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GLICLAZIDE

(Also Known As: DIAMICRON)

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.

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

• 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