Nadolol

Pronunciation

(nay DOE lole)

U.S. Brand Names

Corgard®

Generic Available

Yes

Canadian Brand Names

Alti-Nadolol; Apo-Nadol®; Corgard®; Novo-Nadolol

Use

Treatment of hypertension and angina pectoris; prophylaxis of migraine headaches

Pregnancy Risk Factor

Pregnancy Implications

No data available on crossing the placenta. Beta-blockers have been associated with bradycardia, hypotension, and IUGR; IUGR is probably related to maternal hypertension. Alternative beta-blockers are preferred for use during pregnancy due to limited data and prolonged half-life. Cases of neonatal hypoglycemia have been reported following maternal use of beta-blockers at parturition or during breast-feeding. Monitor breast-fed infant for symptoms of beta-blockade.

Lactation

Enters breast milk/use caution (AAP rates "compatible")

Contraindications

Hypersensitivity to nadolol or any component of the formulation; bronchial asthma; sinus bradycardia; sinus node dysfunction; heart block greater than first degree (except in patients with a functioning artificial pacemaker); cardiogenic shock; uncompensated cardiac failure

Warnings/Precautions

Administer only with extreme caution in patients with compensated heart failure, monitor for a worsening of the condition. Efficacy in heart failure has not been established for nadolol. Beta-blocker therapy should not be withdrawn abruptly (particularly in patients with CAD), but gradually tapered to avoid acute tachycardia, hypertension, and/or ischemia. Use caution with concurrent use of beta-blockers and either verapamil or diltiazem; bradycardia or heart block can occur. In general, patients with bronchospastic disease should not receive beta-blockers. Nadolol, if used at all, should be used cautiously in bronchospastic disease with close monitoring. Use cautiously in diabetics because it can mask prominent hypoglycemic symptoms. Can mask signs of thyrotoxicosis. Can cause fetal harm when administered in pregnancy. Use cautiously in the renally impaired (dosage adjustments are required). Use care with anesthetic agents which decrease myocardial function.

Adverse Reactions

>10%:

Central nervous system: Drowsiness, insomnia

Endocrine & metabolic: Decreased sexual ability

1% to 10%:

Cardiovascular: Bradycardia, palpitation, edema, CHF, reduced peripheral circulation

Central nervous system: Mental depression

Gastrointestinal: Diarrhea or constipation, nausea, vomiting, stomach discomfort

Respiratory: Bronchospasm

Miscellaneous: Cold extremities

<1% (Limited to important or life-threatening): Chest pain, arrhythmia, orthostatic hypotension, nervousness, headache, depression, hallucinations, confusion (especially in the elderly), thrombocytopenia, leukopenia, dyspnea

Overdosage/Toxicology

Symptoms of intoxication include cardiac disturbances, CNS toxicity, bronchospasm, hypoglycemia and hyperkalemia. The most common cardiac symptoms include hypotension and bradycardia. Atrioventricular block, intraventricular conduction disturbances, cardiogenic shock, and asystole may occur with severe overdose. CNS effects include convulsions, coma, and respiratory arrest. Treatment is symptom-directed and supportive. Glucagon has been used to reverse cardiac depression.

Drug Interactions

Albuterol (and other beta2 agonists): Effects may be blunted by nonspecific beta-blockers.

Alpha-blockers (prazosin, terazosin): Concurrent use of beta-blockers may increase risk of orthostasis.

Clonidine: Hypertensive crisis after or during withdrawal of either agent.

Drugs which slow AV conduction (digoxin): Effects may be additive with beta-blockers.

Epinephrine (including local anesthetics with epinephrine): Propranolol may cause hypertension.

Glucagon: Nadolol may blunt the hyperglycemic action of glucagon.

Insulin and oral hypoglycemics: Nadolol may mask symptoms of hypoglycemia.

Nadolol increases antipyrine's half-life.

NSAIDs (ibuprofen, indomethacin, naproxen, piroxicam) may reduce the antihypertensive effects of beta-blockers.

Salicylates may reduce the antihypertensive effects of beta-blockers.

Sulfonylureas: Beta-blockers may alter response to hypoglycemic agents.

Verapamil or diltiazem may have synergistic or additive pharmacological effects when taken concurrently with beta-blockers.

Ethanol/Nutrition/Herb Interactions

Herb/Nutraceutical: Avoid dong quai if using for hypertension (has estrogenic activity). Avoid ephedra, garlic, yohimbe, ginseng (may worsen hypertension). Avoid natural licorice (causes sodium and water retention and increases potassium loss).

