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INNOPRAN-XL (PROPRANOLOL HYDROCHLORIDE): SPECIAL POPULATIONS (see "References")

Pediatric

The pharmacokinetics of Propranolol (InnoPran-XL) have not been investigated in patients younger than 18 years of age.

Geriatric

The pharmacokinetics of Propranolol (InnoPran-XL) capsules have not been investigated in patients older than 65 years. In a study of 12 elderly (62 to 79 years old) and 12 young (25 to 33 years old) healthy subjects, the clearance of the S-enantiomer of propranolol was decreased in the elderly. Additionally, the half-lives of both R- and S-propranolol were prolonged in the elderly compared with the young (11 hours versus 5 hours).

Gender

In a dose-proportionality study, the pharmacokinetics of Propranolol HCl (InnoPran-XL) were evaluated in 22 male and 14 female healthy volunteers. Following single doses under fasting conditions, the mean AUC and Cmax were about 49% and 16% higher for females across the dosage range. The mean elimination half-life was longer in females than in males (11 hours versus 7.5 hours).

Race

A study conducted in 12 white and 13 African-American male subjects taking propranolol showed, that at steady state, the clearance of R- and S-propranolol were about 76% and 53% higher in African-Americans than in whites, respectively.

Renal Insufficiency

The pharmacokinetics of Propranolol HCl (InnoPran-XL) capsules have not been evaluated in patients with renal insufficiency. In a study conducted in 5 patients with chronic renal failure, 6 patients on regular dialysis, and 5 healthy subjects, who received a single oral dose of 40 mg of propranolol, the peak plasma concentrations (Cmax) of propranolol in the chronic renal failure group were 2- to 3-fold higher (161±41 ng/mL) than those observed in the dialysis patients (47±9 ng/mL) and in the healthy subjects (26±1 ng/mL). Propranolol plasma clearance was also reduced in the patients with chronic renal failure.

Chronic renal failure has been associated with a decrease in drug metabolism via down regulation of hepatic cytochrome P450 activity. Propranolol is not significantly dialyzable.

Hepatic Insufficiency

The pharmacokinetics of Propranolol Hydrochloride (InnoPran-XL) have not been evaluated in patients with hepatic impairment. However, propranolol is extensively metabolized by the liver. In a study conducted in 7 patients with cirrhosis and 9 healthy subjects receiving 80 mg oral propranolol every 8 hours for 7 doses, the steady-state unbound propranolol concentration in patients with cirrhosis was increased 3-fold in comparison to controls. In cirrhosis, the half-life increased to 11 hours compared to 4 hours.

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