Indications, posology and method of administration
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
In order for vardenafil to be effective, sexual stimulation is required.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
- The maximum dose for the vardenafil 10 mg orodispersible tablet is 10 mg per day.
- Use in adult men: The vardenafil 10 mg orodispersible tablet should be taken approximately 25 to 60 minutes before sexual activity.
Elderly ( ≥ 65 years old)
Dose adjustments are not required in elderly patients. However, an increase to a maximum 20 mg dose should be carefully considered depending on the individual tolerability.
Hepatic impairment
The vardenafil 10 mg orodispersible tablet is not indicated as a starting dose for patients with mild liver impairment (Child-Pugh A).
Patients with mild liver impairment should start with a dose of 5 mg. Based on tolerance and effectiveness, the dose may subsequently be increased to 10 mg or 20 mg.
The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is 10 mg.
The vardenafil 10 mg orodispersible tablet should not be used in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) liver impairment.
Renal impairment
No dose adjustment is required in patients with mild to moderate renal impairment.
In patients with severe renal impairment (creatinine clearance < 30 ml/min), a starting dose of 5 mg should be considered. Based on tolerability and efficacy the dose may be increased to 10 mg (orodispersible tablet) and 20 mg.
The vardenafil 10 mg orodispersible tablet is not used in patients with end-stage renal disease.
Paediatric population
Vardenafil is not indicated for individuals below 18 years of age. There is no relevant indication for use of vardenafil in children.
Use in patients using other medicinal products
Dose adjustment should be considered if moderate or strong CYP 3A4 inhibitors are prescribed concurrently.
Method of administration:
- For oral use.
- The vardenafil orodispersible tablet should be placed on the tongue, allowed to disintegrate, and then swallowed. Do not drink with any fluids, and take it immediately after removing it from the blister pack.
- The vardenafil orodispersible tablet can be taken with or without food.
CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients.
- The co-administration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated.
- Vardenafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous phosphodiesterase 5 (PDE5) inhibitor exposure.
- Medicinal products for the treatment of erectile dysfunction should generally not be used in men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure [New York Heart Association III or IV]).
- The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available:
+ Severe hepatic impairment (Child-Pugh C)
+ End stage renal disease requiring dialysis
+ Hypotension (blood pressure < 90/50 mmHg)
+ Recent history of stroke or myocardial infarction (within the last 6 months)
+ Unstable angina and known hereditary retinal degenerative disorders such as retinitis pigmentosa.
- Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) is contraindicated in men older than 75 years.
- Concomitant use of vardenafil with HIV protease inhibitors such as ritonavir and indinavir is contraindicated, as they are very potent inhibitors of CYP3A4.
- The co-administration of PDE5 inhibitors, including vardenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension.
© 2016 Hera Biopharm. All Rights Reserved. Designed By Herabiopharm
11.png)
.jpg)
.jpg)
.jpg)
.jpg)