Tolbutamide (patient information)

IMPORTANT WARNING:
Oral hypoglycemic drugs, including tolbutamide, have been associated with increased cardiovascular mortality. Talk to your doctor about the possible risks, benefits, and alternatives of using this drug for your condition.

Why is this medication prescribed
Tolbutamide is used to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood), particularly in people whose diabetes cannot be controlled by diet alone. Tolbutamide lowers blood sugar by stimulating the pancreas to secrete insulin and helping the body use insulin efficiently. The pancreas must produce insulin for this drug to work. Tolbutamide is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood).

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

How should this medicine be used
Tolbutamide comes in tablets to take by mouth. It is usually taken several times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tolbutamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take tolbutamide even if you feel well. Do not stop taking tolbutamide without talking to your doctor.

What special precautions should I follow
Before taking tolbutamide


 * tell your doctor and pharmacist if you are allergic to tolbutamide or any other drugs.
 * tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antibiotics, anticoagulants ('blood thinners') such as warfarin (Coumadin), dexamethasone (Decadron), diuretics ('water pills'), estrogens, isoniazid (INH), MAO inhibitors [phenelzine (Nardil) and tranylcypromine (Parnate)], medications for high blood pressure or heart disease, niacin, oral contraceptives, phenytoin (Dilantin), prednisone, probenecid (Benemid), and vitamins.
 * tell your doctor if you have or have ever had heart or kidney disease.
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tolbutamide, call your doctor immediately.
 * if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tolbutamide.
 * plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Tolbutamide may make your skin sensitive to sunlight.

What special dietary instructions should I follow
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet.

Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking tolbutamide.

What should I do if I forget a dose
Before you start to take tolbutamide, ask your doctor what you should do if you forget to take a dose. Write these directions down so that you can refer to them later.

As a general rule, take the missed dose as soon as you remember it unless it is almost time for the next dose. Do not take a double dose to make up for a missed one.

Side Effects
This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Minor Side Effects
''You may experience hypoglycemia (low blood sugar) while you are taking this medication. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:''


 * shakiness
 * dizziness or lightheadedness
 * sweating
 * nervousness or irritability
 * sudden changes in behavior or mood
 * headache
 * numbness or tingling around the mouth
 * weakness
 * pale skin
 * hunger
 * clumsy or jerky movements

Severe Side Effects
''If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.''


 * confusion
 * seizures
 * loss of consciousness

Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):


 * extreme thirst
 * frequent urination
 * extreme hunger
 * weakness
 * blurred vision

''If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of these symptoms:''


 * dry mouth
 * upset stomach and vomiting
 * shortness of breath
 * breath that smells fruity
 * decreased consciousness

'''Tolbutamide may cause side effects. If you experience any of the following symptoms, call your doctor immediately:'''


 * skin rash
 * itching or redness
 * exaggerated sunburn
 * yellowing of the skin or eyes
 * light-colored stools
 * dark urine
 * unusual bleeding or bruising
 * fever
 * sore throat

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine
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.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to tolbutamide. Your doctor will also tell you how to check your response to this medication by measuring your blood or urine sugar levels at home. Follow these instructions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

 * Orinase®