Acebutolol

Acebutolol comes as a capsule to take by mouth, usually once or twice daily.

Your dose will depend on your medical condition and response to treatment.

Try to take this medicine around the same time each day.

You can take acebutolol with or without food.

Follow the instructions on your prescription label carefully. Don't take more or less acebutolol than is recommended.

Don't stop taking acebutolol without first talking with your doctor.

Acebutolol Overdose

Symptoms of an acebutolol overdose may include:

• Fainting
• Lightheadedness
• Difficulty breathing, especially when lying down
• Shortness of breath
• Seizures
• Weakness
• Swelling of the ankles
• Slow heart rate
• Wheezing

If you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at 800-222-1222.

Missed Dose of Acebutolol

If you miss a dose of acebutolol, take it as soon as you remember.

But if it's almost time for your next scheduled dose, skip the missed dose and continue with your regular medication schedule.

Don't double up on doses to make up for a missed one.

Acebutolol is also used sometimes to treat chest pain (angina). Talk to your doctor about the possible risks of using this medication for your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

If you need surgery, tell the surgeon ahead of time that you are using acebutolol. You may need to stop using the medicine for a short time.

Your blood pressure will need to be checked often.

You should not stop using acebutolol suddenly. Stopping suddenly may make your condition worse.

If you are being treated for high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Acebutolol is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light.

Keep the bottle tightly closed when not in use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Changes in vision
• chest pain
• difficult or labored breathing
• shortness of breath
• swelling of face, fingers, feet, or lower legs
• tightness in chest
• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

• Anxiety
• blurred vision
• chest discomfort
• chills
• cold sweats
• coma
• confusion
• convulsions
• cool, pale skin
• cough
• decreased urine output
• depression
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• extreme fatigue
• headache
• increased hunger
• irregular breathing
• loss of bladder control
• muscle spasm or jerking of all extremities
• nausea
• nervousness
• nightmares
• noisy breathing
• pain in the shoulders, back, neck, or jaw
• shakiness
• slow, fast, pounding, or irregular heartbeat
• slurred speech
• sudden loss of consciousness
• sweating
• troubled breathing
• unusual tiredness or weakness
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• bloated
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty in moving
• discouragement
• excess air or gas in stomach or intestines
• feeling sad or empty
• full feeling
• heartburn
• indigestion
• irritability
• lack of appetite
• loss of interest or pleasure
• muscle aching or cramping
• muscle pain or stiffness
• pain in joints
• passing gas
• problems in urination or increase in amount of urine
• rash
• sleeplessness
• stomach discomfort, upset, or pain
• swollen joints
• tiredness
• trouble concentrating
• trouble sleeping
• unable to sleep
• unusual dreams

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not stop taking acebutolol all of a sudden. If you do, chest pain that is worse and in some cases heart attack may occur. The risk may be greater if you have certain types of heart disease. To avoid side effects, you will want to slowly stop this medicine as ordered by your doctor. Call your doctor right away if you have new or worse chest pain or if other heart problems occur.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how acebutolol affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• Talk with your doctor before you drink alcohol.
• This medicine may hide the signs of low blood sugar. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• If you are taking this medicine and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• If you are 65 or older, use acebutolol with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Very bad dizziness or passing out.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Slow heartbeat.
• A heartbeat that does not feel normal.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Acebutolol hydrochloride capsules are available as follows:

200 mg:lavender opaque and bright orange opaque capsule, marked “Amneal” and “669”

NDC 50268-050-15 10 capsules per card, 5 cards per carton

400 mg:lavender opaque and bright orange opaque capsule, marked "Amneal” and “670”

NDC 50268-051-15 10 capsules per card, 5 cards per carton

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

Dispensed in blister punch material.
For Institutional Use Only.

Manufactured for:

AvKARE, Inc.                 

Pulaski, TN 38478

Mfg. Rev. 01-2016-02

AV Rev. 03/16 (P)
AvPAK

Thyrotoxicosis

Initial research indicates that acebutolol may decrease thyroid hormone levels as well as thyroglobulin levels. Acebutolol has been shown to have symptomatic improvement in patients with hyperthyroidism. However, additional research is needed to determine more definitively the effects of acebutolol in this patient population.

Additional Off-Label Uses

Chronic stable angina (Note: Not recommended for patients with prior MI)

Overt cardiac failure; cardiogenic shock; persistently-severe bradycardia or second- and third-degree heart block (except in patients with a functioning artificial pacemaker)

May be administered without regard to meals.

Adverse effects were observed in some animal reproduction studies. Acebutolol and diacetolol (active metabolite) cross the placenta. Decreases in birth weight, blood pressure, and heart rate have been observed in neonates following maternal use of acebutolol during pregnancy. Hypoglycemia has also been found following in utero exposure to beta-blockers as a class. The half-life of acebutolol is 6 to 14 hours in the newborn. The half-life of diacetolol is 24 to 30 hours for the first 24 hours of life, then 12 to 16 hours. Adequate facilities for monitoring infants at birth should be available. The plasma elimination half-life of acebutolol is longer in pregnant women at term (Bianchetti 1981a; Boutroy 1982).

Untreated chronic maternal hypertension and preeclampsia are also associated with adverse events in the fetus, infant, and mother (ACOG 2015; Magee 2014). When treatment of hypertension in pregnancy is indicated, beta-blockers may be used. Specific recommendations vary by guideline. Although other agents are preferred (ACOG 2013), use of acebutolol may be considered (Magee 2014).

