LEVITRA Famacéutica Form and Formulation Each tablet contains: Vardenafil hydrochloride trihydrate equivalent to 5, 10 and 20 mg of vardenafil Excipient c.b.p. 1 tablet. Dosage and administration Usual recommended dose: The recommended starting dose is one tablet of 10 mg LEVITRA ® administered when necessary, about 25 to 60 minutes before the start of sexual activity. INDICATIONS: Treatment of erectile dysfunction (inability to achieve or maintain a penile erection adequate for satisfactory sexual performance yield). Pharmacokinetics: Pharmacokinetics Vardenafil is rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations 0.5 to 2 hours after oral administration. The mean absolute oral bioavailability is 15% (range: 8.1 to 25.2%). There is no clinically relevant interaction with food. When vardenafil is administered with a high fat meal, the rate of absorption is reduced, with a mean delay in Tmax of 1 hour and a mean reduction in Cmax of 20%. Vardenafil is metabolised predominantly by hepatic enzymes via CYP3A4, with some contribution from CYP3A5 and CYP2C9 isoforms. After oral administration, vardenafil is excreted as metabolites predominantly in the feces (approximately 91-95% of the administered dose) and to a lesser extent in the urine (approximately 2-6% of the administered dose) with a terminal half-life about 4 to 5 hours. In humans increased circulating metabolite (M1) showing a selectivity profile for phosphodiesterase-5 similar to vardenafil and inhibitory potency in vitro for phosphodiesterase-5 of approximately 28% compared to vardenafil is formed, resulting in a contribution to the effectiveness of about 7%. The metabolite is subject to other metabolic process, with a terminal half life of approximately 4-5 hours. The hepatic clearance of vardenafil is not significantly reduced in elderly patients. The pharmacokinetics of vardenafil does not change significantly in patients with renal impairment (including creatinine clearance <30 ml / min; severe renal insufficiency). In patients with hepatic impairment Child-Pugh classification A and B; elimination of vardenafil is reduced in proportion to the degree of hepatic dysfunction. No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh A). In patients with mild hepatic impairment (Child-Pugh A), the AUC and Cmax of vardenafil increased 1.2 times, ABC 17% and Cmax by 22%, compared with healthy controls subjects. In patients with moderate hepatic impairment (Child-Pugh B), the AUC of vardenafil increased 2.6 times (160%) and Cmax increased 2.3 times (130%) compared with healthy controls subjects. Not studied the pharmacokinetics of vardenafil in patients with severe hepatic impairment (Child-Pugh C). pharmacodynamics Pharmacotherapeutic group: Medicinal Product used for erectile dysfunction. Penile erection is a hemodynamic process based on the relaxation of smooth muscles of the corpora cavernosa and arterioles. During sexual stimulation, from nerve ends in the corpus cavernosum nitric oxide (NO), which activates the enzyme guanylate cyclase, which increases levels of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum is released. This, in turn, causes relaxation of vascular smooth muscle, increasing blood entering the penis vessels. The level of cGMP by synthesis via guanylate cyclase index first, and the rate of degradation via hydrolysis by phosphodiesterases (PDEs), is regulated by the other. The predominant PDE in the human corpus cavernosum is phosphodiesterase type 5 PDE-5, specific for cGMP. Through the inhibition of PDE-5, responsible for degradation of cGMP in the corpus cavernosum enzyme, vardenafil significantly increases the effect of endogenous NO to be released locally in the corpus cavernosum during sexual stimulation. Inhibition of PDE-5 by vardenafil leads to increased levels of cGMP in the corpus cavernosum and arteries, resulting in smooth muscle relaxation and concomitantly increased blood inflow into the corpora cavernosa. Thus, vardenafil potentiates the natural response to sexual stimulation. Clinical Studies: Vardenafil demonstrated clinically and statistically significant improvement in erectile function compared with placebo in all major efficacy studies, including special populations. In all global clinical studies vardenafil administered over 17,000 men with erectile dysfunction, many of which have multiple other conditions. Over 2,500 patients were treated with vardenafil for 6 months or more. Of these, 900 patients were treated for one year or more. In a randomized, double-blind, placebo-controlled, fixed-dose, based on a question of overall assessment (SGA), vardenafil at doses of 5, 10 and 20 mg, improved erections in 65, 80 and 85% of patients, respectively, at 6 months, compared with 28% of placebo. In the combined data of the main efficacy studies, including special populations, the percentage of patients who had successful penetration with her first dose of treatment was 68% with 10 mg of vardenafil, 70% with 20 and 37 mg of vardenafil % with placebo. Among patients who had successful penetration with her first dose, patients treated with 10 and 20 mg of vardenafil satisfactorily answered on average 86 and 90%, respectively, subsequent attempts during the study period of 3 months. Vardenafil was effective in patients, irrespective of baseline severity, etiology, organic, psychogenic and mixed, duration of ED, ethnicity and age, as determined in the subgroup analyzes.
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