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STAXYN (VARDENAFIL): PHARMACOKINETICS

The pharmacokinetics of vardenafil and its M1 metabolite from Staxyn (Vardenafil) tablets have been evaluated in healthy male volunteers (18.50 years) and in young (18.45 years) and elderly ( >= 65 years) erectile dysfunction patients. Studies have shown that Staxyn provides higher systemic exposure of vardenafil compared to vardenafil 10 mg film-coated tablets.

Absorption

The median time to reach Cmax (Tmax) in patients receiving Staxyn in the fasted state was 1.5 h [range: 0.75 - 2.5 h].

After administration of Vardenafil Hydrochloride (Staxyn) tablets to elderly ( >= 65 years) and young (18.45 years) patients with erectile dysfunction, mean vardenafil AUC was increased by 21 to 29%, respectively while mean Cmax was lower by 19% and 8%, respectively, in comparison to 10 mg vardenafil (film-coated tablets). In a study of healthy male volunteers (18.50 years), the mean Cmax and AUC of vardenafil from Staxyn were higher by 15% and 44%, respectively compared to 10 mg vardenafil film-coated tablets.

Vardenafil was not found to accumulate in plasma when Staxyn was dosed daily over ten days.

Effect of food

A high fat meal had no effect on vardenafil AUC and Tmax from Staxyn in healthy volunteers and reduced Cmax by 35%. Clinical trials for this medication were conducted without regard to meals. Staxyn (Vardenafil HCl) can be taken with or without food.

Effect of water

When Staxyn was swallowed with water, the AUC of vardenafil was reduced by 29% and median Tmax was shortened by 60 minutes while Cmax was not affected. In clinical trials, dosing was done without water. Staxyn (Vardenafil HCl) tablets should be taken without liquid.

Distribution

The mean steady-state volume of distribution (Vss) for vardenafil is 208 L, indicating extensive tissue distribution. Vardenafil and its major circulating metabolite, M1, are highly bound to plasma proteins (about 95% for parent drug and M1). This protein binding is reversible and independent of total drug concentrations.

Following a single oral dose of 20 mg vardenafil film-coated tablet in healthy volunteers, a mean of 0.00018% of the administered dose was obtained in semen 1.5 hours after dosing.

Metabolism

Vardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms. The major circulating metabolite, M1, results from desethylation at the piperazine moiety of vardenafil. M1 is subject to further metabolism. The plasma concentration of M1 is approximately 26% that of the parent compound. This metabolite shows a phosphodiesterase selectivity profile similar to that of vardenafil and an in vitro inhibitory potency for PDE5 28% of that of vardenafil. Therefore, M1 accounts for approximately 7% of total pharmacologic activity.

Excretion The mean terminal half-life of vardenafil in patients receiving Staxyn tablets varied between about 4.6 hours. The elimination half-life of the metabolite M1 is between 3 to 5 hours. After oral administration, vardenafil is excreted as metabolites predominantly in the feces (approximately 91.95% of administered oral dose) and to a lesser extent in the urine (approximately 2.6% of administered oral dose). Vardenafil is a high clearance drug with a plasma clearance of 56.4 L/h following intravenous administration.

Pharmacokinetics in Specific Populations

Pediatrics

Vardenafil (Staxyn) is not indicated for use in pediatric patients. This drug trials were not conducted in the pediatric population.

Geriatrics

Vardenafil AUC and Cmax in elderly patients (65 years or older) taking Staxyn were increased by 39% and 21%, respectively, in comparison to patients aged 45 years and below.

Hepatic Impairment

In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax and AUC following a 10 mg vardenafil (film-coated tablets) dose were increased by 22% and 17%, respectively, compared to healthy control subjects. In volunteers with moderate hepatic impairment (Child-Pugh B), the Cmax and AUC following a 10 mg vardenafil (film-coated tablets) dose were increased by 130% and 160%, respectively, compared to healthy control subjects. Vardenafil has not been evaluated in patients with severe (Child-Pugh C) hepatic impairment.

Renal Impairment

In volunteers with mild renal impairment (CLcr = 50.80 mL/min), the pharmacokinetics of vardenafil were similar to those observed in a control group with normal renal function. In the moderate (CLcr = 30.50 mL/min) or severe (CLcr < 30 mL/min) renal impairment groups, the AUC of vardenafil was 20.30% higher compared to that observed in a control group with normal renal function (CLcr > 80 mL/min). Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis.

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