Propranolol (Lexi-Drugs)

ALERT: US Boxed Warning
  Cardiac ischemia after abrupt discontinuation (Inderal LA, Inderal XL, Innopran XL):
Pronunciation

(proe PRAN oh lole)

Brand Names: US

Hemangeol; Inderal LA; Inderal XL; InnoPran XL

Brand Names: Canada

APO-Propranolol; DOM-Propranolol HCl [DSC]; DOM-Propranolol [DSC]; Hemangiol; Inderal LA; PMS-Propranolol; TEVA-Propranolol

Dosing: Adult

Akathisia, antipsychotic-induced (off-label use): Oral: Immediate-release formulations: Initial: 10 mg twice daily or 10 mg 3 times daily; adjust dose based on response and tolerability up to 120 mg/day (Adler 1986; Adler 1993; Kane 2009; Kramer 1989). Treatment guidelines recommend doses of 30 to 90 mg/day (APA [Lehman 2004]; WFSBP [Hasan 2013].

Atrial fibrillation:

Oral: Immediate-release formulations: 10 to 30 mg/dose every 6 to 8 hours or a usual maintenance dose of 10 to 40 mg three or four times daily for rate control in patients with atrial fibrillation (AHA/ACC/HRS [January 2014]).

IV: 1 to 3 mg/dose slow IVP; repeat every 2-5 minutes up to a total of 5 mg; titrate initial dose to desired response. Note: Once response achieved or maximum dose administered, additional doses should not be given for at least 4 hours.

or

0.5 to 1 mg over 1 minute; may repeat, if necessary, up to a total maximum dose of 0.1 mg/kg (ACLS guidelines 2010)

or

1 mg over 1 minute; may be repeated every 2 minutes up to 3 doses for rate control in patients with atrial fibrillation (AHA/ACC/HRS [January 2014]).

Essential tremor: Oral: Immediate-release formulations: Initial: 40 mg twice daily; maintenance doses: Usually 120 to 320 mg/day

Hypertension (alternative agents): Oral:

Immediate-release formulations: 40 mg twice daily; titrate weekly as needed based on patient response; usual dosage range: 40 to 80 mg twice daily (ACC/AHA [Whelton 2017]); maximum dose: 640 mg/day

ER formulations:

Inderal LA: Initial: 80 mg once daily; titrate as needed based on patient response; usual dosage range: 80 to 160 mg once daily (ACC/AHA [Whelton 2017]); maximum dose: 640 mg/day

Inderal XL, InnoPran XL: Initial: 80 mg once daily at bedtime; titrate as needed based on patient response at 2- to 3-week intervals; maximum dose: 120 mg/day

Migraine headache prophylaxis: Oral:

Immediate-release formulations: Initial: 80 mg/day divided every 6 to 8 hours; increase by 20 to 40 mg/dose every 3 to 4 weeks to a maximum of 160 to 240 mg/day given in divided doses every 6 to 8 hours; if satisfactory response not achieved within 6 weeks of starting therapy, drug should be withdrawn gradually over several weeks

Inderal LA: Initial: 80 mg once daily; effective dose range: 160 to 240 mg once daily

Obstructive hypertrophic cardiomyopathy: Oral:

Immediate-release formulations: 20 to 40 mg 3 to 4 times daily

Inderal LA: 80 to 160 mg once daily

Performance anxiety (off-label use): Oral: Immediate-release formulations: 40 mg 60 to 90 minutes prior to anxiety-provoking event (Hartley 1983). Additional data may be necessary to further define the role of propranolol in this condition.

Pheochromocytoma: Oral: Immediate-release formulations: 30 to 60 mg/day in divided doses

Post-MI mortality reduction: Oral: Immediate-release formulations: Initial: 40 mg 3 times daily; usual dosage range: 180 to 240 mg/day in 3 to 4 divided doses

Stable angina: Oral:

Immediate-release formulations: 80 to 320 mg/day in doses divided 2 to 4 times daily

Inderal LA: Initial: 80 mg once daily; maximum dose: 320 mg once daily

Supraventricular tachycardias (eg, AV nodal re-entrant tachycardias):

Acute treatment (off-label dose): IV: Initial: 1 mg over 1 minute, may repeat 1 mg after 2-minute intervals, up to 3 doses (ACC/AHA/HRS [Page 2015])

Ongoing management (off-label use): Oral: Initial: 30 to 60 mg daily in divided doses (immediate-release) or once daily (ER); maximum maintenance dose: 160 mg daily in divided doses (immediate-release) or once daily (ER) (ACC/AHA/HRS [Page 2015])

Thyroid storm (off-label use):

Oral: Immediate-release formulations: 60 to 80 mg every 4 hours (ATA [Ross 2016])

IV: 0.5 to 1 mg administered over 10 minutes followed by 1 to 3 mg over 10 to 15 minutes every several hours with continuous cardiac monitoring; when transitioning to oral therapy, IV therapy may need to be continued until the effects of oral therapy are achieved (Braverman 2013).

Thyrotoxicosis (off-label use): Oral: Immediate-release formulations: 10 to 40 mg every 6 to 8 hours; may also consider administering once-daily ER or sustained-release formulations (ATA [Ross 2016])

Tremor, lithium-induced (off-label use): Oral: Immediate-release formulations: 30 to 80 mg/day in divided doses; adjust dose based on response and tolerability (Gelenberg 1995; Kirk 1973; Lapierre 1976). Additional data may be necessary to further define the role of propranolol in this condition.

Variceal hemorrhage prophylaxis (off-label use) (AASLD [Garcia-Tsao 2007]): Oral:

Primary prophylaxis: Immediate-release formulations: Initial: 20 mg twice daily; adjust to maximal tolerated dose. Note: Risk factors for hemorrhage include Child-Pugh class B/C or variceal red wale markings on endoscopy.

Secondary prophylaxis: Immediate-release formulations: Initial: 20 mg twice daily; adjust to maximal tolerated dose

Ventricular arrhythmias due to congenital long QT syndrome (prevention) (off-label use): Oral: Immediate-release formulations: 10 to 40 mg every 6 hours (AHA/ACC/HRS [Al-Khatib 2017])

Ventricular premature beat (suppression) (off-label use): Oral: Immediate-release formulations: 10 to 40 mg every 6 hours (AHA/ACC/HRS [Al-Khatib 2017])

Ventricular tachycardia (off-label dosing):

Oral: Immediate-release formulations: 10 to 40 mg every 6 hours (AHA/ACC/HRS [Al-Khatib 2017])

IV: 1 to 3 mg every 5 minutes up to a total of 5 mg (AHA/ACC/HRS [Al-Khatib 2017])

Dosing: Geriatric

IV: Use caution; initiate at lower end of the dosing range.

Oral:

Hypertension: Consider lower initial doses and titrate to response (Aronow 2011)

Tachyarrhythmias: Immediate-release formulations: Initial: 10 mg twice daily; increase dosage every 3 to 7 days; usual dose range: 10 to 320 mg/day given in 1 to 2 divided doses.

Refer to adult dosing for additional uses.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, renal impairment increases systemic exposure to propranolol. Use with caution.

Not dialyzable (0% to 5%); supplemental dose is not necessary.

Peritoneal dialysis effects: Supplemental dose is not necessary.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, hepatic impairment increases systemic exposure to propranolol. Use with caution.

Dosing: Pediatric

Note: Dosage should be individualized based on patient response.

Essential tremor: Limited data available: Children and Adolescents: Oral: Immediate release formulations: Initial: 0.5 to 1 mg/kg/day in 3 divided doses; maximum daily dose: 4 mg/kg/day (Ferrara 2009)

Hemangioma, infantile; proliferating:

Manufacturer’s labeling (Hemangeol): Infants ≥5 weeks weighing at least 2 kg: Note: Therapy should be initiated at age 5 weeks to 5 months: Oral: Initial dose: 0.6 mg/kg/dosetwice daily for 1 week then beginning with week 2, increase dose to 1.1 mg/kg/dose twice daily and then for week 3 begin maintenance dose of 1.7 mg/kg/dose twice daily; doses should be separated by at least 9 hours; continue maintenance dose for 6 months; readjust dose for patient growth. May repeat course if hemangiomas recur.

Alternate dosing: Infants and Children <5 years: Oral: Immediate release formulations: Initial: 1 mg/kg/day in 2 or 3 divided doses, titrate by 1 mg/kg/day at weekly intervals to maintenance dose; usual daily maintenance dose: 2 to 3 mg/kg/day (Hogeling 2011; Léauté-Labrèze 2015). Optimal duration not defined; duration ranged from 3 to 12 months; discontinuation of therapy may be gradually tapered over 1 to 3 weeks to prevent rebound sinus tachycardia (Darrow 2015).

