Use in Specific Populations STENDRA(Avanafil)
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Pregnancy
Pregnancy Category C
STENDRA isn't indicated for easily use in women. There isn't any adequate and well-controlled studies of STENDRA in expectant women.
Fetal Risk Summary
Based upon animal data, STENDRA is predicted to have a safe 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 proof of teratogenicity, embryotoxicity, or fetotoxicity was observed at exposures as much as approximately 8 times the exposure with the Maximum Recommended Human Dose (MRHD) of 200 mg dependant 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 when using AUC basis, decreased fetal obesity occurred without any 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 around approximately 6 times the human being exposure at the MRHD dependant on AUC. With the high dose regarding maternally-reduced body weights, increased postimplantation loss was observed in line with increased late resorptions.
Within 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 higher than or corresponding to 300 mg/kg/day causing exposures in excess of or corresponding to 17 times the human beings exposure. There was no effects on reproductive performance of the maternal rats or offspring, or on the behavior on the offspring at up to the best dose tested. The no observed adverse effect level (NOAEL) for developmental toxicity (100 mg/kg/day) was approximately 2-fold higher than the systemic exposure in humans in the MRHD.
Pediatric Use
STENDRA will not be indicated for used in pediatric patients. Safety and efficacy in patients below the age of 18 years hasn't been established.
Geriatric Use
Of your final amount of subjects in clinical studies of avanafil, approximately 23% were 65 as well as over. No overall differences in efficacy and safety were observed between subjects over 65 years of age in comparison to younger subjects; therefore no dose adjustment is warranted based upon age alone. However, a better sensitivity to medication in certain older individuals should be thought about [See Clinical Pharmacology ]
Renal Impairment
Inside of a clinical pharmacology trial using single 200 mg doses of STENDRA, avanafil exposure (AUC or Cmax) in normal subjects was comparable to patients with mild (creatinine clearance greater than or add up to 60 to under 90 mL/min) or moderate (creatinine clearance higher than or corresponding to 30 to under 60 mL/min) renal impairment. No dose adjustment is needed for patients with mild to moderate renal impairment (creatinine clearance higher than or corresponding to 30 to a lot less than 90 mL/min). The pharmacokinetics of avanafil in patients with severe renal disease or on renal dialysis isn't studied; avoid the use of STENDRA in such patients [see Clinical Pharmacology ]
Hepatic Impairment
Inside a clinical pharmacology trial, avanafil AUC and Cmax in patients with mild hepatic impairment (Child-Pugh Class A) was akin to that in healthy subjects each time 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) in comparison with subjects with normal hepatic function. No dose adjustment is critical for patients with mild to moderate hepatic impairment (Child Pugh Class A or B).
pharmacokinetics of avanafil in patients with severe hepatic disease has not been studied; avoid the use of STENDRA in such patients [see Clinical Pharmacology ].
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