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Propranolol Hydrochloride
Overview
What is Propranolol Hydrochloride?
hydrochloride(Propranolol is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formulae are:
Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80.
Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration.
The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain FD &C yellow No.6 Aluminium Lake and Color D&C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD&C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D&C Red No. 30 Lake.
What does Propranolol Hydrochloride look like?
What are the available doses of Propranolol Hydrochloride?
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What should I talk to my health care provider before I take Propranolol Hydrochloride?
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How should I use Propranolol Hydrochloride?
Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.
Because of the variable bioavailability of propranolol the dose should be individualized based on response.
What interacts with Propranolol Hydrochloride?
Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.
What are the warnings of Propranolol Hydrochloride?
Angina Pectoris
There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. Therefore, when discontinuance of propranolol is planned, the dosage should be gradually reduced over at least a few weeks and the patient should be cautioned against interruption or cessation of therapy without the physician’s advice. If propranolol therapy is interrupted and exacerbation of angina occurs, it usually is advisable to reinstitute propranolol therapy and take other measures appropriate for the management of angina pectoris. Since coronary artery disease may be unrecognized, it may be prudent to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease who are given propranolol for other indications.
Hypersensitivity and Skin Reactions
Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been associated with the administration of propranolol (see
Cutaneous reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and urticaria, have been reported with use of propranolol (see
Cardiac Failure
Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta-blockade may precipitate more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, some have been shown to be highly beneficial when used with close follow-up in patients with a history of failure who are well compensated and are receiving additional therapies, including diuretics as needed. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle.
In Patients without a History of Heart Failure,
Nonallergic Bronchospasm (e.g., Chronic Bronchitis, Emphysema)
In general, patients with bronchospastic lung disease should not receive beta-blockers. Propranolol should be administered with caution in this setting since it may provoke a bronchial asthmatic attack by blocking bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta-receptors.
Major Surgery
The necessity or desirability of withdrawal of beta-blocking therapy prior to major surgery is controversial. It should be noted, however, that the impaired ability of the heart to respond to reflex adrenergic stimuli in propranolol-treated patients may augment the risks of general anesthesia and surgical procedures.
Propranolol is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension.
Diabetes and Hypoglycemia
Beta-adrenergic blockade may prevent the appearance of certain premonitory signs and symptoms (pulse rate and pressure changes) of acute hypoglycemia, especially in labile insulin-dependent diabetics. In these patients, it may be more difficult to adjust the dosage of insulin.
Propranolol therapy, particularly when given to infants and children, diabetic or not, has been associated with hypoglycemia especially during fasting as in preparation for surgery. Hypoglycemia has been reported in patients taking propranolol after prolonged physical exertion and in patients with renal insufficiency.
Thyrotoxicosis
Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism. Therefore, abrupt withdrawal of propranolol may be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Propranolol may change thyroid-function tests, increasing T and reverse T and decreasing T.
Wolff-Parkinson-White Syndrome
Beta-adrenergic blockade in patients with Wolf-Parkinson-White syndrome and tachycardia has been associated with severe bradycardia requiring treatment with a pacemaker. In one case, this result was reported after an initial dose of 5 mg propranolol.
Pheochromocytoma
Blocking only the peripheral dilator (beta) action of epinephrine with propranolol leaves its constrictor (alpha) action unopposed. In the event of hemorrhage or shock, there is a disadvantage in having both beta and alpha-blockade since the combination prevents the increase in heart rate and peripheral vasoconstriction needed to maintain blood pressure.
What are the precautions of Propranolol Hydrochloride?
General
Propranolol should be used with caution in patients with impaired hepatic or renal function. Propranolol hydrochloride tablets are not indicated for the treatment of hypertensive emergencies.
Beta-adrenergic receptor blockade can cause reduction of intraocular pressure. Patients should be told that propranolol hydrochloride tablets may interfere with the glaucoma screening test. Withdrawal may lead to a return of increased intraocular pressure.
While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
Clinical Laboratory Tests
In patients with hypertension, use of propranolol has been associated with elevated levels of serum potassium, serum transaminases, and alkaline phosphatase. In severe heart failure, the use of propranolol has been associated with increases in Blood Urea Nitrogen.