Hypertension: Note: Beta-blockers are not recommended as initial antihypertensive agents in children (AAP [Flynn 2017). Children and Adolescents ≤17 years: Immediate release formulations: Oral: Initial: 1 to 2 mg/kg/day divided in 2 to 3 doses/day; titrate dose to effect; maximum dose: 4 mg/kg/day up to 640 mg/day; sustained release formulation may be dosed once daily (NHBPEP 2004; NHLBI 2012). Others have suggested a higher maximum daily dose of 16 mg/kg/day up to 640 mg/day (Flynn 2006; Kavay 2010).

Migraine headache; prophylaxis: Limited data available; efficacy results variable; optimal dose not established: Oral: Immediate release formulations:

Weight-directed dosing: Children ≥3 years and Adolescents: Reported range: 0.5 to 3 mg/kg/day in 2 to 3 divided doses; some trials initiated therapy at the low end of the range and titrated upward to response; doses as low as 0.5 to 1 mg/kg/day may be effective; doses up to 4 mg/kg/day have been used; maximum daily dose: 120 mg/day (AAN [Lewis 2004]; Ashrafi 2005; Bonfert 2013; Eidlitz-Markus 2012; El-Chammas 2013; Lanteri-Minet 2014)

Fixed dose: Children ≥7 years and Adolescents: Initial: 10 mg daily; increase at weekly intervals in 10 mg increments; usual dose range: 10 to 20 mg 3 times daily (Kliegman 2016); doses as high as 120 mg daily have been used (AAN [Lewis 2004])

Tachyarrhythmias: Limited data available: Infants, Children, and Adolescents:

Oral: Immediate release formulations: Initial: 0.5 to 1 mg/kg/day in divided doses every 6 to 8 hours; titrate dosage upward every 3 to 5 days; usual daily dose: 2 to 4 mg/kg/day; higher doses may be needed; maximum daily dose: 16 mg/kg/day or 60 mg/day (Kliegman 2016; Park 2014)

IV: 0.01 to 0.15 mg/kg/dose slow IV over 10 minutes; may repeat every 6 to 8 hours as needed; maximum dose is age-dependent: Infants: 1 mg/dose; children and adolescents: 3 mg/dose (Kliegman 2016; Park 2014)

Tetralogy spells:

Oral: Palliative therapy: Infants and Children: 0.5 to 1 mg/kg/dose every 6 hours (Kliegman 2016). Others have used the following: Initial: 0.25 mg/kg/dose every 6 hours (1 mg/kg/day); if ineffective within first week of therapy, may increase by 1 mg/kg/day every 24 hours to maximum of 5 mg/kg/day; if patient becomes refractory may increase slowly to a maximum of 10 to 15 mg/kg/day but must carefully monitor heart rate, heart size, and cardiac contractility; average dose: 2.3 mg/kg/day; range: 0.8 to 5 mg/kg/day (Garson 1981).

IV: Infants and Children: 0.15 to 0.25 mg/kg/dose infused over 10 minutes; maximum initial dose: 1 mg; may repeat dose once (AAP [Hegenbarth 2008]); alternatively, initiate lower doses of 0.015 to 0.02 mg/kg/dose and titrate to effect, up to 0.1 to 0.2 mg/kg/dose (Anderson 2009)

Thyrotoxicosis: Limited data available:

Infants and Children: Oral: Immediate release formulations: 0.5 to 2 mg/kg/day divided every 8 hours; maximum dose: 40 mg/dose (Kliegman 2016)

Adolescents: Oral: Immediate release formulations: 10 to 40 mg every 6 to 8 hours (ATA [Ross 2016])

Thyroid Storm: Limited data available:

Infants and Children: Oral: Immediate release formulations: 1 to 4 mg/kg/day in divided doses, titrate based on blood pressure and heart rate (Cameron 2012; Fuhrman 2011); usual frequency in adolescents and adults is every 4 to 6 hours (ATA [Ross 2016]; Kleigman 2016)

Adolescents:

Oral: Immediate release formulations: 20 to 40 mg every 4 to 6 hours (Kliegman 2016); titrate based on blood pressure and heart rate; doses as high as 60 to 80 mg every 4 hours have been recommended (ATA [Ross 2016])

IV: 0.5 to 1 mg slow IV push over 10 minutes (Braverman 2013; Kliegman 2016). Dosing interval in adolescents is not defined; in adults, doses may be repeated every several hours with continuous cardiac monitoring; when transitioning to oral therapy, IV therapy may need to be continued until the effects of oral therapy are achieved (Braverman 2013)

Dosing: Renal Impairment: Pediatric

Not dialyzable (0% to 5%). There are no dosage adjustments provided in the manufacturer’s labeling; however, renal impairment increases systemic exposure to propranolol. Use with caution.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, hepatic impairment increases systemic exposure to propranolol. Use with caution.

Use: Labeled Indications

Cardiac arrhythmias: Control of supraventricular arrhythmias (such as atrial fibrillation and flutter, AV nodal re-entrant tachycardias), ventricular tachycardias (catecholamine-induced arrhythmias, digoxin toxicity)

Essential tremor: Management of familial or hereditary essential tremor

Hypertension: Management of hypertension. Note: Beta-blockers are not recommended as first-line therapy (ACC/AHA [Whelton 2017])

Migraine headache prophylaxis: Prophylaxis of common migraine headache

Obstructive hypertrophic cardiomyopathy: Symptomatic treatment of obstructive hypertrophic cardiomyopathy (formerly known as hypertrophic subaortic stenosis)

Pheochromocytoma: As an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors

Post-MI mortality reduction: To reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable

Proliferating infantile hemangioma (Hemangeol): Treatment of proliferating infantile hemangioma requiring systemic therapy

Stable angina: To decrease angina frequency and increase exercise tolerance in patients with angina pectoris

Use: Off-Label: Adult

  Akathisia, antipsychotic-inducedLevel of Evidence [C, G]

Data from a limited number of patients in five randomized, double-blind, controlled studies support the use of propranolol in antipsychotic-induced akathisia Ref. Additional trials may be necessary to further define the role or propranolol in this condition.

Based on the American Psychiatric Association (APA) and World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the treatment of schizophrenia, propranolol is an effective and recommended agent in the management of antipsychotic-induced akathisia, however, WFSBP notes that good evidence based data to support this use is lacking.

  Performance anxietyLevel of Evidence [C]

Data from a limited number of patients studied in two double-blind trials suggest that propranolol may be beneficial for the treatment of performance anxiety Ref. Additional data may be necessary to further define the role of propranolol in this condition.

  Supraventricular tachycardia (atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia, atrial flutter, focal atrial tachycardia, multifocal atrial tachycardia) (oral)Level of Evidence [G]

Based on the American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for the management of patients with supraventricular arrhythmias, the use of a beta-blocker, including propranolol, is effective and recommended for a variety of symptomatic supraventricular tachycardias (atrioventricular nodal reentrant tachycardia [AVNRT], atrioventricular reentrant tachycardia [AVRT], focal atrial tachycardia [AT], and multifocal atrial tachycardia [MAT]). Propranolol (intravenous or oral) may be useful for rate control in the acute treatment or ongoing management of hemodynamically stable patients with atrial flutter.

  Thyroid stormLevel of Evidence [C, G]

Clinical experience suggests the utility of IV propranolol in the management of this condition Ref. Additional data may be necessary to further define the role of IV propranolol for the treatment of thyroid storm.

Based on the American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis, beta-blockers, including propranolol, as part of a multimodality approach, are effective and recommended for the treatment of thyroid storm Ref.

  ThyrotoxicosisLevel of Evidence [G]

Based on the American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis, beta-blockers, including propranolol, are effective and recommended in the treatment of symptomatic thyrotoxicosis. Beta-blockers should also be considered in asymptomatic patients who are at increased risk of complications due to worsening hyperthyroidism Ref.

  Tremor, lithium-inducedLevel of Evidence [C]

Data from a limited number of patients studied suggest that propranolol may be beneficial for the treatment of lithium-induced tremor Ref. Additional data may be necessary to further define the role of propranolol in this condition.

