Drug Details
Drug Name(s)\\tLEVATOL
FDA Application No.\\t(NDA) 018976
Active Ingredient(s)\\tPENBUTOLOL SULFATE
Company\\tAUXILIUM PHARMS LLC
Original Approval or Tentative Approval Date\\tDecember 30, 1987
Chemical Type\\t1 New molecular entity (NME)
Review Classification\\tS Standard review drug
Uses
Penbutolol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.This medication belongs to a class of drugs known as beta blockers. It works by blocking the action of certain natural chemicals in your body such as epinephrine on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart.
How to use Levatol
See also Warning section.
Take this medication by mouth with or without food, usually once a day or as directed by your doctor.
Dosage is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. It may take several weeks before you get the full benefit of this drug.
Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings remain high or increase).
Side Effects
Tiredness, slow heartbeat, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: very slow heartbeat, severe dizziness, fainting, blue fingers/toes, trouble breathing, new or worsening symptoms of heart failure (such as swelling ankles/feet, severe tiredness, shortness of breath, unexplained/sudden weight gain), mental/mood changes (such as confusion, mood swings, depression).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Precautions
Before taking penbutolol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block), severe heart failure, breathing problems (such as asthma, chronic bronchitis, emphysema).Before using this medication, tell your doctor or pharmacist your medical history, especially of: treated stable heart failure, kidney disease, liver disease, overactive thyroid disease (hyperthyroidism), serious allergic reactions including those needing treatment with epinephrine, blood circulation problems (such as Raynaud's disease, peripheral vascular disease), mental/mood disorders (such as depression), a certain muscle disease (myasthenia gravis).If you have diabetes, this product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of a low blood sugar level, such as dizziness and sweating, are unaffected by this drug. This product may also make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your diabetes medication or diet may need to be adjusted.Before having surgery, tell your doctor or dentist that you are taking this medication.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to the side effects of this drug, including dizziness and tiredness.During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk or if it may harm a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.