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ANTIDIABETIC AGENTS, SULFONYLUREA (Systemic)

Some commonly used brand names are:

In the U.S.—

• Amaryl ⁴
• DiaBeta ⁶
• Diabinese ²
• Dymelor ¹
• Glucotrol ⁵
• Glucotrol XL ⁵
• Glynase PresTab ⁶
• Micronase ⁶
• Orinase ⁸
• Tolinase ⁷

In Canada—

• Albert Glyburide ⁶
• Apo-Chlorpropamide ²
• Apo-Glyburide ⁶
• Apo-Tolbutamide ⁸
• DiaBeta ⁶
• Diabinese ²
• Diamicron ³
• Dimelor ¹
• Euglucon ⁶
• Gen-Glybe ⁶
• Med Glybe ⁶
• Novo-Butamide ⁸
• Novo-Glyburide ⁶
• Novo-Propamide ²
• Nu-Glyburide ⁶
• Orinase ⁸

Another commonly used name for glyburide is glibenclamide .

Category

• Antidiabetic—Acetohexamide; Chlorpropamide; Gliclazide; Glimepiride; Glipizide; Glyburide; Tolazamide; Tolbutamide
• Antidiuretic—Chlorpropamide

Description

Sulfonylurea antidiabetic agents (also known as sulfonylureas) are used to treat a certain type of diabetes mellitus (sugar diabetes) called type 2 diabetes. When you have type 2 diabetes, insulin is still being produced by your pancreas. Sometimes the amount of insulin you produce may not be enough or your body may not be using it properly and you may still need more. Sulfonylureas work by causing your pancreas to release more insulin into the blood stream. All of the cells in your body need insulin to help turn the food you eat into energy. This is done by using sugar (or glucose) in the blood as quick energy. Or the sugar may be stored in the form of fats, sugars, and proteins for use later, such as for energy between meals.

Sometimes insulin that is being produced by the body is not able to help sugar get inside the body"s cells. Sulfonylureas help insulin get into the cells where it can work properly to lower blood sugar. In this way, sulfonylureas will help lower blood sugar and help restore the way you use food to make energy.

Many people with type 2 diabetes can control their blood sugar level with diet or diet and exercise alone. Following a diabetes diet plan and exercising will always be important with any type of diabetes. To work properly, the amount of sulfonylurea you use must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet, your exercise, or both, you will want to test your blood sugar level so that it does not drop too low (hypoglycemia) or rise too high (hyperglycemia). Your health care professional will teach you what to do if this happens.

Sometimes patients with type 2 diabetes might need to change to treatment with insulin for a short period of time during pregnancy or for a serious medical condition, such as diabetic coma; ketoacidosis; severe injury, burn, or infection; or major surgery. In these conditions, insulin and blood sugar can change fast and blood sugar can be best controlled with insulin instead of a sulfonylurea.

At some point, a sulfonylurea may stop working as well and your blood sugar level will go up. You will need to know if this happens and what to do. Instead of taking more of this medicine, your doctor may change you to another sulfonylurea. Or your doctor may have you inject small doses of insulin or take another oral antidiabetic medicine called metformin along with your sulfonylurea to help the insulin you make work better. If that does not bring down the amount of sugar in your blood, your doctor may have you stop taking the oral antidiabetic agents and begin receiving only insulin injections.

Chlorpropamide may also be used for other conditions as determined by your doctor.

Oral antidiabetic medicines do not help diabetic patients who have type 1 diabetes because these patients cannot produce or release insulin from their pancreas gland. Their blood sugar is best controlled by insulin injections.

Sulfonylureas are available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Acetohexamide
  • Tablets (U.S. and Canada)
• Chlorpropamide
  • Tablets (U.S. and Canada)
• Gliclazide
  • Tablets (Canada)
• Glimepiride
  • Tablets (U.S.)
• Glipizide
  • Tablets (U.S.)
  • Extended-release Tablets (U.S.)
• Glyburide
  • Tablets (U.S. and Canada)
  • Micronized Tablets (U.S.)
• Tolazamide
  • Tablets (U.S.)
• Tolbutamide
  • Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sulfonylurea medicines, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to sulfonylureas, or to sulfonamide-type (sulfa) medicines, including thiazide diuretics (a certain type of water pill). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Sulfonylureas are rarely used during pregnancy. The amount of insulin you need changes during and after pregnancy. For this reason, it is easier to control your blood sugar using injections of insulin, rather than with the use of sulfonylureas. Close control of your blood sugar can reduce your chance of having high blood sugar during the pregnancy and of your baby gaining too much weight, or having birth defects. Be sure to tell your doctor if you plan to become pregnant or if you think you are pregnant. If insulin is not available or cannot be used and sulfonylureas are used during pregnancy, they should be stopped at least 2 weeks before the delivery date (one month before for chlorpropamide and glipizide). Glimepiride should not be used at all during pregnancy. Lowering of blood sugar can occur as a rebound effect at delivery and for several days following birth and will be watched closely by your health care professionals.

Breast-feeding—Chlorpropamide and tolbutamide pass into human breast milk and glimepiride passes into the milk of rats. Chlorpropamide is not recommended in nursing mothers but, in some cases, tolbutamide has been used. Nursing mothers should not take glimepiride. It is not known if other sulfonylureas pass into breast milk. Check with your doctor if you are thinking about breast-feeding.

Children—There is little information about the use of sulfonylureas in children. Type 2 diabetes is unusual in this age group.

Older adults—Some elderly patients may be more sensitive than younger adults to the effects of sulfonylureas, especially when more than one antidiabetic medicine is being taken or if other medicines that affect blood sugar are also being taken. This may increase your chance of developing low blood sugar during treatment. Furthermore, the first signs of low or high blood sugar are not easily seen or do not occur at all in older patients. This may increase the chance of low blood sugar developing during treatment.

Also, elderly patients who take chlorpropamide are more likely to hold too much body water.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Do not take any other medicine, unless prescribed or approved by your doctor . When you are taking sulfonylurea antidiabetic drugs, it is especially important that your health care professional know if you are taking any of the following:

• Alcohol—When low blood sugar occurs, it may last longer than usual if more than a small amount of alcohol is taken, especially on an empty stomach. Small amounts of alcohol at mealtime usually do not cause problems with your blood sugar but may cause a redness (called flushing) in the face, arms, and neck that can be uncomfortable. This can occur with most of the sulfonylureas but is most likely to occur with chlorpropamide and has occurred up to 12 hours after alcohol was taken during chlorpropamide use

• Anticoagulants (blood thinners)—The effect of either the blood thinner or the antidiabetic medicine may be increased or decreased if the two medicines are used together

• Aspirin or other salicylates or
• Azole antifungals (miconazole [e.g., Monistat I.V.], fluconazole [e.g., Diflucan]) or
• Chloramphenicol (e.g., Chloromycetin) or
• Cimetidine (e.g., Tagamet) or
• Fluoroquinolones (ciprofloxacin [e.g., Cipro], enoxacin [e.g., Penetrex], lomefloxacin [e.g., Maxaquin], norfloxacin [e.g., Noroxin], ofloxacin [e.g., Floxin]) or
• Quinidine (e.g., Quinidex) or
• Quinine or
• Ranitidine (e.g., Zantac)—These medicines may increase the chances of low blood sugar

• Asparaginase (e.g., Elspar) or
• Corticosteroids (cortisone-like medicine) or
• Lithium (e.g., Lithonate) or
• Thiazide diuretics (e.g., Dyazide)—These medicines may increase the chances of high blood sugar

• Asthma medicines or
• Cough or cold medicines or
• Hay fever or allergy medicines—Many medicines (including nonprescription [over-the-counter] products) can affect the control of your blood sugar

• Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Betapace], timolol [e.g., Blocadren])—Beta-adrenergic blocking agents may increase the chance that high or low blood sugar can occur. Also, they can hide symptoms of low blood sugar (such as fast heartbeat). Because of this, a person with diabetes might not recognize that he or she has low blood sugar and might not take immediate steps to treat it. Beta-adrenergic blocking agents can also cause low blood sugar to last longer than usual

