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Acebutolol Hydrochloride

ACEBUTOLOL HYDROCHLORIDE

Manufacturer: ANI Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

Acebutolol Hydrochloride is a selective beta-adrenoreceptor blocking agent used for the management of hypertension and ventricular arrhythmias. It is available in capsule form for oral administration. The initial dosage for hypertension is 400 mg, which can be given as a single daily dose or in divided doses. For ventricular arrhythmia, the usual initial dose is 400 mg daily, given as 200 mg twice daily, with gradual increases until optimal clinical response is achieved. The drug has several contraindications, including persistently severe bradycardia, second- and third-degree heart block, overt cardiac failure, and cardiogenic shock. Important safety information includes warnings about cardiac failure, exacerbation of ischemic heart disease, and potential interactions with other medications. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, with specific recommendations for dosing and monitoring.

Key Clinical Findings and Indications

  • Management of hypertension
  • Management of ventricular arrhythmias
  • Reduction of resting and exercise heart rates and systolic blood pressures
  • Antiarrhythmic effect

Important Safety Information

Warning

Cardiac failure, exacerbation of ischemic heart disease, and potential interactions with other medications

Contraindications

  • Persistently severe bradycardia
  • Second- and third-degree heart block
  • Overt cardiac failure
  • Cardiogenic shock

Adverse Reactions

  • Dizziness
  • Fatigue
  • Headache
  • Depression
  • Rash

Dosing Recommendations

General Guidance

Doses above 800 mg/day should be avoided in the elderly

Hypertension

Adult Dose

400 mg daily, given as a single dose or in divided doses

Pediatric Dose

Not established

Ventricular arrhythmia

Adult Dose

400 mg daily, given as 200 mg twice daily, with gradual increases until optimal clinical response is achieved

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Use during pregnancy only if the potential benefit justifies the risk to the fetus
  • Neonates of mothers who have received acebutolol during pregnancy have reduced birth weight, decreased blood pressure, and decreased heart rate

Nursing Mothers

  • Use in nursing mothers is not recommended
  • Acebutolol and diacetolol appear in breast milk with a milk:plasma ratio of 7.1 and 12.2, respectively

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established

Geriatric Use

  • Elderly subjects evidence greater bioavailability of acebutolol
  • It may be appropriate to start elderly patients at the low end of the dosing range

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