Acebutolol (Oral Route)

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure . High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Acebutolol is also used to treat certain heart rhythm problems (ventricular arrhythmia) .

This medicine is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure . When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart .

This medicine is available only with your doctor`s prescription .

This product is available in the following dosage forms:

• Capsule


• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of acebutolol in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of acebutolol in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require an adjustment of dosage in patients receiving acebutolol .

Pregnancy

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Albuterol


• Amiodarone


• Arformoterol


• Bambuterol


• Bitolterol


• Broxaterol


• Clenbuterol


• Clonidine


• Colterol


• Diltiazem


• Dronedarone


• Fenoldopam


• Fenoterol


• Fentanyl


• Formoterol


• Hexoprenaline


• Isoetharine


• Levalbuterol


• Metaproterenol


• Pirbuterol


• Procaterol


• Reproterol


• Rimiterol


• Ritodrine


• Salmeterol


• Terbutaline


• Tretoquinol


• Tulobuterol


• Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose


• Acetohexamide


• Alfuzosin


• Amlodipine


• Arbutamine


• Benfluorex


• Bunazosin


• Chlorpropamide


• Digoxin


• Doxazosin


• Felodipine


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Guar Gum


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Lacidipine


• Lercanidipine


• Manidipine


• Metformin


• Mibefradil


• Miglitol


• Moxisylyte


• Nicardipine


• Nifedipine


• Nilvadipine


• Nimodipine


• Nisoldipine


• Nitrendipine


• Phenoxybenzamine


• Phentolamine


• Pranidipine


• Prazosin


• Repaglinide


• St John`s Wort


• Tamsulosin


• Terazosin


• Tolazamide


• Tolbutamide


• Trimazosin


• Troglitazone


• Urapidil

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain)a€”May provoke chest pain if stopped too quickly .

• Blood vessel diseasea€”Use with caution. This medicine may worsen this condition .

• Bradycardia (slow heartbeat) or


• Heart block or


• Heart failurea€”Should not use in patients with these conditions .

• Diabetes or


• Hyperthyroidism (overactive thyroid) or


• Hypoglycemia (low blood sugar)a€”May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .

• Kidney disease or


• Liver diseasea€”Use with caution. The effects may be increased because of slower removal of the medicine from the body .

• Lung disease (e.g., asthma, bronchitis, emphysema)a€”May cause difficulty with breathing in patients with this condition .

Proper Use

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet .

Many patients who have high blood pressure will not notice any signs of the problem . In fact, many may feel normal . It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down . You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .

Do not interrupt or stop taking this medicine without first checking with your doctor . Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  
  
  • For high blood pressure:
    
    
    
    • Adultsa€”At first, 400 milligrams (mg) once or twice a day. Your doctor may adjust your dose as needed.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For ventricular arrhythmia:
    
    
    
    • Adultsa€”At first, 200 milligrams (mg) twice a day. Your doctor may increase your dose if needed.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

Acebutolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate . Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Side Effects

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:

Less common

• 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:

Symptoms of overdose

• 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:

Less common

• 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.