  Variceal hemorrhage (prophylaxis)Level of Evidence [A, G]

Current guidelines recommend the use of nonselective beta-blockers, such as propranolol, as first-line therapy for the prevention of gastroesophageal varices and variceal hemorrhage. To ensure maximum efficacy, the dose should be titrated to the highest level tolerated while reducing patient heart rate to no lower than 55 bpm. During acute variceal hemorrhage, beta-blockers should not be used since they will decrease blood pressure and blunt the appropriate physiological response to bleeding (ie, increased heart rate). Access Full Off-Label Monograph

  Ventricular arrhythmias due to congenital long QT syndrome (prevention)Level of Evidence [C, G]

In patients with congenital long QT syndrome (LQTS), data from observational studies suggest that beta-blockers may be beneficial at reducing the risk of cardiac events, including ventricular arrhythmias, especially in patients with congenital LQTS type 1 or type 2 Ref. Additional data may be necessary to further define the role of propranolol in this condition. Atenolol, nadolol, and propranolol may be preferred for patients with LQTS based on the currently available data.

Based on the American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guideline for management of patients with ventricular arrhythmias and prevention of sudden cardiac death, beta-blockers are effective for control of ventricular arrhythmias in patients with congenital LQTS.

  Ventricular premature beat (suppression)Level of Evidence [G]

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Advanced Cardiac Life Support (ACLS)/Emergency Cardiovascular Care (ECC):

AHA, “2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care,” October 2015

AHA, “2010 Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care,” November 2010

Arrhythmias:

AHA/ACC/HRS, “2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death,” October 2017

ACC/AHA/HRS, “Guideline for the Management of Adult Patients with Supraventricular Tachycardia,” 2015

AHA/ACC/HRS, “2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation,” March 2014

Canadian Cardiovascular Society, “2016 Focused Update of the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation,” 2016

Coronary Artery Bypass Graft Surgery:

AHA Scientific Statement, “Secondary Prevention After Coronary Artery Bypass Graft Surgery,” February 2015

Hypertension:

“2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults,” November 2017.

AHA/ACC/ASH, “Treatment of Hypertension in Patients with Coronary Artery Disease: A Scientific Statement by the American Heart Association, American College of Cardiology and American Society of Hypertension,” May 2015

“ACCF/AHA Expert Consensus Document on Hypertension in the Elderly,” 2011

AHA/ACC/CDC, “AHA/ACC/CDC Science Advisory: An Effective Approach to High Blood Pressure Control” November 2013

ASH/ISH “Clinical Practice Guidelines for the Management of Hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension,” January 2014

Eighth Joint National Committee (JNC 8), “2014 Evidence-based Guideline for the Management of High Blood Pressure in Adults,” December 2013

“National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents,” May 2005

Hyperthyroidism:

ATA, “Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis,” 2016

Hypertrophic Cardiomyopathy:

“2011 ACCF/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy,” November 2011

Ischemic Heart Disease:

ACC/AHA/AATS/PCNA/SCAI/STS, “2014 Focused Update of the Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease,” July 2014

ACCF/AHA/ACP/AATS/PCNA/SCAI/STS, “2012 Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease,” November 2012

AHA/ACC, “2014 AHA/ACC Guideline for the Management of Patients with Non-ST-Elevation Acute Coronary Syndromes,” September 2014

ACCF/AHA, “2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction,” December 2012

Migraine Prophylaxis:

Neurology, “Evidence-Based Guideline Update: Pharmacologic Treatment for Episodic Migraine Prevention in Adults,” April 2012

Peripheral Arterial Disease:

“ACC/AHA 2005 Guidelines for the Management of Patients With Peripheral Arterial Disease,” March 2006

Prevention:

“AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and Other Atherosclerotic Vascular Disease: 2011 Update,” November 2011

Valvular Heart Disease:

AHA/ACC, “2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease,” March 2014

Administration: IV

IV dose is much smaller than oral dose. When administered acutely for cardiac treatment, monitor ECG and blood pressure. May administer by rapid infusion (IV push) at a rate of 1 mg/minute or by slow infusion over ~30 minutes. Necessary monitoring for surgical patients who are unable to take oral beta-blockers (prolonged ileus) has not been defined. Some institutions require monitoring of baseline and postinfusion heart rate and blood pressure when a patient’s response to beta-blockade has not been characterized (ie, the patient’s initial dose or following a change in dose). Consult individual institutional policies and procedures.

Administration: Injectable Detail

pH: 2.8 to 3.5

Administration: Oral

Tablets (immediate release) should be taken on an empty stomach; capsules (extended release) may be taken with or without food, but should always be taken consistently (with food or on an empty stomach). Do not crush long-acting oral forms.

Administration: Pediatric

Oral:

Immediate-release tablets: Take on an empty stomach

Extended-release capsules: Administer consistently either with food or on an empty stomach; do not chew or crush sustained or extended release capsules, swallow whole

Oral solution: Mix concentrated oral solution with water, fruit juice, liquid, or semisolid food before administration.

Hemangeol oral solution: Infants: Administer during or after a feeding to minimize the risk for hypoglycemia; skip the dose if the patient is not eating or is vomiting. Administer doses at least 9 hours apart. Do not shake bottle before use. Administer Hemangeol directly into the child’s mouth using the supplied oral dosing syringe; if needed, dose may be diluted with a small quantity of milk or fruit juice and administered in a baby’s bottle.

Parenteral: Note: IV dose is much smaller than oral dose. When administered acutely for cardiac treatment, monitor ECG and blood pressure; consult individual institutional policies and procedures.

Neonates, Infants, Children, and Adolescents: Administer undiluted by slow IV injection/infusion over 10 minutes (AAP [Hegenbarth 2008])

Dietary Considerations

Tablets (immediate release) should be taken on an empty stomach; capsules (extended release) may be taken with or without food, but should always be taken consistently (with food or on an empty stomach). Hemangeol should be administered during or right after a feeding to reduce the risk of hypoglycemia; skip dose if child is not eating or is vomiting.

Storage/Stability

Injection: Store at 20°C to 25°C (68°F to 77°F); protect from freezing or excessive heat. Once diluted, propranolol is stable for 24 hours at room temperature in D5W or NS. Protect from light. Solution has a maximum stability at pH of 3 and decomposes rapidly in alkaline pH.

Capsule, tablet, oral solution: Store at controlled room temperature; protect from freezing or excessive heat. Protect from light and moisture. Dispense Hemangeol in original container; discard 2 months after first opening.

Compatibility

See Trissel’s IV Compatibility Database

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience constipation, abdominal cramps, diarrhea, fatigue, loss of strength and energy, nausea, vomiting, nightmares, or insomnia. Have patient report immediately to prescriber severe dizziness, passing out, angina, confusion, hallucinations, memory impairment, mood changes, burning or numbness feeling, vision changes, shortness of breath, excessive weight gain, swelling of arms or legs, bruising, bleeding, chills, pharyngitis, bradycardia, abnormal heartbeat, sensation of cold, sexual dysfunction, signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  High alert medication:
  Administration issues:
  International issues:
Prescribing and Access Restrictions

Prescriptions for Hemangeol may be obtained via the Hemangeol Patient Access program. Visithttp://www.hemangeol.com/hcp/hemangeol-direct/ or call 855-618-4950 for ordering information.

Contraindications

Hypersensitivity to propranolol, beta-blockers, or any component of the formulation; uncompensated heart failure (unless the failure is due to tachyarrhythmias being treated with propranolol); cardiogenic shock; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree (except in patients with a functioning artificial pacemaker); bronchial asthma

Hemangeol (additional contraindications): Premature infants with corrected age <5 weeks; infants weighing <2 kg; heart rate <80 bpm; blood pressure <50/30 mm Hg; pheochromocytoma; history of bronchospasm

Documentation of allergenic cross-reactivity for beta-blockers is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Cor pulmonale; allergic rhinitis during pollen season; patients prone to hypoglycemia; hypotension (blood pressure parameters not specified in labeling); metabolic acidosis; vasospastic angina (also referred to as Prinzmetal angina or variant angina); severe peripheral arterial circulatory disturbance

Hemangiol (additional contraindications): Infants weighing <2.5 kg; breastfed infants if mother is treated with medicines contraindicated with propranolol; heart rate <100 bpm or blood pressure <65/45 mm Hg (<3 months of age), heart rate <90 bpm or blood pressure <70/50 mm Hg (3 to <6 months of age), heart rate <80 bpm or blood pressure <80/55 mm Hg (6 to 12 months of age)

Warnings/Precautions

Concerns related to adverse events:

• Anaphylactic reactions: Use caution with history of severe anaphylaxis to allergens; patients taking beta-blockers may become more sensitive to repeated challenges. Treatment of anaphylaxis (eg, epinephrine) in patients taking beta-blockers may be ineffective or promote undesirable effects.