• Cyclosporine [e.g., Sandimmune]—Sulfonylureas can increase the effects of cyclosporine

• Guanethidine (e.g., Ismelin) or
• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], or tranylcypromine [e.g., Parnate])—Taking a sulfonylurea while you are taking (or within 2 weeks of taking) these medicines may increase the chances of low blood sugar occurring

• Octreotide (e.g., Sandostatin) or
• Pentamidine (e.g., Pentam)—Use of these medicines with sulfonylureas may increase the chance of either high or low blood sugar occurring

Other medical problems—The presence of other medical problems may affect the use of the sulfonylurea antidiabetic medicines. Make sure you tell your doctor if you have any other medical problems, especially:

• Acid in the blood (acidosis) or
• Burns (severe) or
• Diabetic coma or
• Fever, high or
• Injury, severe or
• Ketones in the blood (diabetic ketoacidosis) or
• Surgery, major or
• Any other condition in which insulin needs change rapidly—Insulin may be needed temporarily to control diabetes in patients with these conditions because changes in blood sugar may occur rapidly and without much warning; also, your blood sugar may need to be tested more often

• Diarrhea, continuing or
• Female hormone changes for some women (e.g., during puberty, pregnancy, or menstruation) or
• Infection, severe or
• Mental stress, severe or
• Overactive adrenal gland, not properly controlled or
• Problems with intestines, severe or
• Slow stomach emptying or
• Vomiting, continuing or
• Any other condition that causes severe blood sugar changes—Insulin may be needed temporarily to control diabetes mellitus in patients with these conditions because changes in blood sugar may occur rapidly and without much warning; also, your blood sugar may need to be tested more often

• Heart disease—Chlorpropamide or tolbutamide causes some patients to retain (keep) more body water than usual. Heart disease may be worsened by this extra body water

• Kidney disease or
• Liver disease—Your blood sugar may be increased or decreased, partly because of slower removal of sulfonylurea from the body; this may change the amount of sulfonylurea you need

• Overactive thyroid, not properly controlled or
• Underactive thyroid, not properly controlled—Your blood sugar may be increased or decreased, partly because the medicine may be removed from the body too fast or too slow. Until your thyroid condition is controlled, the amount of sulfonylurea you need may change. Also, your blood sugar may need to be tested more often

• Underactive adrenal gland, not properly controlled or
• Underactive pituitary gland, not properly controlled or
• Undernourished condition or
• Weakened physical condition or
• Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking sulfonylureas

Proper Use of This Medicine

Use this medicine only as directed even if you feel well and do not notice any signs of high blood sugar. Do not take more of this medicine and do not take it more often than your doctor ordered . To do so may increase the chance of serious side effects. Remember that this medicine will not cure your diabetes but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood sugar and keep it low. You may have to take an antidiabetic medicine for the rest of your life . If high blood sugar is not treated, it can cause serious problems, such as heart failure, blood vessel disease, eye disease, or kidney disease.

Your doctor will give you instructions about diet, exercise, how to test your blood sugar levels, and how to adjust your dose when you are sick.

• Diet—The daily number of calories in the meal plan should be adjusted by your doctor or a registered dietitian to help you reach and maintain a healthy body weight. In addition, regular meals and snacks are arranged to meet the energy needs of your body at different times of the day. It is very important that you follow your meal plan carefully .
• Exercise—Ask your doctor what kind of exercise to do, the best time to do it, and how much you should do each day.
• Blood tests—This is the best way to tell whether your diabetes is being controlled properly. Blood sugar testing helps you and your health care team adjust the dose of your medicine, meal plan, or exercise schedule.
• On sick days—When you become sick with a cold, fever, or the flu, you need to take your usual dose of sulfonylurea, even if you feel too ill to eat. This is especially true if you have nausea, vomiting, or diarrhea. Infection usually increases your need to produce more insulin. Sometimes you may need to be switched from your sulfonylurea to insulin for a short period of time while you are sick to properly control blood sugar. Call your doctor for specific instructions.
  Continue taking your sulfonylurea and try to stay on your regular meal plan. If you have trouble eating solid food, drink fruit juices, nondiet soft drinks, or clear soups, or eat small amounts of bland foods. A dietitian or your health care professional can give you a list of foods and the amounts to use for sick days.
  Test your blood sugar level at least every 4 hours while you are awake and check your urine for ketones. If ketones are present, call your doctor at once. If you have severe or prolonged vomiting, check with your doctor. Even when you start feeling better, let your doctor know how you are doing.

