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Propranolol


Pronunciation

 (proe PRAN oh lole)


U.S. Brand Names

 Inderal®; Inderal® LA; InnoPran XL™; Propranolol Intensol™


Synonyms

 Propranolol Hydrochloride


Generic Available

 Yes: Excludes capsule


Canadian Brand Names

 Apo-Propranolol®; Inderal®; Inderal®-LA; Nu-Propranolol


Use

 Management of hypertension; angina pectoris; pheochromocytoma; essential tremor; tetralogy of Fallot cyanotic spells; arrhythmias (such as atrial fibrillation and flutter, AV nodal re-entrant tachycardias, and catecholamine-induced arrhythmias); prevention of myocardial infarction; migraine headache; symptomatic treatment of hypertrophic subaortic stenosis


Use - Unlabeled/Investigational

 Tremor due to Parkinson's disease; ethanol withdrawal; aggressive behavior; antipsychotic-induced akathisia; prevention of bleeding esophageal varices; anxiety; schizophrenia; acute panic; gastric bleeding in portal hypertension; thyrotoxicosis


Pregnancy Risk Factor

 C (manufacturer); D (2nd and 3rd trimesters - expert analysis)


Pregnancy Implications

 Propranolol crosses the placenta. Beta-blockers have been associated with bradycardia, hypotension, and IUGR. IUGR is probably related to maternal hypertension. Available evidence suggests beta-blockers are generally safe during pregnancy (JNC 7). Cases of neonatal hypoglycemia have been reported following maternal use of beta-blockers at parturition or during breast-feeding. Monitor breast-fed infant for symptoms of beta-blockade.


Lactation

 Enters breast milk/use caution (AAP rates "compatible")


Contraindications

 Hypersensitivity to propranolol, beta-blockers, or any component of the formulation; uncompensated congestive heart failure (unless the failure is due to tachyarrhythmias being treated with propranolol), cardiogenic shock, bradycardia or heart block (2nd or 3rd degree), pulmonary edema, severe hyperactive airway disease (asthma or COPD), Raynaud's disease; pregnancy (2nd and 3rd trimesters)


Warnings/Precautions

 Administer cautiously in compensated heart failure and monitor for a worsening of the condition (efficacy of propranolol in CHF has not been demonstrated). Beta-blocker therapy should not be withdrawn abruptly (particularly in patients with CAD), but gradually tapered (over 2 weeks) to avoid acute tachycardia, hypertension, and/or ischemia. Use caution in patient with PVD. Use caution with concurrent use of beta-blockers and either verapamil or diltiazem; bradycardia or heart block can occur. Avoid concurrent I.V. use of both agents. Use cautiously in diabetics because it can mask prominent hypoglycemic symptoms. Can mask signs of thyrotoxicosis. Can cause fetal harm when administered in pregnancy. Use cautiously in hepatic dysfunction (dosage adjustment required). Use care with anesthetic agents which decrease myocardial function. Not indicated for hypertensive emergencies.


Adverse Reactions

 Frequency not defined.

Cardiovascular: Bradycardia, CHF, reduced peripheral circulation, chest pain, hypotension, impaired myocardial contractility, worsening of AV conduction disturbance, cardiogenic shock, Raynaud's syndrome, mesenteric thrombosis (rare), syncope

Central nervous system: Mental depression, lightheadedness, amnesia, emotional lability, confusion, hallucinations, dizziness, insomnia, fatigue, vivid dreams, lethargy, cold extremities, vertigo, cognitive dysfunction, psychosis, hypersomnolence

Dermatologic: Alopecia, contact dermatitis, eczematous eruptions, erythema multiforme, exfoliative dermatitis, hyperkeratosis, nail changes, pruritus, psoriasiform eruptions, rash, ulcerative lichenoid, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine & metabolic: Hypoglycemia, hyperglycemia, hyperlipidemia, hyperkalemia

Gastrointestinal: Diarrhea, nausea, vomiting, stomach discomfort, constipation, anorexia

Genitourinary: Impotence, proteinuria (rare), oliguria (rare), interstitial nephritis (rare), Peyronie's disease

Hematologic: Agranulocytosis, thrombocytopenia, thrombocytopenic purpura

Neuromuscular & skeletal: Weakness, carpal tunnel syndrome (rare), paresthesia, myotonus, polyarthritis, arthropathy