Disease-related concerns:

• Bronchospastic disease: In general, patients with bronchospastic disease should not receive beta-blockers; if used at all, should be used cautiously with close monitoring.

• Conduction abnormality: Consider pre-existing conditions such as sick sinus syndrome before initiating.

• Diabetes: Use with caution in patients with diabetes mellitus; may potentiate hypoglycemia and/or mask signs and symptoms.

• Heart failure (HF): Use with caution in patients with compensated HF and monitor for a worsening of the condition (efficacy of propranolol in HF has not been demonstrated).

• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustment may be required.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis.

• Peripheral vascular disease (PVD) and Raynaud disease: Can precipitate or aggravate symptoms of arterial insufficiency in patients with PVD and Raynaud disease. Use with caution and monitor for progression of arterial obstruction.

• Pheochromocytoma (untreated): Adequate alpha-blockade is required prior to use of any beta-blocker.

• Prinzmetal variant angina: Beta-blockers without alpha1-adrenergic receptor blocking activity should be avoided in patients with Prinzmetal variant angina since unopposed alpha1-adrenergic receptors mediate coronary vasoconstriction and can worsen anginal symptoms (Mayer 1998).

• Psoriasis: Beta-blocker use has been associated with induction or exacerbation of psoriasis, but cause and effect have not been firmly established.

• Renal impairment: Use with caution in patients with renal impairment; may have increased side effects.

• Thyroid disease: May mask signs of hyperthyroidism (eg, tachycardia). If thyrotoxicosis is suspected, carefully manage and monitor; abrupt withdrawal may exacerbate symptoms of hyperthyroidism or precipitate thyroid storm. Alterations in thyroid function tests may be observed.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Infants and children: Considerations when treating infantile hemangioma:

– Cardiovascular concerns: Bradycardia and/or hypotension may occur or be worsened; monitor heart rate and blood pressure after propranolol initiation or increase in dose; discontinue treatment if severe (<80 bpm) or symptomatic bradycardia or hypotension (systolic blood pressure <50 mm Hg) occurs. Infants with large facial infantile hemangioma should be investigated for potential arteriopathy associated with PHACE syndrome prior to propranolol therapy; decreases in blood pressure caused by propranolol may increase risk of stroke in PHACE syndrome patients with cerebrovascular anomalies.

– Hypoglycemia: May potentiate hypoglycemia and/or mask signs and symptoms. Withhold the dose in infants or children who are not feeding regularly or who are vomiting; discontinue therapy and seek immediate treatment if hypoglycemia occurs.

– Respiratory concerns: May cause bronchospasm. Interrupt therapy in infants or children with lower respiratory tract infection associated with dyspnea or wheezing.

• Elderly: Bradycardia may be observed more frequently in elderly patients (>65 years of age); dosage reductions may be necessary.

• Smokers: Cigarette smoking may decrease plasma levels of propranolol by increasing metabolism. Patients should be advised to avoid smoking.

Other warnings/precautions:

• Abrupt withdrawal: [US Boxed Warning]: Beta-blocker therapy should not be withdrawn abruptly (particularly in patients with CAD), but gradually tapered to avoid acute tachycardia, hypertension, and/or ischemia. Severe exacerbation of angina, ventricular arrhythmias, and myocardial infarction (MI) have been reported following abrupt withdrawal of beta-blocker therapy. Temporary but prompt resumption of beta-blocker therapy may be indicated with worsening of angina or acute coronary insufficiency.

• Major surgery: Chronic beta-blocker therapy should not be routinely withdrawn prior to major surgery.

Geriatric Considerations

Since bioavailability is increased about twofold in elderly patients, geriatrics may require lower maintenance doses. Also, as serum and tissue concentrations increase beta1 selectivity diminishes. Beta-adrenergic blockade may result in less hemodynamic response than seen in younger adults due to alterations in the beta-adrenergic autonomic system. Studies indicate that despite decreased sensitivity to the chronotropic effects of beta-blockade with age, there appears to be an increased myocardial sensitivity to the negative inotropic effect during stress (ie, exercise). Controlled trials have shown the overall response rate for propranolol to be only 20% to 50% in elderly populations. Therefore, all beta-adrenergic blocking drugs may result in a decreased response as compared to younger adults. Due to propranolol’s CNS penetration and nonselective action, it may not be the beta-blocker of choice for use in elderly.

The AHA/ACC/ASH 2015 scientific statement on the treatment of hypertension in patients with CAD warns to use caution to avoid decreases in DBP <60 mm Hg especially in patients >60 years of age since reduced coronary perfusion may occur. When lowering SBP in older hypertensive patients with wide pulse pressures, very low DBP values (<60 mm Hg) may result. In patients with obstructive CAD, clinicians should lower blood pressure slowly and carefully monitor for any untoward signs or symptoms, especially those resulting from myocardial ischemia and worsening heart failure (AHA/ACC/ASH [Rosendorff 2015]).

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Propranolol crosses the placenta and is measurable in the newborn serum following maternal use during pregnancy (Taylor 1981). According to the manufacturer, congenital abnormalities have been reported following maternal use of propranolol. Bradycardia, hypoglycemia, and/or respiratory depression have been observed in neonates following in utero exposure to propranolol at parturition. Reduced birth weight has also been observed following in utero exposure to beta-blockers as a class. Adequate facilities for monitoring infants at birth should be available.

Untreated chronic maternal hypertension and preeclampsia are also associated with adverse events in the fetus, infant, and mother (ACOG 2015; Magee 2014). When treatment of hypertension in pregnancy is indicated, beta-blockers may be used. Specific recommendations vary by guideline. Although other agents are preferred (ACOG 2013), use of propranolol may be considered (Magee 2014). Use of propranolol may be considered for some arrhythmias, including SVT, when use of a beta-blocker is needed during pregnancy (ACC/AHA/HRS [Page 2015]; ESC [Regitz-Zagrosek 2011]). Propranolol is recommended for use in controlling hypermetabolic symptoms of thyrotoxicosis in pregnancy (Stagnaro-Green 2011). Propranolol may be used if prophylaxis of migraine is needed in pregnant women; it should be discontinued 2 to 3 days prior to delivery to decrease the risk of adverse events to the fetus/neonate and potential reductions in uterine contraction (Pringsheim 2012).

Breast-Feeding Considerations

Propranolol is present in breast milk.

The relative infant dose (RID) of propranolol is 1% when calculated using the highest breast milk concentration located and compared to an infant therapeutic dose of 1 mg/kg/day. In general, breastfeeding is considered acceptable when the RID is <10%; when an RID is >25% breastfeeding should generally be avoided (Anderson 2016; Ito 2000). Using the highest milk concentration (0.075 mcg/mL), the estimated daily infant dose via breast milk is 11.25 mcg/kg/day. This milk concentration was obtained following maternal administration of propranolol 1.2 mg/kg/day. Using data collected from three women, the same study found the overall half-life of propranolol in breast milk to be 6.5 ± 3.4 hours (Smith 1983). Peak milk concentrations are reported to occur between 2 to 3 hours after an oral dose (Bauer 1979).

In general, propranolol may be compatible with breastfeeding when used at usual doses. Mothers should closely monitor their breastfeeding infants for bradycardia, cyanosis, and hypoglycemia (WHO 2002).

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not always defined.

