Vardenafil hydrochloride trihydrate.
Each tablet contains: Vardenafil Hydrochloride Trihydrate (EP) 23.705 mg (20 mg as vardenafil).
Excipients/Inactive Ingredients: Microcrystalline Cellulose, Low-substituted Hydroxypropyl Cellulose, Colloidal Silicon Dioxide, Sodium Stearyl Fumarate, Hypromellose, Polyethylene Glycol 400, Titanium Dioxide, Yellow Dye #5 (C.I. No. 15985).
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: Use in adult men: The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 20 mg. The maximum recommended dose is 20 mg. The maximum recommended dosing frequency is once per day. Vardenafil can be taken with or without food. The onset of activity may be delayed if taken with a high fat meal.
Special populations: 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.
Paediatric population: Vardenafil is not indicated for individuals below 18 years of age. There is no relevant indication for use of Vardenafil in children.
Method of administration: For oral use.
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 ischaemic 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.
A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure. Patients with left ventricular outflow obstruction, e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors. Serious cardiovascular events including sudden death, tachycardia, myocardial infarction, ventricular tachy-arrhythmia, angina pectoris, and cerebrovascular disorders (including transient ischaemic attack and cerebral haemorrhage), have been reported in temporal association with vardenafil. Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to vardenafil, to sexual activity, or to a combination of these or other factors.
Medicinal products for the treatment of erectile dysfunction should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). The safety and efficacy of combinations of Vardenafil tablets with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
Tolerability of the maximum dose of 20 mg may be lower in elderly patients (≥65 years old).
Concomitant use of alpha-blockers: The concomitant use of alpha-blockers and vardenafil may lead to symptomatic hypotension in some patients because both are vasodilators. Concomitant treatment with vardenafil should only be initiated if the patient has been stabilised on his alpha-blocker therapy. Vardenafil may be administered at any time with tamsulosin or with alfuzosin. With other alpha-blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly. In those patients already taking an optimized dose of vardenafil, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking vardenafil.
Concomitant use of CYP3A4 inhibitors: Concomitant use of vardenafil with potent CYP3A4 inhibitors such as itraconazole and ketoconazole (oral form) should be avoided as very high plasma concentrations of vardenafil are reached if the medicinal products are combined.
Vardenafil dose adjustment might be necessary if moderate CYP3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly.
Concomitant intake of grapefruit or grapefruit juice is expected to increase the plasma concentrations of vardenafil. The combination should be avoided.
Effect on QTc interval: Single oral doses of 10 mg and 80 mg of vardenafil have been shown to prolong the QTc interval by a mean of 8 msec and 10 msec, respectively. And single doses of 10 mg vardenafil co-administered concomitantly with 400 mg gatifloxacin, an active substance with comparable QT effect, showed an additive QTc effect of 4 msec when compared to either active substance alone. The clinical impact of these QT changes is unknown.
The clinical relevance of this finding is unknown and cannot be generalised to all patients under all circumstances, as it will depend on the individual risk factors and susceptibilities that may be present at any time in any given patient. Medicinal products that may prolong QTc interval, including vardenafil, are best avoided in patients with relevant risk factors, for example, hypokalaemia, congenital QT prolongation, concomitant administration of antiarrhythmic medicinal products in Class 1A (e.g. quinidine, procainamide), or Class III (e.g. amiodarone, sotalol).
Effect on vision: Visual defects and cases of non-arteritic ischaemic optic neuropathy (NAION) have been reported in connection with the intake of Vardenafil and other PDE5 inhibitors. Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to PDE5 inhibitors such as vardenafil, tadalafil and sildenafil. As this may be relevant for all patients exposed to vardenafil the patient should be advised that in the case of sudden visual defect, he should stop taking Vardenafil and consult immediately a physician.
Effect on bleeding: In vitro studies with human platelets indicate that vardenafil has no antiaggregatory effect on its own, but at high (super-therapeutic) concentrations vardenafil potentiates the antiaggregatory effect of the nitric oxide donor sodium nitroprusside. In humans, vardenafil had no effect on bleeding time alone or in combination with acetylsalicylic acid. There is no safety information available on the administration of vardenafil to patients with bleeding disorders or active peptic ulceration. Therefore vardenafil should be administered to these patients only after careful benefit-risk assessment.
The adverse reactions reported with Vardenafil tablets in clinical trials were generally transient and mild to moderate in nature. The most commonly reported adverse drug reaction occurring in ≥10% of patients is headache.
Adverse reactions are listed according to the MedDRA frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and not known (can not be estimated from available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The following adverse reactions have been reported: See table.
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Penile haemorrhage, haematospermia and haematuria have been reported in clinical trials and spontaneous post-marketing data with the use of all PDE5 inhibitors, including vardenafil.
At the 20 mg dose Vardenafil tablets, elderly (≥65 years old) patients had higher frequencies of headaches (16.2% versus 11.8%) and dizziness (3.7% versus 0.7%) than younger patients (<65 years old). In general, the incidence of adverse reactions (especially "dizziness") has been shown to be slightly higher in patients with a history of hypertension.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
G04BE09 - vardenafil ; Belongs to the class of drugs used in erectile dysfunction.
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