Management of hypertension, alone or in combination with other antihypertensive agents. Not indicated for the treatment of hypertensive emergencies.
Angina
Management of chronic stable angina pectoris.
A component of the standard therapeutic measures in the management of unstable angina or non-ST-segment elevation/non-Q-wave MI†.
Supraventricular Tachyarrhythmias
β-Adrenergic blocking agents, including propranolol, are one of several preferred antiarrhythmic agents for the treatment of stable, narrow-complex supraventricular tachycardias (e.g., paroxysmal supraventricular tachycardia [reentry supraventricular tachycardia], ectopic or multifocal atrial tachycardia, junctional tachycardia) if the rhythm is not controlled by vagal maneuvers or adenosine in patients with preserved left ventricular function and for rate control in atrial fibrillation or flutter in patients with preserved left ventricular function.
Treatment of persistent atrial extrasystoles and noncompensatory sinus tachycardia that impair the well-being of the patient and do not respond to conventional therapy.
May be especially useful in conjunction with a cardiac glycoside to slow ventricular rates in the treatment of atrial flutter and fibrillation in patients whose arrhythmia is not controlled by adequate doses of a cardiac glycoside alone.
Ventricular Arrhythmias
Treatment of tachyarrhythmias during cardiovascular surgery†, including decreasing ventricular fibrillation time during cardiopulmonary bypass surgery†.
Treatment of persistent ventricular premature contractions that impair the well-being of the patient and do not respond to conventional therapy.
Tachyarrhythmias Associated with Cardiac Glycoside Intoxication or Catecholamine Excess
Management of supraventricular or ventricular tachyarrhythmias associated with cardiac glycoside toxicity when AV block is not present.
Management of resistant tachyarrhythmias associated with catecholamine excess during anesthesia; use with extreme caution and constant ECG and central venous pressure monitoring. More effective and less hazardous therapy, such as lessening the depth of anesthesia or improving ventilation, is preferred.
Hypertrophic Subaortic Stenosis
Management of exertional or other stress-induced angina, vertigo, syncope, and palpitation in patients with hypertrophic subaortic stenosis; clinical improvement may be temporary.
Pheochromocytoma
Management of symptoms resulting from excessive β-receptor stimulation in patients with inoperable or metastatic pheochromocytoma, as an adjunct to α-adrenergic blocking agents. Initiate therapy with an α-adrenergic blocking agent prior to treatment of pheochromocytoma. (See Pheochromocytoma under Cautions.)
Management of tachycardia prior to or during surgery in patients with pheochromocytoma, as an adjunct to α-adrenergic blocking agents. Initiate therapy with an α-adrenergic blocking agent prior to treatment of pheochromocytoma. (See Pheochromocytoma under Cautions.)
Thyrotoxicosis
Short-term (2–4 weeks) adjunctive therapy of tachycardia and supraventricular arrhythmias in patients with thyrotoxicosis when these symptoms are distressful or hazardous, or when immediate therapy is necessary.
Vascular Headache
Prophylaxis of common migraine headache; not recommended for the treatment of a migraine attack that has already started.
AMI
Secondary prevention following AMI to reduce the risk of reinfarction† and mortality.
Management of ventricular arrhythmias complicating AMI.
Essential Tremor
Management of essential (familial, hereditary) tremor.
Not indicated for tremor associated with Parkinsonism.
Dosage and Administration
General
Hypertension
In patients with hypertension, monitor BP during initial titration or subsequent upward dosage adjustment; large or abrupt reductions in BP should generally be avoided. Full hypotensive effect may require weeks of therapy, especially when low initial doses are used.
Adjust antihypertensive dosage at 1–2 month intervals (more aggressively in high-risk patients) if response is inadequate. Larger doses or 3 divided doses daily may be required to maintain effective response throughout the day.
Propranolol hydrochloride/hydrochlorothiazide fixed combination is not recommended for initial combination therapy; adjust initial and subsequent dosages by administering each drug separately.
AMI
In patients with AMI, administer therapy in 2, 3, or 4 divided doses daily. Continue therapy for at least 1–3 years unless contraindicated; some experts recommend that therapy be continued indefinitely unless contraindicated.
