Drugplain

Acebutolol Hydrochloride 200 mg/1

Acebutolol Hydrochloride · CAPSULE · AvPAK

No Recall History
Plain English

Acebutolol Hydrochloride is a capsule containing acebutolol hydrochloride at 200 mg/1, taken oral. Manufactured by AvPAK.

Key Facts

Brand Name
Acebutolol Hydrochloride
Generic Name
Acebutolol Hydrochloride
NDC Code (Product)
50268-050
Manufacturer
AvPAK
Strength
200 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA075047
Marketing Start
09/16/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

cognitive disorder625 reports
fall618 reports
orthostatic hypotension576 reports
balance disorder571 reports
constipation568 reports
hypotension567 reports
sedation541 reports
mobility decreased513 reports
depressed level of consciousness504 reports
pain494 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 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. Ventricular Arrhythmias Acebutolol hydrochloride capsules, USP are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats.

Dosage & Administration

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 th…

Warnings

WARNINGS 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 p…

Contraindications

CONTRAINDICATIONS 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 ).

Adverse Reactions

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. 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 wer…

Frequently Asked Questions

What is Acebutolol Hydrochloride used for?

Acebutolol Hydrochloride contains Acebutolol Hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.

Is Acebutolol Hydrochloride a controlled substance?

Acebutolol Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Acebutolol Hydrochloride?

The generic name for Acebutolol Hydrochloride is Acebutolol Hydrochloride. There are no other listed brand versions of Acebutolol Hydrochloride.

What is the NDC code for Acebutolol Hydrochloride 200 mg/1?

The NDC (National Drug Code) for Acebutolol Hydrochloride 200 mg/1 is 50268-050, listed by AvPAK.

Product NDC

50268-050

Package NDC

50268-050-15

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)