Acebutolol Hydrochloride (Page 3 of 3)

ADVERSE REACTIONS

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.

f1931f84-figure-02
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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.

The incidence of drug-related adverse effects (volunteered and solicited) according to acebutolol dose is shown below. (Data from 266 hypertensive patients treated for 3 months on a constant dose.)

f1931f84-figure-03
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Potential Adverse Events

In addition, certain adverse effects not listed above have been reported with other β-blocking agents and should also be considered as potential adverse effects of acebutolol.

Central Nervous System: Reversible mental depression progressing to catatonia (an acute syndrome characterized by disorientation for time and place), short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance (neuropsychometrics).

Cardiovascular: Intensification of AV block (see CONTRAINDICATIONS).

Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress.

Hematologic: Agranulocytosis, nonthrombocytopenic, and thrombocytopenic purpura.

Gastrointestinal: Mesenteric arterial thrombosis and ischemic colitis.

Miscellaneous: Reversible alopecia and Peyronie’s disease. The oculomucocutaneous syndrome associated with the β-blocker practolol has not been reported with acebutolol during investigational use and extensive foreign clinical experience.

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 AND 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, USP are available as follows:

200 mg: Hard gelatin capsules with bright orange opaque body printed radially “669” with black ink and lavender opaque cap printed radially “Amneal” with black ink.

Bottles of 100 NDC 65162-669-10
Bottles of 500 NDC 65162-669-50

400 mg: 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 65162-670-03
Bottles of 100 NDC 65162-670-10
Bottles of 500 NDC 65162-670-50

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

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

Distributed by:
Amneal Pharmaceuticals
Bridgewater, NJ 08807

Rev. 01-2016-02

PRINCIPAL DISPLAY PANEL

100 Ct.
(click image for full-size original)

200 mg Label

PRINCIPAL DISPLAY PANEL

100 Ct.
(click image for full-size original)

400 mg Label

ACEBUTOLOL HYDROCHLORIDE
acebutolol hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:65162-669-10 100 CAPSULE in 1 BOTTLE None
2 NDC:65162-669-50 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075047 12/01/2009
ACEBUTOLOL HYDROCHLORIDE
acebutolol hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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 (Bright 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:65162-670-03 30 CAPSULE in 1 BOTTLE None
2 NDC:65162-670-10 100 CAPSULE in 1 BOTTLE None
3 NDC:65162-670-50 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075047 12/01/2009
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 123797875 ANALYSIS (65162-669), ANALYSIS (65162-670), LABEL (65162-669), LABEL (65162-670), MANUFACTURE (65162-669), MANUFACTURE (65162-670), PACK (65162-669), PACK (65162-670)

Revised: 05/2019 Amneal Pharmaceuticals LLC

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