Drug Interactions
Caution should be exercised when propranolol hydrochloride tablets are administered with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways. Co-administration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see
Cardiovascular Drugs
Antiarrhythmics
Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.
Quinidine increases the concentration of propranolol and produces greater degrees of clinical beta-blockade and may cause postural hypotension.
Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.
The clearance of lidocaine is reduced with administration of propranolol. Lidocaine toxicity has been reported following coadministration with propranolol.
Caution should be exercised when administering propranolol hydrochloride tablets with drugs that slow A-V nodal conduction, e.g. digitalis, lidocaine and calcium channel blockers.
Digitalis Glycosides
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Calcium Channel Blockers
Caution should be exercised when patients receiving a beta-blocker are administered a calcium-channel-blocking drug with negative inotropic and/or chronotropic effects. Both agents may depress myocardial contractility or atrioventricular conduction.
There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta-blockers.
Coadministration of propranolol and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high degree heart block, and heart failure.
ACE Inhibitors
When combined with beta-blockers, ACE inhibitors can cause hypotension, particularly in the setting of acute myocardial infarction.
The antihypertensive effects of clonidine may be antagonized by beta-blockers. Propranolol hydrochloride tablets should be administered cautiously to patients withdrawing from clonidine.
Alpha Blockers
Prazosin has been associated with prolongation of first dose hypotension in the presence of beta-blockers.
Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin.
Reserpine
Patients receiving catecholamine-depleting drugs, such as reserpine, should be closely observed for excessive reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension.
Inotropic Agents
Patients on long term therapy with propranolol may experience uncontrolled hypertension if administered epinephrine as a consequence of unopposed alpha-receptor stimulation. Epinephrine is therefore not indicated in the treatment of propranolol overdose (see
Isoproterenol and Dobutamine
Propranolol is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol. Also, propranolol may reduce sensitivity to dobutamine stress echocardiography in patients undergoing evaluation for myocardial ischemia.
Non-Cardiovascular Drugs
Nonsteroidal Anti-Inflammatory Drugs
Nonsteroidal anti-inflammatory drugs (NSAIDS) have been reported to blunt the antihypertensive effect of beta-adrenoreceptor blocking agents.
Administration of indomethacin with propranolol may reduce the efficacy of propranolol in reducing blood pressure and heart rate.
Antidepressants
The hypotensive effects of MAO inhibitors or tricyclic antidepressants may be exacerbated when administered with beta-blockers by interfering with the beta-blocking activity of propranolol.
Anesthetic Agents
Methoxyflurane and trichloroethylene may depress myocardial contractility when administered with propranolol.
Warfarin
Propranolol when administered with warfarin increases the concentration of warfarin. Prothrombin time, therefore, should be monitored.
Neuroleptic Drugs
Hypotension and cardiac arrest have been reported with the concomitant use of propranolol and haloperidol.
Thyroxine
Thyroxine may result in a lower than expected T concentration when used concomitantly with propranolol.
Alcohol
Alcohol, when used concomitantly with propranolol, may increase plasma levels of propranolol.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In dietary administration studies in which mice and rats were treated with propranolol hydrochloride for up to 18 months at doses of up to 150 mg/kg/day, there was no evidence of drug-related tumorigenesis. On a body surface area basis, this dose in the mouse and rat is, respectively, about equal to and about twice the maximum recommended human oral daily dose (MRHD) of 640 mg propranolol hydrochloride. In a study in which both male and female rats were exposed to propranolol hydrochloride in their diets at concentrations of up to 0.05% (about 50 mg/kg body weight and less than the MRHD), from 60 days prior to mating and throughout pregnancy and lactation for two generations, there were no effects on fertility. Based on differing results from Ames Tests performed by different laboratories, there is equivocal evidence for a genotoxic effect of propranolol hydrochloride in bacteria (strain TA 1538).
