pharmacopeia
GET
/api/v1/drug/acebutolol

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic beta-Antagonists; Adrenergic beta1-Antagonists.

Indications

Sourced from openFDA
  • Hypertension Acebutolol hydrochloride capsules, USP are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.ICD-10: I10

Contraindications

Sourced from openFDA
  • Acebutolol HCl, USP is contraindicated in: 1) persistently severe bradycardia; 2) second- and third-degree heart block; 3) overt cardiac failure; and 4) cardiogenic shock (see WARNINGS ).contraindicated

Dosage & administration

Sourced from openFDA

Hypertension The initial dosage of acebutolol in uncomplicated mild-to-moderate hypertension is 400 mg. This can be given as a single daily dose, but in occasional patients twice daily dosing may be required for adequate 24-hour blood-pressure control. An optimal response is usually achieved with dosages of 400 to 800 mg per day, although some patients have been maintained on as little as 200 mg per day. Patients with more severe hypertension or who have demonstrated inadequate control may respond to a total of 1200 mg daily (administered b.i.d.), or to the addition of a second antihypertensive agent. Beta-1 selectivity diminishes as dosage is increased. Ventricular Arrhythmia The usual initial dose of acebutolol is 400 mg daily given as 200 mg b.i.d. Dosage should be increased gradually until an optimal clinical response is obtained, generally at 600 to 1200 mg per day. If treatment is to be discontinued, the dosage should be reduced gradually over a period of about two weeks. Use in Older Patients Older patients have an approximately 2-fold increase in bioavailability and may require lower maintenance doses. Doses above 800 mg/day should be avoided in the elderly.

Warnings & precautions

Sourced from openFDA

Cardiac Failure Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by β-adrenergic receptor blockade may precipitate more severe failure. Although β-blockers should be avoided in overt cardiac failure, acebutolol can be used with caution in patients with a history of heart failure who are controlled with digitalis and/or diuretics. Both digitalis and acebutolol impair AV conduction. If cardiac failure persists, therapy with acebutolol should be withdrawn. In Patients Without a History of Cardiac Failure In patients with aortic or mitral valve disease or compromised left ventricular function, continued depression of the myocardium with β-blocking agents over a period of time may lead to cardiac failure. At the first signs of failure, patients should be digitalized and/or be given a diuretic and the response observed closely. If cardiac failure continues despite adequate digitalization and/or diuretic, acebutolol therapy should be withdrawn. Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal Following abrupt cessation of therapy with certain β-blocking agents in patients with coronary artery disease, exacerbation of angina pectoris and, in some cases, myocardial infarction and death have been reported. Therefore, such patients should be cautioned against interruption of therapy without a physician’s advice.

Adverse reactions

Sourced from openFDA

Acebutolol is well tolerated in properly selected patients. Most adverse reactions have been mild, not required discontinuation of therapy, and tended to decrease as duration of treatment increases. The following table shows the frequency of treatment-related side effects derived from controlled clinical trials in patients with hypertension, angina pectoris, and arrhythmia. These patients received acebutolol, propranolol, or hydrochlorothiazide as monotherapy, or placebo. The following selected (potentially important) side effects were seen in up to 2% of acebutolol patients: Cardiovascular: hypotension, bradycardia, heart failure. Central Nervous System: anxiety, hyper/hypoesthesia, impotence. Dermatological: pruritus. Gastrointestinal: vomiting, abdominal pain. Genitourinary: dysuria, nocturia. Liver and Biliary System: A small number of cases of liver abnormalities (increased SGOT, SGPT, LDH) have been reported in association with acebutolol therapy. In some cases increased bilirubin or alkaline phosphatase, fever, malaise, dark urine, anorexia, nausea, headache, and/or other symptoms have been reported. In some of the reported cases, the symptoms and signs were confirmed by rechallenge with acebutolol. The abnormalities were reversible upon cessation of acebutolol therapy. Musculoskeletal: back pain, joint pain. Respiratory: pharyngitis, wheezing. Special Senses: conjunctivitis, dry eye, eye pain. Autoimmune: In extremely rare instances, systemic lupus erythematosus has been reported.

Pharmacokinetics

Sourced from openFDA
Metabolism
and Metabolism Acebutolol is well absorbed from the GI tract. It is subject to extensive first-pass hepatic biotransformation, with an absolute bioavailability of approximately 40% for the parent compound.

Overdosage

Sourced from openFDA

No specific information on emergency treatment of overdosage is available for acebutolol. However, overdosage with other β-blocking agents has been accompanied by extreme bradycardia, advanced atrioventricular block, intraventricular conduction defects, hypotension, severe congestive heart failure, seizures, and in susceptible patients, bronchospasm and hypoglycemia. Although specific information on the emergency treatment of acebutolol overdose is not available on the basis of the pharmacological actions and the observations in treating overdoses with other β-blockers, the following general measures should be considered: Empty stomach by emesis or lavage. Bradycardia: IV atropine (1 to 3 mg in divided doses). If antivagal response is inadequate, administer isoproterenol cautiously since larger than usual doses of isoproterenol may be required. Persistent hypotension in spite of correction of bradycardia: Administer vasopressor (e.g., epinephrine, norepinephrine, dopamine, or dobutamine) with frequent monitoring of blood pressure and pulse rate. Bronchospasm: A theophylline derivative, such as aminophylline and/or parenteral β2-stimulant, such as terbutaline.

Approval history

Sourced from openFDA
  • Oct 18, 1995ANDAANDA074007Ani Pharms
  • Dec 30, 1999ANDAANDA075047Amneal Pharm

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,243 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Cognitive Disorder62550%
  2. 2Fall61850%
  3. 3Orthostatic Hypotension57646%
  4. 4Balance Disorder57146%
  5. 5Constipation56846%
  6. 6Hypotension56746%
  7. 7Sedation54144%
  8. 8Mobility Decreased51341%
  9. 9Depressed Level Of Consciousness50441%
  10. 10Pain49440%
  11. 11Sedation Complication49340%
  12. 12Blood Calcium Decreased48839%
  13. 13Creatinine Renal Clearance Decreased48839%
  14. 14Toxicity To Various Agents47638%
  15. 15Drug Ineffective16013%

Literature

View JSON

Recent PubMed references pinned to Acebutolol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 13 ClinicalTrials.gov registrations naming Acebutolol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

View JSON

CPIC-curated drug–gene pairs for Acebutolol. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Acebutolol work?
Mechanism-of-action classes: Adrenergic beta-Antagonists; Adrenergic beta1-Antagonists.
What is Acebutolol used for?
According to FDA labeling, Acebutolol carries indications including: Hypertension Acebutolol hydrochloride capsules, USP are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Acebutolol?
Acebutolol is classified as Beta blocking agents, selective, beta-Adrenergic Blocker, Adrenergic beta-Antagonists, Adrenergic beta1-Antagonists, Decreased Blood Pressure, Negative Chronotropy, Negative Inotropy.
What are the contraindications for Acebutolol?
Acebutolol labeling lists contraindications including: Acebutolol HCl, USP is contraindicated in: 1) persistently severe bradycardia; 2) second- and third-degree heart block; 3) overt cardiac failure; and 4) cardiogenic shock (see WARNINGS ).. Always consult the full prescribing information and a clinician.
Note. Data for acebutolol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients