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Acebutolol Hydrochloride

Pronunciation

Class: beta-Adrenergic Blocking Agents
VA Class: CV100
Chemical Name: (±)-N-[3-Acetyl-4-[2-hydroxy-3-[(1-meth ylethyl)amino]propoxy]phenyl]butanamide monohydrochloride
Molecular Formula: C18H28N2O4• HCl
CAS Number: 34381-68-5
Brands: Sectral

Introduction

A short-acting β1-selective adrenergic blocking agent.1 2 17 18 113

Uses for Acebutolol Hydrochloride

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 172 280 306 321

One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, ischemic heart disease, and/or diabetes mellitus.354

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.354

Cardiac Arrhythmias

Treatment of frequent ventricular premature complexes (VPCs), including uniform and multiform VPCs and/or coupled VPCs, and R-on-T complexes1 2 137 185 186 187 188 189 190 193 194 195 196 197 198 199 201 204 in patients with primary arrhythmias or arrhythmias secondary to various cardiac disorders (e.g., CAD,137 185 186 187 188 189 194 MI,137 186 187 193 194 195 196 valvular disease).185 186 187 189 190

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Management of various supraventricular tachyarrhythmias.191 192 196 200 202 203 256 266

Angina

Management of chronic stable angina pectoris.205 206 207 208 209 210 211 212 213 214 220 221 222 223 224 225

Acute Myocardial Infarction

Secondary prevention following AMI to reduce the risk of reinfarction and mortality.289 290

Acebutolol Hydrochloride Dosage and Administration

General

  • Individualize dosage according to patient response.1 2 4

  • β-Adrenergic blocking selectivity diminishes as dosage is increased.1

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

  • When substituting another β-adrenergic blocking agent for acebutolol, initiate at a comparable dosage without interruption of β-blocker therapy.1 2

Hypertension

  • Monitor BP carefully during initial titration or subsequent dosage increases.354 354 Large or abrupt BP reductions generally should be avoided.354

Angina

  • Adjust dosage of β-adrenergic blocking agents according to clinical response4 205 and to maintain a resting heart rate of 55–60 bpm.211 216

Administration

Acebutolol hydrochloride is administered orally.1 2 Also been administered IV,25 27 28 29 41 191 192 196 200 202 203 266 but a parenteral dosage form is currently not commercially available in the US.

Oral Administration

Hypertension

Usually administer as a single daily dose;1 245 321 however, for 24-hour BP control, some patients may require administration of the daily dose in 2 divided doses.1 142 143 144 145 149 155 354

Ventricular Arrhythmias

Twice-daily dosing of the drug appears to be more effective than once-daily dosing for the suppression and prevention of frequent VPCs.4 185 186 188 189 195 198 199 203 204 248

Angina

Once-daily administration may be as effective as divided doses;4 208 249 however, further studies are needed.4

Dosage

Available as acebutolol hydrochloride; dosage expressed in terms of acebutolol.1

Adults

Hypertension
Oral

Initially, 200–400 mg daily.1 245 321 Usual maintenance dosage is 200–800 mg daily, 1 140 142 143 144 145 149 150 151 152 153 154 245 246 247 321 354 but some patients may achieve adequate BP control with dosages as low as 200 mg daily.1 4 321 354 Increase dosage up to 1.2 g daily in two divided doses in patients with more severe hypertension or if adequate reduction of BP does not occur;1 2 4 140 142 143 144 145 149 150 151 152 154 155 alternatively, add another hypotensive agent (e.g., thiazide diuretic).1 2 4 142 144 157 158 160 161 165 166 168 172

Ventricular Arrhythmias
Oral

Initially, 200 mg twice daily.1 187 196 Increase gradually until optimum effect is achieved.1 185 186 195 198 204 Usual maintenance dosage is 600–1200 mg daily.1 2 4 185 186 189 190 195 199 204

Angina
Oral

Initially, 200 mg twice daily.4 205 208 Increase dosage gradually until optimum effect is achieved.4 205 Usual maintenance dosage is 800 mg or less daily,4 206 207 208 209 210 211 212 213 214 but patients with severe angina may require higher dosages.4 205 209 211

Prescribing Limits

Adults

Hypertension
Oral

Maximum 1.2 g daily.1 2 4 140 142 143 144 145 149 150 151 152 154 155

Special Populations

Renal Impairment

Active metabolite (diacetolol) eliminated principally by the kidneys;1 123 125 dosage and/or frequency of administration must be modified in response to the degree of renal impairment.1 2 86 123 124 125 126 127

Dosage Reductions in Patients with Renal Impairment

Reduction in Usual Daily Dosage

Clcr(mL/min)

50%

25–49 mL/minute

75%

<25 mL/minute

Acebutolol and diacetolol removed by hemodialysis;1 125 127 individualize dosage carefully in patients with severe renal impairment who undergo chronic intermittent hemodialysis.124 125

Geriatric Patients

Consider reduction in maintenance dosage.1 2 Avoid dosages >800 mg daily.1 2

Cautions for Acebutolol Hydrochloride

Contraindications

  • Patients with heart block >first degree, severe bradycardia, cardiogenic shock, or overt cardiac failure.1

Warnings/Precautions

Warnings

Cardiac Failure

Possible precipitation of CHF.1

Avoid use in patients with decompensated CHF; 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).1

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.1

Abrupt Withdrawal of Therapy

Possible exacerbated angina symptoms or precipitation of MI in patients with CAD.1 Abrupt discontinuance of therapy is not recommended.1 276 Gradually decrease dosage over a period of about 2 weeks; monitor patients carefully and advise to temporarily limit their physical activity.1 276 If exacerbation of angina occurs, reinstitute therapy promptly and initiate appropriate measures for the management of unstable angina pectoris.1

Peripheral Vascular Disease

Possible reduction in cardiac output and precipitation or aggravation of symptoms of arterial insufficiency.1 Use with caution; observe for evidence of disease progression.1

Bronchospastic Disease

Possible bronchoconstriction.1

Use with caution in patients with bronchospastic disease; administer the lowest effective dosage (initially in divided doses). A bronchodilator (e.g., a β2-adrenergic agonist, theophylline) should be available for immediate use, if necessary.1

Major Surgery

Possible risks associated with general anesthesia (e.g., severe hypotension, maintenance of heart beat) due to decreased ability of the heart to respond to reflex β-adrenergic stimuli.1 Use with caution in patients undergoing major surgery involving general anesthesia; anesthetics used should not cause myocardial depression.1

Diabetes and Hypoglycemia

Possible decreased signs and symptoms of hypoglycemia (e.g., tachycardia, palpitation, BP changes, tremor, feelings of anxiety, but not sweating or dizziness) and increased insulin-induced hypoglycemia.1

Use with caution in patients with diabetes mellitus.1

Thyrotoxicosis

Signs of hyperthyroidism (e.g., tachycardia) may be masked.1 Possible thyroid storm if therapy is abruptly withdrawn; carefully monitor patients having or suspected of developing thyrotoxicosis.1

Sensitivity Reactions

Anaphylactic Reactions

Patients with a history of anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenges with such allergens while taking β-blocking agents.1 Such patients may be unresponsive to usual doses of epinephrine.1

Specific Populations

Pregnancy

Category B.1

Lactation

Distributed into milk in higher concentrations than in maternal plasma.1 2 105 Use not recommended by manufacturer.1

Pediatric Use

Safety and efficacy not established in children <12 years of age.1 268

Geriatric Use

Insufficient experience in patients >65 years of age to determine whether geriatric patients respond differently than younger adults.1 However, reduction of maintenance dosage may be necessary,1 2 since bioavailability of acebutolol and diacetolol (active metabolite) may be increased compared with that in younger adults.1 2 122 (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution.1 2 Cirrhosis does not appear to substantially affect the pharmacokinetics of acebutolol or diacetolol; however, the effects of hepatic impairment on elimination of the drug have not been fully evaluated.128

Renal Impairment

Use with caution; dosage should be reduced based on the degree of renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Fatigue, dizziness, headache, dyspnea, constipation, diarrhea, dyspepsia, nausea, flatulence, insomnia, increased micturition, chest pain, edema, depression, abnormal dreams, rash, arthralgia, myalgia, cough, rhinitis, abnormal vision.1

Interactions for Acebutolol Hydrochloride

Specific Drugs

Drug

Interaction

Comments

α-Adrenergic agonists1

Possible exaggerated hypertensive reactions1

Warn patients of potential hazard1

Calcium-channel blockers

Potential additive depressant effects on SA or AV nodal conduction318 319

Cardiac glycosides (digoxin)

Potential additive depressant effects on SA or AV nodal conduction318 319

Pharmacokinetic interaction unlikely1

Diuretics

Possible increased hypotensive effect1 2 142 144 157 158 160 172

Careful dosage adjustment recommended1 2 144 157 158 160 172

Glyburide

Possible decreased hypoglycemic action in type II diabetic patients, presumably by decreasing insulin secretion244

Hydralazine

Pharmacokinetic interaction unlikely1

Hydrochlorothiazide

Pharmacokinetic interaction unlikely1

Hypotensive agents

Possible increased hypotensive effect1 2 142 144 157 158 160 172

Careful dosage adjustment recommended1 2 144 157 158 160 172

NSAIAs

Potential blunting of hypotensive effects1

Oral contraceptives

Pharmacokinetic interaction unlikely1

Reserpine

Possible additive pharmacologic effects1

Observe closely for evidence of marked bradycardia or hypotension (e.g., vertigo, presyncope or syncope, or orthostatic changes in BP without compensatory tachycardia)1

Sulfinpyrazone

Pharmacokinetic interaction unlikely1

Sympathomimetic agents

Antagonism of β1-adrenergic stimulating effects (e.g., bronchodilation)1 2 57 58 59 62

Increased dosage of β-adrenergic agonist bronchodilators may be required 268 277

Tolbutamide

Interaction unlikely1

Warfarin

Interaction unlikely1

Acebutolol Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Well absorbed from the GI tract following oral administration;1 2 4 11 91 109 undergoes extensive first-pass metabolism in the liver.1 2 97 99 109 122 124

Peak plasma acebutolol and diacetolol concentrations occur within 2–2.5 hours (range: 1–4 hours) and 4 hours (range: 2.4–5 hours), respectively, in healthy individuals1 2 94 95 97 98 99 126 135 or patients with hypertension91 or arrhythmias.2 90 137

Absolute bioavailability is approximately 35–50%.1 4 94 97 102

Food

Food may slightly decrease the rate of absorption and peak plasma concentrations of acebutolol and its major metabolite (diacetolol), but the extent of absorption is not substantially affected.1 2 101

Onset

Effect on resting, reflex, or exercise-induced heart rate and systolic BP begins within 1–1.5 hours,1 3 21 91 100 in healthy1 21 98 100 or hypertensive91 individuals.

Duration

Effect may persist for up to 24 hours or longer.1 3 91 98 100

Special Populations

In geriatric patients, peak plasma concentrations and AUCs of acebutolol and diacetolol are increased twofold compared with those observed in younger patients.1 2 122

Distribution

Extent

Acebutolol and diacetolol readily cross the placenta1 2 105 106 107 and can accumulate in the fetus.105 106 107

Acebutolol and diacetolol are distributed into milk at concentrations higher than those in maternal plasma. (See Lactation under Cautions.)1 2 105 106

Plasma Protein Binding

Approximately 11–25% (acebutolol) and 6–9% (diacetolol).2 93 103 Approximately 50% bound to erythrocytes.4 125

Elimination

Metabolism

Rapidly and extensively metabolized in the liver2 110 113 to metabolites (acetolol and diacetolol).2 4 6 99 108 109 110 113

Elimination Route

Acebutolol and its metabolites are excreted in feces and urine.1 87 92 109 111 123

Half-life

About 3 hours in the initial distribution phase (t½α) 95 and about 11 hours (range: 6–12 hours) in the terminal phase (t½β).95 125 About 7.5 (range: 7–11 hours) and 3 hours, respectively, for diacetolol and acetolol following a single oral dose.101 108 125

Special Populations

Renal impairment may reduce clearances of acebutolol and diacetolol.125 Acebutolol and diacetolol are removed by hemodialysis.1 125 127

Stability

Storage

Oral

Capsules

Tight containers1 253 at room temperature (approximately 25°C).1 2 3

Protect from light.1 305

Actions

  • Pharmacologic effects result from both the unchanged drug and diacetolol, 1 2 114 115 116 117 which is equipotent to acebutolol.1 2 114 115 116 117

  • Inhibits response to adrenergic stimuli by competitively blocking β1-adrenergic receptors within the myocardium.1 2 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 34 35 36 37 38 Blocks β2-adrenergic receptors within bronchial and vascular smooth muscle only at high doses.4 24 35 178

  • Decreases exercise-induced heart rate,1 2 4 11 12 13 23 24 25 27 inhibits reflex orthostatic tachycardia,1 2 4 11 12 13 23 24 and may decrease1 2 25 28 29 140 193 or leave unchanged 26 140 cardiac output at rest2 25 140 193 or during exercise.1 28 29 Decreases systolic and diastolic BP at rest1 2 13 19 23 56 57 139 and during exercise.1 2 155 160 171

  • Precise mechanism of hypotensive action has not been determined.7 22 26 34 35 139 178 May reduce BP by blocking peripheral (especially cardiac) adrenergic receptors (decreasing cardiac output), by decreasing sympathetic outflow from the CNS, and/or by suppressing renin release.7 26 34 35 140

  • Exhibits antiarrhythmic activity;1 2 137 185 186 187 188 189 190 193 194 195 196 199 204 considered a class II antiarrhythmic agent.254

  • Can produce nervous system effects,1 2 4 6 150 152 154 158 170 198 although the frequency and/or severity of such effects may be less than those observed with some other β-adrenergic blocking agents.152 154 156 262

  • Unlike some β-adrenergic blocking agents147 148 does not consistently suppress plasma renin activity (PRA).26 71 139 140 141 142 143

  • May increase airway resistance and decrease ventilatory capacity,51 52 53 54 57 58 59 60 61 62 63 64 155 158 especially in patients with asthma and/or COPD or when high dosages are used.52 53 57 58 59 60 61 62 63 64 158 268

  • Does not appear to substantially affect glucose metabolism;73 75 however, the drug may potentiate insulin-induced hypoglycemia in diabetic patients receiving oral hypoglycemic agents.74 (See Interactions.)

Advice to Patients

  • Importance of taking acebutolol exactly as prescribed.1

  • Importance of not interrupting or discontinuing therapy without consulting clinician; patients should temporarily limit physical activity when discontinuing therapy.1 276

  • Importance of immediately informing clinician at the first sign or symptom of impending cardiac failure (e.g., weight gain, increased shortness of breath) or if any difficulty in breathing occurs.1

  • In patients with heart failure, importance of informing clinician of signs or symptoms of exacerbation (e.g., weight gain, difficulty in breathing).1

  • Importance of patients informing anesthesiologist or dentist that they are receiving acebutolol therapy prior to undergoing major surgery.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (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

Acebutolol Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

200 mg (of acebutolol)*

Acebutolol Hydrochloride Capsules

Mylan, Par, Watson

Sectral (with povidone)

ESP Pharma

400 mg (of acebutolol)*

Acebutolol Hydrochloride Capsules

Mylan, Par, Watson

Sectral (with povidone)

ESP Pharma

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.

Acebutolol HCl 200MG Capsules (AMNEAL PHARMACEUTICALS): 100/$54.98 or 200/$91.10

Acebutolol HCl 400MG Capsules (AMNEAL PHARMACEUTICALS): 30/$21.99 or 90/$57.98

Sectral 200MG Capsules (PROMIUS PHARMA): 60/$186.99 or 180/$538.98

Sectral 400MG Capsules (PROMIUS PHARMA): 30/$125.00 or 90/$364.95

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions May 1, 2004. 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.

References

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