Pregnancy:- Pregnancy Category C
In a series of reproductive and developmental toxicology studies, propranolol hydrochloride was given to rats by gavage or in the diet throughout pregnancy and lactation. At doses of 150 mg/kg/day, but not at doses of 80 mg/kg/day (equivalent to the MRHD on a body surface area basis), treatment was associated with embryotoxicity (reduced litter size and increased resorption rates) as well as neonatal toxicity (deaths). Propranolol hydrochloride also was administered (in the feed) to rabbits (throughout pregnancy and lactation) at doses as high as 150 mg/kg/day (about 5 times the maximum recommended human oral daily dose). No evidence of embryo or neonatal toxicity was noted.
There are no adequate and well-controlled studies in pregnant women. Intrauterine growth retardation, small placentas, and congenital abnormalities have been reported in neonates whose mothers received propranolol during pregnancy. Neonates whose mothers received propranolol at parturition have exhibited bradycardia, hypoglycemia, and respiratory depression. Adequate facilities for monitoring such infants at birth should be available. Propranolol hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
Propranolol is excreted in human milk. Caution should be exercised when propranolol hydrochloride tablets are administered to a nursing woman.
Pediatric Use
Safety and effectiveness of propranolol in pediatric patients have not been established.
Bronchospasm and congestive heart failure have been reported coincident with the administration of propranolol therapy in pediatric patients.
Geriatric Use
Clinical studies of propranolol hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
What are the side effects of Propranolol Hydrochloride?
The following adverse events were observed and have been reported in patients using propranolol.
Cardiovascular:
Central Nervous System:
Gastrointestinal:
Allergic:
Respiratory:
Hematologic:
Autoimmune:
Skin and mucous membranes:
Genitourinary:
What should I look out for while using Propranolol Hydrochloride?
Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.
What might happen if I take too much Propranolol Hydrochloride?
Propranolol is not significantly dialyzable. In the event of overdosage or exaggerated response, the following measures should be employed:
General: If ingestion is or may have been recent, evacuate gastric contents, taking care to prevent pulmonary aspiration.
Supportive Therapy: Hypotension and bradycardia have been reported following propranolol overdose and should be treated appropriately. Glucagon can exert potent inotropic and chronotropic effects and may be particularly useful for the treatment of hypotension or depressed myocardial function after a propranolol overdose. Glucagon should be administered as 50-150 mcg/kg intravenously followed by continuous drip of 1-5 mg/hour for positive chronotropic effect. Isoproterenol, dopamine or phosphodiesterase inhibitors may also be useful. Epinephrine, however, may provoke uncontrolled hypertension. Bradycardia can be treated with atropine or isoproterenol. Serious bradycardia may require temporary cardiac pacing.
The electrocardiogram, pulse, blood pressure, neurobehavioral status and intake and output balance must be monitored. Isoproterenol and aminophylline may be used for bronchospasm.
How should I store and handle Propranolol Hydrochloride?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).Propranolol hydrochloride tablets, USP are available as follows:20mgThey are supplied by as follows:Storage: Store at 20°-25C (6877F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]Protect from light.Dispense in a well closed, light-resistant container as defined in USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Propranolol hydrochloride tablets, USP are available as follows:20mgThey are supplied by as follows:Storage: Store at 20°-25C (6877F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]Protect from light.Dispense in a well closed, light-resistant container as defined in USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Propranolol hydrochloride tablets, USP are available as follows:20mgThey are supplied by as follows:Storage: Store at 20°-25C (6877F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]Protect from light.Dispense in a well closed, light-resistant container as defined in USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Propranolol hydrochloride tablets, USP are available as follows:20mgThey are supplied by as follows:Storage: Store at 20°-25C (6877F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]Protect from light.Dispense in a well closed, light-resistant container as defined in USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Propranolol hydrochloride tablets, USP are available as follows:20mgThey are supplied by as follows:Storage: Store at 20°-25C (6877F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]Protect from light.Dispense in a well closed, light-resistant container as defined in USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Propranolol hydrochloride tablets, USP are available as follows:20mgThey are supplied by as follows:Storage: Store at 20°-25C (6877F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]Protect from light.Dispense in a well closed, light-resistant container as defined in USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Propranolol hydrochloride tablets, USP are available as follows:20mgThey are supplied by as follows:Storage: Store at 20°-25C (6877F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]Protect from light.Dispense in a well closed, light-resistant container as defined in USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Propranolol hydrochloride tablets, USP