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InnoPran XL

Generic Name: Propranolol Hydrochloride
Drug Category: Beta Blocker
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 2 years.

Approved Uses

Indicated for the treatment of hypertension, to lower blood pressure.

INNOPRAN XL is not indicated for the treatment of hypertensive emergencies.

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.

INNOPRAN XL may mask clinical signs of hyperthyroidism, such as tachycardia.

Beta-blockers, like INNOPRAN XL, may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.

Avoid abrupt withdrawal of beta-blockade, which may precipitate a thyroid storm.

Beta-blockers, like INNOPRAN XL, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock.

Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of INNOPRAN XL. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders (including Wolff-Parkinson-White) may be at increased risk. The concomitant use of beta adrenergic blockers and non-dihydropyridine calcium channel blockers (e.g., verapamil and diltiazem), digoxin or clonidine increases the risk of significant bradycardia.

INNOPRAN XL is contraindicated in patients with:

  • Cardiogenic shock or decompensated heart failure
  • Sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place
  • Bronchial asthma

Beta adrenergic blocker-treated patients treated with epinephrine for a severe anaphylactic reaction may be less responsive to the typical doses of epinephrine. In these patients, consider other medications (e.g., intravenous fluids, glucagon).

Chronically administered beta-blocking therapy, including INNOPRAN XL, should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

Warfarin concentrations are increased when administered with propranolol.Warfarin concentrations are increased when administered with propranolol.

Co-administration of propranolol increases the plasma concentrations of propafenone. Monitor patients for symptoms of excessive exposure to propafenone including bradycardia and postural hypotension.

CYP2D6, CYP1A2 and CYP2C19 Inhibitors: CYP2D6 inhibitors (e.g. bupropion, fluoxetine, paroxetine, quinidine), CYP1A2 inhibitors (e.g., ciprofloxacin, enoxamine, fluvoxamine) and CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) increase exposure to propranolol when co-administered with INNOPRAN XL. Monitor patients for bradycardia and hypotension.

CYP1A2 and CYP2C19 Inducers: CYP1A2 inducers (e.g., phenytoin, montelukast, smoking) and CYP2C19 inducers (e.g. rifampin) decrease the plasma levels of propranolol resulting in a loss of efficacy.

Co-administered cholestyramine or colestipol significantly reduces the plasma concentrations of co-administered propranolol which may result in loss of efficacy.

Beta-blockers may antagonize the antihypertensive effects of clonidine, and rebound hypertension may result if clonidine is withdrawn abruptly. If clonidine and a beta-blocker are co-administered, withdraw the beta-blocker several days before the withdrawal of clonidine.

Co-administration of beta-blockers with alpha-blocker (e.g., prazosin) has been associated with prolongation of first dose hypotension and syncope.

Propranolol may reduce sensitivity to dobutamine stress echocardiography in patients undergoing evaluation for myocardial ischemia.

The hypotensive effect of MAO inhibitors or tricyclic antidepressants may be exacerbated when administered with beta-blockers. Monitor patients for postural hypotension.

Nonsteroidal anti-inflammatory drugs (NSAIDS) may attenuate the antihypertensive effect of beta-adrenoreceptor blocking agents. Monitor blood pressure.

There are no adequate and well-controlled studies in pregnant women. Intrauterine growth retardation, small placentas, and congenital anomalies have been reported for neonates whose mothers received propranolol HCl during pregnancy.

Propranolol is excreted in human milk.

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Off-label Uses

• Use in patients under the age of 18. GoToSource

• Psychogenic polydipsia and water intoxication. GoToSource

• Neuroleptic-induced akathisia. GoToSource

• Aggression in patients with brain injuries. GoToSource

• Post-traumatic stress disorder. GoToSource

• Tension headache. GoToSource

• Alcohol withdrawal symptoms. GoToSource

• Hyperthyroidism. GoToSource

• Slow progression of aortic dilation in marfan syndrome. GoToSource

• Fibromyalgia syndrome and temporomandibular disorder. GoToSource

• Chronic broca’s aphasia with anomia. GoToSource

• Central serous chorioretinopathy. GoToSource

• Cholinergic urticaria. GoToSource

• Infancy hemangiomas. GoToSource

• Cocaine withdrawal symptoms. GoToSource

• Retinopathy of prematurity. GoToSource 

• Postural tachycardia syndrome. GoToSource 

• Severely burned pediatric patients. GoToSource

Adverse Events

Stevens-johnson syndrome (severe drug reaction). GoToSource

Cardiorespiratory arrest in patients with thyroid storm. GoToSource

Bronchospasm and epinephrine/hypertensive interaction. GoToSource

Sclerosing peritonitis (inflammation of the peritoneum, thin tissue lining inner wall of the abdomen). GoToSource 

Bradycardia (slow heart rate) and hypotension (low blood pressure). GoToSource

Fetal death. GoToSource

Depression, impairment of memory function and impotence. GoToSource

Psychosis. GoToSource

Litigation

No major injury lawsuits reported.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated April 24, 2024