Ocular: Hyperemia of the conjunctiva, decreased tear production, decreased visual acuity, mydriasis

Respiratory: Wheezing, pharyngitis, bronchospasm, pulmonary edema, respiratory distress, laryngospasm

Miscellaneous: Lupus-like syndrome (rare), anaphylactic/anaphylactoid allergic reaction


Overdosage/Toxicology

 Symptoms of intoxication include cardiac disturbances, CNS toxicity, bronchospasm, hypoglycemia, and hyperkalemia. The most common cardiac symptoms include hypotension and bradycardia. Atrioventricular block, intraventricular conduction disturbances, cardiogenic shock, and asystole may occur with severe overdose, especially with membrane-depressant drugs (eg, propranolol). CNS effects include convulsions and coma. Respiratory arrest is commonly seen with propranolol and other membrane-depressant and lipid-soluble drugs. Treatment is symptom-directed and supportive.


Drug Interactions

 Substrate of CYP1A2 (major), 2C19 (minor), 2D6 (major), 3A4 (minor); Inhibits CYP1A2 (weak), 2D6 (weak)

Albuterol (and other beta2 agonists): Effects may be blunted by nonspecific beta-blockers.

Alpha-blockers (prazosin, terazosin): Concurrent use of beta-blockers may increase risk of orthostasis.

Aluminum hydroxide: Absorption of propranolol may be decreased.

Cholestyramine, colestipol: Plasma levels of propranolol may be decreased.

Cimetidine increases the plasma concentration of propranolol and its pharmacodynamic effects may be increased.

Clonidine: Hypertensive crisis after or during withdrawal of either agent

CYP1A2 inducers: May decrease the levels/effects of propranolol. Example inducers include aminoglutethimide, carbamazepine, phenobarbital, and rifampin.

CYP1A2 inhibitors: May increase the levels/effects of propranolol. Example inhibitors include amiodarone, ciprofloxacin, fluvoxamine, ketoconazole, norfloxacin, ofloxacin, and rofecoxib.

CYP2D6 inhibitors: May increase the levels/effects of propranolol. Example inhibitors include chlorpromazine, delavirdine, fluoxetine, miconazole, paroxetine, pergolide, quinidine, quinine, ritonavir, and ropinirole.

Diazepam: Metabolism of diazepam may be inhibited; concentrations of diazepam and metabolites may be increased.

Drugs which slow AV conduction (digoxin): Effects may be additive with beta-blockers.

Epinephrine (including local anesthetics with epinephrine): Propranolol may cause hypertension.

Flecainide: Pharmacological activity of both agents may be increased when used concurrently.

Fluoxetine may inhibit the metabolism of propranolol, resulting in cardiac toxicity.

Glucagon: Propranolol may blunt hyperglycemic action.

Haloperidol: Hypotensive effects may be potentiated.

Hydralazine: The bioavailability propranolol (rapid release) and hydralazine may be enhanced with concurrent dosing.

Insulin: Propranolol inhibits recovery and may cause hypertension and bradycardia following insulin-induced hypoglycemia; also masks the tachycardia that usually accompanies insulin-induced hypoglycemia.

Lidocaine: Metabolism of lidocaine may be decreased.

NSAIDs (ibuprofen, indomethacin, naproxen, piroxicam) may reduce the antihypertensive effects of beta-blockers.

Phenothiazines (chlorpromazine, phenothiazine): Plasma levels of propranolol and phenothiazine may both be increased.

Propafenone: May increase the concentrations/effects of propranolol.

Quinidine: May increase plasma levels of propranolol by decreasing metabolism.

Rifampin: May decrease plasma levels of propranolol by increasing metabolism.

Salicylates may reduce the antihypertensive effects of beta-blockers

Serotonin 5-HT1D receptor agonists (such as rizatriptan, zolmitriptan): Propranolol may increase bioavailability of serotonin 5-HT1D receptor agonists.

Sulfonylureas: Beta-blockers may alter response to hypoglycemic agents.

Theophylline: Theophylline clearance may be decreased by propranolol.

Verapamil or diltiazem may have synergistic or additive pharmacological effects when taken concurrently with beta-blockers; avoid concurrent I.V. use of both.