Cardiovascular: Cold extremities (infants: 7% to 8%), angina pectoris, atrioventricular conduction disturbance, bradycardia, cardiac failure, cardiogenic shock, hypotension, ineffective myocardial contractions, syncope

Central nervous system: Sleep disorder (infants: 16% to 18%), agitation (infants: 5% to 9%), fatigue (5% to 7%), dizziness (4% to 7%), nightmares (infants: 2% to 6%), irritability (infants: 1% to 6%), drowsiness (infants: 1% to 5%), amnesia, carpal tunnel syndrome (rare), catatonia, cognitive dysfunction, confusion, hypersomnia, lethargy, paresthesia, psychosis, vertigo

Dermatologic: Changes in nails, contact dermatitis, dermal ulcer, eczematous rash, erosive lichen planus, hyperkeratosis, pruritus, skin rash

Endocrine & metabolic: Hyperglycemia, hyperkalemia, hyperlipidemia, hypoglycemia

Gastrointestinal: Diarrhea (infants: 5% to 6%), abdominal pain (infants: ≤4%), decreased appetite (infants: 3% to 4%), constipation (1% to 3%), anorexia, stomach discomfort

Genitourinary: Oliguria (rare), proteinuria (rare)

Hematologic & oncologic: Immune thrombocytopenia, thrombocytopenia

Hepatic: Increased serum alkaline phosphatase, increased serum transaminases

Neuromuscular & skeletal: Arthropathy, oculomucocutaneous syndrome, polyarthritis

Ophthalmic: Conjunctival hyperemia, decreased visual acuity, mydriasis

Renal: Increased blood urea nitrogen, interstitial nephritis (rare)

Respiratory: Bronchitis (infants: 8% to 13%; associated with cough, fever, diarrhea, and vomiting), bronchiolitis (infants; associated with cough, fever, diarrhea, and vomiting), bronchospasm, dyspnea, pulmonary edema, wheezing

Miscellaneous: Ulcer

<1%, postmarketing, and/or case reports: Abdominal cramps, agranulocytosis, alopecia, altered mental status, arterial insufficiency, arterial mesenteric thrombosis, decreased heart rate (infants), decreased serum glucose (infants), depression, emotional lability, epigastric distress, erythema multiforme, erythematous rash, exfoliative dermatitis, fever combined with generalized ache, sore throat, laryngospasm, and respiratory distress), hallucination, hypersensitivity reaction (including anaphylaxis, anaphylactoid reaction), impotence, insomnia, ischemic colitis, lassitude, lupus-like syndrome, myotonia, myopathy, nausea, nonthrombocytopenic purpura, peripheral arterial disease (exacerbation), Peyronie’s disease, pharyngitis, psoriasiform eruption, purpura, Raynaud’s phenomenon, second degree atrioventricular block (infants; in a patient with an underlying conduction disorder), Stevens-Johnson syndrome, systemic lupus erythematosus, temporary amnesia, tingling of extremities (hands), toxic epidermal necrolysis, urticaria, visual disturbance, vivid dream, vomiting, weakness, xerophthalmia

Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects

Substrate of CYP1A2 (major), CYP2C19 (minor), CYP2D6 (major), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP1A2 (weak)

Drug Interactions 

Abiraterone Acetate: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Management: Avoid concurrent use of abiraterone with CYP2D6 substrates that have a narrow therapeutic index whenever possible. When concurrent use is not avoidable, monitor patients closely for signs/symptoms of toxicity. Risk D: Consider therapy modification

Acetylcholinesterase Inhibitors: May enhance the bradycardic effect of Beta-Blockers. Risk C: Monitor therapy

Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Alcohol (Ethyl): May decrease the serum concentration of Propranolol. Alcohol (Ethyl) may increase the serum concentration of Propranolol. Risk C: Monitor therapy

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Alpha1-Blockers: Beta-Blockers may enhance the orthostatic hypotensive effect of Alpha1-Blockers. The risk associated with ophthalmic products is probably less than systemic products. Risk C: Monitor therapy

Alpha2-Agonists: May enhance the AV-blocking effect of Beta-Blockers. Sinus node dysfunction may also be enhanced. Beta-Blockers may enhance the rebound hypertensive effect of Alpha2-Agonists. This effect can occur when the Alpha2-Agonist is abruptly withdrawn. Management: Closely monitor heart rate during treatment with a beta blocker and clonidine. Withdraw beta blockers several days before clonidine withdrawal when possible, and monitor blood pressure closely. Recommendations for other alpha2-agonists are unavailable.Exceptions: Apraclonidine. Risk D: Consider therapy modification

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Risk D: Consider therapy modification

Aminoquinolines (Antimalarial): May decrease the metabolism of Beta-Blockers. Risk C: Monitor therapy

Amiodarone: May enhance the bradycardic effect of Beta-Blockers. Possibly to the point of cardiac arrest. Amiodarone may increase the serum concentration of Beta-Blockers. Risk C: Monitor therapy

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Antipsychotic Agents (Phenothiazines): May enhance the hypotensive effect of Beta-Blockers. Beta-Blockers may decrease the metabolism of Antipsychotic Agents (Phenothiazines). Antipsychotic Agents (Phenothiazines) may decrease the metabolism of Beta-Blockers. Risk C: Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]).Risk C: Monitor therapy

Asunaprevir: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk D: Consider therapy modification

Barbiturates: May decrease the serum concentration of Beta-Blockers. Risk C: Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Beta2-Agonists: Beta-Blockers (Nonselective) may diminish the bronchodilatory effect of Beta2-Agonists. Risk X: Avoid combination

Bile Acid Sequestrants: May decrease the serum concentration of Propranolol. Risk C: Monitor therapy

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy

Bretylium: May enhance the bradycardic effect of Bradycardia-Causing Agents. Bretylium may also enhance atrioventricular (AV) blockade in patients receiving AV blocking agents. Risk C: Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Broccoli: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Risk C: Monitor therapy

Bromperidol: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. Risk X: Avoid combination

Bupivacaine: Beta-Blockers may increase the serum concentration of Bupivacaine. Risk C: Monitor therapy

Calcium Channel Blockers (Nondihydropyridine): May enhance the hypotensive effect of Beta-Blockers. Bradycardia and signs of heart failure have also been reported. Calcium Channel Blockers (Nondihydropyridine) may increase the serum concentration of Beta-Blockers. Exceptions: Bepridil. Risk C: Monitor therapy

Cannabis: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Risk C: Monitor therapy

Cardiac Glycosides: Beta-Blockers may enhance the bradycardic effect of Cardiac Glycosides. Risk C: Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Exceptions are discussed in separate monographs. Risk D: Consider therapy modification

Cholinergic Agonists: Beta-Blockers may enhance the adverse/toxic effect of Cholinergic Agonists. Of particular concern are the potential for cardiac conduction abnormalities and bronchoconstriction. Management: Administer these agents in combination with caution, and monitor for conduction disturbances. Avoid methacholine with any beta blocker due to the potential for additive bronchoconstriction. Risk C: Monitor therapy

CloBAZam: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CloZAPine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of CloZAPine. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk C: Monitor therapy

Cobicistat: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP1A2 Inducers (Moderate): May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP1A2 Inhibitors (Moderate): May decrease the metabolism of CYP1A2 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP2D6 Inhibitors (Moderate): May decrease the metabolism of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP2D6 Inhibitors (Strong): May decrease the metabolism of CYP2D6 Substrates (High risk with Inhibitors). Risk D: Consider therapy modification

Cyproterone: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Risk C: Monitor therapy

Dacomitinib: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Management: Avoid concurrent use of dacomitinib with CYP2D6 subtrates that have a narrow therapeutic index. Risk D: Consider therapy modification

Darunavir: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Deferasirox: May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Dipyridamole: May enhance the bradycardic effect of Beta-Blockers. Risk C: Monitor therapy

Disopyramide: May enhance the bradycardic effect of Beta-Blockers. Beta-Blockers may enhance the negative inotropic effect of Disopyramide. Risk C: Monitor therapy

Doxofylline: Propranolol may increase the serum concentration of Doxofylline. Risk C: Monitor therapy

Dronedarone: May enhance the bradycardic effect of Beta-Blockers. Dronedarone may increase the serum concentration of Beta-Blockers. This likely applies only to those agents that are metabolized by CYP2D6. Management: Use lower initial beta-blocker doses; adequate tolerance of the combination, based on ECG findings, should be confirmed prior to any increase in beta-blocker dose. Risk D: Consider therapy modification

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

EPINEPHrine (Nasal): Beta-Blockers (Nonselective) may enhance the hypertensive effect of EPINEPHrine (Nasal). Risk C: Monitor therapy

EPINEPHrine (Oral Inhalation): Beta-Blockers (Nonselective) may enhance the hypertensive effect of EPINEPHrine (Oral Inhalation). Risk C: Monitor therapy

Epinephrine (Racemic): Beta-Blockers (Nonselective) may enhance the hypertensive effect of Epinephrine (Racemic). Risk C: Monitor therapy

EPINEPHrine (Systemic): Beta-Blockers (Nonselective) may enhance the hypertensive effect of EPINEPHrine (Systemic). Risk C: Monitor therapy

Ergot Derivatives: Beta-Blockers may enhance the vasoconstricting effect of Ergot Derivatives. Exceptions: Nicergoline. Risk D: Consider therapy modification

