ifferent laboratories, there is equivocal evidence for a genotoxic effect of propranolol HCl in bacteria (S. typhimurium strain TA 1538).
14 CLINICAL STUDIES
14.1 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 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 in these patients.
16 HOW SUPPLIED/STORAGE AND HANDLING
INNOPRAN XL (propranolol hydrochloride) Extended-Release Capsules are supplied as capsules containing either 80 mg, or 120 mg propranolol hydrochloride imprinted with “InnoPran XL”.
Strength Color Bands NDC 24090-xxx-xx
Bottle/30 Bottle/100
80 mg Gray/white 2 450-85 450-88
120 mg Gray/off-white 3 451-85 451-88
Storage: Store at 25ºC (77ºF); excursions permitted to 15º and 30ºC (59º and 86ºF) [see USP Controlled Room Temperature] in a tightly closed container.
17 PATIENT COUNSELING INFORMATION
Patient Advice
Advise patients:
Do not interrupt or discontinue using INNOPRAN XL without a physician’s advice.
Patients with heart failure should consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.
Inform diabetic patients that certain signs of hypoglycemia may be masked. Patients should report any changes in blood sugar levels to their physician.
For further product information, please visit www.akrimax.com or call our medical communications department toll-free at 1-888-383-1733.
Manufactured for:
Akrimax Pharmaceuticals, LLC
Cranford, NJ 07016
By: Adare Pharmaceuticals, Inc.
Vandalia, OH 45377
Marketed and distributed by:
Akrimax Pharmaceuticals, LLC
Cranford, NJ 07016
Innopran XL®, a DIFFUCAPS® drug delivery product manufactured by Adare
Pharmaceuticals, Inc., Vandalia, OH 45377
245F005
Rev. 05/15
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 80 mg Capsule
NDC 24090-450-85
InnoPran XL®
(propranolol HCl)
Extended Release
Capsules
80 mg
Rx only
30 Capsules
PRINCIPAL DISPLAY PANEL - 80 mg Capsule NDC 24090-450-85 InnoPran XL® (propranolol HCl) Extended Release Capsules 80 mg Rx only 30 Capsules
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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 120 mg Capsule
NDC 24090-451-85
InnoPran XL®
(propranolol HCl)
Extended Release
Capsules
120 mg
Rx only
30 Capsules
PRINCIPAL DISPLAY PANEL - 120 mg Capsule NDC 24090-451-85 InnoPran XL® (propranolol HCl) Extended Release Capsules 120 mg Rx only 30 Capsules
CLOSE
INGREDIENTS AND APPEARANCE
INNOPRAN XL
propranolol hydrochloride capsule, extended