Sectral 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 Sectral, propranolol, or hydrochlorothiazide as monotherapy, or placebo.

TOTAL VOLUNTEERED AND ELICITED (U.S. STUDIES)

The following selected (potentially important) side effects were seen in up to 2% of Sectral 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 Sectral dose is shown below. (Data from 266 hypertensive patients treated for 3 months on a constant dose.)

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 Sectral.

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 Sectral during investigational use and extensive foreign clinical experience.

Acebutolol may be found in some form under the following brand names:

• Sectral

Serious side effects have been reported with acebutolol including the following:

• Hypotension. Hypotension, or low blood pressure, may cause you to feel faint or dizzy. Inadequate fluid intake, excessive sweating, diarrhea, or vomiting can lead to an excessive fall in blood pressure too. Lie down if you feel faint or dizzy. Call your doctor right away.

• Congestive heart failure (CHF). Tell your healthcare provider right away if you experience any of the following symptoms of CHF:

  • sudden weight gain
  • worsening shortness of breath
  • increased swelling of your feet, legs, or abdomen
  • needing to use more pillows to go to sleep or sleeping in a recliner
  • waking from sleep to catch your breath
  • a cough that does not go away
  • new or increasing irregularities in your heart rate

• A decline in liver function. Tell your healthcare provider any signs or symptoms of liver damage, which include the following:

  • fever or rash
  • yellowing of your skin or the whites of your eyes
  • dark urine or light colored stools
  • stomach pain or tenderness
  • feel tired
  • nausea or vomiting
  • loss of appetite or start losing weight (anorexia)
• Acebutolol can cause drowsiness. Do not drive or operate heavy machinery until you know how this medication affects you.
• Acebutolol can cause serious withdrawal side effects. To avoid these side effects, do not suddenly stop taking this medication. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether. Tell your healthcare provider right away if you have any or all of the following symptoms:
  • feeling generally unwell or uneasy
  • chest pain
  • insomnia
  • stomach cramps
  • muscle cramp
  • vomiting

Do not take acebutolol if you:

• are allergic to acebutolol or to any of its ingredients
• have persistently severe bradycardia (slow heart rate)
• have second and third-degree heart block
• have overt cardiac failure
• have cardiogenic shock

Contraindications

Hypersensitivity

Asthma/COPD, severe bradycardia, 2°/3° heart block, cardiogenic shock, overt heart failure, sinus bradycardia, sick sinus syndrome without permanent pacemaker

Avoid during breastfeeding

Cautions

Anesthesia/surgery (myocardial depression); chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures

Bronchospastic disease, cerebrovascular insufficiency, DM, hyperthyroidism/thyrotoxicosis, liver disease, renal impairment, peripheral vascular disease, compromised left ventricular function, elderly, use in pheochromocytoma, IDDM

Avoid abrupt withdrawal; sudden discontinuation can exacerbate angina and lead to myocardial infarction

May increase risk of stroke after surgery

Applies to acebutolol: compounding powder, oral capsule

General

The most common adverse reactions were fatigue and gastrointestinal disorders.[Ref]

Other

Very common (10% or more): Fatigue (11%)
Common (1% to 10%): Chest pain, edema
Frequency not reported: Lactate dehydrogenase (LDH) increased, alkaline phosphatase increased, fever, malaise, withdrawal syndrome[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea, dyspepsia, flatulence, nausea
Frequency not reported: Vomiting, abdominal pain[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia, abnormal dreams
Frequency not reported: Anxiety, psychoses, hallucination, confusion, loss of libido, sleep disorder[Ref]

Respiratory

Common (1% to 10%): Cough, dyspnea, rhinitis
Frequency not reported: Pharyngitis, wheezing, pneumonitis, lung infiltration[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia
Uncommon (0.1% to 1%): Lupus like syndrome
Frequency not reported: Back pain, joint pain, systemic lupus erythematosus[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache
Frequency not reported: Hyper/hypoesthesia, paresthesia[Ref]

Genitourinary

Common (1% to 10%): Micturition frequency
Frequency not reported: Impotence, dysuria, nocturia, dark urine[Ref]

Ocular

Common (1% to 10%): Abnormal vision
Frequency not reported: Conjunctivitis, dry eye, eye pain[Ref]

Dermatologic

Common (1% to 10%): Rash
Frequency not reported: Pruritus[Ref]

Cardiovascular

Frequency not reported: Hypotension, bradycardia, heart failure, first degree atrioventricular block, existing atrioventricular block increased, intermittent claudication, Raynaud's syndrome, cyanosis peripheral, peripheral coldness[Ref]

Hepatic

Frequency not reported: Serum glutamic oxaloacetic transaminase (SGOT) increased, serum glutamic pyruvic transaminase (SGPT) increased, bilirubin increased, hepatic enzymes increased, liver injury[Ref]

Immunologic

Frequency not reported: Antinuclear antibody[Ref]

Metabolic

Frequency not reported: Anorexia[Ref]

Some side effects of acebutolol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Initial dose: 400 mg orally per day in 1 to 2 divided doses
Maintenance dose: 400 to 800 mg orally per day

Comments: Some patients may respond to as little as 200 mg orally per day; patients with inadequately controlled or more severe hypertension may respond to 600 mg orally twice a day or to the addition of a second antihypertensive; beta-1 selectivity diminishes with increasing dose.

Substance Name

Acebutolol

CAS Registry Number

37517-30-9

Drug Class

Antihypertensive Agents

Adrenergic Beta-Antagonists

Antiarrhythmics