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Generic Name: Nadolol
Class: beta-Adrenergic Blocking Agents
VA Class: CV100
CAS Number: 42200-33-9

Introduction

Nonselective β-adrenergic blocking agent.a b

Uses for Corgard

Hypertension

Management of hypertension, alone or in combination with other antihypertensive agents.a b

One of several preferred initial therapies in hypertensive patients with heart failure, post-MI, high coronary disease risk, or diabetes mellitus.153

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC VII.153

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Angina

Long-term prophylactic management of chronic stable angina.a b

A component of standard therapeutic measures for management of unstable angina and non-ST-segment elevation myocardial infarction.a

Supraventricular Tachyarrhythmias

Has been used for management of frequent VPCs, paroxysmal atrial tachycardia, and sinus tachycardia and to decrease heart rate in patients with atrial flutter or fibrillation.a

Vascular Headache

Prophylaxis of migraine headache.100 101 148

US Headache Consortium states there is evidence of efficacy and clinical experience suggests clinically important improvement in most patients.148

Corgard Dosage and Administration

General

  • Individualize dosage according to patient response.a b

  • If long-term therapy is discontinued, reduce dosage gradually over 1–2 weeks.a b (See Abrupt Withdrawal of Therapy under Cautions.)

Hypertension

  • Careful monitoring of BP during initial titration or subsequent upward adjustment in dosage is recommended.119 153 Large or abrupt reductions in BP generally should be avoided.119

  • Adjust antihypertensive dosage at approximately monthly intervals (more aggressively in high-risk patients) if response is inadequate.119 153

  • Nadolol/bendroflumethiazide fixed combination is not recommended for initial combination therapy; adjust initial and subsequent dosages by administering each drug separately.a 135

  • Bendroflumethiazide in the fixed-combination preparation with nadolol is about 30% more bioavailable than the drug alone.a 135

Angina

  • Wide variation in individual dosage requirements; carefully titrate dosage to achieve optimum results.a

  • Periodically evaluate chronic therapy for angina to determine need for dosage alteration or continued therapy.a

Administration

Oral Administration

Administer orally once daily without regard to meals.a b 135

Dosage

Adults

Hypertension
Monotherapy
Oral

Initially, 20–40 mg daily.a

May gradually increase by 40–80 mg daily at 2- to 14-day intervals until optimum BP response is achieved.a

Manufacturers recommend usual maintenance dosage of 40–80 mg daily; dosages up to 240 or 320 mg daily may be needed.a b

JNC 7 currently recommends 40–120 mg daily.153 It usually is preferable to add another antihypertensive agent to the regimen than to continue increasing nadolol dosage; continued increases may not be tolerated.157

Combination Therapy
Oral

Nadolol in fixed combination with bendroflumethiazide: Initially 40 mg of nadolol and 5 mg of bendroflumethiazide once daily.135 If needed, increase to 80 mg of nadolol and 5 mg of bendroflumethiazide once daily.135

If BP is not adequately controlled with the fixed combination alone, may gradually add another nondiuretic hypotensive agent, starting with 50% of the usual recommended starting dosage to avoid excessive reduction in BP.135

Use of fixed-combination preparations initially and for subsequent dosage adjustment generally is not recommended.a 135 Adjust by administering each drug separately, then use the fixed combination if the optimum maintenance dosage corresponds to the ratio in the combination preparation.a Administer separately for subsequent dosage adjustment.a

Angina
Chronic Stable Angina
Oral

Initially, 40 mg daily.a Gradually increase by 40–80 mg daily at 3- to 7-day intervals until optimum control of angina is obtained or there is pronounced slowing of the heart rate (i.e., <55 bpm).a b

Usual maintenance dosage is 40 or 80 mg daily.a b Up to 160 or 240 mg daily may be needed.a b

Supraventricular Tachyarrhythmias
Various Cardiac Arrhythmias
Oral

Maintenance dose: 60–160 mg daily in single or divided doses has been used.a

Vascular Headache
Prevention of Migraine
Oral

Usual effective dosage: 80–240 mg daily.148

Prescribing Limits

Adults

Angina
Oral

Safety and efficacy of dosages >240 mg daily not established.a b

Special Populations

Renal Impairment

Adjust intervals for usual dosage of nadolol alone or in fixed combination with bendroflumethiazide:b

Clcr (mL/minute per 1.73 m2)

