Nadolol (tablet)
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
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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of Ischemic Heart Disease Following Abrupt Withdrawal: Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy.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.
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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:
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[1]
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.[2]
Gastrointestinal Hemorrhage
- Dosing Information
- 40 to 160 mg/day[3]
Hyperthyroidism
- Dosing Information
- 80 to 160 mg/day[4]
Migraine Prophylaxis
- Dosing Information
Tremor
- Dosing information
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.
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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
Hematologic
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
- 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/etc)
Monitoring
Condition 1
(Description regarding monitoring, from Warnings section)
Condition 2
(Description regarding monitoring, from Warnings section)
Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
Solution
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Y-Site
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Admixture
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Syringe
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
TPN/TNA
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Overdosage
Acute Overdose
Signs and Symptoms
(Description)
Management
(Description)
Chronic Overdose
Signs and Symptoms
(Description)
Management
(Description)
Pharmacology
Nadolol (tablet)
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Mechanism of Action
(Description)
Structure
(Description with picture)
Pharmacodynamics
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Pharmacokinetics
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Nonclinical Toxicology
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Clinical Studies
Condition 1
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Condition 2
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Condition 3
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How Supplied
(Description)
Storage
There is limited information regarding Nadolol (tablet) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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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.
- ↑ January CT, Wann LS, Alpert JS, Calkins H, Cleveland JC, Cigarroa JE; et al. (2014). "2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society". J Am Coll Cardiol. doi:10.1016/j.jacc.2014.03.022. PMID 24685669.
- ↑ Olukotun AY, Klein GJ (1987). "Efficacy and safety of intravenous nadolol for supraventricular tachycardia". Am J Cardiol. 60 (6): 59D–62D. PMID 3630923.
- ↑ Gatta A, Merkel C, Sacerdoti D, Bolognesi M, Caregaro L, Zuin R; et al. (1987). "Nadolol for prevention of variceal rebleeding in cirrhosis: a controlled clinical trial". Digestion. 37 (1): 22–8. PMID 3301478.
- ↑ Lazarus JH, Kingswood JC, John R (1987). "The effect of nadolol on heart rate in hyperthyroidism. A controlled trial". Acta Endocrinol (Copenh). 114 (1): 102–6. PMID 3544631.
- ↑ Pascual J, Rivas MT, Leira R (2007). "Testing the combination beta-blocker plus topiramate in refractory migraine". Acta Neurol Scand. 115 (2): 81–3. doi:10.1111/j.1600-0404.2006.00772.x. PMID 17212609.
- ↑ Ryan RE, Ryan RE, Sudilovsky A (1983). "Nadolol: its use in the prophylactic treatment of migraine". Headache. 23 (1): 26–31. PMID 6131052.
- ↑ Edwards RV (1982). "Nadolol use for cerebellar tremor". Am J Psychiatry. 139 (11): 1522. PMID 6127958.
- ↑ Koller WC (1983). "Nadolol in essential tremor". Neurology. 33 (8): 1076–7. PMID 6348587.