Mechanism of Action

Competitively blocks response to beta1- and beta2-adrenergic stimulation; does not exhibit any membrane stabilizing or intrinsic sympathomimetic activity

Pharmacodynamics/Kinetics

Duration: 17-24 hours

Absorption: 30% to 40%

Distribution: Concentration in human breast milk is 4.6 times higher than serum

Protein binding: 28%

Half-life elimination: Adults: 10-24 hours; prolonged with renal impairment; End-stage renal disease: 45 hours

Time to peak, serum: 2-4 hours

Excretion: Urine (as unchanged drug)

Dosage

Oral:

Adults: Initial: 40 mg/day, increase dosage gradually by 40-80 mg increments at 3- to 7-day intervals until optimum clinical response is obtained with profound slowing of heart rate; doses up to 160-240 mg/day in angina and 240-320 mg/day in hypertension may be necessary.

Hypertension: Usual dosage range (JNC 7): 40-120 mg once daily

Elderly: Initial: 20 mg/day; increase doses by 20 mg increments at 3- to 7-day intervals; usual dosage range: 20-240 mg/day.

Dosing adjustment in renal impairment:

Clcr 31-40 mL/minute: Administer every 24-36 hours or administer 50% of normal dose.

Clcr 10-30 mL/minute: Administer every 24-48 hours or administer 50% of normal dose.

Clcr<10 mL/minute: Administer every 40-60 hours or administer 25% of normal dose.

Hemodialysis: Moderately dialyzable (20% to 50%); administer dose postdialysis or administer 40 mg supplemental dose.

Peritoneal dialysis: Supplemental dose is not necessary.

Dosing adjustment/comments in hepatic disease: Reduced dose probably necessary.

Dietary Considerations

May be taken without regard to meals.

Patient Education

Check pulse daily prior to taking medication. If pulse is <50, hold medication and consult prescriber. Take exactly as directed; do not adjust dosage or discontinue without consulting prescriber. May cause dizziness, fatigue, blurred vision; change position slowly (lying/sitting to standing) and use caution when driving or engaging in tasks that require alertness until response to drug is known. Exercise and increasing bulk or fiber in diet may help resolve constipation. If you have diabetes, monitor serum glucose closely (the drug may mask symptoms of hypoglycemia). Report swelling in feet or legs, respiratory difficulty or persistent cough, unresolved fatigue, unusual weight gain >5 lb/week, or unresolved constipation. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Anesthesia and Critical Care Concerns/Other Considerations

Symptomatic bradycardia may be treated with atropine.

Surgery: Atenolol has also been shown to improve cardiovascular outcomes when used in the perioperative period in patients with underlying cardiovascular disease who are undergoing noncardiac surgery. Bisoprolol in high-risk patients undergoing vascular surgery reduced the perioperative incidence of death from cardiac causes and nonfatal myocardial infarction.

Withdrawal: Beta-blocker therapy should not be withdrawn abruptly, but gradually tapered to avoid acute tachycardia and hypertension.

Cardiovascular Considerations

Nadolol is a nonspecific beta-1 and beta-2 blocker.

Hypertension: Beta-blocker therapy in the treatment of hypertension has been associated with improved cardiovascular outcomes. This class of drug is beneficial for elderly patients with hypertension. A recent UKPDS study showed that beta-blocker therapy (atenolol) was as effective as an ACE inhibitor in reducing cardiovascular events and that the benefits of therapy were related more to the degree of antihypertensive efficacy rather than the class of drug used.

Myocardial infarction: Beta-blockers, in general without intrinsic sympathomimetic activity (ISA), have been shown to decrease morbidity and mortality when initiated in the acute treatment of myocardial infarction and continued long-term. In this setting, therapy should be avoided in patients with hypotension, cardiogenic shock, or heart block.

Surgery: Atenolol has also been shown to improve cardiovascular outcomes when used in the perioperative period in patients with underlying cardiovascular disease who are undergoing noncardiac surgery. Bisoprolol in high-risk patients undergoing vascular surgery reduced the perioperative incidence of death from cardiac causes and nonfatal myocardial infarction.

Atrial fibrillation: Beta-blocker therapy provides effective rate control in patients with atrial fibrillation.