Fingolimod: Beta-Blockers may enhance the bradycardic effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and beta-blockers if possible. If coadministration is necessary, patients should have overnight continuous ECG monitoring conducted after the first dose of fingolimod. Monitor patients for bradycardia. Risk D: Consider therapy modification

Floctafenine: May enhance the adverse/toxic effect of Beta-Blockers. Risk X: Avoid combination

FluvoxaMINE: May increase the serum concentration of Propranolol. Management: Use a lower initial propranolol dose and be cautious with propranolol dose titration. Risk D: Consider therapy modification

Grass Pollen Allergen Extract (5 Grass Extract): Beta-Blockers may enhance the adverse/toxic effect of Grass Pollen Allergen Extract (5 Grass Extract). More specifically, Beta-Blockers may inhibit the ability to effectively treat severe allergic reactions to Grass Pollen Allergen Extract (5 Grass Extract) with epinephrine. Some other effects of epinephrine may be unaffected or even enhanced (e.g., vasoconstriction) during treatment with Beta-Blockers. Risk D: Consider therapy modification

Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Imatinib: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Insulins: Beta-Blockers may enhance the hypoglycemic effect of Insulins. Risk C: Monitor therapy

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy

Lacidipine: May enhance the hypotensive effect of Propranolol. Lacidipine may increase the serum concentration of Propranolol. Propranolol may decrease the serum concentration of Lacidipine. Risk C: Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Risk C: Monitor therapy

Lidocaine (Systemic): Beta-Blockers may increase the serum concentration of Lidocaine (Systemic). Risk C: Monitor therapy

Lidocaine (Topical): Beta-Blockers may increase the serum concentration of Lidocaine (Topical). Risk C: Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Mepivacaine: Beta-Blockers may increase the serum concentration of Mepivacaine. Risk C: Monitor therapy

Methacholine: Beta-Blockers may enhance the adverse/toxic effect of Methacholine. Risk X: Avoid combination

Methoxyflurane: May enhance the hypotensive effect of Beta-Blockers. Risk C: Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

NIFEdipine: May enhance the hypotensive effect of Beta-Blockers. NIFEdipine may enhance the negative inotropic effect of Beta-Blockers. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May diminish the antihypertensive effect of Beta-Blockers. Risk C: Monitor therapy

Obeticholic Acid: May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification

Opioids (Anilidopiperidine): May enhance the bradycardic effect of Beta-Blockers. Opioids (Anilidopiperidine) may enhance the hypotensive effect of Beta-Blockers. Risk C: Monitor therapy

Panobinostat: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Peginterferon Alfa-2b: May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Perhexiline: CYP2D6 Substrates (High risk with Inhibitors) may increase the serum concentration of Perhexiline. Perhexiline may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Propafenone: May increase the serum concentration of Propranolol. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

QuiNIDine: May increase the serum concentration of Propranolol. Risk C: Monitor therapy

QuiNINE: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Regorafenib: May enhance the bradycardic effect of Beta-Blockers. Risk C: Monitor therapy

Reserpine: May enhance the hypotensive effect of Beta-Blockers. Risk C: Monitor therapy

Rifamycin Derivatives: May decrease the serum concentration of Beta-Blockers. Exceptions: Rifabutin. Risk C: Monitor therapy

Rivastigmine: May enhance the bradycardic effect of Beta-Blockers. Risk X: Avoid combination

Rizatriptan: Propranolol may increase the serum concentration of Rizatriptan. Management: Rizatriptan adult dose should be reduced to 5 mg in patients who are also being treated with propranolol. Risk D: Consider therapy modification

Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May increase the serum concentration of Beta-Blockers. Exceptions: Citalopram; Escitalopram; FluvoxaMINE. Risk C: Monitor therapy

Sulfonylureas: Beta-Blockers may enhance the hypoglycemic effect of Sulfonylureas. Cardioselective beta-blockers (eg, acebutolol, atenolol, metoprolol, and penbutolol) may be safer than nonselective beta-blockers. All beta-blockers appear to mask tachycardia as an initial symptom of hypoglycemia. Ophthalmic beta-blockers are probably associated with lower risk than systemic agents. Risk C: Monitor therapy

Teriflunomide: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Risk C: Monitor therapy

Terlipressin: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Theophylline Derivatives: Beta-Blockers (Nonselective) may diminish the bronchodilatory effect of Theophylline Derivatives. Risk D: Consider therapy modification

TiZANidine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use is necessary, initiate tizanidine at an adult dose of 2 mg and increase in 2 to 4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions.Risk D: Consider therapy modification

Tobacco (Smoked): May decrease the serum concentration of Propranolol. Risk C: Monitor therapy

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Vemurafenib: May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). Management: Consider alternatives to such combinations whenever possible, particularly if the CYP1A2 substrate has a relatively narrow therapeutic index. Drugs listed as exceptions to this monograph are discussed in separate drug interaction monographs.Risk D: Consider therapy modification

Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Zileuton: May increase the serum concentration of Propranolol. Risk C: Monitor therapy

ZOLMitriptan: Propranolol may increase the serum concentration of ZOLMitriptan. Risk C: Monitor therapy

Food Interactions

Ethanol: Ethanol may increase or decrease plasma levels of propranolol. Reports are variable and have shown both enhanced as well as inhibited hepatic metabolism (of propranolol). Management: Caution advised with consumption of ethanol and monitor for heart rate and/or blood pressure changes.

Food: Propranolol serum levels may be increased if taken with food. Protein-rich foods may increase bioavailability; a change in diet from high carbohydrate/low protein to low carbohydrate/high protein may result in increased oral clearance. Management: Tablets (immediate release) should be taken on an empty stomach. Capsules (extended release) may be taken with or without food, but be consistent with regard to food.

Test Interactions

May lead to false-positive aldosterone/renin ratio (ARR) (Funder 2016)

Monitoring Parameters

Acute cardiac treatment: Monitor ECG, heart rate, and blood pressure with IV administration; heart rate and blood pressure with oral administration

Consult individual institutional policies and procedures.

Hemangeol: Monitor heart rate and blood pressure for 2 hours after initiation or dose increases.

Hypertension: Blood pressure, heart rate, serum glucose regularly (in patients with diabetes)

The 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults (ACC/AHA [Whelton 2017]):

Confirmed hypertension and known CVD or 10-year ASCVD risk ≥10%: Target blood pressure <130/80 mm Hg is recommended.

Confirmed hypertension without markers of increased ASCVD risk: Target blood pressure <130/80 mm Hg may be reasonable.

Advanced Practitioners Physical Assessment/Monitoring

Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed. IV infusion usually requires hemodynamic monitoring; consult institution protocols. When discontinuing, drug must be tapered gradually over 2 weeks to avoid acute tachycardia, hypertension, and/or ischemia. Caution patients with diabetes to monitor blood glucose levels closely; beta-blockers can mask hypoglycemic symptoms.

Nursing Physical Assessment/Monitoring

IV infusion usually requires hemodynamic monitoring; consult institution protocols. When discontinuing, drug must be tapered gradually over 2 weeks to avoid acute tachycardia, hypertension, and/or ischemia. Educate patients with diabetes to monitor blood glucose levels closely; beta-blockers can mask hypoglycemic symptoms.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Extended Release 24 Hour, Oral, as hydrochloride:

Inderal LA: 60 mg, 80 mg, 120 mg, 160 mg [contains brilliant blue fcf (fd&c blue #1)]

Inderal XL: 80 mg, 120 mg

InnoPran XL: 80 mg, 120 mg

Generic: 60 mg, 80 mg, 120 mg, 160 mg

Solution, Intravenous, as hydrochloride:

Generic: 1 mg/mL (1 mL)

Solution, Oral, as hydrochloride:

Hemangeol: 4.28 mg/mL (120 mL) [alcohol free, paraben free, sugar free; contains saccharin sodium]

Generic: 20 mg/5 mL (500 mL); 40 mg/5 mL (500 mL)

Tablet, Oral, as hydrochloride:

Generic: 10 mg, 20 mg, 40 mg, 60 mg, 80 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Extended Release 24 Hour, Oral, as hydrochloride:

Inderal LA: 60 mg, 80 mg, 120 mg, 160 mg [contains BRILLIANT BLUE FCF (FD&C BLUE #1)]

Solution, Intravenous, as hydrochloride:

Generic: 1 mg/mL (1ml)

Solution, Oral, as hydrochloride:

Generic: 4.28 mg/mL (120ml)

Tablet, Oral:

Generic: 120 mg

Tablet, Oral, as hydrochloride:

Generic: 10 mg, 20 mg, 40 mg, 80 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • C07AA05
Generic Available (US)

Yes

Pricing: US

Capsule ER 24 Hour Therapy Pack (Inderal LA Oral)

60 mg (per each): $64.52

80 mg (per each): $75.37

120 mg (per each): $84.97

160 mg (per each): $86.64

Capsule ER 24 Hour Therapy Pack (Inderal XL Oral)

80 mg (per each): $30.20

120 mg (per each): $30.20

Capsule ER 24 Hour Therapy Pack (InnoPran XL Oral)

80 mg (per each): $30.20

120 mg (per each): $30.20

Capsule ER 24 Hour Therapy Pack (Propranolol HCl ER Oral)

60 mg (per each): $2.04 – $2.06

80 mg (per each): $2.38 – $2.41

120 mg (per each): $2.98 – $2.99

160 mg (per each): $3.88 – $3.90

Solution (Hemangeol Oral)

4.28 mg/mL (per mL): $5.36

Solution (Propranolol HCl Intravenous)

1 mg/mL (per mL): $9.60 – $12.08

Solution (Propranolol HCl Oral)

20 mg/5 mL (per mL): $0.13

40 mg/5 mL (per mL): $0.19

Tablets (Propranolol HCl Oral)

10 mg (per each): $0.35 – $0.41

20 mg (per each): $0.51 – $1.34

40 mg (per each): $0.68 – $0.72

60 mg (per each): $1.22 – $1.74

80 mg (per each): $0.90 – $0.97

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Nonselective beta-adrenergic blocker (class II antiarrhythmic); competitively blocks response to beta1– and beta2-adrenergic stimulation which results in decreases in heart rate, myocardial contractility, blood pressure, and myocardial oxygen demand. Nonselective beta-adrenergic blockers (propranolol, nadolol) reduce portal pressure by producing splanchnic vasoconstriction (beta2 effect) thereby reducing portal blood flow.

Pharmacodynamics/Kinetics

Onset of action: Beta-blockade: Oral: 1 to 2 hours; Peak effect: Hypertension: A few days to several weeks

Duration: Immediate release: 6 to 12 hours; Extended-release formulations: ~24 to 27 hours

Absorption: Oral: Rapid and complete

Distribution: Vd: 4 L/kg (adults); crosses the blood-brain barrier

Protein binding: Newborns: 68%; Adults: ~90% (S-isomer primarily to alpha-1 acid glycoprotein; R-isomer primarily to albumin)

Metabolism: Extensive first-pass effect, hepatically metabolized to active and inactive compounds; the 3 main metabolic pathways include: Aromatic hydroxylation (primarily 4-hydroxylation), N-dealkylation followed by further side-chain oxidation and direct glucuronidation; the 4 primary metabolites include: Propranolol glucuronide, naphthyloxylactic acid, and sulfate and glucuronic acid conjugates of 4-hydroxy propranolol; Note: Aromatic hydroxylation is catalyzed primarily by isoenzyme CYP2D6; side chain oxidation is mainly via CYP1A2, but also CYP2D6; 4-hydroxypropranolol possesses beta-adrenergic receptor blocking activity and is a weak inhibitor of CYP2D6.

Bioavailability: ~25% reaches systemic circulation due to high first-pass metabolism; oral bioavailability may be increased in Down syndrome children; protein-rich foods increase bioavailability by ~50%

Half-life elimination: Neonates: Possible increased half-life; Infants (35 to 150 days of age): Median 3.5 hours; Children: 3.9 to 6.4 hours; Adults: Immediate release formulation: 3 to 6 hours; Extended-release formulations: 8 to 10 hours

Time to peak: Immediate release: Adults: 1 to 4 hours; Infants: ≤2 hours (Hemangeol); Extended release capsule (Inderal XL, InnoPran XL): 12 to 14 hours; Long acting capsule (Inderal LA): 6 hours

Excretion: Metabolites are excreted primarily in urine (96% to 99%); <1% excreted in urine as unchanged drug

Local Anesthetic/Vasoconstrictor Precautions

Use with caution; epinephrine has interacted with nonselective beta-blockers to result in initial hypertensive episode followed by bradycardia

Effects on Dental Treatment

Propranolol is a nonselective beta-blocker and may enhance the pressor response to epinephrine, resulting in hypertension and bradycardia. Many nonsteroidal anti-inflammatory drugs, such as ibuprofen and indomethacin, can reduce the hypotensive effect of beta-blockers after 3 or more weeks of therapy with the NSAID. Short-term NSAID use (ie, 3 days) requires no special precautions in patients taking beta-blockers.

Effects on Bleeding

No information available to require special precautions

Index Terms

Hemangeol; Inderal; Propranolol HCl; Propranolol Hydrochloride

FDA Approval Date
November 13, 1967
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Brand Names: International

Adlock (BD); Anaprilan (RU); Anaprilins (LV); Arteflo (LK); Atensin (BF, BJ, CI, ET, GH, GM, GN, JO, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Avlocardyl (FR, VN); Bai Er Luo (CN); Bedranol (AE, BB, BF, BJ, BM, BS, BZ, CI, ET, GH, GM, GN, GY, JM, KE, LB, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, SR, TN, TT, TZ, UG, ZM, ZW); Berkolol (HK); Beta-Prograne (IE); Beta-Timelets (AE, CY, IL, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Betabex (BD); Betalol (TH); Betapress (TH); Betascan (TW); Cardiblok (ZA); Cardilol (AE); Cardinol (NZ); Cardinol LA (NZ); Cardispare (ZA); Cardolol (TW); Ciplar (IN); Colliprol (MX); Corbeta (IN); Coriodal (CL); Deralin (AU, IL); Dideral (TR); Dociton (DE); Duranol (PH); Emforal (MT, TR); Farmadral (ID); Frina (GR); Frixopel (PY); Half Beta-Prograne (IE); Hemangiol (BE, CZ, ES, IE, JP, KR, NL); Hipranol (MY); Indenol (KR); Inderal (AE, AR, AT, AU, BB, BE, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CO, CY, DK, EC, EG, ET, GH, GM, GN, GR, GY, IE, IQ, IR, IT, JM, JO, JP, KE, KR, KW, LB, LR, LU, LY, MA, ML, MR, MU, MW, MY, NE, NG, OM, PE, PH, PK, PT, PY, QA, SA, SC, SD, SE, SG, SI, SL, SN, SR, SY, TN, TT, TW, TZ, UG, UY, VE, VN, YE, ZM, ZW); Inderal LA (AE, BB, BF, BJ, BM, BS, BZ, CI, CY, ET, GH, GM, GN, GY, IQ, IR, JM, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, PE, PT, QA, SA, SC, SD, SL, SN, SR, SY, TN, TT, TZ, UG, YE, ZM, ZW); Inderalici (CR, DO, GT, HN, MX, NI, PA, SV); Indesol (KR); Indever (BD); Indicardin (BF, BH, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Inpanol (HK); Laining (TW); MIDDLEEAST (IL); Normpress (TH); Oposim (AR); Palon (TH); Pranidol (MX); Pranosol (LK); Presin (PY); Presoral (BD); Prestoral (ID); Prolol (EG, IL); Pronol (BD); Propalong (AR); Propayerst (AR); Propra (EE); Propra-Ratiopharm (PL); Propral (FI); Propranolol Eurogenerics (LU); Protolif (EC); Pu Le Xin (CN); Purbloka (ZA); Rebaten LA (BR); Rexigen (ZA, ZW); Slow Deralin (IL); Sumial (ES); Syprol (MT); Tenomal (GR); Tepra (KR); Waucoton (GR)

Propranolol (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(proe PRAN oh lole)

