WARNING: CARDIAC ISCHEMIA AFTER ABRUPT DISCONTINUATION
Following abrupt discontinuation of therapy with beta-blockers, exacerbations of angina pectoris and myocardial infarction have occurred.
When discontinuing chronically administered INNOPRAN XL, particularly in patients with ischemic heart disease, gradually reduce the dose over a period of 1-2 weeks and monitor the patients. If angina markedly worsens or acute coronary insufficiency develops, promptly resume therapy, at least temporarily and take other measures appropriate for the management of unstable angina. Warn patients against interruption or discontinuation of therapy without physician’s advice.
Because coronary artery disease is common and may be unrecognized, avoid abrupt discontinuation of INNOPRAN XL therapy even in patient treated only for hypertension. (5.1)
INNOPRAN XL SUMMARY
INNOPRAN XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended- release product. INNOPRAN XL is available as 80 mg and 120 mg capsules which contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol.
INNOPRAN XL® is 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programs Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Media Articles Related to Innopran XL (Propranolol)
Targeted Therapies May Ease Severe Pulmonary Hypertension
Source: Medscape Critical Care Headlines [2015.09.29]
A new analysis has spotted a mortality reduction in patients with severe pulmonary hypertension caused by lung disease, but doubts remain.
Medscape Medical News
Targeting hypertension by helping pharmacists deliver enhanced patient care
Source: Hypertension News From Medical News Today [2015.09.21]
Patients with high blood pressure are benefiting from the expanded role played by pharmacists in Alberta, according to a new study from the University of Alberta's Faculty of Medicine & Dentistry.
Hypertension drug reduces inflammation from traumatic brain injury
Source: Hypertension News From Medical News Today [2015.09.21]
A new study on the processes causing inflammation after a TBI identifies a protein produced in the liver that can be blocked using a drug for hypertension.
New imaging technique reveals early brain damage caused by hypertension
Source: Hypertension News From Medical News Today [2015.09.18]
Researchers have found that a new imaging technique known as diffusion tensor imaging can show when high blood pressure causes early damage to neural pathways in the brain.
Popular hypertension drugs linked to worse heart health in blacks compared to whites
Source: Hypertension News From Medical News Today [2015.09.16]
Drugs commonly used to treat high blood pressure, and prevent heart attacks and strokes, are associated with significantly worse cardiovascular outcomes in hypertensive African Americans compared...
Published Studies Related to Innopran XL (Propranolol)
The study of antiarrhythmic medications in infancy (SAMIS): a multicenter,
randomized controlled trial comparing the efficacy and safety of digoxin versus
propranolol for prophylaxis of supraventricular tachycardia in infants. 
CONCLUSIONS: There was no difference in SVT recurrence in infants treated with
Status of propranolol for treatment of infantile hemangioma and description of a randomized clinical trial. [2011.10]
OBJECTIVES: Our primary objective was to review the current use of propranolol for treatment of infantile hemangioma (IH), specifically regarding 1) the age at initiation of therapy, 2) the method of initiation, 3) the use of other adjuvant therapy, 4) the duration of therapy and relapse rate, 5) the adverse events, and 6) the outcome. Our secondary objective was to describe a randomized, controlled, single-blinded trial comparing propranolol to prednisolone for treatment of IH... CONCLUSIONS: Propranolol is an attractive alternative to other treatments for IH. Despite apparent widespread use of this medication, the data are limited, and prospective studies are lacking for this indication. The relatively high rate of adverse effects supports the need for careful monitoring of patients on this therapy. Fastidious reporting of adverse events and objective evaluation of early and late outcomes are necessary to improve our understanding of the use of propranolol for this indication.
A randomized controlled trial of propranolol for infantile hemangiomas. [2011.08]
OBJECTIVE: Propranolol hydrochloride is a safe and effective medication for treating infantile hemangiomas (IHs), with decreases in IH volume, color, and elevation... CONCLUSION: Propranolol hydrochloride administered orally at 2 mg/kg per day reduced the volume, color, and elevation of focal and segmental IH in infants younger than 6 months and children up to 5 years of age.
