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The company is pretty adamant about that- and they are right. Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure see section 5. Patients with left ventricular outflow obstruction, 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 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 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. 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. In those patients who are stable on alpha-blocker therapy, vardenafil 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 should 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 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 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 juice is expected to increase the plasma concentrations of vardenafil.

The combination should be avoided see section 4. 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 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 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.

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. 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 acetylsalicyclic acid see section 4. 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. Therefore, inhibitors of these isoenzymes may reduce vardenafil clearance. In vivo studies Co-administration of the HIV protease inhibitor indinavir mg three times a day , a potent CYP3A4 inhibitor, with vardenafil 10 mg film-coated tablet resulted in a fold increase in vardenafil AUC and a 7-fold increase in vardenafil Cmax.

Co-administration of vardenafil with ritonavir mg twice daily resulted in a fold increase in vardenafil Cmax 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 mg , a potent CYP3A4 inhibitor, with vardenafil 5 mg resulted in a fold increase in vardenafil AUC and a 4-fold increase in vardenafil Cmax 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 CYP3A4 inhibitors such as itraconazole and ketoconazole oral use should be avoided see sections 4.

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