carried out in rats by oral administration, stil birth or ateliosis of offsprings were noted at the dose of 300 Each film coated tablet contains: Udenafil 200 mg 4.7 Effect on ability to drive and use machines
3. Pharmaceutical Form:
The effect of Udenafil on the ability to drive and use machinery has not been studied. UDZIRE 100 mg Tablets are pale orange, film-coated oval tablets, marked 100 on one side and Z| Y on the other. 4.8 Undesirable effects
UDZIRE 200 mg Tablets are pale orange, film-coated oval tablets, marked 200 on one side and Z| Y on the other. The adverse events were general y transient and mild in nature 4. Clinical Particulars:
1) Udenafil was administered to 923 patients during Korean nationwide clinical trials. In general, most adverse events were temporal 4.1 Therapeutic indications
and its severity was mild to moderate. The most common adverse events were flushing and headache. UDZIRE Tablets are indicated for the treatment of erectile dysfunction. 2) The fol owing adverse events were reported in clinical trials 4.2 Posology and method of administration
Percentage \
UDZIRE Tablets are for oral administration. In order for Udenafil to be effective, sexual stimulation is required.
Use in Adults
Body System
For most patients, the recommended starting dose of Udenafil is 100 mg, taken oral y approximately 30 minutes to 12 hours before sexual activity. The maximum recommended dosing frequency is once per day. The dose may be increased to 200 mg, based on the Chest Pain, Abdominal Pain, Fatigue, Feeling Hot, Chest Discomfort careful consideration of individual effectiveness and toleration including adverse reactions to 100 mg. This drug can be taken without regard to meals.
Use in Children
Udenafil is not indicated for use in newborns, children Eyelid Edema, Face Edema, Urticaria Pruritus Use in Elderly men
Nausea, Toothache, Constipation, Gastritis, Stomach Discomfort Elderly patients (over 65 years): dose control is not required in elderly patients.
4.3 Contraindications
Use of UDZIRE Tablets is contraindicated in patients with known hypersensitivity to Udenafil or any other component of the product. Udenafil was shown to potentiate the hypotensive effects of acute and chronic nitrates, and its co-administration with nitric oxide donors, organic nitrates or organic nitrites in any form, either regularly or intermittently, is therefore contraindicated. Drugs which must not be used concomitantly include glyceryl trinitrate (injection, tablets, sprays or patches), isosorbide salts, sodium nitroprusside, amyl In additional clinical studies, drug related adverse events unconfirmed before marketing are head discomfort, feeling cold, feeling dim, nitrite, nicorandil or organic nitrates in any form. (see Warnings and Precautions).
palpitation, postural dizziness, somnosis, ear daze, eye discomfort, rash, erythema, vomiting, diarrhea, dyspnea, respiratory distress in Udenafil is contraindicated in men for whom sexual intercourse is inadvisable due to cardiovascular risk factors (e.g. patients with exercise, cough, nasal hemorrhage, increased erection and hypotension. severe cardiovascular disease such as established cardiac failure and unstable angina pectoris) (Warnings and Precautions). The
3) In clinical trials of single doses up to 200 mg per day, the types of adverse events and incidence rates were significantly increased possibility of undiagnosed cardiovascular disorders in men with erectile dysfunction should be considered before prescribing Udenafil. Udenafil is not recommended in patients with male erectile dysfunction with a previous episode of non-arteritic anterior ischaemic optic 4) Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been neuropathy (NAION) (see Warnings and Precautions). occasionally reported in post-marketing surveillance (PMS) studies of PDE5 inhibitors, except Udenaf il. Based on this results, it is The safety of udenafil has not been studied in the fol owing sub-groups of patients and its use is therefore contraindicated until further concluded that phosphodiesterase type 5 (PDE5) inhibitors including Udenafil might have temporal association with non-arteritic information is available: severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), hypertension (blood pressure anterior ischemic optic neuropathy (NAION). Most, but not al , of these patients had underlying anat omic or vascular risk factors for >170/110 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases). coronary artery disease, hyperlipidemia and smoking. It is not possible to determine whether these events are related directly to the The efficacy and safety of combinations of Udenafil and other treatments for erectile dysfunction have not been studied. Therefore, the use of PDE5 inhibitors, to the patient’s underlying vascular risk factors or anatomical defects, to a combination of these factors, or to use of such combinations is not recommended 4.4 Special warnings and precautions for use
