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 INDERAL 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 INDERAL XL therapy even in patient treated only for hypertension. (5.1)
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INDERAL XL SUMMARY
INDERAL XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product.
INDERAL® 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.
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NEWS HIGHLIGHTS
Published Studies Related to Inderal XL (Propranolol)
Oral propranolol--efficacy and comparison of two doses for peri-operative
anxiolysis. [2012] Patients undergoing surgery are having high levels of anxiety and stress.
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. [2012] CONCLUSIONS: There was no difference in SVT recurrence in infants treated with
Efficacy and safety of cinnarizine in the prophylaxis of migraine headaches in
children: an open, randomized comparative trial with propranolol. [2012] Migraine headaches are common in children...
A randomized trial of propranolol versus sodium valproate for the prophylaxis of
migraine in pediatric patients. [2010] valproate in the prevention of migraine in the pediatric population... CONCLUSION: This prospective study supports the efficacy of propranolol and
P3MC: a double blind parallel group randomised placebo controlled trial of
Propranolol and Pizotifen in preventing migraine in children. [2010] BACKGROUND: A recent Cochrane Review demonstrated the remarkable lack of reliable
clinical trials of migraine treatments for children, especially for the two most
prescribed preventative treatments in the UK, Propranolol and Pizotifen.Migraine
trials in both children and adults have high placebo responder rates, e.g...
Clinical Trials Related to Inderal 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.
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.
Propranolol Treatment of Traumatic Memories (PTTM) [Recruiting]
This study will compare the responses of subjects with traumatic memories of varying
vintages to either propranolol or placebo in a double-blind setting. It is hypothesized that
those subjects who receive propranolol will experience less emotional distress when the
memory is subsequently reactivated and less spontaneous re-experiences.
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'
surgical outcomes.
The investigators hypothesize that patients with PTSD randomized to the propranolol group
will demonstrate a reduced incidence of perioperative and postoperative morbidity and
mortality.
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
period.
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