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What is the most important information I should know about tolbutamide?

Treatment with tolbutamide may increase the risk of death from cardiovascular disease compared to treatment of diabetes with diet alone or diet plus insulin. Discuss with your doctor the risks and benefits of treatment with tolbutamide.

Know the signs and symptoms of low blood sugar (hypoglycemia), which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of hard candy or glucose tablets with you to treat episodes of low blood sugar.

Follow your diet, medication, and exercise routines closely. Changing any of them can affect blood sugar levels.

Do not change your dose of tolbutamide without first talking to your doctor. Avoid alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

What is tolbutamide?

Tolbutamide is in a class of drugs called sulfonylureas. It is used to help control blood sugar levels.

Tolbutamide is used with diet and exercise to treat type 2 diabetes mellitus. Insulin or metformin (Glucophage) may also be used in combination with tolbutamide, if necessary.

Tolbutamide may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking tolbutamide?

Before taking tolbutamide, tell your doctor if you

• have kidney disease;
• have liver disease;

• have thyroid disease;

• have type 1 diabetes;

• have a serious infection, illness, or injury; or

• need surgery.

You may not be able to take tolbutamide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Patients 65 years of age and older may have a stronger reaction to tolbutamide and may require a reduced dose.

Tolbutamide is in the FDA pregnancy category C. This means that it is not known whether tolbutamide will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. Insulin is usually the drug of choice for controlling diabetes during pregnancy. Tolbutamide passes into breast milk and may cause hypoglycemia (low blood sugar) in a nursing baby. Do not take tolbutamide without first talking to your doctor if you are breast-feeding a baby.

How should I take tolbutamide?

Take tolbutamide exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Tolbutamide is usually taken before breakfast or the first main meal if it is taken once a day, or before meals if it is taken multiple times each day. Follow your doctor's instructions.

It is important to take tolbutamide regularly to get the most benefit.

Your healthcare provider may recommend regular monitoring of blood sugar levels with blood or urine tests.

Do not change your dose of tolbutamide without first talking to your doctor. Store tolbutamide at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a tolbutamide overdose include hunger, nausea, anxiety, cold sweats, weakness, drowsiness, unconsciousness, and coma.