Tolazamide

Tolazamide is a prescription medication used to treat type 2 diabetes.

Tolazamide belongs to a group of drugs called sulfonylureas. These work by stimulating the pancreas to make insulin and helping the body to use insulin more efficiently.

This medication comes in tablet form and is usually taken once daily, with breakfast or the first main meal of the day.

Common side effects of tolazamide include nausea, a feeling of fullness in the upper abdomen, and heartburn.

Tolazamide can also cause dizziness. Do not drive or operate heavy machinery until you know how tolazamide affects you.

Tolazamide is a prescription medication used to treat type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of tolazamide for the treatment of type 2 diabetes is 100-250 mg once daily. The dose should be gradually adjusted based on patient response, blood glucose levels, and other medications the patient is taking. The maximum daily dose is 1000 mg.

SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY

The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with noninsulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (DIABETES, 19 (supp. 2):747–830, 1970.)

UGDP reported that patients treated for five to eight years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2½ times that of patients with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of TOLAZAMIDE and of alternative modes of therapy.

Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

Serious side effects have been reported with tolazamide including the following:

• Gastrointestinal upset. Tell your healthcare provider right away if you have some or all of the following symptoms of liver problems.
  • Nausea
  • A feeling of fullness in the upper part of the stomach
  • Heartburn
  • Yellowing of the skin or eyes
  • Light-colored stools
  • Dark urine
  • Pain in the upper right part of the stomach
  • Unusual bleeding or bruising
  • Diarrhea

Tolazamide can cause dizziness. Do not drive or operate heavy machinery until you know how tolazamide affects you.

Do not take tolazamide if you:

• are allergic to tolazamide or to any of its ingredients
• have diabetic ketoacidosis
• have type 1 diabetes

Serious side effects have been reported with tolazamide. See the “Tolazamide Precautions” section.

Common side effects of tolazamide include the following:

• nausea
• a feeling of fullness in the upper abdomen
• heartburn

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

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 about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• 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)
• thyroid medications

This is not a complete list of tolazamide drug interactions. Ask your doctor or pharmacist for more information.

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.

Tolazamide 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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if tolazamide crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using tolazamide.