Brand Names: US

Hemangeol; Inderal LA; Inderal XL; InnoPran XL

Brand Names: Canada

Hemangiol; Inderal LA

Warning
  • Do not stop taking this drug all of a sudden. If you do, chest pain that is worse and in some cases heart attack may occur. The risk may be greater if you have certain types of heart disease. To avoid side effects, you will want to slowly stop this drug as ordered by your doctor. Call your doctor right away if you have new or worse chest pain or if other heart problems occur.
What is this drug used for?
  • It is used to treat high blood pressure.
  • It is used to treat chest pain or pressure.
  • It is used to help certain heart problems.
  • It is used to prevent migraine headaches.
  • It is used to treat tremor (essential).
  • It is used after a heart attack to help prevent future heart attacks and lengthen life.
  • It is used to treat pheochromocytoma.
  • It is used to treat certain types of abnormal heartbeats.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to propranolol or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Certain types of abnormal heartbeats called heart block or sick-sinus syndrome, heart failure (weak heart), low blood pressure, poor blood flow to the arms or legs, shock caused by heart problems, or a slow heartbeat.
  • If you have any of these health problems: Asthma or other breathing problems like COPD (chronic obstructive pulmonary disease).
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • Talk with your doctor before you drink alcohol.
  • If you smoke, talk with your doctor.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this drug.
  • This drug may hide the signs of low blood sugar. Talk with the doctor.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • This drug may make it harder to tell if you have signs of an overactive thyroid like fast heartbeat. If you have an overactive thyroid and stop taking this drug all of a sudden, it may get worse and could be life-threatening. Talk with your doctor.
  • If you are taking this drug and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • If you have had a very bad allergic reaction, talk with your doctor. You may have a chance of an even worse reaction if you come into contact with what caused your allergy. If you use epinephrine to treat very bad allergic reactions, talk with your doctor. Epinephrine may not work as well while you are taking this drug.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Oral solution:
  • Make sure you have the right liquid; there is more than one strength.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • Very bad dizziness or passing out.
  • Chest pain that is new or worse.
  • Slow heartbeat.
  • A heartbeat that does not feel normal.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Feeling confused.
  • Hallucinations (seeing or hearing things that are not there).
  • Memory problems or loss.
  • Mood changes.
  • A burning, numbness, or tingling feeling that is not normal.
  • Feeling cold in the arms or legs.
  • Change in eyesight.
  • Any unexplained bruising or bleeding.
  • Fever or chills.
  • Sore throat.
  • Not able to get or keep an erection.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Dizziness.
  • Feeling sleepy.
  • Feeling tired or weak.
  • Upset stomach or throwing up.
  • Stomach cramps.
  • Constipation.
  • Diarrhea.
  • Trouble sleeping.
  • Strange or odd dreams.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Inderal XL and InnoPran XL:
  • Take with or without food but take the same way each time. Always take with food or always take on an empty stomach.
  • Take at bedtime if taking once a day.
  • All other oral products:
  • Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this drug.
  • Oral solution:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • All long-acting products:
  • Swallow capsule whole. Do not chew, break, or crush.
  • All oral products:
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Injection:
  • It is given as a shot into a vein.
What do I do if I miss a dose?
  • All oral products:
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Injection:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Protect from light.
  • Keep lid tightly closed.
  • Store in a dry place. Do not store in a bathroom.
  • Oral solution:
  • Do not freeze.
  • Injection:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Propranolol (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(proe PRAN oh lole)

Brand Names: US

Hemangeol; Inderal LA; Inderal XL; InnoPran XL

Brand Names: Canada

Hemangiol; Inderal LA

Warning
  • Products other than Hemangeol:
  • Do not stop giving this drug to your child all of a sudden. If you do, chest pain that is worse and in some cases heart attack may occur. The chance may be higher if your child has certain types of heart disease. To avoid side effects, you will want to slowly stop this drug as ordered by the doctor. Call the doctor right away if your child has new or worse chest pain or if other heart problems happen.
What is this drug used for?
  • Hemangeol:
  • It is used to treat proliferating infantile hemangioma.
  • Products other than Hemangeol:
  • It is used to treat high blood pressure.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • All products:
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • Hemangeol:
  • If your child was born premature and has not reached the corrected age of 5 weeks.
  • If your child weighs less than 4 ½ pounds (2 kilograms).
  • If your child has asthma or has had breathing problems.
  • If your child has any of these health problems: Certain heart problems, a slow heartbeat, or very low blood pressure.
  • If your child has high blood pressure caused by a tumor of the adrenal gland (pheochromocytoma).
  • If your child is at risk for low blood sugar, like if your child is throwing up or not able to take feedings.
  • Products other than Hemangeol:
  • If your child has any of these health problems: Certain types of abnormal heartbeats called heart block or sick-sinus syndrome, heart failure (weak heart), low blood pressure, poor blood flow to the arms or legs, shock caused by heart problems, or a slow heartbeat.
  • If your child has any of these health problems: Asthma or other breathing problems like COPD (chronic obstructive pulmonary disease).
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child’s blood pressure and heart rate checked often. Talk with your child’s doctor.
  • This drug may hide the signs of low blood sugar. Talk with the doctor.
  • If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
  • If your child has had a very bad allergic reaction, talk with the doctor. Your child may have a chance of an even worse reaction if your child comes into contact with what caused the allergy. If your child uses epinephrine to treat very bad allergic reactions, talk with the doctor. Epinephrine may not work as well while your child is taking this drug.
  • Hemangeol:
  • This drug may raise the chance of stroke in some children who have very bad problems with the blood vessels in their brain. The risk is higher in children with a large hemangioma that affects the face or head. Talk with the doctor.
  • If you are breast-feeding your child, tell the doctor about all the drugs you are taking. Certain drugs may pass to your child through breast milk and may interact with this drug.
  • All liquid products:
  • Make sure you have the right liquid; there is more than one strength.
  • Products other than Hemangeol:
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child smokes, talk with the doctor.
  • If your child is taking warfarin, talk with the doctor. Your child may need to have blood work checked more closely while taking it with this drug.
  • This drug may make it harder to tell if your child has signs of an overactive thyroid like fast heartbeat. If your child has an overactive thyroid and stops taking this drug all of a sudden, it may get worse and could be life-threatening. Talk with the doctor.
  • If your child is taking this drug and has high blood pressure, talk with the doctor before giving OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Slow heartbeat.
  • A heartbeat that does not feel normal.
  • Feeling cold in the arms or legs.
  • Fever or chills.
  • Sore throat.
  • Hemangeol:
  • Feeling fussy.
  • Change in color of skin.
  • Wheezing or coughing.
  • Pale skin.
  • Feeling very tired or weak.
  • This drug may lower blood sugar levels. The chance is higher if your child is not taking feedings or is throwing up. Feed your child on a regular basis while giving this drug. Tell the doctor if your child has a poor appetite. If your child is not taking feedings due to an illness or throwing up, do not give this drug until your child is feeding normally again unless told to do so by the doctor. Call the doctor or get medical help right away if your child has signs of low blood sugar like pale, blue, or purple skin color; sweating; feeling fussy; crying that is not normal; fast heartbeat; a heartbeat that does not feel normal; poor feeding; low body temperature; sleeping more than normal; seizures; or breathing stops for a short time.
  • Products other than Hemangeol:
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • Chest pain that is new or worse.
  • Feeling confused.
  • Hallucinations (seeing or hearing things that are not there).
  • Memory problems or loss.
  • Mood changes.
  • A burning, numbness, or tingling feeling that is not normal.
  • Change in eyesight.
  • Any unexplained bruising or bleeding.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
  • If your child is or may be sexually active:
  • Not able to get or keep an erection.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • All products:
  • Diarrhea.
  • Throwing up.
  • Feeling sleepy.
  • Trouble sleeping.
  • Products other than Hemangeol:
  • Dizziness.
  • Feeling tired or weak.
  • Upset stomach.
  • Stomach cramps.
  • Constipation.
  • Strange or odd dreams.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Inderal XL and InnoPran XL:
  • Give this drug with or without food but give it the same way each time. Always give with food or always give on an empty stomach.
  • Give at bedtime if your child is taking it once a day.
  • All other oral products:
  • Some drugs may need to be given with food or on an empty stomach. For some drugs, it does not matter. Check with your pharmacist about how to give this drug to your child.
  • All liquid products:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Hemangeol:
  • Do not shake the solution.
  • Give this drug right into your child’s mouth. If needed, this drug may be mixed with a little bit of milk or fruit juice and given in a baby’s bottle.
  • Give this drug with or right after a feeding.
  • Give doses of this drug at least 9 hours apart.
  • If giving to your child, the dose of this drug may need to be changed as your child’s weight changes. Have your child’s weight checked often. Talk with the doctor before changing your child’s dose.
  • If your child spits up a dose or if you are not sure your child got all of the drug, do not give another dose. Wait until your child’s next dose to give again.
  • All long-acting products:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • All oral products:
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Injection:
  • It is given as a shot into a vein.
What do I do if my child misses a dose?
  • All oral products:
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Injection:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Protect from light.
  • Keep lid tightly closed.
  • Store in a dry place. Do not store in a bathroom.
  • All liquid products:
  • Do not freeze.
  • Hemangeol:
  • Throw away any part of the solution not used after 2 months.
  • Injection:
  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.