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CARDURA® (XL) (doxazosin mesylate extended release tablets) Use in Specific Populations

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

CARDURA XL is not indicated for use in females and is not indicated for the treatment of hypertension. The limited available data with CARDURA XL in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of doxazosin to pregnant rats and rabbits at doses of up to 10 and 4 times, respectively, the 12 mg/day recommended dose. Postnatal development was delayed in rats at a dose of 8 times the 12 mg/day recommended dose [see Data].

Data

Animal Data

Radioactivity was found to cross the placenta following oral administration of labeled doxazosin to pregnant rats. Studies in pregnant rabbits and rats at daily oral doses of up to 41 and 20 mg/kg, respectively (plasma drug concentrations of 10 and 4 times, respectively, the human AUC exposures with a 12 mg/day therapeutic dose), during organogenesis have revealed no evidence of adverse developmental effects. A dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival. In peri- and postnatal studies in rats, postnatal development at maternal doses of 40 or 50 mg/kg/day of doxazosin (about 8 times human AUC exposure with a 12 mg/day therapeutic dose) was delayed, as evidenced by slower body weight gain and slightly later appearance of anatomical features and reflexes.

8.2 Lactation

Risk Summary

CARDURA XL is not indicated for use in females and is not indicated for the treatment of hypertension. Doxazosin is present in human milk. There is no information on the effects of CARDURA XL on the breastfeed infant or the effects on milk production.

8.4 Pediatric Use

The safety and effectiveness of CARDURA XL in pediatric patients have not been established.

8.5 Geriatric Use

The incidence of hypotension with CARDURA XL use appears to be age related and more prevalent in patients 70 years or older. At steady state, increases of 27% in maximum plasma concentrations (Cmax) and 34% in the area under the concentration-time curve (AUC) were seen in the elderly (>65 years old) compared to the young [see Clinical Pharmacology (12.3)].

Of the 666 patients with BPH who received CARDURA XL in the two controlled clinical efficacy and safety studies, 325 patients (49%) were 65 years of age or older. One hundred thirty-six patients treated with CARDURA XL (20%) were >70 years of age.

In these two studies, the cumulative incidence of hypotension appeared to be age related. The reason for an increased incidence of hypotension in patients older than 70 years of age may be related to a modest increase in systemic exposure to doxazosin [see Clinical Pharmacology (12.3)], to an increased propensity to orthostasis in the elderly, or to an enhanced sensitivity to vasodilatory agents in the elderly. The incidence of hypotension reported as an adverse reaction was higher in patients 70 years of age and older (4/136; 2.9%) as compared to patients < 70 years of age (7/530; 1.3%).

8.6 Hepatic Impairment

Since there is no clinical experience in patients with severe hepatic impairment, use in these patients is not recommended. CARDURA XL should be administered with caution to patients with mild or moderate hepatic impairment [see Warnings and Precautions (5.6), Clinical Pharmacology (12.3)].

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