5) A sudden hearing loss or deafness in one or both ears, which might be in temporal association with the use of phosphodiesterase A thorough medical history and physical examination should be undertaken to diagnose erectile dysfunction, determine potential type 5 (PDE5) inhibitors, has been occasional y reported in post-marketing surveil ance (PMS). underlying causes and identify appropriate treatment. Even though, it is reported that the disease status and other factors wil be related to adverse events about hearing in a few cases, Physicians should consider the cardiovascular status of their patients, since there is a potential for cardiac risk associated with sexual medical tracing data which can be aware of that relationship are not confirmed in major cases. activity. Treatments for erectile dysfunction, including Udenafil, should not be generally used in men for whom sexual activity is It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient’s underlying inadvisable because of their underlying cardiovascular status. deafness risk factors, to a combination of these factors, or to other factors. Physicians should advise patients to stop use of all PDE5 inhibitors, including Udenafil, and seek immediate medical attention in the 5. Pharmacological Properties:
event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy 5.1 Pharmacodynamic properties
(NAION), a cause of decreased vision including permanent loss of vision, that has been reported Rarely post-marketing in temporal Udenafil is an oral therapy for the treatment of erectile dysfunction, the fourth entrant to the global erectile dysfunction market and first association with the use of all PDE-5 inhibitors, except Udenafil. It is not possible to determine w hether these events are related directly to the use of PDE5 inhibitors or to other factors. Physicians should also discuss with patients the increased risk of NAION in Udenafil, an oral therapy for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific individuals who have already experienced NAION in one eye, including whether such individuals could be adversely af ected by use of phosphodiesterase type 5 (PDE5) of the corpus cavernosum. vasodilators, such as PDE5 inhibitors (see Contraindications). Mechanism of Action: The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus
Physicians should advise patients to stop use of al PDES inhibitors, including Udenafil, and seek medical attention in the-event of a cavernosum and al owing inflow of blood.
sudden hearing loss or deafness, which may be accompanied by tinnitus and dizziness, in one or both ears. NO activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing Udenafil has been shown to have systemic vasodilatory properties that result in transient decreases in blood pressure. This is of lit le or smooth relaxation in the corpus cavernosum and al owing inflow of blood. no consequence in most patients. However, prior to prescribing udenafil, physicians should careful y consider whether their patients Udenafil has no direct relaxant ef ect on islated human corpus cavernosum, but enhances the effect of nitric oxide (NO) by inhibiting with certain underlying conditions could be adversely affected by such vasodilatory effects, especial y in combination with sexual phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum activity. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic stenosis, Udenafil at recommended does not recommend does has no effect in the absence of sexual stimulation. hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired Studies in vivo have shown that Udenafil is selective for PED5. Clinical studies
Agents for the treatment of erectile dysfunction should be used with caution in patients with anatomical deformation of the penis (such Udenafil demonstrated 88.5% improvement in patients with erectile dysfunction. as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism Based on the results from the phase III trial performed in 13Korean centers for up to 6 months in duration, Udenafil, compared to (such as sickle cel anaemia, multiple myeloma or leukemia). placebo, showed 81.5% and 88.5% improvement in Global Assessment Questionnaire (GAQ) scores at doses of 100 and 200 mg, As Udenafil is neither an aphrodisiac drug nor a sexual stimulant, it should be used only for the treatment of erectile dysfunction. respectively, in 270 erectile dysfunction patients. The efficacy and safety data of Udenafil were satisfactory in al of the phase I, II, and Udenafil has not been studied for the patients with spinal cord injury, radical prostatectomy, hyposexual desire, anticancer medication, Udenafil is a unique oral therapy for the treatment of erectile dysfunction, which has completed its entire clinical trial processes in As adverse effects such as Dizziness, Blurred Vision was reported in clinical trials, patients should be careful when driving and Korea. The major adverse events are flushing, nasal congestion, headache, and dyspepsia. However, mo st adverse events were temporal and mild in severity, which soon resolved without treatment. 4.5 Interaction with other medicinal products and other forms of interaction Effects of other medicinal products on Udenafil
Udenafil does not inhibit phosphodiesterase type 11 (PDE11) (>3,000-fold selectivity) and adverse effects such as myalgia, back pain, 1) Effects of other drugs on the plasma concentration of Udenafil