For patients taking glipizide extended-release tablets :

• Swallow the tablet whole, without breaking, crushing, or chewing it.
• You may sometimes notice what looks like a tablet in your stool. Do not worry. After you swallow the tablet, the medicine in the tablet is absorbed inside your body. Then the tablet passes into your stool without changing its shape. The medicine has entered your body and will work properly.

Dosing—The dose of these medicines will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the amount of sugar in your blood or urine .

• For acetohexamide
• For oral dosage form (tablets):
  • For treating type 2 diabetes:
    • Adults—At first, 250 milligrams (mg) once a day. Some elderly people may need a lower dose at first. Then, your doctor may change your dose a little at a time if needed. The dose is usually not more than 1.5 grams a day. If your dose is 1 gram or more, the dose is usually divided into two doses. These doses are taken before the morning and evening meals.
    • Children—The type of diabetes treated with this medicine is rare in children. However, if a child needs this medicine, the dose would have to be determined by the doctor.

• For chlorpropamide
• For oral dosage form (tablets):
  • For treating type 2 diabetes:
    • Adults—At first, 250 milligrams (mg) once a day. Some elderly people may need a lower dose of 100 to 125 mg a day at first. Then, your doctor may change your dose a little at a time if needed. The dose is usually not more than 750 mg a day.
    • Children—The type of diabetes treated with this medicine is rare in children. However, if a child needs this medicine, the dose would have to be determined by the doctor.

• For gliclazide
• For oral dosage form (tablets):
  • For treating type 2 diabetes:
    • Adults—80 milligrams (mg) a day with a meal as a single dose or 160 to 320 mg divided into two doses taken with the morning and evening meals.
    • Children—The type of diabetes treated with this medicine is rare in children. However, if a child needs this medicine, the dose would have to be determined by the doctor.

• For glimepiride
• For oral dosage form (tablets):
  • For treating type 2 diabetes:
    • Adults:
      • Glimepiride alone: At first, 1 to 2 milligrams (mg) once a day with breakfast or the first main meal. The dose then may be increased by your doctor based on your blood sugar level.
      • Glimepiride with metformin: The usual dose is 8 mg once a day with breakfast or the first main meal.
      • Glimepiride with insulin: The usual dose is 8 mg once a day with breakfast or the first main meal.
    • Children—The type of diabetes treated with this medicine is rare in children. However, if a child needs this medicine, the dose would have to be determined by the doctor.

• For glipizide
• For oral dosage form (tablets):
  • For treating type 2 diabetes:
    • Adults—At first, 5 milligrams (mg) once a day. Some elderly people may need a lower dose of 2.5 mg a day at first. Then, your doctor may change your dose a little at a time if needed. The dose is usually not more than 40 mg a day. If your dose is 15 mg or more, the dose is usually divided into two doses. These doses are taken thirty minutes before the morning and evening meals.
    • Children—The type of diabetes treated with this medicine is rare in children. However, if a child needs this medicine, the dose would have to be determined by the doctor.
• For oral dosage form (extended-release tablets):
  • For treating type 2 diabetes:
    • Adults—At first, 5 mg once a day with breakfast. Then, your doctor may change your dose a little at a time if needed. The dose is usually not more than 20 mg a day.
    • Children—The type of diabetes treated with this medicine is rare in children. However, if a child needs this medicine, the dose would have to be determined by the doctor.

