Innopran XL (Propranolol Hydrochloride) - Indications and Dosage

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 10PM. InnoPran XL 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 were -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 (greater than or equal to 65 years old) and men and women. There were too few non-White patients to assess the efficacy of InnoPran XL in these patients.

INDICATIONS AND USAGE

Hypertension

InnoPran XL is indicated in the management of hypertension; it may be used alone or in combination with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

InnoPran XL should be administered once daily at bedtime (approximately 10 PM) and should be taken consistently either on an empty stomach or with food. The starting dose is 80 mg but dosage should be individualized and titration may be needed to a dose of 120 mg. In the clinical trial, doses of InnoPran XL above 120 mg had no additional effects on blood pressure (See PHARMACODYNAMICS AND CLINICAL EFFECTS). The time needed for full antihypertensive response is variable, but is usually achieved within 2-3 weeks.

HOW SUPPLIED

InnoPran XL (propranolol hydrochloride) Extended Release Capsules

Each gray/white capsule, imprinted with “80”, 2 segmented bands, “InnoPran XL”, and Reliant logo contains 80 mg of propranolol hydrochloride in bottles of 30 (NDC 65726-250-10), bottles of 100 (NDC 65726-250-25), bottles of 500 (NDC 65726-250-35), and a Unit Dose package of 100 (NDC 65726-250-90).

Each gray/off-white capsule, imprinted with “120”, 3 segmented bands, “InnoPran XL”, and Reliant logo contains 120 mg of propranolol hydrochloride in bottles of 30 (NDC 65726-251-10) bottles of 100 (NDC 65726-251-25), bottles of 500 (NDC 65726-251-35), and a Unit Dose package of 100 (NDC 65726-251-90).

Store at 25ºC (77ºF); excursions permitted to 15 - 30ºC (59 - 86ºF) [see USP Controlled Room Temperature] in a tightly closed container. The unit dose packaging should be stored in the carton.

Rx only

January, 2005

Manufactured for:

Reliant Pharmaceuticals, Inc.

Liberty Corner, NJ 07938, USA

By:

Eurand America, Inc.

Vandalia, OH 45377, USA

Address Medical Inquiries to:

Reliant Pharmaceuticals, Inc.

Medical Affairs

110 Allen Road

Liberty Corner, NJ 07938, USA

©2005 Reliant Pharmaceuticals, Inc.

PRINTED IN USA

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