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STAXYN (VARDENAFIL): USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category B

Staxyn (Vardenafil HCl) is not indicated for use in women. There are no studies of Staxyn use in pregnant women.

No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis. This dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the AUC values for unbound vardenafil and its major metabolite in humans given the maximum recommended human dose (MRHD) of 20 mg.

In the rat pre-and postnatal development study, the NOAEL (no observed adverse effect level) for maternal toxicity was 8 mg/kg/day. Retarded physical development of pups in the absence of maternal effects was observed following maternal exposure to 1 and 8 mg/kg possibly due to vasodilatation and/or secretion of the drug into milk. The number of living pups born to rats exposed pre- and postnatally was reduced at 60 mg/kg/day. Based on the results of the pre- and postnatal study, the developmental NOAEL is less than 1 mg/kg/day. Based on plasma exposures in the rat developmental toxicity study, 1 mg/kg/day in the pregnant rat is estimated to produce total AUC values for unbound vardenafil and its major metabolite comparable to the human AUC at the MRHD of 20 mg. There are no adequate and well-controlled trials of vardenafil in pregnant women.

Nursing Mothers

Staxyn (Vardenafil HCl) tablets is not indicated for use in women. It is not known if vardenafil is excreted in human breast milk.

Vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma. Following a single oral dose of 3 mg/kg, 3.3% of the administered dose was excreted into the milk within 24 hours.

Pediatric Use

Staxyn is not indicated for use in pediatric patients. Safety and efficacy in children has not been established.

Geriatric Use

Vardenafil AUC and Cmax in elderly patients (65 years or older) taking Vardenafil (Staxyn) were increased by 39% and 21%, respectively, in comparison to patients aged 45 years and below. No overall differences in safety or effectiveness were observed between patients >= 65 years old and those < 65 years old in placebo-controlled clinical trials.

Hepatic Impairment

Do not use Vardenafil (Staxyn) tablets in patients with moderate or severe 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. Staxyn can be used in patients with mild hepatic impairment. 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. Do not use Staxyn (Vardenafil Hydrochloride) in patients with moderate to severe hepatic impairment.

Renal Impairment

Do not use Staxyn (Vardenafil Hydrochloride) tablets in patients on renal dialysis.

In volunteers with mild renal impairment (CLcr = 50.80 mL/min), the pharmacokinetics of vardenafil 20 mg film-coated tablets 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). Staxyn can be used in patients with mild, moderate or severe renal impairment. Do not use Vardenafil HCl (Staxyn) in patients on renal dialysis as vardenafil has not been evaluated in such patients.

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