• For glyburide
• For oral dosage form (nonmicronized tablets):
  • For treating type 2 diabetes:
    • Adults—At first, 2.5 to 5 milligrams (mg) once a day. Some elderly people may need a lower dose of 1.25 to 2.5 mg a day at first. Then, your doctor may change your dose a little at a time if needed. The dose is usually not more than 20 mg a day. If your dose is 10 mg or more, the dose usually is divided into two doses. These doses are taken with the morning and evening meals.
    • Children—The type of diabetes treated with this medicine is rare in children. However, if a child needs this medicine, the dose would have to be determined by the doctor.
• For oral dosage form (micronized tablets):
  • For treating type 2 diabetes:
    • Adults—At first, 1.5 to 3 mg a day. Some elderly people may need a low dose of 0.75 to 3 mg a day at first. Then, your doctor may change your dose a little at a time if needed. The dose is usually not more than 12 mg a day. If your dose is 6 mg or more, the dose is usually divided into two doses. These doses are taken with the morning and evening meals. A single dose is taken with breakfast or with the first meal.
    • Children—The type of diabetes treated with this medicine is rare in children. However, if a child needs this medicine, the dose would have to be determined by the doctor.

• For tolazamide
• For oral dosage form (tablets):
  • For treating type 2 diabetes:
    • Adults—At first, 100 to 250 milligrams (mg) once a day in the morning. Then, your doctor may change your dose a little at a time if needed. The dose is usually not more than 1 gram a day. If your dose is 500 mg or more, the dose is usually divided into two doses. These doses are taken with the morning and evening meals.
    • Children—The type of diabetes treated with this medicine is rare in children. However, if a child needs this medicine, the dose would have to be determined by the doctor.

• For tolbutamide
• For oral dosage form (tablets):
  • For treating type 2 diabetes:
    • Adults—At first, 1000 to 2000 milligrams (mg) a day. Some elderly people may need lower doses to start. The dose is usually divided into two doses. These doses are taken before the morning and evening meals. Your doctor may change your dose a little at a time if needed. The dose is usually not more than 3000 mg a day.
    • Children—The type of diabetes treated with this medicine is rare in children. However, if a child needs this medicine, the dose would have to be determined by the doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor will want to check your progress at regular visits , especially during the first few weeks that you take this medicine.

It is very important to follow carefully any instructions from your health care team about :

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Tobacco—If you have been smoking for a long time and suddenly stop, your dosage of sulfonylurea may need to be reduced. If you decide to quit, tell your doctor first.
• Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects in the patient if they occur. Also, patients with diabetes, especially teenagers, may need special counseling about sulfonylurea or insulin dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in women with diabetes who become pregnant.
• Travel—Carry a recent prescription and your medical history. Be prepared for an emergency as you would normally. Make allowances for changing time zones, and keep your meal times as close as possible to your usual meal times.
• Protecting skin from sunlight—Sulfonylureas can make you more sensitive to the sun. Use of sunblock products that have a skin protection factor (SPF) of at least 15 on your skin and lips can help to prevent sunburn. Do not use a sunlamp or tanning bed or booth.

In case of emergency —There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

• Wear a medical identification (I.D.) bracelet or neck chain at all times. Also, carry an I.D. card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
• Keep some kind of quick-acting sugar handy to treat low blood sugar.
• Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

Too much of a sulfonylurea can cause low blood sugar (also called hypoglycemia). Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out) . Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly .

• Symptoms of low blood sugar can include: anxious feeling, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty in concentrating, drowsiness, excessive hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, and unusual tiredness or weakness.
• The symptoms of low blood sugar may develop quickly and may result from:
  • delaying or missing a scheduled meal or snack.
  • exercising more than usual.
  • drinking a significant amount of alcohol.
  • taking certain medicines.
  • taking too high a dose of sulfonylurea.
  • if using insulin, using too much insulin.
  • sickness (especially with vomiting or diarrhea).
• Know what to do if symptoms of low blood sugar occur. Eating some form of quick-acting sugar when symptoms of low blood sugar first appear will usually prevent them from getting worse.
  Good sources of sugar include:
  • Glucose tablets or gel, fruit juice or nondiet soft drink (4 to 6 ounces [one-half cup]), corn syrup or honey (1 tablespoon), sugar cubes (6 one-half-inch sized), or table sugar (dissolved in water).
    • Do not use chocolate because its fat slows down the sugar entering the bloodstream.
    • If a snack is not scheduled for an hour or more you should also eat a light snack, such as crackers or a half sandwich, or drink an 8-ounce glass of milk.
  • Glucagon is used in emergency situations such as unconsciousness. Have a glucagon kit available, along with a syringe and needle, and know how to prepare and use it. Members of your household also should know how and when to use it.

High blood sugar (hyperglycemia) is another problem related to uncontrolled diabetes. If you have any symptoms of high blood sugar, contact your health care team right away . If high blood sugar is not treated, severe hyperglycemia can occur, leading to ketoacidosis (diabetic coma) and death.

• Symptoms of high blood sugar appear more slowly than those of low blood sugar. Symptoms can include: blurred vision; drowsiness; dry mouth; flushed and dry skin; fruit-like breath odor; increased urination; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); and unusual thirst.
• Symptoms of severe high blood sugar (called ketoacidosis or diabetic coma) that need immediate hospitalization include: flushed dry skin, fruit-like breath odor, ketones in urine, passing out, troubled breathing (rapid and deep).
• High blood sugar symptoms may occur if you:
  • have a fever, diarrhea, or an infection.
  • if using insulin, do not take enough insulin or skip a dose of insulin.
  • do not exercise as much as usual.
  • overeat or do not follow your meal plan.
• Know what to do if high blood sugar occurs. Your doctor may recommend changes in your sulfonylurea dose or meal plan to avoid high blood sugar. Symptoms of high blood sugar must be corrected before they progress to more serious conditions. Check with your doctor often to make sure you are controlling your blood sugar, but do not change the dose of your medicine without checking with your doctor . Your doctor might discuss the following with you:
  • Decreasing your dose for a short time for special needs, such as when you cannot exercise as you normally do.
  • Increasing your dose when you plan to eat an unusually large dinner, such as on holidays. This type of increase is called an anticipatory dose.
  • Delaying a meal if your blood sugar is over 200 mg/dL to allow time for your blood sugar to go down. An extra dose or an injection of insulin may be needed if your blood sugar does not come down shortly.
  • Not exercising if your blood sugar is over 240 mg/dL and reporting this to your doctor immediately.
  • Being hospitalized if ketoacidosis or diabetic coma occurs with a possible change of treatment.

Side Effects of This Medicine

The use of sulfonylurea antidiabetic agents has been reported, but not proven in all studies, to increase the risk of death from heart and blood vessel disease. Patients with diabetes are already more likely to have these problems if they do not control their blood sugar. Some sulfonylureas, such as glyburide and gliclazide, can have a positive effect on heart and blood vessel disease. It is important to know that problems can occur, but it is also not known if other sulfonylureas, particularly tolbutamide, help to cause these problems. It is known that if blood sugar is not controlled, such problems can occur.

Along with their needed effects, sulfonylureas may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

For patients taking chlorpropamide or tolbutamide:

• Rarely, some patients who take chlorpropamide may retain (keep) more body water than usual. This happens even less often with tolbutamide. Check with your doctor as soon as possible if any of the following signs occur:

Depression; swelling or puffiness of face, ankles, or hands

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, chlorpropamide is used in certain patients with the following medical condition:

• Diabetes insipidus (water diabetes)

If you are taking this medicine for water diabetes, the advice listed above that relates to diet for patients with sugar diabetes does not apply to you . However, the advice about hypoglycemia (low blood sugar) does apply to you. Call your doctor right away if you feel any of the symptoms described.

Other than the above information, there is no additional information relating to its proper use, precautions, or side effects for this use.

Revised: 10/14/2004

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