bilateral nerve-sparing radical prostatectomy for prostate cancer, the mean age of patients was 58.4 years (range 40 – 70). The pharmacokinetics of avanafil in patients with severe renal disease or on renal 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. Additional maximum supine systolic/diastolic blood pressure decreases of 3.5/4.5 mm Hg and additional maximum pulse rate increase of 9.3 bpm were observed when avanafil was taken with alcohol compared to alcohol alone. Use of PDE5 inhibitors has been associated with sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness. The STENDRA or placebo doses were administered 3.3 hours after the tamsulosin administration on Days 8 and 11. Avanafil was not mutagenic in Ames assays. At the maternally toxic dose (1000 mg/kg/day), decreased fetal body weight occurred with no signs of teratogenicity. The IIEF is a 4-week recall questionnaire that was administered at baseline and at 4-week intervals during treatment. A causal relationship to STENDRA is uncertain. AUC0-inf increased by 9.1% and Cmax decreased by 2.8% in patients with moderate renal impairment, compared to healthy volunteers with normal renal function. The effect of strong CYP3A4 inhibitors, ketoconazole and ritonavir, and moderate CYP3A4 inhibitor, erythromycin, on avanafil pharmacokinetics was studied in an open-label, randomized, one-sequence crossover, three-way parallel study.Fifteen healthy male volunteers received 400 mg ketoconazole (2 tablets containing 200 mg ketoconazole) once daily for 5 days (Days 2-6) and a single 50 mg avanafil on Days 1 and 6. There may be new information. The pharmacokinetics of STENDRA are dose proportional from 12.5 to 600 mg.STENDRA is rapidly absorbed after oral administration, with a median Tmax of 30 to 45 minutes in the fasted state. The no observed There is no information on the presence of avanafil and/or its metabolites in human or animal milk, the effects on the
Patients should be counseled regarding the dosing of STENDRA. Studies have shown that drugs that inhibit CYP3A4 can increase avanafil exposure.Ketoconazole (400 mg daily), a selective and strong inhibitor of CYP3A4, increased STENDRA 50 mg single-dose systemic exposure (AUC) and maximum concentration (Cmax) equal to 13-fold and 3-fold, respectively, and prolonged the half-life of avanafil to approximately 9 hours. Adult Dosing . AUC0-inf decreased by 2.9% and Cmax increased by 2.8% in patients with mild renal impairment, compared to healthy volunteers with normal renal function. Two subjects experienced standing DBP values less than 45 mmHg following STENDRA. The SEP included diary-based measures of erectile function. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Patients should be made aware that both alcohol and PDE5 inhibitors including STENDRA act as mild vasodilators. Stendra avanafil. On Days 8 and 11, the subjects also received a single oral dose of either 200 mg STENDRA or placebo, according to the treatment randomization code. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.Physicians should advise patients to stop use of all PDE5 inhibitors, including STENDRA, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Co-administration with avanafil resulted in an approximate 5.7% increase in AUC0-inf and 5.2% increase in Cmax of desipramine.Repeated oral administration of avanafil in multiple species resulted in signs of centrally-mediated toxicity including ataxia, tremor, convulsion, hypoactivity, recumbency, and/or prostration at doses resulting in exposures approximately 5-8 times the MRHD based on Cmax and 8-30 times the MRHD based on AUC.STENDRA was evaluated in three randomized, double-blind, placebo-controlled, parallel trials of 2 to 3 months in duration.