Nadolol (tablet)

Nadolol (tablet)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alonso Alvarado, M.D. [2]

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal: Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy. When discontinuing chronically administered nadolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of one to two weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, nadolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue nadolol therapy abruptly even in patients treated only for hypertension.

Overview

Nadolol (tablet) is a beta-adrenergic blocker that is FDA approved for the {{{indicationType}}} of agina pectoris, hypertension. There is a Black Box Warning for this drug as shown here. Common adverse reactions include bradyarrhythmia, dizziness, fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Angina Pectoris

• Dosing infromation

• The usual initial dose is 40 mg nadolol once daily. Dosage may be gradually increased in 40 to 80 mg increments at 3 to 7 day intervals until optimum clinical response is obtained or there is pronounced slowing of the heart rate. The usual maintenance dose is 40 or 80 mg administered once daily. Doses up to 160 or 240 mg administered once daily may be needed.
• The usefulness and safety in angina pectoris of dosage exceeding 240 mg per day have not been established. If treatment is to be discontinued, reduce the dosage gradually over a period of one to two weeks

Hypertension

• Dosing infromation

• The usual initial dose is 40 mg nadolol once daily, whether it is used alone or in addition to diuretic therapy. Dosage may be gradually increased in 40 to 80 mg increments until optimum blood pressure reduction is achieved. The usual maintenance dose is 40 or 80 mg administered once daily. Doses up to 240 or 320 mg administered once daily may be needed.

Dosage Adjustment in Renal Failure

Absorbed nadolol is excreted principally by the kidneys and, although nonrenal elimination does occur, dosage adjustments are necessary in patients with renal impairment. The following dose intervals are recommended:

This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Atrial Fibrillation, Heart Rate Control

• Developed by: AHA/ACC

• Class of Recommendation: Class I

• Strength of Evidence: Level B

• Dosing Information/Recommendation

• 10 to 240 mg PO daily

Non–Guideline-Supported Use

Supraventricular Tachycardia

• Dosing information

• Initial dose of 0.01 followed by 0.02 and then 0.04 mg/kg administered every 10 minutes until achieving a positive response or the maximum dose of 0.07 mg/kg is reached. Do not exceed 10 mg.

Gastrointestinal Hemorrhage

• Dosing Information

• 40 to 160 mg/day

Hyperthyroidism

• Dosing Information

• 80 to 160 mg/day

Migraine Prophylaxis

• Dosing Information

• Combined therapy: nadolol 40 to 80 mg + tipiramate 50 to 200 mg
• Monotherapy: 80 to 240 mg daily

Tremor

• Dosing information

• 80 to 240 mg/day

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Nadolol (tablet) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nadolol in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nadolol in pediatric patients.

Contraindications

• Bronchial asthma
• Sinus bradycardia
• Second degree conduction block
• Third degree conduction block
• Cardiogenic shock
• Cardiac failure

Warnings

WARNING See full prescribing information for complete Boxed Warning. Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal: Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy. When discontinuing chronically administered nadolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of one to two weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, nadolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue nadolol therapy abruptly even in patients treated only for hypertension.

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, if necessary, they can be used with caution in patients with a history of failure who are well-compensated, usually with digitalis and diuretics. Beta-blockers do not abolish the inotropic action of digitalis on heart muscle.

In patients without a history of heart failure, continued use of beta-blockers can, in some cases, lead to cardiac failure. Therefore, at the first sign or symptom of heart failure, the patient should be digitalized and/or treated with diuretics, and the response observed closely, or nadolol should be discontinued (gradually, if possible).

Nonallergic Bronchospasm (e.g., chronic bronchitis, emphysema)

Patients with bronchoespastic disease should in general not receive beta-blockers. Nadolol should be administered with caution since it may block bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta2 receptors.

Major Surgery

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

Diabetes and Hypoglycemia

Beta-blockers may prevent the appearance of premonitory signs and symptoms (e.g., tachycardia and blood pressure changes) of acute hypoglycemia. This is especially important with labile diabetics. Beta-blockade also reduces the release of insulin in response to hyperglycemia; therefore, it may be necessary to adjust the dose of antidiabetic drugs.

Thyrotoxicosis

Beta-blockers may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blockade which might precipitate a thyroid storm.

Adverse Reactions

Clinical Trials Experience

Cardiovascular

• Bradycardia with heart rates of less than 60 beats per minute occurs commonly, and heart rates below 40 beats per minute and/or symptomatic bradycardia were seen in about 2 of 100 patients. Symptoms of peripheral vascular insufficiency, usually of the Raynaud type, have occurred in approximately 2 of 100 patients.
• Cardiac failure, hypotension, and rhythm/conduction disturbances have each occurred in about 1 of 100 patients.
• Single instances of first degree heart block and third degree heart block have been reported; intensification of AV block is a known effect of beta-blockers.

=Central Nervous System

• Dizziness or fatigue has been reported in approximately 2 of 100 patients.
• Paresthesias, sedation, change in behavior have each been reported in approximately 6 of 1000 patients.

Respiratory

• Bronchospasm has been reported in approximately 1 of 1000 patients.

