Generic Zudena (Udenafil)

Description

Common use

Udenafil is a therapeutic agent hypothesized to improve erectile function endpoints through interaction with the phosphodiesterase type 5 (PDE5) enzyme. Udenafil has unique properties, with a T max of 1.0-1.5 h and a T 1/2 of 11-13 h (a relatively rapid onset and a long duration of action). Therefore, both on-demand and once-daily use of Udenafil have been reported. Udenafil’s efficacy and tolerability have been evaluated in several studies, and recent and continuing studies have demonstrated Udenafil’s promise in both dosing regimens. Udenafil as an on-demand or once-daily dose is effective and tolerable, but more studies are needed in patients of other ethnicities and with comorbid conditions such as diabetes mellitus, hypertension, and benign prostate hyperplasia.

Dosage and direction

Zudena is taken inside, regardless of the meal.

Recommended dose- 100 mg, taken 30 minutes before anticipated sexual activity.

The dose may be increased to 200 mg given individual efficacy and tolerability.

The maximum recommended frequency of application – 1 times per day.

Do not break or split a Zudena tablet. Swallow it whole.

Precautions

Sexual activity is a potential risk for patients with cardiovascular disease, so treatment of erectile dysfunction, including using of Udenafil, should not hold for men with heart disease, in which sexual activity is not recommended.

Patients with obstruction of blood outflow from the left ventricle (aortic stenosis) may be more sensitive to the action of vasodilators, including inhibitors of PDE. Despite the lack of clinical trials of cases of prolonged erection (longer than 4 hours) and priapism (painful erections lasting more than 6 h), such phenomena are peculiar to this class of drugs. In the event of an erection lasting more than 4 hours (regardless of pain), patients should immediately seek medical help. In the absence of timely treatment of priapism can lead to irreversible damage to the erectile tissue and erectile function.

List of those who must take Zudena with extra caution: Patients with uncontrolled hypertension (blood pressure> 170/100 mm Hg.), hypotension (blood pressure <90/50 mmHg..); Patients with hereditary degenerative diseases of the retina (including retinitis pigmentosa, proliferative diabetic retinopathy); Patients who have undergone over the last 6 months of stroke, myocardial infarction or coronary artery bypass grafting; Patients with severe hepatic or renal impairment; presence of congenital long QT syndrome, or an increase in the QT interval as a result of taking the drugs; predisposition to priapism; patients with anatomical deformation of the penis; the presence of penile implant; sexual activity in patients with diseases of the cardiovascular system such as unstable angina or angina occurring during sexual intercourse, chronic heart failure (II-IV functional class NYHA classification), which developed during the last 6 months, uncontrolled heart rhythm disorders, – should take into account the potential risk of complications; while receiving of Udenafil and CCBs, alpha-blockers or other hypotensive drugs – may mark the additional reduction in SBP and DBP by 7-8 mmHg.

According to the registered indication the drug is not intended for use in women.

The drug is not intended for use under the age of 18 years.

Contraindications

Do not use Udenafil in combination with other treatments for erectile dysfunction.

Hypersensitivity to any component of the drug; simultaneous reception of nitrates and other donor of nitric oxide. Do not take Udenafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite (“poppers”). Taking Udenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

Effects on ability to drive and operate machinery. Before you manage the equipment and vehicles, patients need to know how they react to the reception of Zudena.

Possible side effect

Get emergency medical help if you have signs of an allergic reaction to Udenafil: hives, difficult breathing, your face, lips, tongue, or throat swelling.

Stop using Zudena and get emergency medical help if you have: Palpitations, prolonged erections, flushing, dizziness eye pain, increased lacrimation, nasal congestion, headache.

There is no research for its side effects for the men over 71 y.o.

There are no side effects on sperm quality.

In case you notice any of these side effects or other not listed above – contact your doctor or pharmacist.

Drug interaction

Consult your doctor before taking Udenafil. Tell your doctor about all your current medicines and any you start or stop using, especially:

– Inhibitors of cytochrome P450 isoenzyme CYP3A4 (ketoconazole, itraconazole, ritonavir, indinavir, cimetidine, erythromycin, grapefruit juice) may enhance the action of Udenafil.

– Ketoconazole (400 mg) increases the bioavailability and Cmax of Udenafil (100 mg) almost 2-fold (212%) and 0.8-fold (85%), respectively.

– Ritonavir and indinavir substantially increases the effects of Udenafil.

– Dexamethasone, rifampin, and anticonvulsants drugs (carbamazepine, phenytoin and phenobarbital) may accelerate the metabolism of Udenafil, so joint application with the above medications weakens the effect of Udenafil.

– The joint application of Udenafil (30 mg / kg orally) and nitroglycerin (2.5 mg / kg once, w / w) did not reveal any effect on the pharmacokinetics of Udenafil in experimental studies, but the simultaneous use of nitroglycerin and of Udenafil is not recommended because of possible reduce blood pressure.

– Udenafil and drugs from the group of alpha-blockers are vasodilator, therefore, in the joint admission should be appointed at the minimum doses.

Missed dose

If Zudena is used as needed, you are not likely to be on a dosing schedule. The maximum recommended frequency of application – 1 times per day.

Overdose

Symptoms: with single dose of the drug in a dose of 400 mg of adverse events were comparable to those observed when receiving of Udenafil at lower doses, but occurred more frequently.

Treatment: symptomatic. Dialysis does not accelerate the elimination of Udenafil.

If you think you have used too much of Zudena – seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Storage

Store Zudena in a dry, dark place at a temperature no higher than 86° F (30° C). Do not store drugs in the bathroom. Keep all drugs out of the reach children and pets.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.