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Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including vardenafil, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting) . Consideration should be given to the following:
Inform patient’s that in some patients concomitant use of PDE5 inhibitors, including vardenafil hydrochloride tablets, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting).
Physicians should advise patients to stop taking all PDE5 inhibitors, including vardenafil orally disintegrating tablet, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including vardenafil. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors .
WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING VARDENAFIL ORALLY DISINTEGRATING TABLETS? Before taking vardenafil orally disintegrating tablet, tell your doctor about all your medical problems, including if you:
Vardenafil significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (61% on 10 mg and 64% on 20 mg vardenafil compared to 36% on placebo; p <0.0001).
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CYP3A4 Inhibitors: The dosage of vardenafil hydrochloride tablets may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin . For ritonavir, a single dose of 2.5 mg vardenafil hydrochloride tablets should not be exceeded in a 72-hour period. For indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, and clarithromycin, a single dose of 2.5 mg vardenafil hydrochloride tablets should not be exceeded in a 24-hour period. For ketoconazole 200 mg daily, itraconazole 200 mg daily, and erythromycin, a single dose of 5 mg vardenafil hydrochloride tablets should not be exceeded in a 24-hour period.
Vardenafil and its metabolites had no effect on CYP1A2, 2A6, and 2E1 (Ki >100 micromolar). Weak inhibitory effects toward other isoforms (CYP2C8, 2C9, 2C19, 2D6, 3A4) were found, but Ki values were in excess of plasma concentrations achieved following dosing. The most potent inhibitory activity was observed for vardenafil metabolite M1, which had a Ki of 1.4 micromolar toward CYP3A4, which is about 20 times higher than the M1 Cmax values after an 80 mg vardenafil dose.
The effect of 10 mg and 80 mg vardenafil on QT interval was evaluated in a single-dose, double-blind, randomized, placebo-and active-controlled (moxifloxacin 400 mg) crossover study in 59 healthy males (81% White, 12% Black, 7% Hispanic) aged 45 to 60 years. The QT interval was measured at one hour post dose because this time point approximates the average time of peak vardenafil concentration. The 80 mg dose of vardenafil (four times the highest recommended dose) was chosen because this dose yields plasma concentrations covering those observed upon co-administration of a low-dose of vardenafil (5 mg) and 600 mg BID of ritonavir. Of the CYP3A4 inhibitors that have been studied, ritonavir causes the most significant drug-drug interaction with vardenafil. Table 6 summarizes the effect on mean uncorrected QT and mean corrected QT interval (QTc) with different methods of correction (Fridericia and a linear individual correction method) at one hour post-dose. No single correction method is known to be more valid than the other. In this study, the mean increase in heart rate associated with a 10 mg dose of vardenafil compared to placebo was 5 beats/minute and with an 80 mg dose of vardenafil the mean increase was 6 beats/minute.
In humans, vardenafil alone in doses up to 20 mg does not prolong the bleeding time. There is no clinical evidence of any additive prolongation of the bleeding time when vardenafil is administered with aspirin. Vardenafil has not been administered to patients with bleeding disorders or significant active peptic ulceration. Therefore vardenafil should be administered to these patients after careful benefit-risk assessment.
CYP3A4 Inhibitors: The dosage of vardenafil hydrochloride tablets may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin . For ritonavir, a single dose of 2.5 mg vardenafil hydrochloride tablets should not be exceeded in a 72-hour period. For indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, and clarithromycin, a single dose of 2.5 mg vardenafil hydrochloride tablets should not be exceeded in a 24-hour period. For ketoconazole 200 mg daily, itraconazole 200 mg daily, and erythromycin, a single dose of 5 mg vardenafil hydrochloride tablets should not be exceeded in a 24-hour period.
Vardenafil and its metabolites had no effect on CYP1A2, 2A6, and 2E1 (Ki >100 micromolar). Weak inhibitory effects toward other isoforms (CYP2C8, 2C9, 2C19, 2D6, 3A4) were found, but Ki values were in excess of plasma concentrations achieved following dosing. The most potent inhibitory activity was observed for vardenafil metabolite M1, which had a Ki of 1.4 micromolar toward CYP3A4, which is about 20 times higher than the M1 Cmax values after an 80 mg vardenafil dose.
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Vardenafil ist als Tablette in den Dosierungen 10 Milligramm und 20 Milligramm erhältlich. In den meisten Fällen ist die Anfangsdosis von 10mg ausreichend für eine zufriedenstellende Wirkung. Die tägliche Maximaldosis liegt bei 20mg.
Vardenafil Soft beginnt innerhalb von 30 Minuten nach der Einnahme zu wirken. Die Wirkung von Vardenafil online hält in der Regel bis zu 4 Stunden an, bei manchen Männern kann sie aber auch bis zu 6 Stunden anhalten. Vardenafil hat sich bei mehr als 70 % der Männer als wirksam erwiesen, insbesondere bei Männern, die an Diabetes leiden und über 65 Jahre alt sind.
Die Kombination aus Vardenafil und Alphablockern kann ebenfalls in einem starken Abfall des Blutdrucks münden. Der Abbau von Vardenafil erfolgt zu einem großen Teil über das hepatische (in der Leber lokalisierte) Enzym CYP3A4. Ein Großteil der Arzneistoffe wird über dieses Enzym abgebaut und anschließend ausgeschieden, doch einige Vertreter sind in der Lage das Enzym in seiner Funktion zu manipulieren. Im Fall von Vardenafil weniger gefährlich ist die Stimulation von CYP3A4 durch sogenannte Enzym Induktoren.
Relationship problems can also contribute to ED, as communication breakdowns and emotional distance can create tension and anxiety, making it challenging to connect intimately. Imagine a bridge with cracks and gaps, hindering the smooth flow of communication and intimacy between partners, making it difficult to build a strong foundation for a fulfilling sexual relationship.
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