Warfarin: Propranolol may increase bioavailability of warfarin and PT may be increased.


Ethanol/Nutrition/Herb Interactions

Ethanol: Ethanol may decrease plasma levels of propranolol by increasing metabolism.

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.

Cigarette: Smoking may decrease plasma levels of propranolol by increasing metabolism.

Herb/Nutraceutical: Avoid dong quai if using for hypertension (has estrogenic activity). Avoid ephedra, yohimbe, ginseng (may worsen hypertension or arrhythmia). Avoid natural licorice (causes sodium and water retention and increases potassium loss). Avoid garlic (may have increased antihypertensive effect).


Stability

 Compatible in saline, incompatible with HCO3 - ; protect injection from light; solutions have maximum stability at pH of 3 and decompose rapidly in alkaline pH; propranolol is stable for 24 hours at room temperature in D5W or NS


Compatibility

 Stable in D5 1 /2NS, D5NS, D5W, LR, 1 /2NS, NS

Y-site administration: Compatible: Alteplase, gatifloxacin, heparin, hydrocortisone sodium succinate, inamrinone, linezolid, meperidine, milrinone, morphine, potassium chloride, propofol, tacrolimus, vitamin B complex with C. Incompatible: Amphotericin B cholesteryl sulfate complex, diazoxide

Compatibility in syringe: Compatible: Inamrinone, milrinone

Compatibility when admixed: Compatible: Dobutamine, verapamil


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


Pharmacodynamics/Kinetics

Onset of action: Beta-blockade: Oral: 1-2 hours

Duration: ~6 hours

Distribution: Vd: 3.9 L/kg in adults; crosses placenta; small amounts enter breast milk

Protein binding: Newborns: 68%; Adults: 93%

Metabolism: Hepatic to active and inactive compounds; extensive first-pass effect

Bioavailability: 30% to 40%; may be increased in Down syndrome

Half-life elimination: Neonates and Infants: Possible increased half-life; Children: 3.9-6.4 hours; Adults: 4-6 hours

Excretion: Urine (96% to 99%)


Dosage

Akathisia: Oral: Adults: 30-120 mg/day in 2-3 divided doses

Angina: Oral: Adults: 80-320 mg/day in doses divided 2-4 times/day

Long-acting formulation: Initial: 80 mg once daily; maximum dose: 320 mg once daily

Essential tremor: Oral: Adults: 20-40 mg twice daily initially; maintenance doses: usually 120-320 mg/day

Hypertension:

Oral:

Children: Initial: 0.5-1 mg/kg/day in divided doses every 6-12 hours; increase gradually every 5-7 days; maximum: 16 mg/kg/24 hours

Adults: Initial: 40 mg twice daily; increase dosage every 3-7 days; usual dose: 320 mg divided in 2-3 doses/day; maximum daily dose: 640 mg; usual dosage range (JNC 7): 40-160 mg/day in 2 divided doses

Long-acting formulation: Initial: 80 mg once daily; usual maintenance: 120-160 mg once daily; maximum daily dose: 640 mg; usual dosage range (JNC 7): 60-180 mg/day once daily

I.V.: Children: 0.01-0.05 mg/kg over 1 hour; maximum dose: 10 mg

Hypertrophic subaortic stenosis: Oral: Adults: 20-40 mg 3-4 times/day

Long-acting formulation: 80-160 mg once daily

Migraine headache prophylaxis: Oral:

Children: Initial: 2-4 mg/kg/day or

35 kg: 10-20 mg 3 times/day

>35 kg: 20-40 mg 3 times/day

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

Long-acting formulation: Initial: 80 mg once daily; effective dose range: 160-240 mg once daily

Myocardial infarction prophylaxis: Oral: Adults: 180-240 mg/day in 3-4 divided doses

Pheochromocytoma: Oral: Adults: 30-60 mg/day in divided doses

Tachyarrhythmias:

Oral:

Children: Initial: 0.5-1 mg/kg/day in divided doses every 6-8 hours; titrate dosage upward every 3-7 days; usual dose: 2-6 mg/kg/day; higher doses may be needed; do not exceed 16 mg/kg/day or 60 mg/day