Angina: Beta-blockers are effective in the treatment of angina as monotherapy or when combined with nitrates and/or calcium channel blockers. In patients with severe intractable angina requiring negative cardiac chronotropic medications, pacemaker placement has been carried out to maintain heart rate in the setting of large doses of beta-blockers and/or calcium channel blockers. Beta-blockers are ineffective in the treatment of pure vasospastic (Prinzmetal) angina.

Unstable angina/non-ST-segment elevation MI: In the treatment of unstable angina/non-ST-segment elevation MI, a beta-blocker, with the first dose administered intravenously if there is ongoing chest pain, followed by oral administration, is recommended (in the absence of contraindications).

Withdrawal: Beta-blocker therapy should not be withdrawn abruptly, but gradually tapered to avoid acute tachycardia and hypertension.

Heart failure: There is emerging evidence that beta-blocker therapy, without intrinsic sympathomimetic activity (ISA), should be initiated in select patients with stable congestive heart failure (NYHA Class II-III). To date, carvedilol, sustained release metoprolol, and bisoprolol have demonstrated a beneficial effect on morbidity and mortality. It is important that beta-blocker therapy be instituted initially at very low doses with gradual and very careful titration.

Dental Health: Effects on Dental Treatment

Nadolol is a nonselective beta-blocker and may enhance the pressor response to epinephrine, resulting in hypertension and bradycardia. Many nonsteroidal anti-inflammatory drugs, such as ibuprofen and indomethacin, can reduce the hypotensive effect of beta-blockers after 3 or more weeks of therapy with the NSAID. Short-term NSAID use (ie, 3 days) requires no special precautions in patients taking beta-blockers.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

Use with caution; epinephrine has interacted with nonselective beta-blockers to result in initial hypertensive episode followed by bradycardia

Mental Health: Effects on Mental Status

May cause drowsiness, dizziness, depression, insomnia, or confusion

Mental Health: Effects on Psychiatric Treatment

Barbiturates may decrease the effects of beta-blockers; has been used to treat akathisia; propranolol preferred; concurrent use with antipsychotics may potentiate antihypertensive effect or antipsychotic blood levels; use with MAO inhibitors may cause bradycardia; effects of benzodiazepines may be increased by beta-blockers; monitor for clinical changes

Dosage Forms

Tablet: 20 mg, 40 mg, 80 mg, 120 mg, 160 mg

References

Antman EM, Anbe SC, Alpert JS, et al, "ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction - Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction)," Circulation, 2004, 110:588-636. Available at: http://www.circulationaha.org/cgi/content/full/110/5/588. Last accessed October 26, 2004.

Braunwald E, Antman EM, Beasley JW, et al, "ACC/AHA 2002 Guideline Update for the Management of Patients With Unstable Angina and Non-ST-Segment Elevation Myocardial Infarction - Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina)," J Am Coll Cardiol , 2002, 40(7):1366-74. Available at: http://www.acc.org/clinical/guidelines/unstable/incorporated/index.htm. Accessed May 20, 2003.

Chobanian AV, Bakris GL, Black HR, et al, "The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: The JNC 7 Report," JAMA , 2003, 289(19):2560-71.

"Consensus Recommendations for the Management of Chronic Heart Failure. On Behalf of the Membership of the Advisory Council to Improve Outcomes Nationwide in Heart Failure," Am J Cardiol , 1999, 83(2A):1A-38A.

Gibbons RJ, Abrams J, Chatterjee K, et al, "ACC/AHA 2002 Guideline Update for the Management of Patients With Chronic Stable Angina - Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Chronic Stable Angina)," J Am Coll Cardiol , 2003, 41(1):159-68.

Hunt SA, Baker DW, Chin MH, et al, "ACC/AHA Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult: Executive Summary. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure)," J Am Coll Cardiol , 2001, 38(7):2101-13.

Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings," Chest , 2003, 123(3):897-922.

Villaneuva C, Minana J, Ortiz J, et al, "Endoscopic Ligation Compared With Combined Treatment With Nadolol and Isosorbide Mononitrate to Prevent Recurrent Variceal Bleeding," N Engl J Med , 2001, 345(9):647-55.

International Brand Names

Alti-Nadolol (CA); Anabet® (PT); Apo-Nadol® (CA, PL); Apo-Nadolol® (NZ); Corgard® (AR, BE, BR, CA, CH, CN, CO, CZ, ES, FR, GB, ID, IT, LU, NZ, ZA); Corgarg® (CL); Nadolol® (CY); Novo-Nadolol (CA); Solgol® (DE, ES)

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