and testicular toxicity, etc. have not been reported. - In vitro studies; Udenafil metabolism is principal y mediated by the cytochrome P450 (CYP) isoforms 3A4. Therefore, inhibitors of Udenafil does not inhibit phosphodiesterase type 11 (PDE11) and adverse events such as myalgia, back pain, and testicular toxicity these enzymes are expected to increase the plasma concentration of udenafil. In human, ketoconazole, itraconazole, ritonavir, indinavir, cimetidine, erythromycin, and grapefruit juice are representative CYP450 3A4 inhibitors. 5.2 Pharmacokinetic properties
- In vivo studies; Ketoconazole (400 mg) induced 212% and 85% increase in AUC and Cmax of udenafil, respectively, when Udenafil has an optimal duration of action of up to 8 to 12 hours. Clinical pharmacokinetic study showed that the time to maximum coadministered with Udenafil (100 mg) to healthy volunteers. concentration (Tmax) and half-life (T1/2) of Udenafil are approximately 1 hour and 10 to 12 hours, respectively. The ability to maintain - Even though the interaction studies have not been studied, the coadministration with other CYP450 3A4 inhibitors, such as an erection suf icient for a successful intercourse (SEP3) at 8 to 12 hours after taking Udenafil (100 mg) was significantly superior to itraconazole, cimetidine, erythromycin, and grapefruit juice, are expected to increase the plasma concentration of udenafil. placebo in phase I I trial. The duration of action was neither too short nor long, and was considered appropriate. Therefore, careful consideration is needed. Pharmacokinetics in special patient groups:
- The coadministration with HIV protease inhibitors ritonavir or indinavir, potent CYP450 3A4 i nhibitors, results in a significant increase in plasma udenafil concentration. Therefore, the coadministration is not recommended. When udenafil (100mg) was given to 12 healthy elderly volunteers (65-80 years) and 12 healthy younger volunteers (19-45 years), AUC - Moreover, CYP450 3A4 inducers such as dexamethasone, rifampin, and anticonvulsants (carbamazepine, phenytoin, and and Cmax, of Udenafil (l00mg) in elderly group is lower 0.73 fold and 0.88 fold respectively than that of younger group. Therefore, phenobarbital) can accelerate udenafil metabolism and decrease the plasma concentration of udenafil. separate control of dose is not needed due to rare possibility of increasing Plasma concentration of Udenafil in the case of treatment in - The coadministration of udenafil (200 mg) with alcohol (0.6 g/kg, mean maximum blood alcohol levels of 0.088%) did not potentiate the effect of alcohol on blood pressure and heart rate. The pharmacokinetics of udenafil was not affected by alcohol. 6. Pharmaceutical Particulars:
However, physicians should inform patients of the possible symptoms, such as increased heart rate, decreased blood pressure, 6.1 List of excipients.
dizziness, myalgia, and orthostatic syndrome, as both udenafil and alcohol have mild vasodilatory properties. Each UDZIRE Tablet contains the following inactive ingredients: 2) When udenafil (30 mg/kg, p.o.) was coadministered with nitroglycerine (2.5 mg/kg, i.v.) to rats, the pharmacokinetics of udenafil was lactose, corn starch, light anhydrous silicic acid, low substituted hydroxyrpopyl cel ulose, hydroxyrpopyl cel ulose, talc, magnesium not af ected. However, due to the blood-pressure-lowering ef ect of nitroglycerine, the concomitant use is not recommended. stearate, hydroxyrpopylmethyl cel ulose 2910, titanium dioxide, al lake yel ow 5 3) When amlodipine besylate (5 mg/kg, 3 days, p.o.) was administered to rats, the blood pressure was significantly lowered. Therefore, 6.2 Incompatibilities
the concomitant use with udenafil requires careful consideration. 4) When Udenafil (200 mg) was given simultaneously with 0.4 mg of tamsulosin to healthy volunteers, the mean standing systolic 6.3 Shelf life
blood pressure was decreased by 4 mmHg (maximum). Although 4 out of 28 subjects temporarily experienced a standing systolic blood pressure of lower than 85 mmHg, no subjects showed symptomatic hypotension. Udenafil and alpha-blockers have not been 6.4 Presentation:
evaluated to determine whether they can be safely administered together. However, as these two class es of drugs both act as vasodilators with blood-pressure-lowering effects, patients must be warned. 6.5 Special Precautions for Storage
In some patients, concomitant use of alpha-blockers and PDE5 inhibitors including Udenafil, may lead to symptomatic hypotension so, Store below 30°C. Protect from light and moisture.
coadministration should be initiated at the lowest dose only when the patients are stable on either alpha-blockers or PDE 5 inhibitor. Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by variables including hypovolemia and other Marketed by : Zydus Urosciences
5) When Udenafil (30 mg/kg) was administered to rats after a week administration of omeprazole (30 mg/kg), Cmax and AUC of udenafil were increased by approximately 30% and 37%, respectively. Imported by : Cadila Healthcare Ltd.
Sarkhej - Bavla N. H. No. 8 A, Moraiya.
Tal.: Sanand, Dist.: Ahmedabad 382 210.
Manufactured by : Dong-A Pharmaceutical Co. Ltd.
unlikely that Udenafil wil alter the clearance of substrates of these isozymes. # 404/405, Chaam-dong, Cheonan-si, Chungcheongnam-do, Korea.

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