Nadolol (tablet)

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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of Ischemic Heart Disease Following Abrupt Withdrawal: Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy.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
  • 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
  • Combined therapy: nadolol 40 to 80 mg + tipiramate 50 to 200 mg[5]
  • Monotherapy: 80 to 240 mg daily[6]
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

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.
Conidition 1

(Description)

Adverse Reactions

Clinical Trials Experience

Central Nervous System
(list/description of adverse reactions)
Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Miscellaneous
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Condition 2
Central Nervous System
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Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Miscellaneous
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Postmarketing Experience

(Description)

Drug Interactions

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Drug 1

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Drug 2

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Drug 3

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Drug 4

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Drug 5

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Use in Specific Populations

Pregnancy

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Pregnancy Category (AUS): (Description)

Labor and Delivery

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Nursing Mothers

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Pediatric Use

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Geriatic Use

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Gender

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Race

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Renal Impairment

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Hepatic Impairment

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Females of Reproductive Potential and Males

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Immunocompromised Patients

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Others

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Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

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Condition 2

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Condition 3

(Description regarding monitoring, from Warnings section)

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

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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

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Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

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Pharmacology

Nadolol (tablet)
Systematic (IUPAC) name
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Structure

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Pharmacokinetics

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Nonclinical Toxicology

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Clinical Studies

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Condition 2

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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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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.

  1. 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.
  2. Olukotun AY, Klein GJ (1987). "Efficacy and safety of intravenous nadolol for supraventricular tachycardia". Am J Cardiol. 60 (6): 59D–62D. PMID 3630923.
  3. 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.
  4. 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.
  5. 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.
  6. Ryan RE, Ryan RE, Sudilovsky A (1983). "Nadolol: its use in the prophylactic treatment of migraine". Headache. 23 (1): 26–31. PMID 6131052.
  7. Edwards RV (1982). "Nadolol use for cerebellar tremor". Am J Psychiatry. 139 (11): 1522. PMID 6127958.
  8. Koller WC (1983). "Nadolol in essential tremor". Neurology. 33 (8): 1076–7. PMID 6348587.