Asle pharmaceuticals

Levisma

Indications and effects: Erectile dysfunction (patients who are unable to achieve and maintain an erection sufficient for satisfactory sexual activity)

Contraindication

Patients with a history of hypersensitivity to the components of this product.
Patients receiving nitrates or nitric oxide donors (nitroglycerin, amyl nitrite, isosorbide nitrate, nicorandil, etc.)
Patients for whom sexual activity is considered inappropriate, such as those with cardiovascular disorders.
Patients with congenital QT prolongation (QT prolongation syndrome), on Class IA (quinidine, procainamide, disopyramide (oral), cibenzoline, pyrmenol) or Class III (amiodarone (oral), sotalol) antiarrhythmic drugs.
Patients with a history of cerebral infarction, cerebral hemorrhage, or myocardial infarction within the last 6 months.
Patients with severe hepatic dysfunction.
Patients with renal impairment requiring hemodialysis.
Patients with hypotension (resting systolic blood pressure < 90 mmHg) or uncontrolled hypertension (resting systolic blood pressure > 170 mmHg or resting diastolic blood pressure > 100 mmHg)
Patients with unstable angina pectoris.
Patients receiving riociguat, drugs that inhibit CYP3A4 (preparations containing ritonavir, atazanavir, fosamprenavir, lopinavir/ritonavir, darunavir, preparations containing ketoconazole (excluding topical preparations), itraconazole, cobicistat)
Patients with retinitis pigmentosa [A small number of patients with retinitis pigmentosa have a genetic disorder of phosphodiesterase (PDE).

Dosage and Administration

The usual dosage for adults is 10 mg of vardenafil orally once a day, approximately one hour before sexual activity.
The dose may be increased to 20 mg for patients with organic or mixed erectile dysfunction who do not respond adequately to the 10 mg dose and are judged to be well tolerated.
In elderly patients (65 years old or older) and patients with moderate hepatic impairment, plasma concentrations of the drug have been observed to increase, so the starting dose should be 5 mg and the maximum dose should be 10 mg.
The daily dose should be one time, and the interval between doses should be at least 24 hours.
Clozapine is not affected by a standard diet. (700kcal and less than 23.3g of fat)

Cautions for use

Sexual activity poses a risk to the heart, so pay attention to cardiovascular status before starting treatment for erectile dysfunction.
Because of the vasodilator effect of this drug, transient mild hypotension may occur.
Since QTc prolongation has been observed in clinical pharmacology studies with this drug, ECG tests should be performed as necessary during treatment with this drug in patients with cardiovascular or hepatic disorders.
A small number of cases of prolonged or sustained erection lasting more than 4 hours (painful erection lasting more than 6 hours) have been reported in foreign clinical trials. If symptoms of erection lasting more than 4 hours are observed, patients should be instructed to seek medical advice immediately because failure to promptly treat sustained erection may result in damage to penile tissue or permanent impairment of erectile function.
Since dizziness and visual disturbances have been observed in clinical trials, caution should be exercised when working at heights, driving a car, or operating other dangerous machinery.
Patients should be instructed to discontinue taking the drug and seek immediate medical attention from an ophthalmologist if they experience a sudden decrease in vision or a sudden loss of vision after taking the drug.