Pronunciation: tole BUE ta mide

Brand: Orinase

Tolbutamide 500 mg-MYL

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

Do not use this medicine if you are in a state of diabetic ketoacidosis. Call your doctor for treatment with insulin.

What is tolbutamide?

Tolbutamide is an oral diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin.

Tolbutamide is used together with diet and exercise to treat type 2 diabetes. Other diabetes medicines are sometimes used in combination with tolbutamide if needed.

Tolbutamide should not be used by itself to treat type 1 diabetes.

Tolbutamide may also be used for purposes not listed in this medication guide.

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

You should not use this medicine if you are allergic to tolbutamide, or if you are in a state of diabetic ketoacidosis. Call your doctor for treatment with insulin.

To make sure tolbutamide is safe for you, tell your doctor if you have:

  • liver disease;
  • kidney disease;
  • a disorder of your pituitary or adrenal glands;
  • an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);
  • a history of heart disease; or
  • if you are malnourished.

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of taking tolbutamide.

It is not known whether tolbutamide will harm an unborn baby. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant while using tolbutamide.

It is not known whether tolbutamide passes into breast milk or if it could be harmful to a nursing baby. You should not breast-feed while you are taking tolbutamide.

How should I take tolbutamide?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Follow your doctor's instructions about how often to take tolbutamide, and whether or not you should take it with food.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Use tolbutamide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Tolbutamide is only part of a treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember (with food if your doctor instructs you to). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of tolbutamide can cause severe hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking tolbutamide?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

Avoid exposure to sunlight or tanning beds. Tolbutamide can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What are the possible side effects of tolbutamide?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe skin rash, redness, or itching;
  • easy bruising or bleeding,
  • fever, chills, sore throat, mouth sores;
  • pale or yellowed skin, dark colored urine;
  • low blood sugar --headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or
  • low levels of sodium in the body --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Common side effects may include:

  • nausea;
  • heartburn; or
  • full feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tolbutamide?

You may be more likely to have hypoglycemia (low blood sugar) if you take tolbutamide with other drugs that can lower blood sugar, such as:

  • exenatide (Byetta);
  • probenecid (Benemid);
  • aspirin or other salicylates (including Pepto Bismol);
  • a blood thinner (warfarin, Coumadin, Jantoven);
  • sulfa drugs (Bactrim, SMZ-TMP, and others);
  • a monoamine oxidase inhibitor (MAOI); or
  • insulin or other oral diabetes medications.

This list is not complete, and many other medicines can increase or decrease the effects of tolbutamide on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with tolbutamide. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about tolbutamide.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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