Adults: 10-30 mg/dose every 6-8 hours

Elderly: Initial: 10 mg twice daily; increase dosage every 3-7 days; usual dosage range: 10-320 mg given in 2 divided doses

I.V.:

Children: 0.01-0.1 mg/kg/dose slow IVP over 10 minutes; maximum dose: 1 mg for infants; 3 mg for children

Adults (in patients having nonfunctional GI tract): 1 mg/dose slow IVP; repeat every 5 minutes up to a total of 5 mg; titrate initial dose to desired response

Tetralogy spells: Children:

Oral: Palliation: Initial: 1 mg/kg/day every 6 hours; if ineffective, may increase dose after 1 week by 1 mg/kg/day to a maximum of 5 mg/kg/day; if patient becomes refractory, may increase slowly to a maximum of 10-15 mg/kg/day. Allow 24 hours between dosing changes.

I.V.: 0.01-0.2 mg/kg/dose infused over 10 minutes; maximum initial dose: 1 mg

Thyrotoxicosis:

Oral:

Children: 2 mg/kg/day, divided every 6-8 hours, titrate to effective dose

Adolescents and Adults: Oral: 10-40 mg/dose every 6 hours

I.V.: Adults: 1-3 mg/dose slow IVP as a single dose

Dosing adjustment/comments in renal impairment:

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

Peritoneal dialysis effects: Supplemental dose is not necessary.

Dosing adjustment/comments in hepatic disease: Marked slowing of heart rate may occur in cirrhosis with conventional doses; low initial dose and regular heart rate monitoring


Administration

 I.V. dose is much smaller than oral dose. When administered acutely for cardiac treatment, monitor ECG and blood pressure. May administer by rapid infusion (I.V. 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. Do not crush long-acting oral forms.


Monitoring Parameters

Acute cardiac treatment: Monitor ECG and blood pressure with I.V. administration; heart rate and blood pressure with oral administration


Reference Range

 Therapeutic: 50-100 ng/mL (SI: 190-390 nmol/L) at end of dose interval


Dietary Considerations

 Tablets should be taken on an empty stomach; capsules may be taken with or without food, but should always be taken consistently (with food or on an empty stomach)


Patient Education

 Take exactly as directed; do not increase, decrease, or discontinue without consulting prescriber. Tablets may be crushed and taken with liquids. Do not chew or crush long-acting forms; take whole. Take at the same time each day. Do not alter dietary intake of protein or carbohydrates without consulting prescriber. You may experience orthostatic hypotension, dizziness, drowsiness, or blurred vision (use caution when driving, climbing stairs, or changing position - rising from sitting or lying to standing - or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, or stomach discomfort (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); or decreased sexual ability (reversible). If you have diabetes, monitor serum glucose closely. Report unusual swelling of extremities, respiratory difficulty, unresolved cough, or unusual weight gain, cold extremities, persistent diarrhea, confusion, hallucinations, headache, nervousness, lack of improvement, or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.


Anesthesia and Critical Care Concerns/Other Considerations

 Propranolol is not indicated for hypertensive emergencies. It is not significantly removed by hemodialysis.

Myocardial Infarction: Beta-blockers, in general without intrinsic sympathomimetic activity (ISA), have been shown to decrease morbidity and mortality when initiated in the acute treatment of myocardial infarction and continued long-term. In this setting, therapy should be avoided in patients with hypotension, cardiogenic shock, or heart block.

Surgery: Atenolol has also been shown to improve cardiovascular outcomes when used in the perioperative period in patients with underlying cardiovascular disease who are undergoing noncardiac surgery. Bisoprolol in high-risk patients undergoing vascular surgery reduced the perioperative incidence of death from cardiac causes and nonfatal myocardial infarction.

Atrial Fibrillation: Beta-blocker therapy provides effective rate control in patients with atrial fibrillation.

Withdrawal: Beta-blocker therapy should not be withdrawn abruptly, but gradually tapered over 2 weeks to avoid acute tachycardia and hypertension.


Cardiovascular Considerations

Hypertension: Beta-blocker therapy in the treatment of hypertension has been associated with improved cardiovascular outcomes. This class of drug is beneficial for elderly patients with hypertension. A recent UKPDS study showed that beta-blocker therapy (atenolol) was as effective as an ACE inhibitor in reducing cardiovascular events and that the benefits of therapy were related more to the degree of antihypertensive efficacy rather than the class of drug used.

