Cialis , Levitra , and Fildena 50 are all in a class of drugs called PDE-5 inhibitors These drugs work by blocking an enzyme called phosphodiesterase type 5.
However, according to the prescribing information, Fildena may be taken anywhere within a range from 30 minutes to four hours prior to sexual activity. In some patients, concomitant use of these two drug classes can lower blood pressure significantly see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY leading to symptomatic hypotension (e.g., dizziness, lightheadedness , fainting ). No dose adjustment is required for mild (CLcr=50-80 mL/min) and moderate (CLcr=30-49 mL/min) renal impairment. Larger effects were recorded among patients receiving concomitant nitrates see CONTRAINDICATIONS.
No severe adverse events potentially related to blood pressure effects were reported in this group. Blood pressure was measured after administration of Fildena at the same times as those specified for the first doxazosin study. The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 100 mg Fildena or matching placebo are shown in Figure 4.
Fildena (50 mg) did not potentiate the hypotensive effect of alcohol (0.5 g/kg) in healthy volunteers with mean maximum blood alcohol levels of 0.08%. Even though this total dosage produced plasma sildenafil concentrations which were approximately 2 to 5 times higher than the mean maximum plasma concentrations following a single oral dose of 100 mg in healthy male volunteers, the hemodynamic response to exercise was preserved in these patients. These results demonstrated that the effect of Fildena on the primary endpoint was statistically non-inferior to placebo.
Fildena is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (range 2563%). This metabolite has a PDE selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% of the parent drug. Renal Impairment: In volunteers with mild (CLcr=50-80 mL/min) and moderate (CLcr=30-49 mL/min) renal impairment, the pharmacokinetics of a single oral dose of Fildena (50 mg) were not altered.
The concomitant use of erythromycin or strong CYP3A4 inhibitors (https://www.drvolcanoe.com/fildena-side-effects/ saquinavir, ketoconazole, itraconazole) as well as the nonspecific CYP inhibitor, cimetidine, is associated with increased plasma levels of sildenafil see DOSAGE AND ADMINISTRATION. Population pharmacokinetic data from patients in clinical trials also indicated a reduction in sildenafil clearance when it was co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, or cimetidine) see DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS. This is consistent with ritonavir's marked effects on a broad range of P450 substrates.
In a study of healthy male volunteers, co-administration of sildenafil at steady state (80 mg t.i.d.) with endothelin receptor antagonist bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) at steady state (125 mg b.i.d.) resulted in a 63% decrease of sildenafil AUC and a 55% decrease in sildenafil Cmax Concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma levels of sildenafil. In healthy male volunteers, there was no evidence of a clinically significant effect of azithromycin (500 mg daily for 3 days) on the systemic exposure of sildenafil or its major circulating metabolite. Effects of Fildena on Other Drugs.
Given sildenafil peak plasma concentrations of approximately 1 ?M after recommended doses, it is unlikely that Fildena will alter the clearance of substrates of these isoenzymes.
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