What is the most important information I should know about Glucotrol?

• Treatment with Glucotrol may increase the risk of death from cardiovascular disease compared to treatment of diabetes with diet alone or diet plus insulin. Discuss with your doctor the risks and benefits of treatment with Glucotrol.
• Know the signs and symptoms of low blood sugar (hypoglycemia), which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of hard candy or glucose tablets with you to treat episodes of low blood sugar.
• Follow diet, medication, and exercise routines closely. Changing any of them can affect blood sugar levels.
• Do not change your dose of Glucotrol without first talking to your doctor.
• Avoid alcohol. It lowers blood sugar and may interfere with diabetes treatment.
• The Glucotrol XL extended release tablets (Glucotrol extended release tablets) should be swallowed whole. Do not chew, divide, or crush the tablets.

What is Glucotrol?

• Glucotrol is in a class of drugs called sulfonylureas. It is used to help control blood sugar levels.
• Glucotrol is used to treat type 2 diabetes along with diet, exercise, and insulin therapy, if necessary.
• Glucotrol may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Glucotrol?

• Before taking Glucotrol, tell your doctor if you
  • have kidney disease;
  • have liver disease;
  • have thyroid disease;
  • have type 1 diabetes;
  • have a serious infection, illness, or injury; or
  • need surgery.
• You may not be able to take Glucotrol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Patients 65 years of age and older may have a stronger reaction to Glucotrol and may require a reduced dose.
• Glucotrol is in the FDA pregnancy category C. This means that it is not known whether Glucotrol will be harmful to an unborn baby. Insulin is usually the drug of choice to control diabetes during pregnancy. Do not take Glucotrol without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• It is not known whether Glucotrol passes into breast milk. Do not take Glucotrol without first talking to your doctor if you are breast-feeding a baby.

How should I take Glucotrol?

• Take Glucotrol exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Glucotrol is usually taken before breakfast if it is taken once a day, or before meals if it is taken multiple times each day. Follow your doctor's instructions.
• The Glucotrol XL extended release tablets (Glucotrol extended release tablets) should be swallowed whole. Do not chew, divide, or crush the tablets.
• If you are taking Glucotrol XL extended release tablets (Glucotrol extended release tablets), do not be concerned if something that looks like a tablet occasionally appears in the stool. The medication is contained in a non-absorbable shell that has been specially designed to slowly release the drug so the body can absorb it. When this process is completed, the empty tablet is eliminated from the body.
• It is important to take Glucotrol regularly to get the most benefit.
• Do not change your dose of Glucotrol without first talking to your doctor.
• Your healthcare provider may recommend regular monitoring of blood sugar levels with blood or urine tests.
• Store Glucotrol at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of a Glucotrol overdose include hunger, nausea, anxiety, cold sweats, weakness, drowsiness, unconsciousness, and coma.

What should I avoid while taking Glucotrol?

• Follow diet, medication, and exercise routines closely. Changing any of these things can effect blood sugar levels.
• Avoid alcohol. It lowers blood sugar and may interfere with your diabetes treatment.
• Tell your doctor and dentist that you are taking this medication before you undergo any surgery.
• Do not take any prescription, over-the-counter, or herbal cough, cold, allergy, pain, or weight loss medications without first talking to your doctor.

What are the possible side effects of Glucotrol?

• Stop taking Glucotrol and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
• Other, less serious side effects from Glucotrol result mostly from blood sugar levels that are either too high or too low. You should be familiar with the symptoms of both high and low blood sugar levels and know how to treat both conditions. Also, be sure your family and close friends know how to help you in an emergency situation.
• Low blood sugar may occur when too much Glucotrol is taken; when meals are missed or delayed; if you exercise more than usual; during illness, especially with vomiting or diarrhea; if you take other medications; after drinking alcohol; and in other situations.
• Hypoglycemia or Low blood sugar has the following symptoms:
  • shaking;
  • headache;
  • cold sweats;
  • pale, cool skin;
  • anxiety; and
  • difficulty concentrating.
• Keep hard, sugary candy; chocolate; fruit juice; or glucose tablets on hand to treat episodes of low blood sugar.
• Increased blood sugar may occur when not enough Glucotrol is taken; if you eat significantly more food than usual; if you exercise less than usual; if you take other medications; during fever or other illness; and in other situations.
• Hyperglycemia or High blood sugar has the following symptoms:
  • increased thirst,
  • increased hunger, and
  • increased urination.
• There may be an increased risk of death due to cardiovascular (heart and blood vessels) complications with the use of Glucotrol when compared to the treatment of diabetes with diet or diet plus insulin. The long-term use of Glucotrol should be discussed with your doctor.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Glucotrol?

• Many other medicines may increase or decrease the effects of Glucotrol or affect your condition. Before taking Glucotrol, tell your doctor if you are taking any of the following medicines:
  • aspirin or another salicylate such as magnesium/ choline salicylate (Trilisate), salsalate (Disalcid, others), choline salicylate (Arthropan), magnesium salicylate (Magan), or bismuth subsalicylate (Pepto-Bismol);
  • a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), diclofenac (Voltaren, Cataflam), etodolac (Lodine), indomethacin (Indocin), nabumetone (Relafen), oxaprozin (Daypro), naproxen (Anaprox, Naprosyn, Aleve), and others;
  • a sulfa-based drug such as sulfamethoxazole-trimethoprim (Bactrim, Septra), sulfisoxazole (Gantrisin), or sulfasalazine (Azulfidine);
  • a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil);
  • a beta-blocker such as propranolol (Inderal), atenolol (Tenormin), acebutolol (Sectral), metoprolol (Lopressor), and others;
  • a diuretic (water pill) such as hydrochlorothiazide (HCTZ, Hydrodiuril), chlorothiazide (Diuril), and others;
  • a steroid medicine such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol, others), prednisolone (Prelone, Pediapred, others), and others;
  • a phenothiazine such as chlorpromazine (Thorazine), fluphenazine (Prolixin, Permitil), prochlorperazine (Compazine), promethazine (Phenergan), and others;
  • phenytoin (Dilantin);
  • isoniazid (Nydrazid); or
  • prescription, over-the-counter, or herbal cough, cold, allergy, or weight loss medications.
• You may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Glucotrol or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.