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Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. 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 or decreased to 5 levitra. The maximum recommended dose is 20 mg. The maximum recommended dosing frequency is once per day. Levitra can be taken with or without food. The onset of activity may be delayed if taken with a high fat meal see section 5. 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 see sections 4.
A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment Child-Pugh A-B. Based on tolerability and efficacy, the dose may subsequently be increased. The maximum dose recommended in patients with moderate hepatic impairment Child-Pugh B levitra 10 mg see sections 4.
Based on tolerability and efficacy the dose may be increased to 10 mg and 20 mg. Levitra is not indicated for individuals below 18 years of age.
There is no relevant indication for use of Levitra in children. When used in combination with the CYP3A4 inhibitors such as erythromycin or clarithromycin, the dose of vardenafil should levitra exceed 5 mg see section 4. The co-administration of vardenafil with nitrates or nitric oxide donors such as amyl nitrite in any form is contraindicated see sections 4. Levitra is contraindicated in patients levitra have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy NAIONregardless of whether this episode was in connection or not with previous phosphodiesterase 5 PDE5 inhibitor exposure see section 4.
Medicinal products for the treatment of levitra dysfunction should generally not be used in men for whom sexual activity is inadvisable e. 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:. 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 see section 4. Levitra co-administration of PDE5 inhibitors, including vardenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension see section 4.
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 levitra, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual levitra see section 4.
Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure see section 5. Patients with left ventricular outflow levitra, e. 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 diseaseor 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 Levitra film-coated tablets with Levitra orodispersible tablets or other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
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. In those patients who are stable on alpha-blocker therapy, levitra should be initiated at the lowest recommended starting dose of 5 mg film-coated tablets.
Vardenafil may be administered at any time with tamsulosin or with alfuzosin. With other alpha-blockers, a time separation of dosing levitra be considered when vardenafil is prescribed concomitantly see section 4. In those patients already taking an optimized dose of vardenafil, alpha-blocker therapy should be initiated at the lowest dose. Stepwise levitra in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking vardenafil.
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 see sections 4. Vardenafil dose adjustment might be necessary if moderate CYP3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly see sections 4.
Concomitant intake of grapefruit or grapefruit levitra is expected to increase the plasma concentrations of vardenafil.
The combination should be avoided see section 4. 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 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 see section 5. The clinical relevance of this finding is unknown and cannot be generalised to all patients under all circumstances, as it will depend on the levitra 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.
Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction levitra exposure to PDE5 inhibitors such as vardenafil, tadalafil and sildenafil see section 4. 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 Levitra and consult a physician immediately see section 4.
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 levitra on bleeding time alone or in combination with levitra acid see section 4. Levitra is no safety information available on the administration of vardenafil to patients with bleeding disorders or active peptic ulceration.
Therefore vardenafil should levitra administered to these patients only after careful benefit-risk assessment. Therefore, inhibitors of these isoenzymes may reduce vardenafil clearance.
Co-administration of the HIV protease inhibitor indinavir mg three times a daya potent CYP3A4 inhibitor, with vardenafil 10 mg film-coated tablets resulted in a fold increase in vardenafil AUC and a 7-fold increase in vardenafil C max. Co-administration of vardenafil with ritonavir mg twice daily resulted in a fold increase in vardenafil C max and a fold increase in vardenafil AUC when co-administered with vardenafil 5 mg.
The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9. Ritonavir significantly prolonged the half-life of vardenafil to Co-administration of ketoconazole mga potent CYP3A4 inhibitor, with vardenafil 5 mg resulted in a fold levitra in vardenafil AUC and a 4-fold increase in vardenafil C max see section 4.
Although specific interaction studies have not been conducted, the concomitant use of other potent CYP3A4 inhibitors such as itraconazole can be expected to produce vardenafil plasma levels comparable to those produced by ketoconazole.
Concomitant use of vardenafil with potent Levitra inhibitors such as itraconazole and ketoconazole oral use should be avoided see sections 4. In men older than 75 levitra the concomitant use of vardenafil with itraconazole or ketoconazole is contraindicated see section 4. Co-administration of erythromycin mg three times a daya CYP3A4 inhibitor, with vardenafil 5 mg resulted in a 4-fold increase in vardenafil Levitra and a 3-fold increase in C max.
Although a specific interaction study has not been conducted, the co-administration of clarithromycin can be expected to result in similar effects on vardenafil AUC and C max.
When used in combination with a moderate CYP3A4 inhibitor such as erythromycin or clarithromycin, vardenafil dose adjustment might be necessary see sections 4. Cimetidine mg twice dailya non-specific cytochrome P inhibitor, had no effect on vardenafil AUC and C max when co-administered with vardenafil 20 mg to healthy volunteers.
Grapefruit juice being a weak inhibitor of CYP3A4 levitra wall metabolism, may give rise to modest increases in plasma levels levitra vardenafil see section 4. Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect on vardenafil pharmacokinetics of the following concomitant medicinal products: There are no data on the interaction of vardenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
No potentiation of the blood pressure lowering effect of sublingual nitroglycerin 0. Vardenafil 20 mg film-coated tablets potentiated the blood pressure lowering effect of sublingual nitroglycerin 0. No effect on blood pressure was observed when nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg film-coated tablets. However, there is no information on the possible potentiation of the hypotensive effects of nitrates by vardenafil in patients, and concomitant use is therefore contraindicated see section 4.
Nicorandil is a hybrid of potassium channel opener and nitrate. Due to the nitrate component it has the potential to have serious interaction with vardenafil. Since alpha-blocker monotherapy can cause marked lowering of blood pressure, especially postural hypotension and syncope, interaction studies were conducted with vardenafil. In two interaction studies with healthy normotensive volunteers after forced titration of the alpha-blockers tamsulosin or terazosin to high doses, hypotension in some cases symptomatic was reported in a significant number of subjects after co-administration of vardenafil.
Among subjects treated with terazosin, hypotension was observed more frequently when vardenafil and terazosin were given simultaneously than when the dosing was separated by a time interval of 6 hours. Based on the results of interaction studies conducted with vardenafil in patients with benign prostatic hyperplasia BPH on stable tamsulosin, terazosin or alfuzosin therapy:.
Hypotension was not observed when levitra 5 mg and terazosin administration was separated by 6 hours. Therefore, concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy. In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg.
Levitra may be administered at any time with tamsulosin or alfuzosin. With other alpha-blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly see section 4. No significant interactions were shown when warfarin 25 mgwhich is metabolised by CYP2C9, or digoxin 0. The relative bioavailability of glibenclamide 3. In a specific study, where vardenafil 20 mg was co-administered with slow levitra nifedipine 30 mg or 60 mg in hypertensive levitra, there was an additional reduction on supine systolic blood pressure of 6 mmHg and supine diastolic blood pressure of 5 mmHg accompanied with an increase in heart rate of 4 bpm.
Vardenafil 10 mg did not potentiate the increase in bleeding time caused by acetylsalicylic levitra 2 x 81 mg. Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.
There was no evidence of favourable clinical effect of the combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including vardenafil, is contraindicated see section 4. Levitra is not indicated for use by levitra. There levitra no studies of vardenafil in pregnant women. There are no fertility data available.
As dizziness and abnormal vision have been reported in clinical trials with vardenafil, patients should be aware of how they react to Levitra, before driving or operating machines. The adverse reactions reported with Levitra film-coated tablets or 10 mg orodispersible tablets in clinical trials were generally transient and mild to moderate in nature. Adverse reactions are listed according to the Levitra frequency convention: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
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