Hypertension

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

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.

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.

June 2007. Distributed by: Reliant Pharmaceuticals, Inc.Liberty Corner, NJ 07938, USA. Address Medical Inquiries to: Reliant Medical Inquiries c/o PPD, 2655 Meridian Parkway Durham, NC 27713-2203 or Call: 877-311-7515. FDA rev date: 1/2/2008.

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