Dosage Interval

>50

24 h

31–50

24–36 h

10–30

24–48 h

<10

40–60 h

Cautions for Corgard

Contraindications

  • Bronchial asthma.a b

  • Sinus bradycardia and heart block greater than first degree.a b

  • Cardiogenic shock.a b

  • Overt cardiac failure.a b

Warnings/Precautions

Warnings

Cardiac Failure

Possible precipitation of CHF.a b Avoid use in patients with overt CHF;a b 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).a b 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.a b

Abrupt Withdrawal of Therapy

Abrupt withdrawal of nadolol not recommended as it may exacerbate angina symptoms or precipitate MI in patients with angina pectoris and/or CAD.a b Avoid abrupt discontinuance, even when used only for hypertension.a b Abrupt withdrawal may cause transient symptoms (e.g., tremulousness, sweating, palpitation, headache, malaise) in patients without CAD.a Discontinue long-term therapy gradually (particularly in patients with myocardial ischemia); decrease dosage over 1–2 weeks and monitor carefully.a b 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.a b

Bronchospastic Disease

Possible inhibition of bronchodilation produced by endogenous or exogenous catecholamines;a b use not recommended in patients with bronchial asthma.b (See Contraindications under Cautions.) Generally, β-adrenergic blocking agents should not be used in patients with bronchospastic disease.a b Use with caution in patients with a history of nonallergic bronchospasm (e.g., chronic bronchitis, emphysema).a b

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.a b Use with caution in major surgery involving general anesthesia; if possible, withdraw drug before surgery.a b If nadolol is continued during surgery, inform the anesthesiologist.a b

Diabetes and Hypoglycemia

Possible masked signs and symptoms of acute hypoglycemia (e.g., tachycardia and BP changes but not sweating), impaired glucose tolerance, delayed rate of recovery of blood glucose concentration following drug-induced hypoglycemia, altered hemodynamic response to hypoglycemia (possibly resulting in an exaggerated hypertensive response), and impaired peripheral circulation.a b

Use with caution in patients with diabetes mellitus (especially those with labile diabetes or those prone to hypoglycemia).a b If used with hypoglycemic agents, may need to adjust hypoglycemic agent dosage.a

Thyrotoxicosis

Signs of hyperthyroidism (e.g., tachycardia) may be masked.a b Possible thyroid storm if therapy is abruptly withdrawn; carefully monitor patients having or suspected of developing thyrotoxicosis.a b

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.a b

Other Precautions

Shares the toxic potentials of β-adrenergic blocking agents; observe usual precautions of these agents.a In addition, when used in fixed-combination with bendroflumethiazide, consider the cautions, precautions, and contraindications associated with thiazide diuretics.a

Specific Populations

Pregnancy

Category C.135 b

Lactation

Distributed into milk.a b Discontinue nursing or the drug.a b

Pediatric Use

Safety and efficacy not established.a b

Hepatic Impairment

Use with caution.a

Renal Impairment

Use with caution.b

Clearance may be decreased; dosage adjustments necessary depending on degree of renal impairment.a b (See Renal Impairment under Dosage and Administration)

Common Adverse Effects

Bradycardia (heart rate <60 bpm), peripheral vascular insufficiency (usually Raynaud’s type), dizziness, fatigue.a

Interactions for Corgard

Specific Drugs

Drug

Interaction

Comments

Antidiabetic agents

Potential for altered antidiabetic responseb

Adjust antidiabetic agent dosage if neededb

Cardiovascular drugs (e.g., cardiac glycosides, nondihydropyridine calcium-channel blocking agents)

Possible additive negative effects on SA or AV nodal conduction116 117

Catecholamine-depleting drugs (e.g., reserpine)

Potential for additive effects (increased hypotension and marked bradycardia) a b

Monitor closely for symptoms (e.g., vertigo, syncope, postural hypotension)b

Diuretics

Possible increased hypotensive effecta

Careful dosage adjustments recommendeda

Drugs with anticholinergic effects

Potential for antagonism of cardiac β-adrenergic blocking effects

Hypotensive agents

Possible increased hypotensive effect a

Careful dosage adjustments recommendeda

Mibefradil (no longer commercially available in the US)

Slowing or complete suppression of SA node activity with development of slow ventricular rates116 117

Reported principally in geriatric patients with concomitant β-adrenergic blocker therapy116 117

Myocardial depressant general anesthetics

Increased risk of hypotension, myocardial depression, and heart failureb

See Major Surgery under Cautions

Neuromuscular blocking agents (e.g., tubocurarine chloride)

High doses of nadolol may increase effects of neuromuscular blocking agentsa

Phenothiazines

Possible additive hypotensive effect, especially when large phenothiazine doses are useda

Sympathomimetic agents (e.g., isopoterenol, epinephrine)

Possible antagonism of β-adrenergic stimulating effectsa

Administer epinephrine with caution; decreased pulse rate with first- and second-degree heart block and hypertension may occura

Very large doses of isoproterenol may be needed to overcome β-adrenergic blocking effectsa

Corgard Pharmacokinetics

Absorption

Bioavailability

Following oral administration, absorption is variable; averages about 30–40%.135 a b

Duration

Following doses of 40–320 mg daily, duration of antihypertensive and antianginal effects is ≥24 hours.a

Food

Food does not affect the rate or extent of absorption.a b

Distribution

Extent

Widely distributed; minimal amounts detected in the brain of dogs.a Distributed into bile.a

Nadolol crosses the placenta in ratsa and is distributed into human milk.b

Plasma Protein Binding

About 30%.135 a b

Elimination

Metabolism

Not metabolized.a b

Elimination Route

Excreted principally unchanged in feces (about 76.9%) and urine (about 24.6%) in 4 days.a

Half-life

10–24 hours.135 a b

Special Populations

Increased half-life in patients with renal impairment.a b Removed by hemodialysis.a

Stability

Storage

Oral

Tablets

Tight, light-resistant containers at room temperature.a b

Actions

  • Inhibits response to adrenergic stimuli by competitively blocking β1-adrenergic receptors within the myocardium and β2-adrenergic receptors within bronchial and vascular smooth muscle.a b

  • Decreases resting heart rate, inhibits exercise-induced increases in heart rate, and decreases cardiac output at rest and during exercise.a

  • Decreases AV node conduction velocity and decreases myocardial automaticity.a

  • No intrinsic sympathomimetic activity, little direct myocardial depressant activity, and no membrane-stabilizing effect on the heart.a

  • Reduces BP by blocking peripheral (especially cardiac) adrenergic receptors (decreasing cardiac output), by decreasing sympathetic outflow from the CNS, and/or by suppressing renin release.a

  • Decreases BP in both supine and standing positions.a

  • In patients with angina, blocks catecholamine-induced increases in heart rate, velocity and extent of myocardial contraction, and BP resulting in a net decrease in myocardial oxygen consumption.a

  • May increase oxygen requirements by increasing left ventricular fiber length and end diastolic pressure in patients with heart failure.a

  • Increases airway resistance (especially in asthmatic patients) and inhibits the release of free fatty acids and insulin.a

Advice to Patients

  • Importance of taking exactly as prescribed.a

  • Importance of not interrupting or discontinuing therapy without consulting clinician.a

  • Importance of immediately informing clinician at the first sign or symptom of impending cardiac failure or if any difficulty in breathing occurs.a

  • Importance of patient informing anesthesiologist or dentist about nadolol therapy before undergoing major surgery.a

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.a

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a

  • 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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Nadolol

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

20 mg*

Corgard (scored)

Monarch

Nadolol Tablets

Mylan, Teva, UDL

40 mg*

Corgard (scored)

Monarch

Nadolol Tablets

Mylan, Sandoz, Teva, UDL

80 mg*

Corgard (with povidone; scored)

Monarch

Nadolol Tablets

Mylan, Sandoz, Teva, UDL

120 mg*

Corgard (with povidone; scored)

Monarch

Nadolol Tablets

Teva

160 mg*

Corgard (with povidone; scored)

Monarch

Nadolol Tablets

Sandoz, Teva, UDL

Nadolol Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

40 mg with Bendroflumethiazide 5 mg

Corzide (with povidone; scored)

Monarch

80 mg with Bendroflumethiazide 5 mg

Corzide (with povidone; scored)

Monarch

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Corgard 20MG Tablets (KING PHARMA): 30/$93.99 or 90/$265.98

Corgard 40MG Tablets (KING PHARMA): 30/$110.98 or 90/$310.96

Corgard 80MG Tablets (KING PHARMA): 30/$129.99 or 90/$375.98

Nadolol 20MG Tablets (MYLAN): 30/$14.99 or 60/$19.97

Nadolol 40MG Tablets (MYLAN): 30/$16.99 or 90/$29.97

Nadolol 80MG Tablets (MYLAN): 30/$22.99 or 90/$44.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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a. AHFS Drug Information 2004. McEvoy GK, ed. Nadolol. Bethesda, MD: American Society of Health-System Pharmacists; 2004:1770-3 .

b. Monarch Pharmaceuticals. Corgard (nadolol) tablets prescribing information. Bristol, TN; 2001 Oct.

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