Angina
Periodically reevaluate chronic therapy for angina to determine the need for dosage adjustment or continued therapy.
In patients with unstable angina or non-ST-segment elevation/non-Q-wave MI, the ACC and the AHA suggest initiation with IV loading dose of a β-blocker (in patients who tolerate IV therapy), followed by oral therapy.
If long-term therapy is to be discontinued, reduce dosage gradually over a period of about 2 weeks. (See Abrupt Withdrawal of Therapy under Cautions.)
Vascular Headache
If an adequate response for prophylaxis of migraine is not obtained within 4–6 weeks after reaching the maximum dose, discontinue therapy gradually over several weeks.
Administration
Administer orally or IV.
Individualize dosage according to patient response.
Oral Administration
Administer conventional tablets in divided doses before meals and at bedtime.
Administer extended-release capsules once daily.
Extended-release capsules produce lower blood concentrations than conventional tablets; do not substitute on a mg-for-mg basis. Consider dosage retitration when switching from conventional tablets to extended-release capsules, especially to maintain effectiveness at the end of the dosing interval.
Dilute oral concentrate solution with water, juice, or carbonated beverages or mix with semisolid foods (e.g., applesauce, puddings) just prior to administration.
IV Administration
For solution and drug compatibility information, see Compatibility under Stability.
Monitor ECG and central venous pressure carefully during IV administration.
Replace IV therapy with oral therapy as soon as possible.
Rate of Administration
Administer by slow IV injection at a rate not >1 mg/minute.
Dosage
Pediatric Patients
Usual Dosage
Oral
Conventional tablets: 2–4 mg/kg daily in 2 equally divided doses. Weight-adjusted initial dosage is approximate; adjust dosage according to response, up to 16 mg/kg daily.
Do not calculate dosage based on body surface area; may result in excessive plasma concentrations.
If propranolol is to be discontinued, decrease dosage gradually over 7–14 days.
Hypertension
Oral
Conventional tablets: initially, 1 mg/kg daily in 2 equally divided doses. Adjust according to response and tolerance.
Usual maintenance dosage is 2–4 mg/kg daily in 2 equally divided doses, up to 16 mg/kg daily.
Alternatively, some experts recommend a usual initial dosage of 1–2 mg/kg daily given in 2 or 3 divided doses. Increase dosage as necessary up to a maximum dosage of 4 mg/kg (up to 640 mg) daily given in 2 or 3 divided doses.
Cardiac Arrhythmias
Oral
Initially, 1.5–2 mg/kg daily; titrate upward as necessary to 16 mg/kg daily in 4 divided doses to control the arrhythmia.
Dosages >4 mg/kg daily may be necessary for the management of supraventricular tachyarrhythmias.
IV
10–20 mcg/kg infused over 10 minutes has been recommended.
Thyrotoxicosis
Treatment of Tachyarrhythmias in Neonates with Thyrotoxicosis
Oral
2 mg/kg daily in 2–4 divided doses has been used. Higher dosages occasionally may be needed.
Adults
Hypertension
Monotherapy
Oral
Conventional tablets or oral solution: initially, 40 mg twice daily. Usual effective dosage is 120–240 mg daily.
Extended-release capsules: initially, 80 mg once daily. Usual effective dosage is 120–160 mg once daily.
Increase dosage gradually at 3- to 7-day intervals until optimum affect is achieved; some patients may require doses of 640 mg daily.
Fixed Combination Therapy
Oral
Propranolol in fixed combination with hydrochlorothiazide: administer in 2 divided doses daily (up to 160 mg of propranolol and 50 mg of hydrochlorothiazide total daily dosage).
Combination preparation is inappropriate with propranolol dosages >160 mg daily due to excessive dosage of the thiazide component. May gradually add another antihypertensive agent when necessary using half of the usual initial dosage to avoid an excessive decrease in BP.
Initial use of fixed-combination preparations is not recommended; adjust by administering each drug separately, then use the fixed combination if the optimum maintenance dosage corresponds to the drug dosages in the combination preparation. Administer separately for subsequent dosage adjustment.
Angina
Chronic Stable Angina
Oral
Conventional tablets or oral solution: usual dosage is 80–320 mg daily in 2–4 divided doses. More than 320 mg daily has been recommended when there is only a partial response to usual dosage.
