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INNOPRAN-XL (PROPRANOLOL HYDROCHLORIDE): CLINICAL PHARMACOLOGY

General

Propranolol is a nonselective, beta-adrenergic receptor-blocking agent possessing no other autonomic nervous system activity. It specifically competes with beta-adrenergic receptor-stimulating agents for available receptor sites. When access to beta-receptor sites is blocked by propranolol, chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation are decreased proportionately. At dosages greater than required for beta blockade, InnoPran-XL (Propranolol) also exerts a quinidine-like or anesthetic-like membrane action, which affects the cardiac action potential. The significance of the membrane action in the treatment of arrhythmias is uncertain.

Mechanism of Action

The mechanism of the antihypertensive effect of InnoPran-XL (Propranolol) capsules has not been established. Among factors that contribute to the antihypertensive action are: decreased cardiac output, inhibition of renin release by the kidneys, and diminution of tonic sympathetic nerve outflow from vasomotor centers in the brain. Although total peripheral resistance may increase initially, it readjusts to or below the pretreatment level with chronic use of propranolol. Effects of propranolol on plasma volume appear to be minor and somewhat variable.

Pharmacodynamics and Clinical Effects

Hypertension

In a double-blind, parallel dose-response study in patients with mild-to-moderate hypertension (n=434), doses of InnoPran-XL from 80 to 640 mg were taken once daily at approximately 10 p.m. InnoPran-XL (Propranolol) significantly lowered sitting systolic and diastolic blood pressure when measurements were taken approximately 16 hours later. The placebo-subtracted diastolic blood pressure effect for the 80- and 120-mg doses was -3.0 and -4.0 mm Hg, respectively. Higher doses of InnoPran-XL (160, 640 mg) had no additional blood-pressure lowering effect when compared with 120 mg. The antihypertensive effects of InnoPran-XL were seen in the elderly (>= 65 years old) and men and women. There were too few non-white patients to assess the efficacy of InnoPran-XL (Propranolol) capsules in these patients.

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