are available as follows:20mgThey are supplied by as follows:Storage: Store at 20°-25C (6877F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]Protect from light.Dispense in a well closed, light-resistant container as defined in USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Propranolol hydrochloride tablets, USP are available as follows:20mgThey are supplied by as follows:Storage: Store at 20°-25C (6877F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]Protect from light.Dispense in a well closed, light-resistant container as defined in USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Propranolol hydrochloride tablets, USP are available as follows:20mgThey are supplied by as follows:Storage: Store at 20°-25C (6877F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]Protect from light.Dispense in a well closed, light-resistant container as defined in USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Propranolol hydrochloride tablets, USP are available as follows:20mgThey are supplied by as follows:Storage: Store at 20°-25C (6877F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]Protect from light.Dispense in a well closed, light-resistant container as defined in USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Propranolol hydrochloride tablets, USP are available as follows:20mgThey are supplied by as follows:Storage: Store at 20°-25C (6877F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]Protect from light.Dispense in a well closed, light-resistant container as defined in USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Propranolol is a nonselective beta-adrenergic receptor blocking agent possessing no other autonomic nervous system activity. It specifically competes with beta-adrenergic receptor agonist agents for available receptor sites. When access to beta-receptor sites is blocked by propranolol, the chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation are decreased proportionately. At dosages greater than required for beta blockade, propranolol also exerts a quinidine-like or anesthetic-like membrane action, which affects the cardiac action potential. The significance of the membrane action in the treatment of arrhythmias is uncertain.
Non-Clinical Toxicology
Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.Caution should be exercised when propranolol hydrochloride tablets are administered with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways. Co-administration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see
Cardiovascular Drugs
Antiarrhythmics
Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.
Quinidine increases the concentration of propranolol and produces greater degrees of clinical beta-blockade and may cause postural hypotension.
Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.
The clearance of lidocaine is reduced with administration of propranolol. Lidocaine toxicity has been reported following coadministration with propranolol.
Caution should be exercised when administering propranolol hydrochloride tablets with drugs that slow A-V nodal conduction, e.g. digitalis, lidocaine and calcium channel blockers.
Digitalis Glycosides
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Calcium Channel Blockers
Caution should be exercised when patients receiving a beta-blocker are administered a calcium-channel-blocking drug with negative inotropic and/or chronotropic effects. Both agents may depress myocardial contractility or atrioventricular conduction.
There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta-blockers.
Coadministration of propranolol and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high degree heart block, and heart failure.
ACE Inhibitors
When combined with beta-blockers, ACE inhibitors can cause hypotension, particularly in the setting of acute myocardial infarction.
The antihypertensive effects of clonidine may be antagonized by beta-blockers. Propranolol hydrochloride tablets should be administered cautiously to patients withdrawing from clonidine.
Alpha Blockers
Prazosin has been associated with prolongation of first dose hypotension in the presence of beta-blockers.
Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin.
Reserpine
Patients receiving catecholamine-depleting drugs, such as reserpine, should be closely observed for excessive reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension.
Inotropic Agents
Patients on long term therapy with propranolol may experience uncontrolled hypertension if administered epinephrine as a consequence of unopposed alpha-receptor stimulation. Epinephrine is therefore not indicated in the treatment of propranolol overdose (see
Isoproterenol and Dobutamine
Propranolol is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol. Also, propranolol may reduce sensitivity to dobutamine stress echocardiography in patients undergoing evaluation for myocardial ischemia.
Propranolol should be used with caution in patients with impaired hepatic or renal function. Propranolol hydrochloride tablets are not indicated for the treatment of hypertensive emergencies.
Beta-adrenergic receptor blockade can cause reduction of intraocular pressure. Patients should be told that propranolol hydrochloride tablets may interfere with the glaucoma screening test. Withdrawal may lead to a return of increased intraocular pressure.
While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
The following adverse events were observed and have been reported in patients using propranolol.
Cardiovascular:
Central Nervous System:
Gastrointestinal:
Allergic:
Respiratory:
Hematologic:
Autoimmune:
Skin and mucous membranes:
Genitourinary:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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