Orinase

Before taking tolbutamide,

• tell your doctor and pharmacist if you are allergic to tolbutamide, any other medications, or any of the ingredients in tolbutamide. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan); chloramphenicol; diuretics ('water pills'); fluconazole (Diflucan), hormone replacement therapy and hormonal contraceptives (birth control pills, patches, rings, implants, and injections); insulin or other medications to treat high blood sugar or diabetes; isoniazid (INH); MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); medications for asthma and colds; medications for mental illness and nausea; miconazole (Monistat); niacin; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); phenytoin (Dilantin); probenecid (Benemid); salicylate pain relievers such as choline magnesium trisalicylate, choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic); sulfa antibiotics such as co-trimoxazole (Bactrim, Septra); sulfasalazine (Azulfidine); and thyroid medications. Also be sure to tell your doctor or pharmacist if you stop taking any medications while taking tolbutamide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had G6PD deficiency (an inherited condition causing premature destruction of red blood cells or hemolytic anemia); if you have hormone disorders involving the adrenal, pituitary, or thyroid gland; or if you have heart, kidney, or liver 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.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tolbutamide.
• ask your doctor about the safe use of alcoholic beverages while you are taking tolbutamide. Alcohol can make the side effects from tolbutamide worse. Consuming alcohol while taking tolbutamide also may cause symptoms such as flushing (reddening of the face), headache, nausea, vomiting, chest pain, weakness, blurred vision, mental confusion, sweating, choking, breathing difficulty, and anxiety.
• 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.
• ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of tolbutamide you may need.

Before you start to take tolbutamide, ask you 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. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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.

Symptoms of overdose may include hypoglycemia symptoms as well as the following:

• seizures
• loss of consciousness

Common side effects include:

• nausea
• upper abdominal fullness
• heartburn
• rash
• headache
• changes in taste

This is not a complete list of Orinase side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Orinase falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

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.

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.

Use with caution; initial and maintenance dosing should be conservative to avoid hypoglycemic reactions.

Data not available

Breastfeeding is not recommended during use of this drug Excreted into human milk: Yes Comments: There is a theoretical risk of hypoglycemia in the nursing infant; if diet alone is adequate for controlling blood glucose in the mother, insulin therapy should be considered.

Low amounts of this drug have been detected in human breastmilk. There is some information to suggest this may be too low to cause harm to the breastfed infant, but the potential for hypoglycemia exists. If used, it is advisable to monitor infant for hypoglycemia.