Acebutolol Hydrochloride (Page 3 of 3)

OVERDOSAGE

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:

1. Empty stomach by emesis or lavage.

2. 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.

3. 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.

4. Bronchospasm: A theophylline derivative, such as aminophylline and/or parenteral β2-stimulant, such as terbutaline.

5. Cardiac failure: Digitalize the patient and/or administer a diuretic. It has been reported that glucagon is useful in this situation.

Acebutolol is dialyzable.

DOSAGE & ADMINISTRATION

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.

HOW SUPPLIED

Acebutolol hydrochloride capsules are available as follows:


400 mg: Size “2” hard gelatin capsules with bright orange opaque body printed radially “670” with black ink and lavender opaque cap printed radially “Amneal” with black ink.

Bottles of 30
NDC 54868-4216-0

Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).

Protect from light. Keep tightly closed. Dispense in a light resistant, tight container.

Manufactured by:

Amneal Pharmaceuticals of NY

Hauppauge, NY 11788

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42164

Rev. 09-2010

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of 200 mg package label
(click image for full-size original)

image of 400 mg package label
(click image for full-size original)

f1931f84-figure-01f1931f84-figure-02f1931f84-figure-03image of 200 mg package labelimage of 400 mg package label
ACEBUTOLOL HYDROCHLORIDE
acebutolol hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5520(NDC:65162-669)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACEBUTOLOL HYDROCHLORIDE (ACEBUTOLOL) ACEBUTOLOL 200 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
Product Characteristics
Color PURPLE (Lavender Opaque) , ORANGE (Bright Orange Opaque) Score no score
Shape CAPSULE (Hard Gelatin) Size 18mm
Flavor Imprint Code Amneal;669
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5520-0 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075047 02/01/2006 06/30/2012
ACEBUTOLOL HYDROCHLORIDE
acebutolol hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4216(NDC:65162-670)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACEBUTOLOL HYDROCHLORIDE (ACEBUTOLOL) ACEBUTOLOL 400 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
Product Characteristics
Color PURPLE (Lavender Opaque) , ORANGE (Bring Orange Opaque) Score no score
Shape CAPSULE (Hard Gelatin) Size 23mm
Flavor Imprint Code Amneal;670
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4216-0 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075047 04/22/2005
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-5520), relabel (54868-4216), repack (54868-5520), repack (54868-4216)

Revised: 09/2012 Physicians Total Care, Inc.

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