Gastrointestinal

• Nausea, diarrhea, abdominal discomfort, constipation, vomiting, indigestion, anorexia, bloating, and flatulence have been reported in 1 to 5 of 1000 patients.

Miscellaneous

Each of the following has been reported in 1 to 5 of 1000 patients:

• Rash
• Pruritus
• Headache
• Dry mouth, eyes, or skin
• Impotence or decreased libido
• Facial swelling
• Weight gain
• Slurred speech
• Cough
• Nasal stuffiness
• Sweating
• Tinnitus
• Blurred vision
• Reversible alopecia has been reported infrequently.

The following adverse reactions have been reported in patients taking nadolol and/or other beta-adrenergic blocking agents, but no causal relationship to nadolol has been established.

Central Nervous System

• Reversible mental depression progressing to catatonia
• Visual disturbances
• Hallucinations
• An acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability with slightly clouded sensorium, and decreased performance on neuropsychometrics.

=Gastrointestinal

• Mesenteric arterial thrombosis
• Ischemic colitis
• Elevated liver enzymes

Hematologic

• Agranulocytosis
• Thrombocytopenic purpura or nonthrombocytopenic purpura

Allergic

• Fever combined with aching and sore throat
• Laryngospasm
• Respiratory distress

Miscellaneous

• Pemphigoid rash
• Hypertensive reaction in patients with pheochromocytoma
• Sleep disorders
• Peyronie's disease
• The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with nadolol.

Postmarketing Experience

There is limited information regarding Nadolol (tablet) Postmarketing Experience in the drug label.

Drug Interactions

When administered concurrently, the following drugs may interact with beta-adrenergic receptor blocking agents:

• General anesthetics: Exaggeration of the hypotension induced by general anesthetics.
• Antidiabetic drugs (oral agents and insulin): Hypoglycemia or hyperglycemia; adjust dosage of antidiabetic drug accordingly.
• Catecholamine-depleting drugs (e.g., reserpine): Additive effect; monitor closely for evidence of hypotension and/or excessive bradycardia (e.g., vertigo, syncope, orthostatic hypotension).
• Digitalis glycosides: Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Response to Treatment for Anaphylactic Reaction: 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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• In animal reproduction studies with nadolol, evidence of embryo- and fetotoxicity was found in rabbits, but not in rats or hamsters, at doses 5 to 10 times greater (on a mg/kg basis) than the maximum indicated human dose. No teratogenic potential was observed in any of these species.
• There are no adequate and well-controlled studies in pregnant women. Nadolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates whose mothers are receiving nadolol at parturition have exhibited bradycardia, hypoglycemia, and associated symptoms.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nadolol (tablet) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nadolol (tablet) during labor and delivery.

Nursing Mothers

• Nadolol is excreted in human milk. Because of the potential for adverse effects in nursing infants, a decision should be made whether to discontinue nursing or to discontinue therapy taking into account the importance of nadolol to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

There is no FDA guidance on the use of Nadolol (tablet) in geriatric settings.

Gender

There is no FDA guidance on the use of Nadolol (tablet) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nadolol (tablet) with respect to specific racial populations.

Renal Impairment

Nadolol should be used with caution in patients with impaired renal function.

Hepatic Impairment

There is no FDA guidance on the use of Nadolol (tablet) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nadolol (tablet) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nadolol (tablet) in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral/Intravenous

Monitoring

There is limited information regarding Nadolol (tablet) Monitoring in the drug label.

IV Compatibility

Solution

Compatible

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Not Tested

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Variable

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Incompatible

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Y-Site

Compatible

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Not Tested

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Variable

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Incompatible

• Solution 1
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Admixture

Compatible

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Not Tested

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Variable

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Incompatible

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Syringe

Compatible

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Not Tested

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Variable

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Incompatible

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TPN/TNA

Compatible

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Not Tested

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Variable

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Incompatible

• Solution 1
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Overdosage

• Nadolol can be removed from the general circulation by hemodialysis.
• In addition to gastric lavage, the following measures should be employed, as appropriate. In determining the duration of corrective therapy, note must be taken of the long duration of the effect of nadolol:

• Excessive Bradycardia: Administer atropine (0.25 to 1.0 mg). If there is no response to vagal blockade, administer isoproterenol cautiously.
• Cardiac Failure: Administer a digitalis glycoside and diuretic. It has been reported that glucagon may also be useful in this situation.
• Hypotension: Administer vasopressors, e.g., epinephrine or levarterenol. (There is evidence that epinephrine may be the drug of choice.)
• Bronchospasm: Administer a beta2-stimulating agent and/or a theophylline derivative.

Pharmacology

Nadolol (tablet)
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Mechanism of Action

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Structure

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Pharmacodynamics

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Nonclinical Toxicology

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Clinical Studies

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How Supplied

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Storage

There is limited information regarding Nadolol (tablet) Storage in the drug label.

Images

Drug Images

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Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Nadolol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Nadolol (tablet) Brand Names in the drug label.

Look-Alike Drug Names

• (Paired Confused Name 1a) — (Paired Confused Name 1b)
• (Paired Confused Name 2a) — (Paired Confused Name 2b)
• (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.