Avanafil Information

Where to Buy Avanafil Online?
It was approved by the FDA in April of 2012 and the official brand name it was given by it's manufacturer Vivus is Stendra. You can now officially order Avanafil.
 
Buy Avanafil
There is a protein in the body that prevents blood vessels from expanding. Avanafil in essence prevents or blocks this protein so blood vessels can expand. Thus allowing blood to enter the penis and become erect during times of sexual excitement. Its premises is similar to that of vardenafil, sildenafil and tadalafil.
 
Avanafil
"If things are heated up, theoretically you can get improved function earlier, within 15 minutes, with this drug," said Dr. Irwin Goldstein, director of sexual medicine at Alvarado Hospital in San Diego, and co-author of a recent study about Avanafil in the Journal of Sexual Medicine. "You can argue this is the first potential on-demand drug." The "on-demand" drug could end up in high demand for men with ED who do not respond to drugs like Sildenafil, Tadalafil and Vardenafil.

USE IN SPECIFIC POPULATIONS

Pregnancy Category C
Avanafil is not indicated for use in women. There are no adequate and well-controlled studies of Avanafil in pregnant women.

Fetal Risk Summary
Based on animal data, Avanafil is predicted to have a low risk for major developmental abnormalities in humans.

Animal Data
In pregnant rats administered 100, 300, or 1000 mg/kg/day from gestation days 6 to 17, no evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed at exposures up to approximately 8 times the exposure at the Maximum Recommended Human Dose (MRHD) of 200 mg based on AUCs for total avanafil (protein bound plus free avanafil). At the maternally toxic dose (1000 mg/kg/day), a dose producing exposures approximately 30 times the MRHD on an AUC basis, decreased fetal body weight occurred with no signs of teratogenicity. In pregnant rabbits administered 30, 60, 120, or 240 mg/kg/day from gestation days 6 to 18, no teratogenicity was observed at exposures up to approximately 6 times the human exposure at the MRHD based on AUC. At the high dose associated with maternally-reduced body weights, increased postimplantation loss was observed consistent with increased late resorptions. In a pre- and post-natal development study in rats given 100, 300, or 600 mg/kg/day on gestation days 6 through lactation day 20, offspring growth and maturation were reduced when maternal rats were given avanafil doses greater than or equal to 300 mg/kg/day resulting in exposures greater than or equal to 17 times the human exposure. There was no effect on reproductive performance of the maternal rats or offspring, or on the behavior of the offspring at up to the highest dose tested. The no observed adverse effect level (NOAEL) for developmental toxicity (100 mg/kg/day) was approximately 2-fold greater than the systemic exposure in humans at the MRHD.

Pediatric Use
Avanafil is not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years has not been established.

Geriatric Use
Of the total number of subjects in clinical studies of avanafil, approximately 23% were 65 and over. No overall differences in efficacy and safety were observed between subjects over 65 years of age compared to younger subjects; therefore no dose adjustment is warranted based on age alone. However, a greater sensitivity to medication in some older individuals should be considered.

Renal Impairment
In a clinical pharmacology trial using single 200 mg doses, avanafil exposure (AUC or Cmax) in normal subjects was comparable to patients with mild (creatinine clearance greater than or equal to 60 to less than 90 mL/min) or moderate (creatinine clearance greater than or equal to 30 to less than 60 mL/min) renal impairment. No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance greater than or equal to 30 to less than 90 mL/min). The pharmacokinetics of avanafil in patients with severe renal disease or on renal dialysis has not been studied; do not use Avanafil in such patients.

Hepatic Impairment
In a clinical pharmacology trial, avanafil AUC and Cmax in patients with mild hepatic impairment (Child-Pugh Class A) was comparable to that in healthy subjects when a dose of 200 mg was administered. Avanafil Cmax was approximately 51% lower and AUC was 11% higher in patients with moderate hepatic impairment (Child Pugh Class B) compared to subjects with normal hepatic function. No dose adjustment is necessary for patients with mild to moderate hepatic impairment (Child Pugh Class A or B). The pharmacokinetics of avanafil in patients with severe hepatic disease has not been studied; do not use Avanafil in such patients.

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