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tolbutamide

Pronunciation: tole BUE ta mide

Brand: Orinase

Tolbutamide 500 mg-MYL

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Image of Tolbutamide 500 mg-MYL
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What is the most important information I should know about tolbutamide?

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

Before taking tolbutamide, tell your doctor if you have kidney or liver disease, a disorder of your pituitary or adrenal glands, an enzyme deficiency called G6PD, a history of heart disease, or if you are malnourished.

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your tolbutamide dose.

Tolbutamide is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

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.

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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 doctor before taking tolbutamide?

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Do not use this medication 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 you can safely take tolbutamide, tell your doctor if you have any of these other conditions:

  • 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.
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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 treating your diabetes with tolbutamide.

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FDA pregnancy category C. 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 this medication.

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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?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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. Visit your doctor regularly.

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Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Your doctor may want you to stop taking tolbutamide for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

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Ask your doctor how to adjust your tolbutamide dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Tolbutamide is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

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

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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. Be sure to take the medication 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?

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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?

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

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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?

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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.

Hypoglycemia, or low blood sugar, is the most common side effect of tolbutamide. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

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Stop taking tolbutamide and call your doctor at once if you have a serious side effect such as:

  • easy bruising or bleeding, unusual weakness;
  • pale or yellowed skin, dark colored urine, fever, confusion; or
  • memory problems, loss of appetite, feeling unsteady, or hallucinations.

Less serious side effects may include:

  • mild nausea, heartburn, full feeling;
  • headache;
  • unusual or unpleasant taste in your mouth; or
  • skin rash, redness, or itching.

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 hyperglycemia (high blood sugar) if you take tolbutamide with other drugs that can raise blood sugar, such as:

  • isoniazid;
  • diuretics (water pills);
  • steroids (prednisone and others);
  • heart or blood pressure medication (Cartia, Cardizem, Covera, Isoptin, Verelan, and others);
  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);
  • phenothiazines (Compazine and others);
  • thyroid medicine (Synthroid and others);
  • birth control pills and other hormones;
  • seizure medicines (Dilantin and others);
  • diet pills or medicines to treat asthma, colds or allergies; and
  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others.

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);
  • some nonsteroidal anti-inflammatory drugs (NSAIDs);
  • aspirin or other salicylates (including Pepto-Bismol);
  • a blood thinner (warfarin, Coumadin, Jantoven, and others);
  • heart or blood pressure medication (Accupril, Altace, Lotensin, Prinivil, Vasotec, Zestril, and others);
  • sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others);
  • a monoamine oxidase inhibitor (MAOI); or
  • other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos), or rosiglitazone (Avandia).

These lists are not complete and there are many other medicines that can increase or decrease the effects of tolbutamide on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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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