HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use INNOPRAN XL safely and effectively. See full prescribing information for INNOPRAN XL.  
INNOPRAN XL(propranolol hydrochloride) extended release capsules, for oral use
Initial U.S. Approval: 2003
WARNING: CARDIAC ISCHEMIA AFTER ABRUPT DISCONTINUATION SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Following abrupt cessation of therapy with beta-blockers, exacerbations of angina pectoris and myocardial infarction have occurred. Warn patients against interruption or discontinuation of therapy without physician advice. (5.1)
INDICATIONS AND USAGE
INNOPRAN XL is a beta adrenergic blocker indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1)
Limitation of Use: INNOPRAN XL is not indicated for the treatment of hypertensive emergencies. (1)
DOSAGE AND ADMINISTRATION
Administer once daily at bedtime consistently either on an empty stomach or with food. (2)
Initiate dosage at 80 mg and titrate up to 120 mg if needed. (2)
DOSAGE FORMS AND STRENGTHS
Capsules: 80 mg, 120 mg. (3)
CONTRAINDICATIONS
Cardiogenic shock and decompensated heart failure. (4)
Sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place. (4)
Bronchial asthma. (4)
Hypersensitivity to propranolol or any of the components of INNOPRAN XL. (4)
WARNINGS AND PRECAUTIONS
May worsen congestive heart failure. (5.2)
Avoid discontinuing therapy prior to major surgery (5.3)
Diabetes: May mask symptoms of hypoglycemia. (5.4)
Bradycardia. (5.6)
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥3% and greater than placebo) included the following: fatigue, dizziness, and constipation. (6.1
To report SUSPECTED ADVERSE REACTIONS, contact Akrimax Pharmaceuticals, LLC at 1-888-383-1733 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP2D6, 1A2, or 2C19 enzyme inhibitors increase propranolol levels (7.1)
CYP1A2 and 2C19 inducers decrease propranolol levels (7.1)
Monitor prothrombin time when propranolol is co-administered with warfarin. (7.1)
USE IN SPECIFIC POPULATIONS
Pregnancy, Labor and Delivery: Neonates whose mothers received propranolol at parturition have exhibited bradycardia, hypoglycemia, and/or respiratory depression. (8.2)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 11/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CARDIAC ISCHEMIA AFTER ABRUPT DISCONTINUATION
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Cardiac Ischemia after Abrupt Discontinuation
5.2 Cardiac Failure
5.3 Maintain During Major Surgery
5.4 Masked Signs of Hypoglycemia
5.5 Thyrotoxicosis
5.6 Bradycardia
5.7 Reduced Effectiveness of Epinephrine in Treating Anaphylaxis
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Pharmacokinetic Drug-Drug Interactions
7.2 Pharmacodynamic Drug-Drug Interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery