Acebutolol

Overview

A cardioselective beta-adrenergic antagonist with little effect on the bronchial receptors. The drug has stabilizing and quinidine-like effects on cardiac rhythm as well as weak inherent sympathomimetic action.

Indication

For the management of hypertension and ventricular premature beats in adults.

Associated Conditions

Chronic Stable Angina Pectoris
Hypertension
Ventricular Arrhythmia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma	2012/12/06	NCT01743885	Phase 3	Terminated	University Hospital, Montpellier
An Open-label, Single-dose, Two-treatment, Randomized, Cross-over Study to Investigate the Effects of the SLCO2B1 c.1457C>T Polymorphism and Apple Juice on the Pharmacokinetics and Pharmacodynamics of Acebutolol in Healthy Korean and Japanese Volunteers	2012/01/20	NCT01514019	Phase 4	Completed	In-Jin Jang, MD, PhD
Treatment of Mild Hypertension Study (TOMHS)	1999/10/28	NCT00000522	Phase 2	Completed	University of Minnesota

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
APO-ACEBUTOLOL TABLET 200 mg	APOTEX INC	SIN08620P	TABLET, FILM COATED	200 mg	3/21/1996
APO-ACEBUTOLOL TABLET 400 mg	APOTEX INC	SIN08636P	TABLET, FILM COATED	400 mg	4/4/1996
APO-ACEBUTOLOL TABLET 100 mg	APOTEX INC	SIN08621P	TABLET, FILM COATED	100 mg	3/21/1996

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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