Extended-release capsules: initially, 80 mg daily. Gradually increase dosage at 3- to 7-day intervals as needed to control symptoms. Optimum response usually occurs at 160 mg daily, but there is wide variation in response.
Unstable Angina or Non-ST-Segment Elevation/Non-Q-Wave MI
IV
Initial dose of 0.5–1 mg, followed in 1–2 hours by oral therapy.
Oral
Conventional tablets or oral solution: initially, 40–80 mg every 6–8 hours; thereafter, maintain on 20–80 mg twice daily. Titrate to target heart rate of 50–60 bpm in patients with unstable angina in the absence of dose-limiting adverse effects.
Cardiac Arrhythmias
Oral
Conventional tablets or oral solution: usually 10–30 mg 3 or 4 times daily.
Life-threatening Arrhythmias or Those Occurring during Anesthesia
IV
1–3 mg by slow IV injection. If necessary, repeat dose after 2 minutes. May administer additional doses at intervals of ≥4 hours until desired response is obtained.
Supraventricular Tachyarrhythmias
IV
Initial dosage: 0.1 mg/kg (divided in 3 equal doses) by slow IV injection (≤1 mg/minute) at 2- to 3-minute intervals has been recommended. May repeat total dose in 2 minutes if needed.
Rate Control in Atrial Fibrillation and Flutter
IV
Initial dosage: 0.1 mg/kg (divided in 3 equal doses) by slow IV injection (≤1 mg/minute) at 2- to 3-minute intervals has been recommended. May repeat total dose in 2 minutes if needed.
Slowing of Ventricular Response during Acute Atrial Fibrillation
IV
Loading dose: 0.15 mg.
Oral
Maintenance dosage for persistent atrial fibrillation: 80–240 mg daily in divided doses.
Hypertrophic Subaortic Stenosis
Oral
Conventional tablets or oral solution: 20–40 mg 3 or 4 times daily.
Extended-release capsules: 80–160 mg once daily.
Pheochromocytoma
Prior to Surgery
Oral
Conventional tablets or oral solution: 60 mg daily in divided doses (in conjunction with an α-adrenergic blocking agent) for 3 days prior to surgery. (See Pheochromocytoma under Cautions.)
Adjunctive Treatment for Inoperable Pheochromocytoma.
Oral
30 mg daily in divided doses (in conjunction with an α-adrenergic blocker). (See Pheochromocytoma under Cautions.)
Vascular Headache
Prevention of Common Migraine
Oral
Conventional tablets or oral solution: initially, 80 mg daily in divided doses.
Extended-release capsules: 80 mg once daily.
Gradually increase dosage to achieve optimum response; usual effective dosage is 80–240 mg daily.
Discontinue if response is inadequate after 4–6 weeks; gradual withdrawal over several weeks may be advisable.
AMI
Mortality Reduction after AMI
Oral
Conventional tablets or oral solution: 180–240 mg daily in divided doses, beginning 5–21 days after infarction. Higher dosage may be necessary for patients with coexisting conditions (e.g., angina, hypertension).
Administered in 3–4 divided doses daily in clinical studies, but twice-daily dosing also may be adequate.
Optimum benefit may be achieved when oral therapy with β-adrenergic blocking agent is continued for at least 1–3 years after infarction (when not contraindicated); some experts recommend continuing therapy indefinitely unless contraindicated.
Response is variable and dosage must be individualized; optimal suppression of tremor usually occurs with 120–320 mg daily in 3 divided doses.
Complete suppression of tremor rarely is achieved; dosages exceeding 320 mg daily may not provide substantial added benefit but are associated with an increased risk of adverse effects.
Extended-release capsules: usual dosages administered once daily each morning appear to be at least as effective as equivalent dosages of conventional tablets administered in divided doses daily.
Intermittent Therapy
Oral
Conventional tablets: 80–120 mg as a single dose 1–3 hours before planned activity or anticipated stress associated with tremor.
Prescribing Limits
Pediatric Patients
Hypertension
Oral
Maximum 16 mg/kg daily; however, some experts recommend a maximum dosage of 4 mg/kg (up to 640 mg) daily.
Adults
Angina
Oral
320 mg daily; some clinicians recommend higher dosage if there is only a partial response to usual dosage.
AMI
Oral
240 mg daily.
Essential Tremor
Oral
320 mg daily; higher dosages do not provide substantial added benefit and are associated with an increased risk of adverse effects.
Special Populations
Hepatic Impairment
Use with caution.
Renal Impairment
Dosage adjustments not required. Use with caution.
Geriatric Patients
Use caution in dosage selection; initiate therapy at low end of dosage range.
Possible precipitation of CHF. Avoid use in patients with overt CHF; may use cautiously in patients with inadequate myocardial function and, if necessary, in patients with well-compensated heart failure (e.g., those controlled with cardiac glycosides and/or diuretics). Adequate treatment (e.g., with a cardiac glycoside and/or diuretic) and close observation recommended if signs or symptoms of impending cardiac failure occur; if cardiac failure continues, discontinue therapy, gradually if possible. Possible decreased exercise tolerance in patients with left ventricular dysfunction.
Abrupt Withdrawal of Therapy
Abrupt withdrawal of propranolol is not recommended as it may exacerbate angina symptoms or precipitate MI in patients with CAD. Gradually decrease dosage over about 2 weeks and monitor patients carefully. If exacerbation of angina occurs or acute coronary insufficiency develops, reinstitute therapy promptly, at least temporarily, and initiate appropriate measures for the management of unstable angina.
Bronchospastic Disease
Possible inhibition of bronchodilation produced by endogenous catecholamines. Possible increased airway resistance and bronchospasm, particularly in patients with a history of asthma. Use with caution in patients with a history of nonallergic bronchospasm (e.g., chronic bronchitis, emphysema). Use not recommended in patients with bronchial asthma. (See Contraindications under Cautions.)
Major Surgery
Possible increased risks associated with general anesthesia (e.g., severe hypotension, difficulty restarting or maintaining heart beat) due to decreased ability of the heart to respond to reflex β-adrenergic stimuli. Use with extreme caution for management of arrhythmias occurring during anesthesia with myocardial depressant anesthetics. (See Specific Drugs under Interactions.)
Diabetes and Hypoglycemia
Possible decreased signs and symptoms of hypoglycemia (e.g., tachycardia, palpitation, BP changes, tremor). Possible hypoglycemia, especially in those undergoing dialysis, prolonged fasting, or severe exercise regimens. Use with caution in patients with diabetes mellitus.
Possible bradycardia, occasionally severe and accompanied by hypotension, syncope, shock, or angina. Severe bradycardia requiring a demand pacemaker has occurred in patients with Wolff-Parkinson-White syndrome. Treat severe bradycardia with IM or IV atropine sulfate. If response is inadequate, consider cautious administration of IV isoproterenol. Possible depressed SA node automaticity; use with caution in patients with sinus node dysfunction.
AV Block
Possible intensification of AV block, AV dissociation, AV conduction delays, complete heart block, or cardiac arrest, especially in patients with preexisting heart block caused by digitalis or other factors.
Pheochromocytoma
To prevent severe hypertension, institute α-adrenergic blocking agent therapy prior to the use of propranolol and continue during propranolol therapy.
General Precautions
History of Anaphylactic Reactions
Possible increased reactivity to a variety of allergens; patients may be unresponsive to usual doses of epinephrine used to treat anaphylactic reactions.
Ocular Effects
Possible dry eyes, generalized hyperemia of the conjunctivae, decreased tear production, and eye pain.
Myasthenia Gravis
Myasthenic condition (e.g., ptosis, weakness of limbs, and double vision) reported rarely with propranolol; use may be contraindicated in patients with myasthenia gravis.
Other Precautions
Shares the toxic potentials of β-adrenergic blocking agents; observe usual precautions of these agents.
When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with thiazide diuretics.
Specific Populations
Pregnancy
Category C.
Lactation
Distributed into milk. Use with caution.
Pediatric Use
Efficacy and adverse effect profiles in children generally similar to such profiles in adults. Bioavailability may be increased in children with Down’s syndrome. Safety and efficacy of extended-release capsules, oral solution, and injection not established in children.
Geriatric Use
Insufficient evidence in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients. Select dosage with caution, usually initiating therapy at the low end of the dosage range because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.
Hepatic Impairment
Use with caution; assess hepatic function prior to and periodically during prolonged therapy.
Renal Impairment
Use with caution; assess renal function prior to and periodically during prolonged therapy.
Caution recommended with concomitant use and in those with impaired cardiac conduction
Sympathomimetics
Potential pharmacodynamic interaction (antagonism of β-adrenergic stimulating effects). Very large doses of isoproterenol may be needed to overcome β-adrenergic blocking effects
Administer epinephrine with caution; decreased pulse rate with first- and second-degree heart block may occur
Drugs with anticholinergic effects
Potential pharmacodynamic interaction (antagonism of cardiac β-adrenergic blocking effects)
Need to avoid concomitant use or stagger dosing of an aluminum hydroxide antacid has not been fully elucidated; consider increasing propranolol dosage if interaction suspected
3.4–6 hours with chronic administration of usual therapeutic doses; 2–3 hours after single dose.
Extended-release capsules: apparent half-life about 10 hours.
Special Populations
In patients with severely impaired renal function, a compensatory increase in fecal excretion of propranolol occurs. Propranolol apparently not substantially removed by hemodialysis.
Stability
Storage
Oral
Capsules
Tight, light-resistant containers at 20–25°C; protect from moisture, freezing or excessive heat.
Tablets
10, 60, and 80 mg: Tight containers at 20–25°C.
20 and 40 mg: Tight, light-resistant containers at 20–25°C.
Tablets (Propranolol Hydrochloride and Hydrochlorothiazide)
Tight containers at about 25°C; protect from moisture, freezing or excessive heat.
Solution and Solution Concentrate
Tight, light-resistant containers at 20–25°C.
Maximum stability at pH 3, rapidly decomposes at alkaline pH.
Decomposition in aqueous solution is accompanied by lowered pH and discoloration.
Parenteral
Injection
20–25°C; Protect from freezing or excessive heat.
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Inhibits response to adrenergic stimuli by competitively blocking β-adrenergic receptors within the myocardium and within bronchial and vascular smooth muscle; no intrinsic sympathomimetic activity.
Decreases resting and exercise-stimulated heart rate, myocardial contractility, and cardiac output; increases systolic ejection time and cardiac volume; decreases conduction velocity through the sinoatrial (SA) and atrioventricular (AV) nodes; and decreases myocardial automaticity.
Initially increases peripheral resistance; however, peripheral resistance decreases with chronic administration.
Membrane-stabilizing effect on the heart occurs at high dosages.
Reduces BP by decreasing cardiac output, decreasing sympathetic outflow from the CNS, and/or by suppressing renin release.
Reduces the frequency of anginal attacks and increases exercise tolerance by decreasing myocardial oxygen consumption and coronary blood flow. May reduce myocardial oxygen requirements.
Antimigraine effect results from inhibition of vasodilation, the presence of β-adrenergic receptors in pial vessels of the brain, and inhibition of arteriolar spasms over the cortex.
Increases airway resistance (especially in asthmatic patients), inhibits glycogenolysis in the skeletal and cardiac muscles, blocks the release of free fatty acids and insulin, increases the number of circulating eosinophils, and increases uterine activity.
Advice to Patients
Importance of taking medication exactly as prescribed.
Importance of not interrupting or discontinuing therapy without consulting clinician; importance of temporarily limiting physical activity when discontinuing therapy.
Importance of immediately informing clinician at the first sign or symptom of impending cardiac failure or if any difficulty in breathing occurs.
Importance of patient informing anesthesiologist or dentist about propranolol therapy before undergoing major surgery.
Importance of informing patients that propranolol may interfere with glaucoma screening test.
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
40 mg Propranolol Hydrochloride and Hydrochlorothiazide 25 mg*
Inderide® (scored)
Wyeth
Propranolol Hydrochloride and Hydrochlorothiazide Tablets
Mylan, Pliva, Purepac
80 mg Propranolol Hydrochloride and Hydrochlorothiazide 25 mg*
Inderide® (scored)
Wyeth
Propranolol Hydrochloride and Hydrochlorothiazide Tablets
Mylan, Pliva, Purepac
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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