Endoscopic variceal band ligation compared with propranolol for prophylaxis of first variceal bleeding. [2011.04]
Administration of nonselective beta-blockers in prophylaxis of first variceal bleeding is not suitable for all patients. Thus, we evaluated endoscopic variceal band ligation (EVBL) in primary prevention of bleeding in patients with cirrhosis and large esophageal varices... In conclusion, EVBL was an effective and safe alternative to propranolol in primary prophylaxis of bleeding in patients with large esophageal varices.
Effect of propranolol on word fluency in autism. [2011.03]
OBJECTIVE AND BACKGROUND: Autism is characterized by repetitive behaviors and impaired socialization and communication. Preliminary evidence showed possible language benefits in autism from the beta-adrenergic antagonist propranolol. Earlier studies in other populations suggested propranolol might benefit performance on tasks involving a search of semantic and associative networks under certain conditions. Therefore, we wished to determine whether this benefit of propranolol includes an effect on semantic fluency in autism... CONCLUSIONS: Results are consistent with a selective beneficial effect of propranolol on flexibility of access to semantic and associative networks in autism, with no observed effect on phonological networks. Further study will be necessary to understand potential clinical implications of this finding.
Clinical Trials Related to Innopran XL (Propranolol)
Propanolol and Red Cell Adhesion Non-asthmatic Children Sickle Cell Disease [Recruiting]
Propanolol is a beta blocker which has been found to inhibit the ability of epinephrine to
upregulate sickle red cell adhesion to laminin and endothelial cells in vitro. The purpose
of this pilot study is to administer one dose of propanolol to children with sickle cell
disease and to measure pre and post dose red cell adhesion. The hypothesis is that a single
dose of propanolol will decrease red cell adhesion to laminin and endothelial cells as
compared to baseline.
Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD) [Recruiting]
Understanding what treatments may facilitate perioperative care of Veterans with
posttraumatic stress disorder (PTSD) is of great importance to the U. S. health care system.
Patients with PTSD are characterized by elevated central nervous system catecholamine
concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At
present, there are no data on the effects of perioperative beta blocker therapy in patients
with PTSD, despite the rising significance of PTSD in Veteran populations.
This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled
for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to
either a 14-day course of propranolol or placebo. This study will then follow these
Veterans for a one-year period to evaluate the effects of the intervention on Veterans'
The investigators hypothesize that patients with PTSD randomized to the propranolol group
will demonstrate a reduced incidence of perioperative and postoperative morbidity and
Efficacy of Propranolol Treatment to Prevent Melanoma Progression [Not yet recruiting]
Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to
an earlier detection of the primary tumour and a better prognosis, but melanoma remains an
aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies
compared groups of patients diagnosed with primary melanoma and treated with betablockers
for another indication to patients who never received betablockers. In these three studies,
the outcome of the disease is significantly better for people under betablocker treatment
with a decreased rate of recurrence and a better 5 years survival rate. Here we want to
investigate the efficacy and the tolerability of an adjuvant treatment with propranolol for
patients suffering from a primary melanoma with a high risk of recurrence.
Study of Propranolol in Newly Diagnosed Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy [Recruiting]
This study is being conducted in patients with newly diagnosed breast cancer that will be
undergoing chemotherapy prior to surgery - neoadjuvant chemotherapy. The study involves
treatment with standard chemotherapy and a commonly used, FDA-approved, blood pressure drug
called propranolol (Inderal). The purposes of this study are to:
1. Determine the effect of propranolol plus chemotherapy on breast cancer cells as well as
the growth of blood vessels surrounding breast cancer cells.
2. Determine the side effect profile of propranolol and chemotherapy in patients with
breast cancer receiving neoadjuvant chemotherapy.
This research is being done because previous laboratory work has shown that propranolol may
decrease the ability for the blood vessels around breast cancer cells to grow, which may be
important in helping cancer cells grow. It also may reduce the likelihood for breast cancer
cells to spread. If changes are seen in the breast cancer cells and surrounding blood
vessels in this study, we will pan to evaluate whether propranolol decreases the likelihood
of breast cancer from recurring in future, later studies. The use of propranolol is
experimental in this study.
Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH) [Terminated]
This is a prospective randomized, double-blind study to compare the clinical efficacy of
infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy
with corticosteroids and placebo. We hypothesize that a two-month treatment period with
propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and
vascularity when compared to corticosteroids used without propranolol for the same time
Page last updated: 2015-09-29