Myocardial infarction: Beta-blockers, in general without intrinsic sympathomimetic activity (ISA), have been shown to decrease morbidity and mortality when initiated in the acute treatment of myocardial infarction and continued long-term. In this setting, therapy should be avoided in patients with hypotension, cardiogenic shock, or heart block.

Surgery: Atenolol has also been shown to improve cardiovascular outcomes when used in the perioperative period in patients with underlying cardiovascular disease who are undergoing noncardiac surgery. Bisoprolol in high-risk patients undergoing vascular surgery reduced the perioperative incidence of death from cardiac causes and nonfatal myocardial infarction.

Atrial fibrillation: Beta-blocker therapy provides effective rate control in patients with atrial fibrillation.

Angina: Beta-blockers are effective in the treatment of angina as monotherapy or when combined with nitrates and/or calcium channel blockers. In patients with severe intractable angina requiring negative cardiac chronotropic medications, pacemaker placement has been carried out to maintain heart rate in the setting of large doses of beta-blockers and/or calcium channel blockers. Beta-blockers are ineffective in the treatment of pure vasospastic (Prinzmetal) angina.

Unstable angina/non-ST-segment elevation MI: In the treatment of unstable angina/non-ST-segment elevation MI, a beta-blocker, with the first dose administered intravenously if there is ongoing chest pain, followed by oral administration, is recommended (in the absence of contraindications).

Withdrawal: Beta-blocker therapy should not be withdrawn abruptly, but gradually tapered to avoid acute tachycardia and hypertension.

Heart failure: There is emerging evidence that beta-blocker therapy, without intrinsic sympathomimetic activity (ISA), should be initiated in select patients with stable congestive heart failure (NYHA Class II-III). To date, carvedilol, sustained release metoprolol, and bisoprolol have demonstrated a beneficial effect on morbidity and mortality. It is important that beta-blocker therapy be instituted initially at very low doses with gradual and very careful titration.


Dental Health: 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.


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

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


Mental Health: Effects on Mental Status

 Fatigue and malaise are common and often mistaken for depression; may also cause dizziness, confusion, insomnia, or hallucinations


Mental Health: Effects on Psychiatric Treatment

 Low-dose propranolol is considered by many to be the drug of choice for akathisia. Concurrent use with psychotropic drugs may produce additive hypotensive effects; monitor blood pressure. Cutaneous reactions, including Stevens-Johnson syndrome, have been reported with use of propranolol; use caution with lamotrigine or valproic combination as combined usage with propranolol has been associated with these reactions.


Dosage Forms

Capsule, extended release, as hydrochloride (InnoPran XL™): 80 mg, 120 mg

Capsule, sustained release, as hydrochloride (Inderal® LA): 60 mg, 80 mg, 120 mg, 160 mg

Injection, solution, as hydrochloride (Inderal®): 1 mg/mL (1 mL)

Solution, oral, as hydrochloride: 4 mg/mL (5 mL, 500 mL); 8 mg/mL (500 mL) [strawberry-mint flavor; contains alcohol 0.6%]

Solution, oral concentrate, as hydrochloride (Propranolol Intensol™): 80 mg/mL (30 mL)

Tablet, as hydrochloride (Inderal®): 10 mg, 20 mg, 40 mg, 60 mg, 80 mg


References

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Bartosh S and Aronson A, "Childhood Hypertension. An Update on Etiology, Diagnosis and Treatment" Pediatr Clin North Am , 1999, 46(2):235-52.

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International Brand Names

 Anaprilin® (RU); Apo-Propranolol® (CA); Ely-Press® (AR); Emforal® (JO); Impanol® (SG); Inderal® (CA, LU); Inderal®-LA (CA); Indicardin® (RO); Inpanol® (HK); N-Propranolol® (RO); Nu-Propranolol (CA); Palon® (TH); Propanix® (GB); Propanolol® (CL); Propanolol Clorhidrato® (CL); Propranolol® (CL, RO); Propranolol Eurogenerics® (LU); Propranolol Gador® (AR); Slow Deralin® (IL)


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